tag:theconversation.com,2011:/au/topics/informed-consent-19705/articlesInformed consent – The Conversation2023-06-29T15:01:08Ztag:theconversation.com,2011:article/2084162023-06-29T15:01:08Z2023-06-29T15:01:08ZResearchers can learn a lot with your genetic information, even when you skip survey questions – yesterday’s mode of informed consent doesn’t quite fit today’s biobank studies<figure><img src="https://images.theconversation.com/files/534693/original/file-20230628-29-j4a0gl.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1999%2C1499&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Participants in biobank studies are often asked for broad consent to use their data.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/genetic-research-royalty-free-image/136810911">Science Photo Library - TEK IMAGE/Brand X Pictures via Getty Images</a></span></figcaption></figure><p>Imagine you agreed to be part of a new and exciting long-term research study to better understand human health and behavior. For the past few years, you’ve been visiting a collection site where you fill out some questionnaires about your health and daily activities. Research assistants take your height, weight and some other physical characteristics about you. Because you agreed to contribute your genetic data to the study, you also provided a saliva sample during your first visit.</p>
<p>Later, you see a news article reporting that researchers analyzing data from the study you’re participating in have <a href="https://www.vox.com/science-and-health/2018/8/23/17527708/genetics-genome-sequencing-gwas-polygenic-risk-score">found genetic variants</a> that predict the likelihood of someone completing college. You remember reading a long form when you consented to giving your data, but you can’t quite remember all the details. You know the study was about health, but how do these findings about genes and education have anything to do with health? Did they analyze your data specifically? What did they find? </p>
<h2>What are biobanks?</h2>
<p>Many scientific research studies collect data meant to answer a specific research question. For example, to study the genetics of diabetes, researchers might collect data on your blood pressure and lipid levels in addition to genetic data. But increasingly, scientists are collecting large amounts of data to be <a href="https://doi.org/10.1186/s12967-019-1922-3">kept in biobanks</a> – repositories that store genetic data and other biospecimens like blood, urine or tumor tissue to be used in a wide number of future studies.</p>
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<figcaption><span class="caption">Biobank data is often used to conduct genome-wide association studies, or GWAS.</span></figcaption>
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<p>Some biobanks, like the <a href="https://www.ukbiobank.ac.uk">UK Biobank</a>, link biospecimen data to other collected data, such as sexual behavior, medical history, weight, diet and lifestyle. Private companies <a href="https://theconversation.com/how-a-south-african-communitys-request-for-its-genetic-data-raises-questions-about-ethical-and-equitable-research-166940">like 23andMe</a> also obtain consent from their customers to have their data used in research efforts.</p>
<p><a href="https://scholar.google.com/citations?user=zCedU50AAAAJ&hl=en&oi=ao">As a researcher</a> interested in the intersection between <a href="https://www.robbeewedow.com">social behaviors and genetics</a>, I frequently have conversations with people who weren’t aware of how their genetic data is being used. They’re often surprised that the genetic data they consented to be used for research at a private company by using a DNA testing kit or at a biobank while visiting their local clinic might be used to study the genetics of <a href="https://doi.org/10.1126/science.aat7693">same-sex sexual behavior</a> or <a href="https://doi.org/10.1038/s41588-018-0309-3">risk-taking</a>. </p>
<p>In our newly published research, my colleagues and I found that even <a href="https://www.nature.com/articles/s41562-023-01632-7">choosing not to respond to survey questions</a> can reveal information about the population (we found that not responding to survey questions is correlated with a person’s education, health and income levels) if genetic data is available.</p>
<h2>Genetic data and informed consent</h2>
<p>The research that can be done with biobank data might sound scary, but it shouldn’t be. Genetic data, like the data used in our study, is de-identified. This means that it cannot be linked back to individual research participants, who remain anonymous. Further, genetic data for these sorts of genetic studies is used <a href="https://doi.org/10.1038/s43586-021-00056-9">at the aggregate level</a>, meaning it isn’t used to predict or evaluate any one particular individual’s responses or behaviors.</p>
<p>Researchers aren’t using genetic data to target individuals with certain genetic profiles. Almost all genetic research is used to better understand how health behaviors and other factors affect health and to figure out ways to improve outcomes. This goal is why most research participants agree to contribute their data to research in the first place: to help the world through science.</p>
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<figcaption><span class="caption">Many developments in human subject protections arose in response to unethical research.</span></figcaption>
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<p>The problem is whether research participants really understand how their data can be used. Many of the original ideas around the development of the <a href="https://doi.org/10.1186/s12910-019-0414-6">informed consent process and Institutional Review Boards</a>, or IRBs, intended to protect research participants from direct harm or privacy violations were based on the expectation that research studies would be addressing particular questions about a single subject, like cardiovascular disease or lung cancer. This focus was so as not to repeat unethical research atrocities like the infamous <a href="https://www.cdc.gov/tuskegee/timeline.htm">Tuskegee Syphilis Study</a>, where researchers did not tell participants, who were all Black men, that they had syphilis and withheld treatment that was already widely available and known to be highly effective.</p>
<p>But since genetic data is de-identified, it is <a href="https://www.hhs.gov/ohrp/node/4350/index.html">often considered exempt from full IRB review</a>, which is a protocol to ensure studies meet ethical standards and institutional policies. And the broad number of research questions that can be explored with biobanks, along with the amount and types of data collected, has made these original protections to ensure truly informed consent insufficient.</p>
<h2>Improving informed consent</h2>
<p>To be clear, biobanks are enormously important for public health research. They allow researchers to <a href="https://theconversation.com/people-dont-mate-randomly-but-the-flawed-assumption-that-they-do-is-an-essential-part-of-many-studies-linking-genes-to-diseases-and-traits-194793">link many different outcomes and variables</a> together to paint a critical overall picture of human health and behavior. And in contrast with the <a href="https://theconversation.com/most-americans-dont-realize-what-companies-can-predict-from-their-data-110760">personally identifiable online or phone data</a> that companies collect to show you targeted ads, biobanks collect de-identified data that is evaluated in aggregate.</p>
<p>In the age of vast data collection, ensuring that participants are aware of how their data can and cannot be used is necessary to ensure that biobanks are a transparent tool for global good. Biobanks can’t predict how a participant’s data will be used in the future, so it can be difficult for researchers and ethicists to bring back the “informed” part of “informed consent.” Even so, more needs to be done to earn the trust of the valuable research participants who contribute the data to improve science and the world.</p><img src="https://counter.theconversation.com/content/208416/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Robbee Wedow is a research fellow at AnalytiXIN, which is a consortium of health-data organizations, industry partners and university partners in Indiana primarily funded through the Lilly Endowment, IU Health and Eli Lilly and Company.</span></em></p>Biobanks collect and store large amounts of data that researchers use to conduct a wide range of studies. Making sure participants understand what they’re getting into can help build trust in science.Robbee Wedow, Assistant Professor of Sociology and Data Science, Purdue UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1997212023-02-15T13:23:10Z2023-02-15T13:23:10ZPrisoners donating organs to get time off raises thorny ethical questions<figure><img src="https://images.theconversation.com/files/509871/original/file-20230213-14-12rt3m.jpg?ixlib=rb-1.1.0&rect=0%2C34%2C4556%2C2998&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Prisoners at a yard at the Nebraska State Penitentiary in Lincoln, Neb.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/PrisonCrowdingNebraska/27819d626cb24aa586c3f2983975ec4b/photo?Query=prison%20u.s.%20inmates&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=4733&currentItemNo=42">AP Photo/Nati Harnik</a></span></figcaption></figure><p>In January 2023 two Democratic representatives, Judith Garcia and Carlos Gonzalez, <a href="https://malegislature.gov/Bills/193/HD3822">proposed a bill</a> that would offer prisoners in Massachusetts a new way to win reduction in their sentences: by donating their bone marrow or vital organs.</p>
<p>The bill stated that the commissioner of the Department of Corrections should establish both a bone marrow and organ donation program within the department and a committee focused on bone marrow and organ donation that would set eligibility standards for inmates interested in the program. While forbidding commissions or monetary payments for donors, it stated that prisoners could “gain not less than 60 and not more than 365 day reduction in the length of their committed sentence” if they donated bone marrow or an organ. </p>
<p><a href="https://www.cbsnews.com/boston/news/massachusetts-bill-prisoners-donate-organs-reduced-sentences/">The legislators claimed</a> that their proposal would respect the bodily autonomy of incarcerated people by letting them decide what to do with their vital organs. It also would <a href="https://doi.org/10.1097/MOT.0b013e3283447b1c">address racial disparities</a> by helping to expand the pool of donors.</p>
<p>Recently, however, Garcia and Gonzalez <a href="https://abcnews.go.com/US/massachusetts-bill-allowing-prisoners-donate-organs-reduced-time/story?id=96989325">have walked back their proposal</a> and are planning to introduce a version without the promise of a sentence reduction. </p>
<p>Still, the idea of giving sentence reductions in return for organ donation <a href="https://apnews.com/article/organ-donation-massachusetts-state-government-health-a11a7f93dd13ad018bbb1899dbb4623a">raises serious ethical issues</a>. As someone who <a href="https://www.sup.org/books/title/?id=20093">has studied punishment and imprisonment</a>, including the conditions of confinement in American prisons, I’m aware that some states have allowed prisoners to donate organs without any external incentives. But the question is whether prison inmates can ever consent freely to organ donation.</p>
<h2>The history of organ donation</h2>
<p>The idea of transplanting organs as a medical cure <a href="https://doi.org/10.1101/cshperspect.a014977">is quite old</a>. In 600 B.C., skin flaps were used for replacing missing noses, and 16th -century surgeons considered taking grafts of a patient’s tissue for another patient. But the practice of organ donation and transplantation began in earnest only in 1954, when Joseph Murray <a href="https://doi.org/10.1001/jama.1956.02960390027008">carried out the first successful kidney transplant</a>. Other donated organs, including livers and hearts, were transplanted a decade later. However, it <a href="https://doi.org/10.1101/cshperspect.a015685">has always been an ethically fraught area</a>, as the need for donated organs far outstrips the supply.</p>
<p>In 2022, 6,466 people <a href="https://unos.org/news/2022-organ-transplants-again-set-annual-records/">became living organ donors</a> in the United States, and another 14,903 people became posthumous organ donors. Yet, as of early 2023, more than 100,000 men, women and children <a href="https://www.donors1.org/learn-about-organ-donation/who-can-donate/get-the-facts/">are waiting for an organ donation so they can have a transplant</a>. The MIT Technology Review <a href="https://www.technologyreview.com/2023/02/03/1067768/massachusetts-bill-prisoners-swap-organs-freedom/">notes</a> that it is even harder for racial and ethnic minorities to get the organs they need. And thousands of people will die before the organ they need becomes available.</p>
<p>Altruism and the generosity of donors have <a href="https://journalofethics.ama-assn.org/article/organ-donation-altruism-vs-incentive/2002-08">neither closed the gap between the supply of donated organs</a> and the demand nor addressed the issue that <a href="https://nap.nationalacademies.org/catalog/26364/realizing-the-promise-of-equity-in-the-organ-transplantation-system">people of color struggle to find a match</a>.</p>
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<a href="https://images.theconversation.com/files/509882/original/file-20230213-3866-ejcubu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two health care professionals working on a procedure with a patient lying on a bed." src="https://images.theconversation.com/files/509882/original/file-20230213-3866-ejcubu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/509882/original/file-20230213-3866-ejcubu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/509882/original/file-20230213-3866-ejcubu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/509882/original/file-20230213-3866-ejcubu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/509882/original/file-20230213-3866-ejcubu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/509882/original/file-20230213-3866-ejcubu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/509882/original/file-20230213-3866-ejcubu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Two organ procurement coordinators work on the body of a potential organ donor at Mid-America Transplant Services in St. Louis.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/OrganTransplants/c44be320e3434762b75923c5f8207890/photo?Query=subjects.code:97b84b58814a1004819ddf092526b43e&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=260&currentItemNo=39">AP Photo/Whitney Curtis</a></span>
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<p>Recognizing these facts, various organizations and advocacy groups <a href="https://optn.transplant.hrsa.gov/professionals/by-topic/ethical-considerations/ethical-principles-in-the-allocation-of-human-organs/">have developed codes of ethics for donating organs</a>. For example,
according to the American Medical Association, organ donation is acceptable only if <a href="https://journalofethics.ama-assn.org/article/ama-code-medical-ethics-opinions-organ-transplantation/2012-03">donors give their informed consent</a>. Additionally, donors <a href="https://doi.org/10.1007/s10561-012-9303-7">must be provided with</a> information regarding the purpose and risks associated with tissue donation. They must also be made familiar with any alternatives to donation and the right to withdraw consent. </p>
<p>Congress <a href="https://www.govinfo.gov/content/pkg/STATUTE-98/pdf/STATUTE-98-Pg2339.pdf">passed the National Organ Transplant Act</a> in 1984 and established the Organ Procurement and Transplantation Network to maintain a national system to match organs and individuals. The organ transplant law intended to make sure that organs are not treated as commodities to be bought and sold. </p>
<h2>Inmates as organ donors</h2>
<p>Garcia and Gonzalez are not the first state officials to propose turning to prisoners to help with the organ supply problem in recent years.</p>
<p>Some of those cases are quite unusual. For example, in 2010, Mississippi Gov. Haley Barbour suspended <a href="http://www.cnn.com/2010/CRIME/12/30/mississippi.sisters.prison.release/index.html">the life sentences of two sisters</a>, Gladys and Jamie Scott, on the condition that Gladys donate one of her kidneys to Jamie. Her dialysis treatment was costing the state almost US$200,000 per year, and Barbour wanted to save money by <a href="https://www.nytimes.com/2011/01/01/opinion/01herbert.html">facilitating the organ donation</a>. </p>
<p>In 2013, another governor, Ohio’s John Kasich, <a href="https://apnews.com/article/ef3c4e4fbd3540e29cac52cfadd5a8e0">took executive action</a> to explore the feasibility of allowing death row inmate Ronald Phillips to donate a kidney and other organs to sick relatives before he was put to death. But ultimately the state refused his request because of logistical and security issues involved in having the needed medical procedure done at an outside medical facility.</p>
<p>That same year, Utah became the first state <a href="https://www.prisonlegalnews.org/news/2015/jan/13/utah-first-explicitly-allow-organ-donation-prisoners/#">to enact legislation authorizing prisoners to donate organs</a>. It permits voluntary, posthumous organ donations by prisoners who die while they are behind bars. But, unlike the Massachusetts proposal, the Utah law <a href="https://www.ksl.com/article/23914638/inmates-donating-organs-bill-would-formalize-the-process">does not offer incentives or rewards to inmates</a> who sign up for the program.</p>
<p>Since 2016 Texas <a href="https://www.tdcj.texas.gov/divisions/cmhc/docs/cmhc_policy_manual/E-31.02.pdf">has had a policy similar to Utah’s</a>. That policy allows inmates who die in custody to arrange to donate organs after their death. The Texas policy states: “The inmate will receive no award or compensation of any kind for his donation, including but not limited to preferred treatment by the [Texas Department of Criminal Justice] or improved opportunity for parole.”</p>
<p>In 2018, South Carolina joined Utah and Texas <a href="https://law.justia.com/codes/south-carolina/2018/title-24/chapter-1/section-24-1-285/">in writing permission for inmate organ donation into state law</a>.</p>
<p>But they are exceptions. Today <a href="https://www.law.com/ctlawtribune/2022/12/14/the-ethics-and-politics-of-death-row-organ-donations/?slreturn=20230109213801">most states do not allow prisoners to donate organs at all</a>. And federal prison inmates cannot make posthumous organ donations – but they can make living donations to immediate family members so long as they freely consent to do so.</p>
<h2>Consent in a coercive environment</h2>
<p>Some scholars do not think that prison inmates can <a href="https://www.ojp.gov/ncjrs/virtual-library/abstracts/experimentation-prisoners-inadequacy-voluntary-consent">freely consent to organ donation</a> while being in the coercive environment of a prison. They regard inmate organ donation as <a href="https://optn.transplant.hrsa.gov/professionals/by-topic/ethical-considerations/the-ethics-of-organ-donation-from-condemned-prisoners/">exploiting a vulnerable population</a>.</p>
<p>And even some who believe that inmates should be allowed to donate organs were troubled by the initial proposal from Garcia and Gonzales. As the journalist Matthew Cunningham-Cook <a href="https://jacobin.com/2023/02/massachusetts-democrats-prisoner-organ-bone-marrow-donation">noted</a>, their original bill asked prisoners to “choose between their organs and their freedom” and was probably “not even … legal.” </p>
<p>While Rep. Gonzales <a href="https://abcnews.go.com/US/massachusetts-bill-allowing-prisoners-donate-organs-reduced-time/story?id=96989325">recently told</a> ABC News that “he was amending the language to remove the incentives,” he also noted that he would continue to push for legislation to allow inmate organ donation. Such legislation would, in his view, ensure that when it comes to the choice of whether to donate organs, inmates would “have the same basic rights as every citizen has in Massachusetts.”</p>
<p>In my view, this is a worthwhile goal, which, as Garcia and Gonzales now recognize, is best achieved without linking organ donation and sentence reductions.</p><img src="https://counter.theconversation.com/content/199721/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Austin Sarat does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A scholar who has studied imprisonment explains why the promise of sentence reductions in return for organ donation raises ethical issues about whether inmates can ever consent freely.Austin Sarat, William Nelson Cromwell Professor of Jurisprudence and Political Science, Amherst CollegeLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1914302022-10-04T15:46:02Z2022-10-04T15:46:02ZFive steps every researcher should take to ensure participants are not harmed and are fully heard<figure><img src="https://images.theconversation.com/files/487476/original/file-20220930-15-6msqnn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Research comes with risks, so participants must be protected and supported as much as possible.</span> <span class="attribution"><span class="source">bangoland/Shutterstock</span></span></figcaption></figure><p>Academic research is not always abstract or theoretical. Nor does it take place in a vacuum. Research in many different disciplines is often grounded in the real world; it aims to understand and address problems that affect people and the environment, such as climate change, poverty, migration or natural hazards.</p>
<p>This means researchers often have to interact with and collect data from a wide range of different people in government, industry and civil society. These are known as research participants.</p>
<p>Over the last 50 years, the relationship between researcher and participant has <a href="https://www.who.int/activities/ensuring-ethical-standards-and-procedures-for-research-with-human-beings">fundamentally changed</a>. Previously, research participants were viewed merely as objects of study. They had little input into the research process or its outcomes. Now, participants are increasingly viewed as collaborative partners and co-creators of knowledge. There are also <a href="https://sajs.co.za/article/view/6349">many ways</a> in which they can engage with researchers. This shift has been largely driven by the need for research that is relevant to today’s world as well as greater recognition of the diversity of people and cultures, and the internet, social media and other communication tools. </p>
<p>In this context, ethical research practices are more important than ever. However, guidelines and standards for research ethics vary between country and institution. Expectations may also vary between disciplines. So, it’s a good time to identify <a href="https://www.tei.org.za/wp-content/uploads/2020/05/Codes_of_Ethics_Handbook_2020_for_WEB.pdf">the key issues</a> in human research ethics that transcend institutional or disciplinary differences. </p>
<h2>Issues to consider</h2>
<p>I am a long-time chair of one my institutions’ research ethics committees, and I do research ethics training for researchers and managers across southern Africa. I have also published on research ethics. Based on this experience and drawing from <a href="https://www.tei.org.za/wp-content/uploads/2020/05/Codes_of_Ethics_Handbook_2020_for_WEB.pdf">other work done on the topic</a>, I suggest there are five critical ethics issues for researchers to consider.</p>
<p><strong>Managing vulnerability:</strong> Research participants, especially in the developing world, may be potentially vulnerable to coercion, exploitation and the exertion of soft power. </p>
<p>This vulnerability may arise because of systemic social, economic, political and cultural inequalities, which are particularly marked in developing countries. And it may be amplified by inequalities in healthcare and education. Some groups in any society – among them minors, people with disabilities, prisoners, orphans, refugees, and those with stigmatised conditions like HIV and AIDS or albinism – may be more vulnerable than others.</p>
<p>This issue can be managed by considering what the participant group is like and by making sure that the data collection process does not increase any existing vulnerabilities. </p>
<p><strong>Obtaining informed consent:</strong> This is a key precondition for participation in any study. Potential participants should first be informed about the nature of the study and the terms and conditions of their participation. That includes details about anonymity, confidentiality and their right to withdraw. </p>
<p>The researcher then needs to ensure that the potential participant understands this information and has the opportunity to ask questions. This should be done in a language and using words that the person can understand. After these steps are taken, the participant can give informed consent. Informal (verbal or any other non-written) consent is more appropriate if participants are not literate or are particularly vulnerable.</p>
<p><strong>Protecting people:</strong> The overarching principle of protecting research participants was articulated in the landmark <a href="https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html">Belmont Report</a>. The report emerged from a national commission in the US in the 1970s to consider research ethics principles. It called for researchers in any study to demonstrate non-maleficence (the principle of not doing harm) and ensure that they protect both participants and their data. </p>
<p>This can be done at different stages through the research process: by decreasing the potential for risk or harm through careful study design; by providing support or counselling services to participants during or after data collection; and by maintaining confidentiality and anonymity in data collection and reporting. Finally, personal data must be protected or de-identified if they are being stored for later analysis.</p>
<p><strong>Managing risk:</strong> Potential sources of risk or harm to participants should, as far as possible, be identified and mitigated when the study is being designed. Risk may arise in any study, either at the time of data collection or afterwards. Sometimes this is unexpected, such as where data collection becomes more dangerous due to <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3571111/">civil unrest</a> or under COVID-19 restrictions.</p>
<p>It is important that researchers provide the details of support or counselling service for participants in case these are needed. Any trade-offs between risk and benefits can be considered through a risk-benefits analysis. But researchers should be realistic about any potential benefits that may result from their study.</p>
<p><strong>Championing human rights:</strong> Researchers have responsibilities: to their disciplines, funders, institutions and participants. This means they should not merely be passive analysers of data. Instead they should be positive role models in society by seeking solutions, advocating for change and upholding human rights and social justice through their actions. </p>
<p>Research activities, especially those involving participants, should address and find solutions for local and global problems. They ought to result in positive societal and environmental outcomes. This should be the context for all types of research activities in a 21st century world.</p>
<h2>Making it happen</h2>
<p>Increasingly, there are national and international codes of research ethics, guiding researchers in different fields. An example is the 2010 <a href="https://wcrif.org/guidance/singapore-statement">Singapore Statement on Research Integrity</a>. It emphasises the principles of honesty, accountability, professional courtesy and fairness, and good stewardship of data. These are the characteristics not just of ethical researchers, but of good researchers too.</p>
<p>These principles and processes should make research less risky and protect the rights of participants by building trust between researchers and participants. These principles can also help in making research more transparent, accountable and equitable – critical in an increasingly divided and unequal world.</p><img src="https://counter.theconversation.com/content/191430/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jasper Knight does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Researchers have a number of responsibilities when embarking on their work - not least of all to the participants.Jasper Knight, Professor of Physical Geography, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1689362021-10-25T19:50:18Z2021-10-25T19:50:18ZIntersex children in New Zealand are routinely undergoing unnecessary surgery – that needs to change<figure><img src="https://images.theconversation.com/files/427915/original/file-20211021-13-wticee.jpg?ixlib=rb-1.1.0&rect=15%2C23%2C5160%2C3422&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Until very recently, people with intersex variations have often been unseen, stigmatised and routinely discriminated against. <a href="https://interactadvocates.org/intersex-awareness-day/">Intersex Awareness Day</a> today (October 26) is therefore an opportunity to examine how much progress has been made and how far we still have to go.</p>
<p>It’s estimated <a href="https://www.amnesty.org/en/latest/news/2018/10/its-intersex-awareness-day-here-are-5-myths-we-need-to-shatter/">1.7 to 4%</a> of people globally are intersex – meaning they don’t fit within typical female or male norms. </p>
<p>In particular, the rights of children with intersex variations are coming under scrutiny. </p>
<p>With surgery in infancy or early childhood still considered an option,
<a href="https://docstore.ohchr.org/SelfServices/FilesHandler.ashx?enc=6QkG1d%2fPPRiCAqhKb7yhsrXsJ3pRx9xOCak0Ed1mLElSXcY5e%2bSYJ4cCIPH2iPOgLuEWmnttJAXCYk1WXW5fu9WagFa0bDhf72L%2fqDxeYU66nhVpJwtkgNIsCxADWOks">questions</a> are now being asked about how to ensure no child is subjected to unnecessary procedures or treatment, and that the child’s consent is obtained for necessary interventions. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1449981202698579968"}"></div></p>
<h2>Surgery can be delayed</h2>
<p>Intersex people have <a href="https://www.ogmagazine.org.au/20/4-20/intersex-variations-in-sex-characteristics/">variations in sex characteristics</a> that can occur naturally at the level of chromosomes, hormones and/or anatomy. </p>
<p>There is a wide range of variations. Hypospadias, where the urethral opening appears on the underside of the penis, is most common. Although not a health problem, surgery to alter the hypospadic appearance is “routine” in many places, including Aotearoa New Zealand.</p>
<p>The latest <a href="https://www.health.govt.nz/publication/publicly-funded-hospital-discharges-1-july-2017-30-june-2018">Ministry of Health data</a> shows that in 2017-18, 265 people aged under 15 were diagnosed with hypospadias, with 206 surgical operations performed – 85% of those operations performed on children aged under five. </p>
<p>These surgeries could be delayed until the children are older and able to give or refuse consent. There is no clear biomedical basis for such surgery, it is not lifesaving and it puts the child at risk (as surgery inevitably does). </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/surgery-to-make-intersex-children-normal-should-be-banned-76952">Surgery to make intersex children 'normal' should be banned</a>
</strong>
</em>
</p>
<hr>
<p>While there are some <a href="https://www.cincinnatichildrens.org/health/m/mixed-gonadal-dysgenesis">gonadal variations</a> (affecting the development of ovaries or testes) that can be life-threatening and require surgical treatment, few variations in sex characteristics are life-threatening in infancy. </p>
<p>Surgery on children with genital variations might appear to promote wellbeing but research highlights the harmful effects of any surgery intended to produce a more “<a href="https://pubmed.ncbi.nlm.nih.gov/31971496/">male</a>” or more “<a href="https://pubmed.ncbi.nlm.nih.gov/30272250/">female</a>” genital appearance. </p>
<p>Like their overseas counterparts, Aotearoa New Zealand <a href="https://www.stuff.co.nz/life-style/gender-and-society/125333190/queens-birthday-honours-intersex-advocate-mani-bruce-mitchell-on--doing-the-mahi">intersex people</a> who have spoken publicly have opposed the interventions they underwent as children.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"685022646308700161"}"></div></p>
<h2>Who gives consent?</h2>
<p>The issue of genital surgery has implications for the <a href="https://www.renews.co.nz/we-cant-forget-new-zealand-still-discriminates-against-rainbow-communities/">legal rights</a> of New Zealanders with variations in sex characteristics, including their right to <a href="https://www.legislation.govt.nz/act/public/1990/0109/latest/DLM224792.html">refuse</a> medical treatment, and the rules around informed consent. </p>
<p>The young age at which most surgeries are carried out means consent is provided by parents, who have the right and responsibility to decide on important matters affecting the child, including non-routine <a href="https://www.legislation.govt.nz/act/public/2004/0090/latest/whole.html#DLM317233">medical treatment</a>. </p>
<p>With such decisions, the best interests and welfare of the child in their particular circumstances must be the <a href="https://www.legislation.govt.nz/act/public/2004/0090/latest/DLM317240.html">paramount</a> consideration. The right to be <a href="https://www.hdc.org.nz/your-rights/about-the-code/code-of-health-and-disability-services-consumers-rights/">fully informed</a> is contained in the Code of Health and Disability Services Rights. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/choosing-childrens-sex-is-an-exercise-in-sexism-45836">Choosing children's sex is an exercise in sexism</a>
</strong>
</em>
</p>
<hr>
<p>In essence, every New Zealander has a right to an explanation of their condition and an explanation of the options available, including risks, side effects, costs and benefits of each option, and honest and accurate answers to questions, including the results of research. </p>
<p>But <a href="https://www.facebook.com/renewsnz/videos/168623591785700/">intersex advocates</a> in Aotearoa New Zealand argue that they and their families have been isolated from sources of information and from others in similar situations.</p>
<p>And there is the added complexity of current responses to intersex variations being <a href="https://www.hrc.co.nz/files/9615/2270/4142/HRC_Intersex_Roundtable_2017.pdf">insensitive</a> to cultural contexts, reflecting as they do binary Western constructions of gender that categorise individuals as either male or female.</p>
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<h2>International progress</h2>
<p>The issue of genital surgery is gaining traction in international law. For example, the right to be protected from <a href="https://www.ohchr.org/en/professionalinterest/pages/cat.aspx">degrading treatment</a> was extended to <a href="https://www.ohchr.org/documents/hrbodies/hrcouncil/regularsession/session22/a.hrc.22.53_english.pdf">health-care settings</a> in 2013, with the call from a UN special rapporteur for states to repeal any law allowing genital-normalising surgery when “enforced or administered without the free and informed consent of the person concerned.” </p>
<p>Overall, the <a href="http://docstore.ohchr.org/SelfServices/FilesHandler.ashx?enc=4slQ6QSmlBEDzFEovLCuW1a0Szab0oXTdImnsJZZVQfQejF41Tob4CvIjeTiAP6sGFQktiae1vlbbOAekmaOwDOWsUe7N8TLm%2BP3HJPzxjHySkUoHMavD%2Fpyfcp3Ylzg">right to health</a> is violated when states fail to take steps to prevent young children from undergoing medically unnecessary, irreversible and involuntary surgery and treatment.</p>
<p>In 2016, the <a href="https://docstore.ohchr.org/SelfServices/FilesHandler.ashx?enc=6QkG1d%2fPPRiCAqhKb7yhsrXsJ3pRx9xOCak0Ed1mLEkIUHtKTSHNWA9ddXmo8oiUgGuB9JUoxS6ES4ymmXawE3W7Z52o%2b4tn33VBe09mSo1Rr6ta1lLVkTxmo%2fSYUATQ">UN Committee on the Rights of the Child</a> recommended Aotearoa New Zealand develop and implement a healthcare protocol for intersex children, based on children’s rights, setting the procedures and steps to be followed by health teams. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/beyond-the-binary-how-teaching-children-about-gender-could-help-reduce-sexism-113140">Beyond the binary: how teaching children about gender could help reduce sexism</a>
</strong>
</em>
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<p>This followed a submission to the committee from Aotearoa New Zealand’s <a href="https://www.hrc.co.nz/files/6814/7426/0090/Supplementary_Report_of_NZHRC_for_CRC_73rd_session_NZ.pdf">Human Rights Commission</a>. The UN committee called on the country to ensure no one is subjected to unnecessary medical or surgical treatment during infancy or childhood, and to guarantee the child’s right to bodily integrity, autonomy and self-determination. </p>
<p>In response to the <a href="https://docstore.ohchr.org/SelfServices/FilesHandler.ashx?enc=6QkG1d%2fPPRiCAqhKb7yhsrXsJ3pRx9xOCak0Ed1mLEkIUHtKTSHNWA9ddXmo8oiUgGuB9JUoxS6ES4ymmXawE3W7Z52o%2b4tn33VBe09mSo1Rr6ta1lLVkTxmo%2fSYUATQ">recommendations</a> of the UN committee, as well as domestic advocacy, the Ministry of Health directed the Paediatric Society to set up an <a href="https://www.msd.govt.nz/about-msd-and-our-work/publications-resources/monitoring/uncroc/reporting/sixth-report/issues/rights/violence/harmful-practices.html">intersex working group</a> to develop <a href="https://starship.org.nz/guidelines/differences-of-sex-development-atawhai-taihemahema/">guidelines</a> for infants born intersex. </p>
<p>But this has so far failed to make significant changes to the practice of surgical intervention on children’s genitalia. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-are-gender-pronouns-and-why-is-it-important-to-use-the-right-ones-169025">What are gender pronouns and why is it important to use the right ones?</a>
</strong>
</em>
</p>
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<h2>Aotearoa New Zealand can do better</h2>
<p>Meanwhile, <a href="https://www.renews.co.nz/we-cant-forget-new-zealand-still-discriminates-against-rainbow-communities/">advocates</a> continue to call for legislation to defer interventions until children themselves are capable of consenting or expressing their own views. </p>
<p>Central to any policy, legislative or medical development must be the child’s right to be free from discrimination. </p>
<p>Children have the right to have their voices heard. This means, with the exception of life-saving treatment, any interventions should be postponed until a child is competent to decide. </p>
<p>Where necessary, a skilled, independent advocate should be appointed to represent the child’s interests. Current medical practice in Aotearoa New Zealand falls well short of those goals.</p>
<hr>
<p><em>The authors are grateful to the contribution of researchers Craig Dempster and Sam Johnston, and to members of the Intersex Health and Well-Being Working Group (Incentive), who gave feedback on an earlier draft.</em></p><img src="https://counter.theconversation.com/content/168936/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>With no clear biomedical basis for most early surgery on intersex children, interventions should be postponed until a child is competent to decide for themselves.Claire Breen, Professor of Law, University of WaikatoKatrina Roen, Professor of Sociology, University of WaikatoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1630642021-07-04T11:28:18Z2021-07-04T11:28:18ZEradicating sexual exploitation in porn should not be at the expense of sex workers<figure><img src="https://images.theconversation.com/files/408945/original/file-20210629-24-1u4rk04.jpg?ixlib=rb-1.1.0&rect=24%2C32%2C5382%2C3333&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Before drafting legislation that seeks to protect sex workers and minors, law-makers should consult with sex workers. </span> <span class="attribution"><span class="source">(AP Photo/John Locher) </span></span></figcaption></figure><p>Conservative MP Arnold Viersen recently introduced <a href="https://parl.ca/DocumentViewer/en/43-2/bill/C-302/first-reading">Bill C-302</a>, adding two offences to the Canadian Criminal Code regarding pornography: one for making material without written confirmation of performer’s legal age and consent and another for distributing such material. </p>
<p>Curiously, both acts are already illegal. </p>
<p>Canada has some of the most stringent laws in the world around child sexual abuse material and consent to sexual activity. It is <a href="https://laws-lois.justice.gc.ca/eng/acts/c-46/page-37.html#docCont">a federal offence to distribute “intimate images” without a subject’s prior knowledge and consent</a>. Rules are stricter with higher punishment if the material depicts a minor, including fictional characters. </p>
<p>This new bill would not enhance existing measures to curb online sexual abuse. Instead, it vastly increases surveillance of porn workers, a highly stigmatized and overly policed group.</p>
<p>There is absolutely a need to prevent online sexual exploitation, but protective measures must extend to everyone — including porn performers. Laws must be developed with meaningful sex worker consultation. Failure to do so risks exacerbating the violence Viersen claims he is seeking to prevent.</p>
<p>Evidence of dangerous policy is clear in the United States, where 2018 legislation — Fight Online Sex Trafficking Act (FOSTA) and the Stop Enabling Sex Traffickers Act (SESTA) — have resulted in sex workers’ social media accounts being banned and <a href="https://hackinghustling.org/erased-the-impact-of-fosta-sesta-2020/">entire platforms shut down</a>.</p>
<p>Other restrictions have <a href="https://www.vice.com/en/article/n7v33d/sex-workers-what-visa-and-mastercard-dropping-pornhub-means-to-performers">discriminated, delayed and outright cancelled payment processes</a> for legal sex workers. A recent U.S. government accountability office report found these laws made life <a href="https://newrepublic.com/article/162823/sex-trafficking-sex-work-sesta-fosta">significantly more dangerous</a> for sex workers, but have only been applied to <a href="https://www.gao.gov/products/gao-21-385">a single trafficking prosecution</a> over three years. </p>
<h2>The problem with ‘written consent’</h2>
<p>Currently in Canada, it is <a href="https://laws-lois.justice.gc.ca/eng/acts/C-46/section-162.1.html">illegal</a> to circulate in any way “an intimate image of a person knowing that the person depicted in the image did not give their consent to that conduct.” Written proof from the person depicted isn’t necessary, ensuring greater privacy for performers. </p>
<p>In contrast, the proposed new bill states that consent “means the voluntary agreement, in writing, of the person whose image is depicted in the pornographic material.” But documentation isn’t voluntary if mandated by law and potentially made public any time a complaint is filed. </p>
<p>Porn studio productions already follow extensive <a href="https://www.freespeechcoalition.com/forms-templates">informed consent</a> and model release documentation processes, similar to other media and performance industry standards.</p>
<p>Nothing in Bill C-302 improves upon those practices. Instead, the expansion of legal powers would be felt most heavily by independent content producers, burdened with having to prove they are not exploiting themselves. </p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/408437/original/file-20210625-9546-1m02sxy.jpg?ixlib=rb-1.1.0&rect=207%2C172%2C3754%2C2459&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/408437/original/file-20210625-9546-1m02sxy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/408437/original/file-20210625-9546-1m02sxy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/408437/original/file-20210625-9546-1m02sxy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/408437/original/file-20210625-9546-1m02sxy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/408437/original/file-20210625-9546-1m02sxy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/408437/original/file-20210625-9546-1m02sxy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Porn studio productions follow extensive informed consent and model release documentation processes.</span>
<span class="attribution"><span class="source">Donald Tong/Pexels</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>Such record keeping requirements represent a risk to sex workers who are already stigmatized. <a href="https://www.nswp.org/sites/nswp.org/files/impact_of_criminalisation_pb_prf01.pdf">Fear of exposure and harassment</a> can lead workers into illegal or quasi-legal activities where they need not provide identifying information to police or government officials, <a href="https://doi.org/10.1007/s13178-021-00576-9">who have demonstrated little concern with their well-being</a>. </p>
<p>As Conservative Sen. <a href="https://ricochet.media/en/265/sex-workers-demand-rights-and-respect-not-draconian-legislation">Don Plett said in 2014</a>: “Of course, we don’t want to make life safe for prostitutes; we want to do away with prostitution.” </p>
<p>Similar sentiments against pornography persist. </p>
<h2>Sex worker testimony an afterthought</h2>
<p>Deeming sex workers either helpless and incompetent — or immoral and obscene — politicians routinely ignore their expertise on the relationship between porn, online platforms and consent violations. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/porn-not-to-blame-for-public-health-issues-82116">Porn not to blame for public health issues</a>
</strong>
</em>
</p>
<hr>
<p>This was clear during the <a href="https://sencanada.ca/en/Content/SEN/Committee/412/lcjc/15ev-51557-e">2014 senate hearings on Bill C-36</a>, the Protection of Communities and Exploited Persons Act, when sex worker concerns were dismissed by Plett and others. </p>
<p>It happened again in 2016 when <a href="https://www.ourcommons.ca/members/en/89211/motions/8136502">Viersen introduced M-47</a>, a motion for the Standing Committee on Health “to examine the public health effects of the ease of access and viewing of online violent and degrading sexually explicit material on children, women and men.” </p>
<p>Most recently, sex workers were sidelined when Viersen instigated parliamentary committee meetings on “<a href="https://www.ourcommons.ca/Committees/en/ETHI/StudyActivity?studyActivityId=11088039">ensuring the protection of privacy and reputation on platforms such as Pornhub</a>.”</p>
<p>Sandra Wesley, director of the Montréal-based sex worker advocacy agency Stella, <a href="https://globalnews.ca/news/7695681/commons-committee-pornhub/">released a statement after their request to speak at those meetings was rebuffed</a>: “The response that I got back is that sex workers are not relevant to this conversation.” Invited to the hearings, however, were <a href="https://www.thedailybeast.com/inside-exodus-cry-the-shady-evangelical-group-with-trump-ties-waging-war-on-pornhub">American anti-porn activists backed by evangelical Christian organizations</a>.</p>
<p>After mounting a social media campaign, sex worker rights groups were finally included - in the final day of meetings. In <a href="https://www.ourcommons.ca/DocumentViewer/en/43-2/ETHI/meeting-31/evidence#Int-11243030">her testimony</a>, Jenn Clamen of the Canadian Alliance for Sex Work Law Reform said: </p>
<blockquote>
<p>“[Sex workers] have been organizing for over 50 years against violence and abuse in the industry. It’s why we started organizing …For this reason, sex workers are best placed to be at the centre of this discussion.” </p>
</blockquote>
<p>Bill C-302 fails to recognize the <a href="https://theconversation.com/we-need-a-new-definition-of-pornography-with-consent-at-the-centre-111994">high standards of consent</a> established by porn industry professionals and activists. This bill isn’t about consent, but eradicating an undesirable sexual citizen: the sex worker. </p>
<h2>Exploiting consent to harm sexual minorities</h2>
<p>Legal scholar <a href="https://www.routledge.com/Law-and-Consent-Contesting-the-Common-Sense/ORegan/p/book/9780367785635">Karla O’Regan</a> notes, while consent is ostensibly about ensuring personal freedoms, it actually entails “a series of unspoken presumptions about what is normal human behaviour,” such that “the availability of consent hinges on the ‘reasonableness’ of the defendant’s conduct.” </p>
<p>Since what is judged reasonable is contained within laws governing morality, some sexualities and acts are considered <em>fundamentally</em> objectionable, falling outside what groundbreaking sexuality studies scholar <a href="https://sites.middlebury.edu/sexandsociety/files/2015/01/Rubin-Thinking-Sex.pdf">Gayle Rubin</a> called the “charmed circle” of heteronormative monogamy. </p>
<p>Anti-sex worker policies, steeped in moralization and infantilization, do not recognize porn performers’ ability to consent to sex work. This reproduces the stigma underlying <a href="https://journals.msvu.ca/index.php/atlantis/article/view/3041/pdf_38">systemic cultures of sexual abuse</a> that prioritize “good” victims over “bad” ones. </p>
<p>Consent is too critical a framework to be weaponized by politicians looking to do away with undesirable sexual citizens.</p><img src="https://counter.theconversation.com/content/163064/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rebecca Sullivan has received funding from Social Sciences and Humanities Research Council and the University of Calgary Research Grant Committee.</span></em></p><p class="fine-print"><em><span>Maggie MacDonald receives funding from the Social Sciences and Humanities Research Council, through a Joseph-Armand Bombardier Canada Graduate Scholarship in support of her doctoral research. </span></em></p><p class="fine-print"><em><span>Valerie Webber is the Board Chair of PASS (Performer Availability Screening Services), an independent nonprofit organization dedicated to the health and safety of adult industry workers. PASS maintains a working relationship with the Free Speech Coalition, an industry trade association. </span></em></p>Why are sex workers routinely excluded from debates on their own legal and human rights?Rebecca Sullivan, Professor, Women's Studies, University of CalgaryMaggie MacDonald, PhD Student, Faculty of Information, University of TorontoVal Webber, PhD Candidate, Community Health & Humanities, Memorial University of NewfoundlandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1553802021-02-18T19:11:25Z2021-02-18T19:11:25ZCOVID vaccine consent for aged-care residents: it’s ethically tricky, but there are ways to get it right<figure><img src="https://images.theconversation.com/files/384929/original/file-20210218-17-rjjjpa.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C6720%2C4466&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>The much anticipated rollout of the Pfizer-BioNTech COVID-19 vaccine <a href="https://www.theguardian.com/australia-news/2021/feb/15/australias-covid-vaccine-rollout-to-begin-next-monday-as-first-pfizer-shipment-arrives">will begin</a> in Australia on Monday. </p>
<p>The <a href="https://www.health.gov.au/sites/default/files/documents/2021/01/covid-19-vaccination-australia-s-covid-19-vaccine-national-roll-out-strategy.pdf">first groups to receive the jab</a> will be quarantine and border workers, frontline health-care workers, aged-care and disability-care workers, and aged-care and disability-care residents.</p>
<p>For aged-care residents, their age, health and living situation <a href="https://www.mja.com.au/journal/2020/covid-19-sydney-nursing-home-case-study-and-lessons-learnt">makes them especially susceptible</a> to becoming very sick or dying from COVID-19. So it’s right they are receiving priority access to a vaccine.</p>
<p>But there are also ethical issues that arise when administering vaccines to aged-care residents, who often have diminished capacity to provide consent. Health authorities now face a significant challenge to ensure older members of the community feel safe, comfortable and respected during the vaccination process. </p>
<h2>A vulnerable group</h2>
<p>One challenge of vaccination in aged care is the fact many older people have dementia, or other conditions that affect their ability to communicate and process information. </p>
<p>Around <a href="https://www.healthdirect.gov.au/dementia-overview#:%7E:text=Dementia%20affects%20around%201%20in,known%20as%20younger%20onset%20dementia.">one in 15 Australians</a> over the age of 65 have dementia, and the risk of developing some form of dementia increases significantly once people enter their 70s and 80s. Among a host of challenges, dementia makes it more difficult for people to consent to medical treatment. </p>
<p>Older people with dementia may also become upset and agitated when things change in their routine or living environment. This means they can easily become distressed during medical procedures.</p>
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Read more:
<a href="https://theconversation.com/why-we-should-prioritise-older-people-when-we-get-a-covid-vaccine-148432">Why we should prioritise older people when we get a COVID vaccine</a>
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<p>Evidence supporting the safety of COVID-19 vaccines is growing every day. We do know, however, that mild side-effects like headache, fever and chills <a href="https://www.nature.com/articles/d41586-021-00290-x">are more common in COVID mRNA vaccines</a> than standard flu vaccines (the Pfizer vaccine is based on mRNA technology). </p>
<p>These mild side-effects <a href="https://theconversation.com/the-pfizer-vaccine-may-not-be-the-best-choice-for-frail-people-but-its-too-early-to-make-firm-conclusions-153445">may be exacerbated</a> when someone is already <a href="https://www.sciencedirect.com/science/article/pii/S0091743518303992?casa_token=XAguRZZAttoAAAAA:aHdDZ_9K7pC5uvHr4PG50fyk7Hs0zDJcqru41zcAImkHSVrsBB4B7fzX-FzuGGW_3sf9FQ384To4">frail</a> and suffering from several pre-existing illnesses. </p>
<p>That said, <a href="https://www.healthline.com/health-news/heres-why-your-second-dose-of-covid-19-vaccine-will-likely-have-stronger-side-effects">trial data suggests</a> people over the age of 55 are less likely to experience side-effects from the Pfizer vaccine than younger people. </p>
<figure class="align-center ">
<img alt="A health-care worker wearing a mask talks to an elderly person." src="https://images.theconversation.com/files/384931/original/file-20210218-12-7bpm6r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/384931/original/file-20210218-12-7bpm6r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/384931/original/file-20210218-12-7bpm6r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/384931/original/file-20210218-12-7bpm6r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/384931/original/file-20210218-12-7bpm6r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/384931/original/file-20210218-12-7bpm6r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/384931/original/file-20210218-12-7bpm6r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Health-care workers will provide information to aged-care residents about the vaccine.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
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</figure>
<h2>Informed consent</h2>
<p>A special team of health-care workers assembled by the federal government will administer COVID vaccines in aged care. These health-care workers must obtain <a href="https://www.health.gov.au/resources/publications/covid-19-vaccination-consent-guidance-material-for-residential-aged-care">consent</a> from residents receiving the vaccine.</p>
<p>One challenge here is determining whether aged-care residents have capacity to consent. Capacity refers to a person’s ability <a href="https://www1.racgp.org.au/newsgp/clinical/test-for-medical-capacity-what-gps-need-to-know">to make their own decisions</a>. </p>
<p>Generally, a person is said to have capacity if they understand the information relevant to the decision, and the effect of the decision. In the case of vaccination for COVID-19, people must understand they are receiving a vaccine for coronavirus. They must also be made aware of relevant risks and benefits of the vaccine.</p>
<p>The concept becomes more complicated when a patient has a condition like dementia, as their <a href="https://journalofethics.ama-assn.org/article/dementia-decision-making-and-quality-life/2017-07">decision-making capacity</a> can ebb and flow depending on the time of day, their location, and the support they have when receiving information.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/social-housing-aged-care-and-black-americans-how-coronavirus-affects-already-disadvantaged-groups-142046">Social housing, aged care and Black Americans: how coronavirus affects already disadvantaged groups</a>
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<p>Unfortunately, the stigma surrounding ageing and physical and cognitive decline means older patients are sometimes <a href="https://www.dementia.org.au/sites/default/files/NATIONAL/documents/dementia-and-stigma-2017.pdf">subject to prejudice</a> and inappropriate treatment. </p>
<p>It’s important clinicians avoid making assumptions about older patients’ decision-making capacity before speaking to them, and then provide information in a manner the person can understand. </p>
<p>When health-care workers determine a person doesn’t have capacity to consent, they will require what’s called a substitute decision-maker. This is usually someone who has a close and continuing relationship with the person (such as a partner or other family member). </p>
<p>Many people, particularly in aged-care settings, would have completed <a href="https://www.dementia.org.au/planning-ahead/about">the relevant legal documentation</a> to appoint a substitute decision-maker (sometimes known as medical power of attorney). Where a substitute decision-maker has not been appointed, aged-care staff must determine who is legally allowed to make decisions on behalf of the patient.</p>
<h2>What can we learn from other countries?</h2>
<p>Many countries are already weeks or months into their vaccine rollout, so we can take their experiences into account.</p>
<p>One challenge that’s arisen overseas has been tracking down <a href="https://www.washingtonpost.com/health/nursing-homes-covid-vaccine-consent-delays/2020/12/19/730ecd4a-3fd5-11eb-8bc0-ae155bee4aff_story.html">substitute decision-makers</a> when they’re needed. This process can sometimes take days or weeks.</p>
<p>We should also be prepared for complex situations where substitute decision-makers refuse vaccination for those in their care. In <a href="https://www.lexology.com/library/detail.aspx?g=70945676-792a-479f-9913-7270e7d76fe6">a recent case</a> in the United Kingdom, the British Court of Protection ruled it was in the best interests of an 80-year-old woman with dementia and diabetes living in a care home to have the COVID vaccine, despite her son’s objections. </p>
<p>Similar situations will likely come up in Australia. Aged-care staff should contact substitute decision-makers as soon as possible to avoid unnecessary conflicts. </p>
<p>Some aged-care providers <a href="https://residential-care.mercyhealth.com.au/covid-19-vaccination-for-rac-150221/">have already released messages</a> to residents and their families addressing common concerns about vaccination in general, and COVID-19 vaccines in particular.</p>
<h2>Looking ahead</h2>
<p>There will be immense pressure on medical practitioners to deliver COVID-19 vaccines quickly to those who are most vulnerable to infection and illness. It already takes significant time and resources to deliver vaccines in aged-care homes, and there may be a temptation to give less importance to consent procedures. </p>
<p>But it’s vital COVID-19 vaccines are given in a manner that respects the autonomy and dignity of older members of the community. </p>
<p>This is particularly important in light of the disastrous response to COVID-19 outbreaks in aged-care facilities during the height of the pandemic <a href="https://theconversation.com/grattan-on-friday-morrison-government-needs-to-improve-rather-than-defend-its-poor-covid-aged-care-performance-144447">in Australia</a> and around the world. Residents’ dignity and autonomy has already been violated once, and we can and should avoid a repeat. </p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/the-astrazeneca-vaccine-and-over-65s-we-may-not-have-all-the-data-yet-but-limiting-access-could-be-counterproductive-154272">The AstraZeneca vaccine and over-65s: we may not have all the data yet, but limiting access could be counterproductive</a>
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<img src="https://counter.theconversation.com/content/155380/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Xavier Symons does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Aged-care residents will be among the first to receive the Pfizer vaccine when the rollout begins next week. For some, the process of consenting to the vaccine could raise ethical questions.Xavier Symons, Postdoctoral Research Fellow, Australian Catholic UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1489462020-11-03T12:30:04Z2020-11-03T12:30:04Z‘You may be hacked’ and other things doctors should tell you<figure><img src="https://images.theconversation.com/files/366855/original/file-20201101-18-1or50dz.jpg?ixlib=rb-1.1.0&rect=0%2C26%2C6000%2C3961&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/russian-hacker-hacking-server-dark-1068509705">Dmytro Tyshchenko/Shutterstock</a></span></figcaption></figure><p>On September 9 2020, a woman died during a cyber-attack on a hospital in Düsseldorf, Germany. The woman was in a critical condition and about to be treated when hackers disabled the computer systems of the hospital. Unable to avert the attack, medical staff had to transfer the woman to another hospital, but the help came too late and <a href="https://www.bbc.com/news/technology-54204356">the woman died</a>.</p>
<p>This incident was the first reported case of death after a cyber-attack and shows that such attacks are not just a threat to our data anymore, but also to our lives. In fact, the situation is urgent. We know that cyber-attacks on medical devices and hospital networks are a <a href="https://digitalcommons.law.scu.edu/cgi/viewcontent.cgi?article=1578&=&context=chtlj&=&sei-redir=1&referer=https%253A%252F%252Fscholar.google.com%252Fscholar%253Fhl%253Den%2526as_sdt%253D0%25252C5%2526q%253DCyberattacks%252Bon%252Bmedical%252Bdevices%252Band%252Bhospital%252Bnetworks%25253A%252Blegal%252Bgaps%252Band%252Bregulatory%252Bsolutions.%2526btnG%253D#search=%22Cyberattacks%20medical%20devices%20hospital%20networks%3A%20legal%20gaps%20regulatory%20solutions.%22">growing threat</a>. During the current pandemic, some types of cyber-attacks have <a href="https://arxiv.org/pdf/2006.11929.pdf">increased by 600%</a>.</p>
<p>And it’s not just old computer systems that are vulnerable. Even the very best artificial intelligence (AI) in medicine can be compromised. Academic research continually reveals <a href="https://arxiv.org/pdf/1806.11146.pdf?source=post_page---------------------------">new ways in which state-of-the-art AI can be attacked</a>. Such attacks can block life-saving interventions, undermine diagnostic accuracy, administer lethal drug doses, or sabotage critical moves in an operation.</p>
<h2>Inherent risks</h2>
<p>Doctors need to do everything they can to keep patients safe, but as a matter of general medical disclosure, should they have to tell patients about the risk of a cyber-attack, at least when their healthcare critically relies on computers? After all, patients have to give their informed consent to medical procedures and doctors are required to warn patients about potentially harmful consequences.</p>
<p>In some US legal cases, judges have argued that doctors need to disclose a risk only if it is “inherent” in a medical procedure, that is, a risk that “<a href="https://casetext.com/case/jones-v-papp">exists in and is inseparable from the procedure itself</a>”. Relying on such a view, one may argue that the risk of cyber-attacks is not an “inherent” risk and so does not require disclosure. Many equate “inherent” risks with “medical” risks and thereby rule out the “criminal” risk of a cyber-attack.</p>
<p>This view against disclosure raises an important point. There is indeed a connection between the requirement of disclosure and the expertise of a doctor as a medical professional. Doctors need to disclose inherent medical risks because they are, unlike laypeople, especially well placed to know about them. But doctors cannot be expected to predict whether certain people will target their patients through cyber-attacks. After all, doctors are not criminologists. So they are not really able, let alone obliged, to disclose those risks.</p>
<p>On the other hand, this view against disclosure underestimates several important aspects. To begin with, the growing digitalisation and use of computer systems in medicine will render the risk of cyber-attacks ubiquitous in healthcare. Even though it may not be an “inherent” risk, it will certainly be an inevitable part of future clinical reality, and if we want patients to make well-informed decisions, they should know about such a risk.</p>
<p>Also, even though doctors don’t need to disclose general criminal risks, they are required to disclose the risks that their medical equipment poses to patients. After all, being subject to medical procedures leaves people vulnerable in important ways, and if certain computer-based procedures introduce new vulnerabilities, an informed patient will need to know about them.</p>
<p>Finally, unlike traditional cyber-attacks, the risk of some new cyber-attacks may become “inherent”, as defined above. Consider the case of medical AI. In so-called “input attacks” on medical AI, an attacker can change the pixel value of an MRI scan so that the AI system will categorise tissue as falsely malignant with a confidence rate of over 99% when it would correctly categorise it as benign with the same confidence rate in absence of the attack. The human eye is unable to detect such changes. The attacker would only have to <a href="https://science.sciencemag.org/content/363/6433/1287">scatter some well-placed digital dust over the image</a>.</p>
<figure class="align-center ">
<img alt="A medic examines a scan of a patient's head." src="https://images.theconversation.com/files/366856/original/file-20201101-23-gl1pkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/366856/original/file-20201101-23-gl1pkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=397&fit=crop&dpr=1 600w, https://images.theconversation.com/files/366856/original/file-20201101-23-gl1pkv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=397&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/366856/original/file-20201101-23-gl1pkv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=397&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/366856/original/file-20201101-23-gl1pkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=498&fit=crop&dpr=1 754w, https://images.theconversation.com/files/366856/original/file-20201101-23-gl1pkv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=498&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/366856/original/file-20201101-23-gl1pkv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=498&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Hackers can change a scan to make benign tissue look malignant.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-attentively-examines-mri-scan-patient-390249514">sfam_photo/Shutterstock</a></span>
</figcaption>
</figure>
<p>The only way to detect an attack is to detect the intrusion in another computer system where the medical images have been stored. But even here, we may not know whether, in addition to the intrusion into the database and the potential theft of medical data, attackers made any changes to medical images at all, what their motives might have been, and what consequences could await patients as a result.</p>
<p>So, unlike other cyber-attacks, input attacks no longer compromise their target system. The AI system itself, its algorithm, and how it works can be left completely untouched. In other words, the AI system would still work normally, not be affected by any bug or interference, and the doctor performing or supervising the procedure would act as professionally as possible.</p>
<p>Therefore, no such AI-based procedures can avoid the vulnerability to input attacks. But if this is so, then the risk of input attacks does become “inherent” to certain medical procedures, as defined earlier. </p>
<h2>Be prepared</h2>
<p>There are sound reasons to require the disclosure of cyber-risks to patients, at least in certain high-stakes medical procedures. However, cyber-risks are only one new type of risk that patients may face in the future. When algorithms play an increasingly large role, we also need to think about whether doctors should disclose the risk that these algorithms are systematically biased or the risk that, because of the opacity of certain AI systems, doctors may no longer be able to understand and double-check the AI’s decisions. </p>
<p>In any case, the growing reliance on computer-systems and AI <a href="https://link.springer.com/article/10.1007/s00146-020-01085-w">demands that we think afresh</a> about medical disclosure and which risks to disclose to patients. Otherwise, our clinical practice will be unprepared for the major transformations that await it.</p><img src="https://counter.theconversation.com/content/148946/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The author gratefully acknowledges the support of the European Research Council, under the European Union’s Horizon 2020 research and innovation programme (project ID: 789270).</span></em></p>Cyber-attacks on medical devices and hospital networks are a growing threat, and patients have the right to know.Maximilian Kiener, Extraordinary Junior Research Fellow in Philosophy, University of OxfordLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1398842020-06-05T09:01:46Z2020-06-05T09:01:46ZInfecting a volunteer with coronavirus to develop a vaccine – here’s what consent should look like<figure><img src="https://images.theconversation.com/files/339160/original/file-20200602-133924-h84m9r.jpg?ixlib=rb-1.1.0&rect=0%2C199%2C5800%2C3638&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/single-bottle-vial-covid19-coronavirus-vaccine-1716494026">solarseven/Shutterstock</a></span></figcaption></figure><p>The World Health Organization (WHO) recently announced that it <a href="https://www.theguardian.com/science/2020/may/08/who-conditionally-backs-covid-19-vaccine-trials-that-infect-people">supports challenge trials</a> against COVID-19. Challenge trials deliberately expose people to infectious diseases to test vaccines or treatments.</p>
<p>They have long been key to clinical research and promise to be of even greater importance now. Researchers believe that challenge trials could significantly speed up the development of a COVID-19 vaccine, thereby saving thousands of lives.</p>
<p>Despite the serious risks for participants in the COVID-19 trials, over <a href="https://1daysooner.org/">24,000 people across 102 countries</a> have already offered to volunteer. One of them is Gavriel Kleinwaks, a 23-year-old undergraduate who wants to contribute to the greater good. </p>
<p>In an interview, <a href="https://www.theatlantic.com/ideas/archive/2020/04/challenge-trial-ethical-imperative/610309/">published in The Atlantic</a>, she said: “I’m young. I don’t get sick a lot. This seems like a way that I can share some of that luck. I empathize with other people.” </p>
<p>Another volunteer is Mabel Rosenheck, a 35-year-old historian, who shares these reasons for volunteering and is equally confident about her health. “Your body can do a lot of things that you might think it can’t,” she said. </p>
<p>Gavriel and Mabel could indeed make a significant contribution. But since COVID-19 challenge trials pose serious risks to participants, they can only be justified if, as <a href="https://apps.who.int/iris/bitstream/handle/10665/331976/WHO-2019-nCoV-Ethics_criteria-2020.1-eng.pdf?ua=1">the WHO stresses</a>, participants give “rigorous informed consent”. But unfortunately, the WHO glosses over the difficult challenges consent raises. </p>
<h2>Confront, control and compensate</h2>
<p>To make participants’ consent as good as it can be and so justify the COVID-19 challenge trials, we need to confront participants more explicitly with the risks they face. Statistical information is not enough. </p>
<p>Participants need to see realistic pictures or even videos about what can happen when risks materialise. This is important because people are likely to underestimate their own risk of being harmed and be subject to <a href="http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.507.9932&rep=rep1&type=pdf">“optimism bias”</a>, where people overestimate the odds of positive events and underestimate the odds of negative events happening to them.</p>
<p>Optimism bias also seems exacerbated when an outcome is something people greatly identify with, just as the way Gavriel and Mabel strongly identify with the moral significance of their participation. Consider Gavriel’s “I’m young. I don’t get sick a lot,” and Mabel’s “Your body can do a lot of things that you might think it can’t.”</p>
<p>What’s more, we need to ensure that their consent remains as informed as it can be. This is especially important because the possibility of genuinely informed consent is very limited right now. </p>
<p>As the <a href="https://apps.who.int/iris/bitstream/handle/10665/331976/WHO-2019-nCoV-Ethics_criteria-2020.1-eng.pdf?ua=1">WHO concedes</a>, “the pathogenesis of COVID-19 is currently poorly understood”. Yet we may gain new information about the virus during the trials, and if so, we need to inform participants about it and allow them to reconsider their consent. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/339164/original/file-20200602-133933-vzp95w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/339164/original/file-20200602-133933-vzp95w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/339164/original/file-20200602-133933-vzp95w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/339164/original/file-20200602-133933-vzp95w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/339164/original/file-20200602-133933-vzp95w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/339164/original/file-20200602-133933-vzp95w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/339164/original/file-20200602-133933-vzp95w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Consent needs to be as informed as it can.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/close-on-businessman-hand-signing-contract-394377388">charnsitr/Shutterstock</a></span>
</figcaption>
</figure>
<p>If participants are not informed or are deprived of the opportunity to withdraw from the trial without penalty or disadvantage, their consent to continued participation will be invalidated. </p>
<p>Finally, we need to compensate participants. As in other challenge trials, compensation should not only comprise reimbursement, such as travel expenses to medical facilities, but also further payment (in the UK, volunteers are paid <a href="https://www.telegraph.co.uk/global-health/science-and-disease/students-paid-3500-catch-potentially-deadly-diseases-science/">£ 3,500 to take part in challenge trials</a>). After all, participants like Gavriel and Mabel would accept serious personal risks to make a significant contribution to the fight against COVID-19.</p>
<p>But payment is not made just so Gavriel and Mabel are treated identically to participants in other trials. It is also about consent. </p>
<p>Contrary to widespread opinion, offering money <a href="https://pubmed.ncbi.nlm.nih.gov/15173366/">does not distort people’s judgment about risks</a>. In fact, when people are offered payment for their participation, their consent may even be better informed because they may be more likely to realise that what they are about to do is not a small favour but a significant burden. </p>
<p>Admittedly, some people will experience high pressure to enrol. As the virus has also caused an economic crisis, they will consider paid trial participation their best or even only option to avoid financial ruin. In this situation, the pressure and reluctance to enrol may arguably undermine the requirement for people’s consent to be voluntary. </p>
<p>We cannot ignore these people’s predicaments. Their situation is often not just a consequence of personal misfortune but one of social injustice, as certain groups are particularly vulnerable to the economic decline caused by the virus. </p>
<p>But excluding people from participation based on their supposedly involuntary consent is the wrong response. Volunteering is not enthusiasm, and being paid doesn’t signify reluctance. </p>
<p>To consent voluntarily, participants need to be free from external coercion or manipulation by others, but not from financial incentives. In fact, in many areas of our lives, we act voluntarily despite financial motives. </p>
<p>Also, it would seem paradoxical to exclude people with financial motives from the challenge trials. After all, our aim would be to protect them, but removing what they reasonably consider their best option would hardly be a way of protecting them.</p>
<p>So where does this leave us? The WHO correctly highlights the importance of informed consent in justifying COVID-19 challenge trials. But the WHO left us without guidance here. </p>
<p>To make consent as good as it can be and so justify the COVID-19 challenge trials, we need three Cs: we need to <em>confront</em> participants with salient information, constantly <em>control</em> the validity of their consent so it remains informed, and <em>compensate</em> them well.</p><img src="https://counter.theconversation.com/content/139884/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Maximilian Kiener receives funding from the European Research Council, under the European Union’s Horizon 2020 research and innovation programme (project ID: 789270). </span></em></p>There is a growing call for so-called challenge trials to speed up vaccine development.Maximilian Kiener, Extraordinary Junior Research Fellow in Philosophy, University of OxfordLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1287722019-12-16T03:54:00Z2019-12-16T03:54:00ZCall for clearer risk information for tourists following Whakaari/White Island tragedy<figure><img src="https://images.theconversation.com/files/306985/original/file-20191215-85404-hoj6ur.jpg?ixlib=rb-1.1.0&rect=32%2C68%2C2663%2C1657&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The Royal New Zealand Navy during a recovery operation on Whakaari/White Island, on December 13. Rescue and recovery efforts have been hampered by hazardous conditions on the island, and the danger of another eruption. </span> <span class="attribution"><span class="source">EPA/Royal NZ Navy</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span></figcaption></figure><p>In the aftermath of the tragedy at Whakaari/White Island on December 9, many are analysing the <a href="https://theconversation.com/why-were-tourists-allowed-on-white-island-128621">risks of adventure tourism</a>, particularly volcano tourism, and asking pointed questions. </p>
<p>It is a sensitive time, with 16 people now confirmed dead, many hospitalised in critical condition, and two bodies yet to be retrieved from the disaster zone. </p>
<p>We question whether the tourists caught up in the events actually knew the risks they faced, and whether other tourist groups may be unaware of the potential risks that their travel decisions may carry.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/sNpc3JcbPU0?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Although geologists are monitoring Whakaari/White Island, some volcanic activity cannot be predicted.</span></figcaption>
</figure>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-were-tourists-allowed-on-white-island-128621">Why were tourists allowed on White Island?</a>
</strong>
</em>
</p>
<hr>
<h2>Risk assessment and visitor safety</h2>
<p>The websites for White Island Tours and the promotion pages on the Bay of Plenty website are currently not viewable. But the <a href="https://www.tripadvisor.com.au/Attraction_Review-g652408-d1603032-Reviews-White_Island_Tours-Whakatane_Bay_of_Plenty_Region_North_Island.html">Trip Advisor site for Whakaari</a> calls it “New Zealand’s most active volcano”. It mentions the need for gas masks and hard hats and describes conditions of a still active volcano, including steam vents and sulphurous fumes.</p>
<p>But it is doubtful that cruise ship passengers, such as those from the Ovation of the Seas, would have done such research. Cruises offer a variety of shore excursions when in port, ranging from passive sightseeing to adventure activities. </p>
<p>Many tourists will assume endorsed excursions have been properly vetted by their cruise company and assume there is negligible risk to personal safety. But this may not be the case. </p>
<p>Major cruise lines such as Royal Caribbean visit multiple destinations with very different regulatory environments. The assumption that shore excursions will be safe may be misplaced, both by the cruise line and the visitors they book on such excursions. This is now clear from the events at Whakaari but also in previous incidents, such as <a href="https://www.seattletimes.com/life/travel/can-cruise-lines-ensure-shore-excursions-are-safe/">last year’s fatal bus crash</a> in Mexico.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/306987/original/file-20191215-85391-1csvpub.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/306987/original/file-20191215-85391-1csvpub.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=439&fit=crop&dpr=1 600w, https://images.theconversation.com/files/306987/original/file-20191215-85391-1csvpub.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=439&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/306987/original/file-20191215-85391-1csvpub.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=439&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/306987/original/file-20191215-85391-1csvpub.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=552&fit=crop&dpr=1 754w, https://images.theconversation.com/files/306987/original/file-20191215-85391-1csvpub.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=552&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/306987/original/file-20191215-85391-1csvpub.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=552&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Local supporters gather on the quayside as a boat that carried families for a morning blessing at White Island returns during a recovery operation to retrieve the remaining bodies.</span>
<span class="attribution"><span class="source">AAP/David Rowland</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<h2>Adventure capital</h2>
<p>New Zealand is known as an adventure tourism destination, but its regulatory systems have undergone recent change. After 37 deaths over four years, then prime minister John Key <a href="http://www.stuff.co.nz/ipad-editors-picks/10339571/The-dark-side-of-adventure-tourism">ordered an urgent safety audit</a> in 2009. </p>
<p>This resulted in a shift, from 2013, from a voluntary system under Outdoors New Zealand and the regulatory system under Worksafe NZ to the <a href="https://www.jas-anz.org/new-zealand-adventure-activities-certification-nzaac-scheme">New Zealand adventure activity certification scheme</a>. Some tour operators have found this audit system too onerous. Striking the right balance between risk management while allowing the adventure tourism sector to thrive has proved difficult.</p>
<p>But the case of Whakaari/White Island is unique in many ways. The island is privately owned. GeoNet monitors volcanic activity and <a href="https://www.geonet.org.nz/volcano/vab/">rates the threat level</a>. The tour companies then assess the risk and determine if visits can proceed or should be temporarily suspended. </p>
<p>Three companies have operated tours to Whakaari/White Island, including the Māori-owned White Island Tours (owned by Ngāti Awa). The other two are helicopter companies Kahu and Volcanic Air Safaris. White Island Tours was accredited under <a href="https://www.adventuremark.co.nz/">AdventureMark</a>, which is a Worksafe NZ approved certification body.</p>
<p>We must await the Worksafe investigation to know whether it was reasonable to allow the tours to go ahead when volcanic risk rating had risen from level 1 to level 2. We also still await the full human toll, knowing that recovery for survivors may take years. It is also clear that the impact on Ngāti Awa and the <a href="https://www.theguardian.com/world/2019/dec/11/white-island-eruption-mayor-of-whakatane-wants-tours-to-eventually-resume">Whakatāne community</a> has been profound.</p>
<h2>Inherent risk in active environments</h2>
<p>In laying out these complexities in which small private tour companies and large internationally owned cruise ships took <a href="https://www.nzherald.co.nz/business/news/article.cfm?c_id=3&objectid=12292390">thousands of visitors to Whakaari each year</a>, we underscore how difficult an assessment of risk might be for some visitors. </p>
<p>Adventure tourists typically make an assessment weighing up risks against the thrills they seek to achieve. New Zealand’s reputation for adventure tourism is built in part on well developed policy settings and regulatory regimes, and an expectation among visitors of high adventure safety standards. </p>
<p>Risk - both perceived and actual – is carefully managed to ensure that perceived risk is high but actual risk is as low as humanly possible. The reputation of the sector and, indeed, the interests of the wider New Zealand tourism industry hinge on high safety standards. For example, bungy jumping appears to be very high risk, but its commercial viability comes from the highly controlled operation, which means actual risk is in fact very low. </p>
<p>Set against this are longstanding activities that take visitors into spectacular settings to experience firsthand the wonders of nature. Such environments do present inherent risk even if many decades may pass between natural events. </p>
<p>The <a href="https://www.stuff.co.nz/national/108949437/pink-and-white-terraces-niwa-scientists-confirm-the-location-of-nzs-lost-natural-wonder">Pink and White Terraces</a> – the largest silica sinter deposit on earth - were a spectacular visitor attraction in the mid-19th century, and the centrepiece of Māori tourism development. That was until they were completely destroyed by the eruption of Mount Tarawera in 1886. </p>
<p>New Zealand’s most stunning natural vistas – Aoraki/Mount Cook, the fjords of Te Wahipounamu world heritage area, towering glaciers and raging rivers - are the result of millions of years of seismic activity on the <a href="https://www.otago.ac.nz/geology/research/structural-geology/alpine-fault/nz-tectonics.html">Pacific and Australian tectonic plate boundary</a>. These environments are dynamic and, at times, very destructive. </p>
<p>These settings contrast adventure tourism activities. Risk may be perceived as low or non-existent given that these environments may be largely inactive for years. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-white-island-erupted-and-why-there-was-no-warning-128550">Why White Island erupted and why there was no warning</a>
</strong>
</em>
</p>
<hr>
<h2>Informed consent</h2>
<p>In a complex international environment, the ultimate decision to participate in activities in dynamic and potentially destructive environments rests with the visitors. </p>
<p>Ultimately, visitor welfare depends on informed visitor choice. This case highlights the need for consent forms to be signed in many more cases, beyond those already used in <a href="https://www.gadventures.com.au/terms-conditions/participation-waiver/">adventure tourism</a> and medical tourism. </p>
<p>Such documents should make clear the nature of the possible risks. Elevated risk levels on the day of the visit as well as changing risk levels in the days prior to the scheduled visit should be clearly communicated. Participation should only proceed after informed consent is secured.</p>
<p>Such an approach does not obviate the need for accreditation, audits, regulations and strict oversight by relevant authorities. But it does ensure that tourists play their part in deciding what risks are worth taking on their holidays.</p>
<p>We cannot undo the events that unfolded at Whakaari/ White Island, but we can honour lives lost by making absolutely sure that we learn from this tragedy.</p><img src="https://counter.theconversation.com/content/128772/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The tragedy at Whakaari/White Island highlights the need for consent forms to ensure tourists are fully informed when choosing to visit dangerous locations.Freya Higgins-Desbiolles, Senior Lecturer in Tourism Management, University of South AustraliaJames Higham, Professor of Tourism, University of OtagoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1272192019-12-03T12:58:24Z2019-12-03T12:58:24ZThe tricky ethics of Google’s Project Nightingale, an effort to learn from millions of health records<figure><img src="https://images.theconversation.com/files/304594/original/file-20191202-156090-bijojj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Sharing electronic medical records broadly could identify trends as well as mistakes, but it also poses privacy concerns.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/electronic-medical-record-concept-776687482">Metamorworks/Shutterstock.com</a></span></figcaption></figure><p>The nation’s second-largest health system, <a href="https://ascension.org/about">Ascension</a>, has agreed to allow the software behemoth Google access to tens of millions of patient records. The partnership, called Project Nightingale, aims to improve how information is used for patient care. Specifically, Ascension and Google are trying to build tools, including artificial intelligence and machine learning, “<a href="https://www.blog.google/technology/health/google-health-provider-tools-launch/">to make health records more useful, more accessible and more searchable</a>” for doctors. </p>
<p>Ascension did not announce the partnership: <a href="https://www.wsj.com/articles/google-s-secret-project-nightingale-gathers-personal-health-data-on-millions-of-americans-11573496790">The Wall Street Journal</a> first reported it. </p>
<p>Patients and doctors have <a href="https://khn.org/morning-breakout/fallout-from-googles-project-nightingale-revelation-a-federal-inquiry-lawmakers-criticism-and-patient-privacy-fears/">raised privacy concerns</a> about the plan. Lack of notice to doctors and consent from patients are the primary concerns. </p>
<p>As a <a href="https://scholar.google.com/citations?user=tmpezAkAAAAJ&hl=en">public health lawyer</a>, I study the legal and ethical basis for using data to promote public health. Information can be used to identify health threats, understand how diseases spread and decide how to spend resources. But it’s more complicated than that. </p>
<p>The law deals with what can be done with data; this piece focuses on ethics, which asks what should be done. </p>
<h2>Beyond Hippocrates</h2>
<p>Big-data projects like this one should always be ethically scrutinized. However, data ethics debates are often narrowly focused on consent issues.</p>
<p>In fact, ethical determinations require balancing different, and sometimes competing, ethical principles. Sometimes it might be ethical to collect and use highly sensitive information without getting an individual’s consent.</p>
<p>Public health ethics are useful to evaluate activities that affect population health. A recent report by the <a href="https://www.who.int/ethics/publications/public-health-surveillance/en/">World Health Organization (WHO)</a> describes public health ethics with four principles: </p>
<ul>
<li>Common Good – Does the activity promote collective benefit?</li>
<li>Equity – Does the activity reduce the burdens or risks to health or opportunity?</li>
<li>Respect for Persons – Does the activity support individual rights and interests?</li>
<li>Good Governance – Does the activity have processes for public transparency and accountability?</li>
</ul>
<p>Public health ethics is an appropriate framework for evaluating Project Nightingale, given its massive scale. But the current health care context is relevant. </p>
<h2>The system and its struggles</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/304779/original/file-20191202-67034-hoysyw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/304779/original/file-20191202-67034-hoysyw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/304779/original/file-20191202-67034-hoysyw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/304779/original/file-20191202-67034-hoysyw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/304779/original/file-20191202-67034-hoysyw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/304779/original/file-20191202-67034-hoysyw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/304779/original/file-20191202-67034-hoysyw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A doctor at a patient’s bedside could benefit from knowing how other patients in similar situations have fared. That knowledge could be enhanced by sharing data contained in medical records.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-talking-senior-couple-hospital-280365218">Monkey Business Images/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>For over a <a href="https://doi.org/10.1377/hlthaff.26.2.w107">decade</a>, scholars have argued that technological solutions are needed to address three major challenges to how the health system uses information. </p>
<p>First, the health system struggles to integrate new knowledge into patient care. New medical evidence takes <a href="http://www.ihi.org/resources/Pages/Publications/Managingclinicalknowledgeforhealthcareimprovement.aspx">17 years</a> to change clinical practice, on average. The breakneck <a href="https://doi.org/10.1377/hlthaff.26.2.w107">pace of science</a> challenges doctors to keep up. And, applying modern medical knowledge requires doctors to consider <a href="https://doi.org/10.1200/JCO.2010.28.5478">more factors than is humanly possible</a>.</p>
<p>Second, information is central to preventing many medical errors, the <a href="https://doi.org/10.1136/bmj.i2139">third leading cause of death</a> in America. Communication problems, judgment errors and incorrect diagnosis or treatment decisions can have devastating consequences for patients. </p>
<p>Third, the system does not learn from care. For example, a doctor and patient might try several different medications before finding the right one. One medication might not help, another might cause awful side effects, and finding the best medication might take months or years. The health system does not learn from that care process. Individual providers will gain knowledge over a lifetime, but that knowledge is never aggregated or shared efficiently. </p>
<p>To help address these challenges, the Institute of Medicine in 2007 introduced a vision for a <a href="http://www.nationalacademies.org/hmd/reports/2007/the-learning-healthcare-system-workshop-summary.aspx">learning health system</a> that would quickly learn from patient care and use that knowledge to improve future care. </p>
<p>The concept is simple, but learning health systems require sophisticated information technology platforms capable of extracting knowledge from the existing evidence and millions of treatment records. </p>
<h2>The benefits of Project Nightingale</h2>
<p>Project Nightingale appears to align with the learning health system concept.
Systematically improving health care is a clear common good. </p>
<p>Although a learning health system requires sharing patient data, patients stand to benefit from improved health care. Reciprocal data sharing by patients for a collective benefit is a prototypical example of the “common good” principle in public health ethics. </p>
<p>Project Nightingale might also improve health equity. For example, <a href="https://www.aamc.org/news-insights/more-minorities-needed-clinical-trials-make-research-relevant-all">minorities </a>and <a href="https://doi.org/10.1186/s12978-017-0419-x">pregnant women</a> are underrepresented in research studies, raising concerns that some medical knowledge might not be well tailored to these patients. A learning health system would improve understanding of what treatments are effective and safe for these underrepresented populations.</p>
<p>For small-scale activities, respect for persons usually demands giving people an opportunity to make a free and informed decision to participate. However, for activities carried out at the scale of the whole population, it is possible to show respect for persons by engaging the public and inviting them into the decision-making process. It is not clear whether Ascension or Google involved the public or patients in Project Nightingale.</p>
<h2>The downsides</h2>
<p>Some patients have <a href="https://www.theguardian.com/technology/2019/nov/12/google-medical-data-project-nightingale-secret-transfer-us-health-information">criticized</a> Project Nightingale because it does not have an “opt-out” for patients who do not want their information shared. </p>
<p>However, opt-out systems raise ethical concerns, too. They permit free riders who will benefit from the knowledge gained from the participants. Second, knowledge from a learning health system could be <a href="https://doi.org/10.1136/hrt.2007.120113">biased</a> if <a href="https://academic.oup.com/jssam/article-abstract/4/3/382/2399768?redirectedFrom=fulltext">enough people opt out</a>. If so, opting out could expose others to riskier health care. </p>
<p>Good governance is critical to support a “common good” activity that conflicts with some individual interests. Transparency and accountability are crucial to keep the parties honest and open to public scrutiny. They also empower people to demand government action against an activity that cannot be ethically justified. There is little, if any, reported evidence that Project Nightingale has sufficient transparency or accountability processes. This is likely to be the biggest ethical challenge to Project Nightingale. </p>
<h2>Issues of consent</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/304781/original/file-20191202-67023-1jfmpe5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/304781/original/file-20191202-67023-1jfmpe5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/304781/original/file-20191202-67023-1jfmpe5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/304781/original/file-20191202-67023-1jfmpe5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/304781/original/file-20191202-67023-1jfmpe5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/304781/original/file-20191202-67023-1jfmpe5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/304781/original/file-20191202-67023-1jfmpe5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">In most circumstances, patients must sign consent forms before their private medical information can be shared.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/female-doctor-hand-hold-silver-pen-1183430263">H_Ko/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>Some of the biggest concerns have been about consent. However, public health ethics do not always require consent. One recent <a href="https://www.who.int/ethics/publications/public-health-surveillance/en/">WHO ethical guideline</a> says:</p>
<p>“Individuals have an obligation to contribute … when reliable, valid, complete data sets are required and relevant protection is in place. Under these circumstances, informed consent is not ethically required.”</p>
<p>The basic argument is that individuals have a moral obligation to contribute when there is low individual risk and high population benefit. </p>
<p>Currently, the public does not know enough about Project Nightingale to make definitive ethical judgments. However, public health ethics likely provides some support for what Google and Ascension are trying to do. The more critical ethical issue might turn on how Google and Ascension are doing it. </p>
<p>[ <em><a href="https://theconversation.com/us/newsletters?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=expertise">Expertise in your inbox. Sign up for The Conversation’s newsletter and get a digest of academic takes on today’s news, every day.</a></em> ]</p><img src="https://counter.theconversation.com/content/127219/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Cason Schmit does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A project involving tens of millions of patient records poses ethical issues, even though patients could ultimately gain. Here’s why privacy concerns are a hurdle.Cason Schmit, Assistant Professor of Public Health, Texas A&M UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1162632019-06-27T03:31:46Z2019-06-27T03:31:46ZInfecting healthy people in vaccine research can be ethical and necessary<figure><img src="https://images.theconversation.com/files/278473/original/file-20190607-52762-rsjii1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Human challenge studies can be useful to test new vaccines and are increasingly being used internationally. Yet there are several ethical issues to consider.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/181674146?src=XTw248nYCP_PwgL1Gs9HJQ-1-11&studio=1&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>Medical experiments involving intentionally infecting people with bacteria, viruses, and parasites are surprisingly common. And they are becoming more common worldwide, particularly in developing countries.</p>
<p>The ultimate aim of these “human challenge studies” is usually to test potential new vaccines.</p>
<p>However, because of the risks involved, this kind of research raises difficult ethical questions. For example, who should be infected? And which pathogens would be too dangerous to use?</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/care-and-consent-the-fraught-ethics-of-international-clinical-trials-12602">Care and consent: the fraught ethics of international clinical trials</a>
</strong>
</em>
</p>
<hr>
<p>In many challenge studies, people are first vaccinated with an experimental vaccine, then deliberately exposed to a pathogen and monitored to see if the vaccine protected them against infection.</p>
<p>These studies can be especially valuable from a scientific perspective. They can be significantly <a href="https://www.ncbi.nlm.nih.gov/pubmed/21179119">faster and less expensive</a> than other kinds of vaccine research. They are also usually much smaller, because <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6215823/">fewer people</a> need to be given experimental vaccines (that might not turn out to be safe or effective).</p>
<p>These studies sometimes involve infecting people with deadly diseases such as <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0038434">malaria</a>. In such cases, however, researchers are especially careful to minimise risks by ensuring study participants are provided with treatment.</p>
<h2>How can this be ethical?</h2>
<p>The very idea of intentionally infecting humans with diseases will likely strike many people as unethical. </p>
<p>The history of human challenge studies is <a href="https://global.oup.com/academic/product/the-oxford-textbook-of-clinical-research-ethics-9780199768639?q=oxford%20textbook%20research%20ethics&lang=en&cc=au#">tarnished</a>. Some of the most blatantly unethical medical research ever conducted involved intentional infection. During world war two, for example, German and Japanese researchers infected prisoners with diseases such as tuberculosis and plague, killing them in the process.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/two-steps-forward-one-step-back-how-world-war-ii-changed-how-we-do-human-research-39929">Two steps forward, one step back: how World War II changed how we do human research</a>
</strong>
</em>
</p>
<hr>
<p>According to most bioethicists who have discussed this topic, however, intentionally infecting people in a clinical trials isn’t necessarily unethical, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5926904/">at least under certain conditions</a>.</p>
<p>Rather than intentional infection, the problem with the infamous historical cases is they involved cruel and brutal treatment of people against their will.</p>
<p>But human challenge studies can be ethically acceptable so long as we meet <a href="https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/">basic research ethics requirements</a>. </p>
<p>Among other things, this should involve proper informed consent and minimising risks. There should also be legitimate scientific reasons for performing the study.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/human-experiments-the-good-the-bad-and-the-ugly-39876">Human experiments – the good, the bad, and the ugly</a>
</strong>
</em>
</p>
<hr>
<p>Modern human challenge studies are regularly approved by research ethics committees. They have been <a href="https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00068-7/fulltext">safely conducted</a> with no deaths or severe lasting harms.</p>
<p>Other types of research with healthy volunteers are sometimes more dangerous. One UK trial of an <a href="https://www.bbc.com/news/magazine-35766627">experimental drug</a> had life-threatening consequences for six volunteers. One reportedly remained in hospital for four months, and all his toes had to be amputated. By comparison, infections in challenge studies are usually much more predictable and easier to treat.</p>
<h2>Should this occur in developing countries?</h2>
<p>Most recent human challenges studies have taken place in wealthy, developed nations. This might partly reflect the aim of scientists to avoid conducting experiments on especially vulnerable people in developing countries.</p>
<p>But a recent development is the expansion of human challenge studies into low- and middle-income countries – such as Thailand, Colombia, Kenya (and other African countries) – where diseases of interest are more common.</p>
<p>One motivation for this shift is to obtain results more relevant to the populations in these countries. For instance, the diseases and/or vaccines might affect these populations differently to people in developed nations due to variation in immunity, genetics or nutrition.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-researchers-assess-whether-medications-work-102773">How researchers assess whether medications work</a>
</strong>
</em>
</p>
<hr>
<p>Beyond being merely permissible, there may be an ethical imperative to <a href="https://ijme.in/articles/ethical-challenges-posed-by-human-infection-challenge-studies-in-endemic-settings/?galley=html">conduct more challenge studies in countries where the target disease is endemic</a> or widespread.</p>
<p>The fact that participants from endemic countries are more likely to be partially immune to diseases being studied means that conducting local challenge studies might involve less risk to them. </p>
<p>Studies can also sometimes directly benefit trial participants. That’s because infection during a study can lead to immunity against a disease to which they otherwise would have been at risk, or because they receive a vaccine that protects them. </p>
<p>Such benefits do not usually result when challenge studies are conducted in rich countries where the disease does not normally occur.</p>
<h2>What ethical issues remain?</h2>
<p>Though human challenge studies can be ethical – even in low- and middle-income countries – there are numerous unresolved issues about the conditions under which this kind of research should be conducted.</p>
<p><strong>Who should take part in these studies?</strong> </p>
<p>Some studies have aimed to <a href="https://malariajournal.biomedcentral.com/articles/10.1186/s12936-015-0671-x">recruit university students</a> because, being more educated, they may be better able to provide adequate informed consent. But students might not provide a good representative sample of the general population, or they might feel pressure to participate in research being conducted at their institutions or by their academic superiors.</p>
<p><strong>How much should participants be paid?</strong></p>
<p>It is generally agreed that subjects should <a href="https://www.nejm.org/doi/full/10.1056/NEJMsb1710591">be paid for the costs they incur</a> while taking part in a study. This might include the costs of travel or loss of usual income. </p>
<p>Whether, or the extent to which, they should receive further payments reflecting the risks or other burdens endured, is more controversial. </p>
<p>Some say <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/bioe.12596">higher levels of payment</a> reflecting burdens or risks endured would be appropriate, just as some workers receive higher pay for doing dangerous jobs. </p>
<p>Others <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4214066/">worry</a> that high levels of payment might be an irresistible lure, especially for poor people. It appears that <a href="https://www.telegraph.co.uk/news/0/students-paid-3500-catch-potentially-deadly-diseases-science/">payment has been a major motivation</a> for people to participate in challenge studies in both <a href="https://journals.sagepub.com/doi/abs/10.1177/1556264618820219">high-income</a> and <a href="https://wellcomeopenresearch.org/articles/3-39/v2">low-income</a> countries. </p>
<p><strong>Should children be involved?</strong></p>
<p>Would it ever be acceptable to involve children in challenge studies?</p>
<p>Because diseases and/or vaccines might affect children differently, conducting research with adults might not always provide reliable enough information about the safety and efficacy of vaccines for children.</p>
<p>But children are widely considered especially vulnerable because, among other reasons, they cannot provide informed consent.</p>
<p><strong>Are there some pathogens that should never be tested?</strong></p>
<p>In general, challenge studies involving high risks that cannot be easily controlled should presumably not be permitted. The use of pathogens <a href="https://wellcomeopenresearch.org/articles/3-39/v2">like HIV</a>, for example, should be off limits.</p>
<h2>In a nutshell</h2>
<p>Human challenge studies are sometimes ethically acceptable. And it may be important to conduct them, especially in low- and middle-income countries where neglected diseases are most common. </p>
<p>Yet we still need bioethicists, policymakers and the general public to discuss unresolved ethical questions about where, when and how they should be conducted.</p><img src="https://counter.theconversation.com/content/116263/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>This work was supported by the Wellcome Trust (210551/Z/18/Z)</span></em></p>Deliberately infecting people with a disease-causing agent as part of carefully considered medical research can be ethically acceptable or even necessary.Michael Selgelid, Director, Centre for Human Bioethics; Director, World Health Organization Collaborating Centre for Bioethics, Monash UniversityEuzebiusz Jamrozik, PhD Candidate, Centre for Human Bioethics, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1090592019-01-14T11:41:12Z2019-01-14T11:41:12ZChange your phone settings so Apple, Google can’t track your movements<figure><img src="https://images.theconversation.com/files/253289/original/file-20190110-43532-1j995wv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Your phone tracks your movements all the time.</span> <span class="attribution"><a class="source" href="https://www.nytimes.com/interactive/2018/12/10/business/location-data-privacy-apps.html">grapestock/Shutterstock.com</a></span></figcaption></figure><p>Technology companies have been pummeled by revelations about how <a href="https://theconversation.com/7-in-10-smartphone-apps-share-your-data-with-third-party-services-72404">poorly they protect</a> their customers’ <a href="https://theconversation.com/should-cybersecurity-be-a-human-right-72342">personal information</a>, including an in-depth New York Times report detailing the ability of <a href="https://www.nytimes.com/interactive/2018/12/10/business/location-data-privacy-apps.html">smartphone apps to track users’ locations</a>. Some companies, most notably Apple, have begun promoting the fact that they <a href="https://phys.org/news/2019-01-privacy-tech.html">sell products and services</a> that safeguard consumer privacy. </p>
<p>Smartphone users are never asked explicitly if they want to be tracked every moment of each day. But cellular companies, smartphone makers, app developers and social media companies all <a href="https://www.businessinsider.com/facebook-gave-device-makers-apple-and-samsung-user-data-2018-6">claim they have users’ permission</a> to conduct near-constant personal surveillance. </p>
<p>The underlying problem is that most people don’t understand <a href="https://theconversation.com/your-mobile-phone-can-give-away-your-location-even-if-you-tell-it-not-to-65443">how tracking really works</a>. The technology companies haven’t helped <a href="https://theconversation.com/your-smartphone-apps-are-tracking-your-every-move-4-essential-reads-108586">teach their customers</a> about it, either. In fact, they’ve intentionally obscured important details to build a multi-billion-dollar data economy based on an ethically questionable notion of informed consent.</p>
<h2>How consumers are made to agree</h2>
<p>Most companies disclose their data protection practices in a privacy policy; most software requires users to click a button saying they accept the terms before using the program. </p>
<p>But people don’t always have a free choice. Instead, it’s a “take-it-or-leave-it” agreement, in which a customer can use the service only if they agree.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/253292/original/file-20190110-43541-15qs5mk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/253292/original/file-20190110-43541-15qs5mk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/253292/original/file-20190110-43541-15qs5mk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/253292/original/file-20190110-43541-15qs5mk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/253292/original/file-20190110-43541-15qs5mk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/253292/original/file-20190110-43541-15qs5mk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/253292/original/file-20190110-43541-15qs5mk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Consumers often do not have a free choice when it comes to privacy agreements.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/data-privacy-technology-concept-538396183?src=d4-hzpqBFlCASOZSa-jb3Q-1-50">Marta Design/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>Anyone who actually wants to <a href="https://theconversation.com/nobody-reads-privacy-policies-heres-how-to-fix-that-81932">understand what the policies say</a> finds the details are buried in <a href="http://lorrie.cranor.org/pubs/readingPolicyCost-authorDraft.pdf">long legal documents</a> unreadable by nearly everyone, perhaps except the lawyers who helped create them.</p>
<p>Often, these policies will begin with a blanket statement like “<a href="https://www.google.com/search?q=%22privacy+is+important+to+us%22+%22privacy+policy%22">your privacy is important to us</a>.” However, the actual terms describe a different reality. It’s usually not too far-fetched to say that the company can basically <a href="https://www.facebook.com/policy.php">do whatever it wants</a> with your personal information, <a href="https://theconversation.com/fragmented-us-privacy-rules-leave-large-data-loopholes-for-facebook-and-others-94606">as long as it has informed you</a> about it.</p>
<p>U.S. federal law <a href="https://theconversation.com/fragmented-us-privacy-rules-leave-large-data-loopholes-for-facebook-and-others-94606">does not require</a> that a company’s privacy policy actually protect users’ privacy. Nor are there any requirements that a company must inform consumers of its practices in clear, nonlegal language or provide consumers a <a href="https://theconversation.com/teaching-machines-to-understand-and-summarize-text-78236">notice in a user-friendly way</a>.</p>
<p>Theoretically, users might be able to vote with their feet and find similar services from a <a href="https://theconversation.com/how-companies-can-stay-ahead-of-the-cybersecurity-curve-74414">company with better data-privacy practices</a>. But take-it-or-leave-it agreements for technologically advanced tools <a href="https://ssrn.com/abstract=3141290">limit the power of competition</a> across nearly the entire technology industry.</p>
<h2>Data sold to third parties</h2>
<p>There are a few situations where mobile platform companies like Apple and Google have let people exercise some control over data collection. </p>
<p>For example, both companies’ mobile operating systems let users turn off location services, such as GPS tracking. Ideally, this should prevent most apps from collecting your location – but it <a href="https://theconversation.com/your-mobile-phone-can-give-away-your-location-even-if-you-tell-it-not-to-65443">doesn’t always</a>. Further, it does nothing if <a href="https://motherboard.vice.com/en_us/article/nepxbz/i-gave-a-bounty-hunter-300-dollars-located-phone-microbilt-zumigo-tmobile">your mobile provider resells your phone’s location information to third parties</a>. </p>
<p>App makers are also able to persuade users not to turn off location services, again with take-it-or-leave-it notifications. When managing privileges for iOS apps, <a href="https://support.apple.com/en-us/HT203033">users get to choose</a> whether the app can access the phone’s location “always,” “while using the app” or “never.” </p>
<p>But changing the setting can trigger a discouraging message: “We need your location information to improve your experience,” says one app. Users are not asked other important questions, like whether they approve of the app <a href="https://theconversation.com/7-in-10-smartphone-apps-share-your-data-with-third-party-services-72404">selling their location history</a> to other companies.</p>
<p>And many users don’t know that even when their name and contact information is removed from location data, even a modest location history can <a href="https://www.nytimes.com/interactive/2018/12/10/business/location-data-privacy-apps.html">reveal their home addresses</a> and the places they visit most, offering clues to their identities, medical conditions and personal relationships.</p>
<h2>Why people don’t opt out</h2>
<p>Websites and apps make it difficult, and sometimes impossible, for most people <a href="http://science.sciencemag.org/content/347/6221/509.full">to say no</a> to aggressive surveillance and data collection practices. In my role as a <a href="https://scholar.google.com/citations?user=O5jENBMAAAAJ&hl=en">scholar of human-computer interaction</a>, one issue I study is the power of defaults.</p>
<p>When companies set a default in a system, such as “location services set to on,” <a href="https://chicagounbound.uchicago.edu/cgi/viewcontent.cgi?article=1184&context=public_law_and_legal_theory">people are unlikely to change it</a>, especially if they are unaware there are other options they could choose. </p>
<p>Further, when it is inconvenient to change the location services, as is the case on both iOS and Android systems today, <a href="https://www.nngroup.com/articles/minimize-cognitive-load/">it’s even less likely that people will opt out of location collection</a> – even when they dislike it.</p>
<p>Companies’ take-it-or-leave-it privacy policies and default choices for users’ privacy settings have created an environment where people are unaware that their lives are being subjected to minute-by-minute surveillance. </p>
<p>They’re also mostly not aware that information that could identify them individually is resold to create <a href="https://theconversation.com/solving-the-political-ad-problem-with-transparency-85366">ever-more-targeted advertising</a>. Yet the companies can legally, if not ethically, <a href="https://www.brookings.edu/research/why-protecting-privacy-is-a-losing-game-today-and-how-to-change-the-game/">claim that everyone agreed</a> to it.</p>
<h2>Overcoming the power of defaults</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/253290/original/file-20190110-43538-m9duzu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/253290/original/file-20190110-43538-m9duzu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=426&fit=crop&dpr=1 600w, https://images.theconversation.com/files/253290/original/file-20190110-43538-m9duzu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=426&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/253290/original/file-20190110-43538-m9duzu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=426&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/253290/original/file-20190110-43538-m9duzu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=535&fit=crop&dpr=1 754w, https://images.theconversation.com/files/253290/original/file-20190110-43538-m9duzu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=535&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/253290/original/file-20190110-43538-m9duzu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=535&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Monitor your phone’s default settings.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/close-man-using-3d-generated-mobile-430745644?src=s1_-hhp3cvVqzzC59yoLqQ-1-16">Georgejmclittle/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>Privacy researchers know that people <a href="https://dx.doi.org/10.2139/ssrn.2103405">dislike these practices</a>, and that <a href="https://escholarship.org/uc/item/5hw5w5c1">many would stop using these services</a> if they understood the extent of the data collection. If invasive surveillance is the price of using free services, many would rather pay or at least see companies held to <a href="http://www.pewinternet.org/2016/01/14/the-state-of-privacy/">stronger data collection regulations</a>.</p>
<p>The companies know this too, which is why, I argue, they use a form of coercion to ensure participation.</p>
<p>Until the U.S. has regulations that, at a minimum, require companies to ask for explicit consent, individuals will need to know how to protect their privacy. Here are my three suggestions: </p>
<ul>
<li><p>Start by learning how to turn off location services on your <a href="https://support.apple.com/en-us/HT207092">iPhone</a> or <a href="https://support.google.com/accounts/answer/3467281?hl=en">Android</a> device. </p></li>
<li><p>Turn location on only when using an app that clearly needs location to function, such as a map.</p></li>
<li><p>Avoid apps, such as Facebook Mobile, that <a href="https://www.theverge.com/2018/3/25/17160944/facebook-call-history-sms-data-collection-android">dig deeply into your phone</a> for as much personal information as possible; instead, use a browser with a private mode, <a href="https://www.mozilla.org/en-US/firefox/new/">like Firefox</a>, instead. </p></li>
</ul>
<p>Don’t let default settings reveal more about you than you want.</p><img src="https://counter.theconversation.com/content/109059/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The Center for Internet and Society receives funding from multiple organizations; information is available here: <a href="http://cyberlaw.stanford.edu/about-us">http://cyberlaw.stanford.edu/about-us</a></span></em></p>Most tech companies make it difficult for users to say no to aggressive surveillance practices. But it is helpful to know about the default settings on your smartphone and how to change them.Jen King, Director of Consumer Privacy, Center for Internet and Society, Stanford UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1080082018-12-03T11:33:25Z2018-12-03T11:33:25ZCRISPR babies raise an uncomfortable reality – abiding by scientific standards doesn’t guarantee ethical research<figure><img src="https://images.theconversation.com/files/248287/original/file-20181202-194922-5bsecs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">What does oversight really ensure?</span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/gKUC4TMhOiY">Ousa Chea/Unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>Uncertainty continues to swirl around scientist He Jiankui’s gene editing experiment in China. Using CRISPR technology, He modified a gene related to immune function in human embryos and transferred the embryos to their mother’s womb, producing twin girls.</p>
<p>Many <a href="https://theconversation.com/rogue-science-strikes-again-the-case-of-the-first-gene-edited-babies-107684">questions about the ethical acceptability</a> of the experiment have focused on ethical oversight and informed consent. These are important issues; compliance with established standards of practice is crucial for public trust in science.</p>
<p>But public debate about the experiment should not make the mistake of equating ethical oversight with ethical acceptability. Research that follows the rules is not necessarily good by definition. As He pushed ahead with human gene editing, how much he skirted the rules may not be his primary ethical failing.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">He is taking heat from the scientific community.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Hong-Kong-Gene-Edited-Babies/c4861b5b2a384c5f955b6b8a77839100/12/0">AP Photo/Kin Cheung</a></span>
</figcaption>
</figure>
<h2>The ‘right’ way to conduct research</h2>
<p>A statement signed by 122 Chinese scientists <a href="https://doi.org/10.1038/d41586-018-07545-0">proclaimed He’s work “crazy”</a> and in violation of ethical standards. Is that really the case?</p>
<p>Scientists undertake medical research to generate knowledge that may one day be used to improve human health. This work can help determine new strategies for prevention and early detection of disease, or develop new drugs and new technologies for treatment, for example. Without investigating them, no one knows which preventive measures, diagnostic tools, or treatments are most beneficial. They need to be rigorously tested.</p>
<p>Ethicists tend to focus most on studies that ask a lot of human subjects because these usually carry the most risks for volunteers. Picture a drug study with participants taking an experimental medication, keeping a daily diary of symptoms and side effects, meeting frequently with a physician and so on.</p>
<p>There’s a long history of abuse and misuse of human subjects in research, from medical workers <a href="https://www.theatlantic.com/politics/archive/2016/06/tuskegee-study-medical-distrust-research/487439/">withholding syphilis treatment from unsuspecting black men in Tuskegeee, Alabama</a> so they could track the disease’s progress, to the <a href="https://doi.org/10.2105/AJPH.2013.301520">deliberate infection of research participants with syphilis</a> in Guatemala in the 1940s to more recently the role of <a href="https://www.motherjones.com/environment/2010/09/dan-markingson-drug-trial-astrazeneca/2/">conflicted investigators involved in psychiatric research</a> at the University of Minnesota. In recognition of the potential for abuse, all research undertaken in the U.S. in institutions like universities that receive public research funds or by companies seeking FDA approval for a product is overseen by various ethical and regulatory committees.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/248321/original/file-20181202-194947-15suicw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/248321/original/file-20181202-194947-15suicw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/248321/original/file-20181202-194947-15suicw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=432&fit=crop&dpr=1 600w, https://images.theconversation.com/files/248321/original/file-20181202-194947-15suicw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=432&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/248321/original/file-20181202-194947-15suicw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=432&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/248321/original/file-20181202-194947-15suicw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=543&fit=crop&dpr=1 754w, https://images.theconversation.com/files/248321/original/file-20181202-194947-15suicw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=543&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/248321/original/file-20181202-194947-15suicw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=543&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A man included in a syphilis study has blood drawn by a doctor in Tuskegee, Alabama.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Tuskegee-Syphilis-Study-Legacy/06764fabc735439db3dc0c99fed01732/7/0">National Archives via AP</a></span>
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</figure>
<p>The ethical acceptability of research is contingent on an <a href="https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm">institutional review board’s judgment</a> that the procedure has the potential for benefit that counterbalances risk of harm. Institutional review boards are typically internal to research institutions but are meant to be independent of investigators. The board also works to ensure the process of informed consent is robust, such that participants are appropriately educated about the relevant risks of participation, are free from coercion to participate and are aware of their ability to decline to participate without penalty.</p>
<p>Funders of research will also conduct scientific peer review of a protocol to ensure the quality of the research design. Poorly designed research is ethically problematic since it wastes financial, human and other resources that could be allocated to better justified research. </p>
<p>Journal editors play an important gatekeeper role, as well. Studies conducted without appropriate ethical oversight may not be reviewed for publication in journals that abide by the <a href="http://www.icmje.org/recommendations/">Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals</a> adopted by the International Committee of Medical Journal Editors.</p>
<p>Concerns at any of these steps along the way can prevent health research from proceeding or from contributing to the scientific and medical literature. </p>
<h2>Passing ethical review doesn’t mean it’s ethical</h2>
<p><a href="https://theconversation.com/tension-as-scientist-at-centre-of-crispr-outrage-speaks-at-genome-editing-summit-107807">When He presented his work</a> at a session of the <a href="http://www.nationalacademies.org/gene-editing/2nd_summit/index.htm">Second International Summit on Genome Editing</a> in Hong Kong, many people raised questions about the informed consent process. Important as they are, the queries also seemed to be groping for a smoking gun – some clear violation of existing standards – in order to declare what people already felt: that the research was unethical.</p>
<p>Having those standards and discovering a violation of them makes judgments of ethical responsibility feel straightforward and objective. A rule was broken, the research was unethical. Case closed. There are certainly questions about the adequacy of the processes He’s research went through. Were collaborators kept in the dark about its nature and aims? Was the experimental protocol and the informed consent process subjected to rigorous review by an independent oversight body? Was the consent process itself robust and not compromised by the interests of the researchers?</p>
<p>But by focusing heavily on these still-open questions, the scientific community risks implying that mere compliance with routines of oversight would have made it ethical. That approach fails to ask what is being overseen, what is being overlooked and whether that matters to how we judge the ethical acceptability of an experiment.</p>
<p>It’s important to ask not only whether there was ethical oversight, but what it consisted in. Just because there has been a process does not mean that it is thorough or sufficient.</p>
<p>This is particularly important in the case of germline editing, because it’s so unlike most conventional therapies. <a href="http://nuffieldbioethics.org/project/genome-editing-human-reproduction">As the U.K. Nuffield Council has pointed out</a>, it is incorrect to call it a therapy. If one were undertaking gene therapy in a baby, or even a fetus, to address a life-threatening genetic disease, it would be appropriate to accept a certain amount of risk, because the alternative is much worse: living with a life-threatening disease.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">A nonimplanted embryo doesn’t need to be saved from a life-threatening condition.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Genetic-Frontiers-Gene-Edited-Babies/26ccf64759494db198cb1afb01a68480/11/0">AP Photo/Mark Schiefelbein</a></span>
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<p>But in the case of embryo editing, there is not yet a child that is sick and needs to be healed. Because the genome editing molecules are delivered into the egg at the same time as the sperm, one brings the “patient” into being in the same moment as one undertakes the “therapy.” So, when the experiment is being contemplated, there is no child to heal.</p>
<p>Thus the parents’ desires and interest are the focus. They are the patients/research subjects that the ethical oversight process is primarily built to address. This is a problem: There is something missing in a process that fails to prioritize the interests of the resulting child(ren). Yet since bringing them into being would involve risks that are significantly higher than normal reproduction, taking their interests into account may mean that the experiment simply should not be done.</p>
<p>In the case of the Chinese experiment, the situation is still more complex because the edit was made not to address a genetic disease that would otherwise affect the life of the resulting children, but to protect them against an entirely hypothetical risk, namely exposure to HIV. </p>
<p>These are highly unusual scenarios, and existing ethical oversight, even when done extremely well, is <a href="https://insights.ovid.com/irb-advisor/irba/2016/04/000/irbs-germline-editing-research-outer-limits/7/01080341">poorly equipped to deal with them</a>. Even if He’s experiment had satisfied all the questions of the reviewing oversight body, that may have been insufficient simply because that oversight body may not be asking (or, indeed, allowed to ask) the right questions.</p>
<p>One risk of locating ethics primarily in research oversight is that in cases like this, the focus tends to be on whether the research was ethically compliant – that is, whether it followed the rules – not on whether it was ethically responsible. In a profoundly novel case like this, it’s worth questioning not only whether the rules were followed, but what they are, and are not, designed to protect against.</p>
<h2>Today’s outrage suggests a need to revisit rules</h2>
<p>He’s experiments push into radically new territory.</p>
<p>His work should cause people to ask hard questions about this technology, its implications for human identity and for the integrity of foundational social relationships: parent to child, medicine to patient, state to citizen and society to its members. Under what circumstances if any might it be appropriate to tinker in the genomes of our children-to-be?</p>
<p>It should also cause us to ask hard questions about our “technologies” of research ethics – the machineries of evaluation that experiments must pass through. Like any test, they are necessarily incomplete. Yet functionally they are the standard, the primary repository of ethical judgment. And there is no already-settled higher standard against which we can evaluate these processes.</p>
<p>The difficult task of setting standards for the standards belongs to wider society. Processes of ethical oversight for genome editing research should ideally reflect society’s shared values and norms, not merely as they pertain to informed consent, but as they pertain to our sensibilities about the right ways to care for – and to bring into being – our children. </p>
<p>The crucial question is not what rules were broken, but what – and whose – judgments about what is right and appropriate should rule the human future. Deeming He “crazy” and a “rogue” does not answer the question of what went wrong. To answer that, we must all take a hard look at the potential limitations of current routines of ethical oversight. Are they asking the right questions – questions that those whose lives will be affected by these powerful new technologies would want researchers to ask? That is a question whose answer cannot come purely from within the hallowed halls of science but must be calibrated to the whole human community’s shared visions of the good.</p><img src="https://counter.theconversation.com/content/108008/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Questions abound about whether the scientist who created the first gene edited human beings took shortcuts in the ethical oversight process. But pedantically focusing on protocol misses the point.J. Benjamin Hurlbut, Associate Professor of Life Sciences, Arizona State UniversityJason Scott Robert, Director of the Lincoln Center for Applied Ethics, Arizona State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/995892018-07-10T20:02:40Z2018-07-10T20:02:40ZInformed consent, individual care vital to ensure reproductive rights of transgender Australians<figure><img src="https://images.theconversation.com/files/226882/original/file-20180710-70054-47a28u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It's hard to plan for future fertility. </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/diverse-group-people-hands-together-partnership-620220920">from www.shutterstock.com </a></span></figcaption></figure><p>For any person needing medical care, informed consent is vital. Yet for transgender people, informed consent may be hindered by how medical professionals share information. This is especially the case in the context of reproductive health, where speaking about reproductive materials is often highly gendered. </p>
<p>Both the World Professional Association for Transgender Health <a href="https://www.wpath.org/publications/soc">Standards of Care</a> and the Royal Children’s Hospital’s <a href="https://www.rch.org.au/uploadedFiles/Main/Content/adolescent-medicine/australian-standards-of-care-and-treatment-guidelines-for-trans-and-gender-diverse-children-and-adolescents.pdf">Standards of Care and Treatment Guidelines for Trans and Gender Diverse Children and Adolescents</a> emphasise the importance of discussing fertility preservation as an option for transgender people. </p>
<p>Yet little guidance is given on how to do so in ways that are inclusive. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/rethinking-how-we-represent-transgender-children-in-the-media-63722">Rethinking how we represent transgender children in the media</a>
</strong>
</em>
</p>
<hr>
<h2>Barriers to informed consent</h2>
<p>How medical professionals share information about fertility preservation can be distressing for some transgender people. This is because the terms typically used may be seen as referencing gender. </p>
<p>Sperm are typically associated with men. Eggs are typically associated with women. For women who produce sperm, or men who produce eggs, these terms can be distressing. Such distress can mean disengagement from information.</p>
<p>Further compounding issues of terminology are assumptions about people’s desire to reproduce. In countries such as Australia, <a href="https://theconversation.com/what-the-baby-bonus-boost-looks-like-across-ten-years-81563">population growth is considered important</a>. This places an expectation on all people to reproduce. This is especially true for people who are assigned female at birth. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/227059/original/file-20180711-70042-fdyzy2.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/227059/original/file-20180711-70042-fdyzy2.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/227059/original/file-20180711-70042-fdyzy2.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=479&fit=crop&dpr=1 600w, https://images.theconversation.com/files/227059/original/file-20180711-70042-fdyzy2.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=479&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/227059/original/file-20180711-70042-fdyzy2.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=479&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/227059/original/file-20180711-70042-fdyzy2.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=602&fit=crop&dpr=1 754w, https://images.theconversation.com/files/227059/original/file-20180711-70042-fdyzy2.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=602&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/227059/original/file-20180711-70042-fdyzy2.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=602&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Role of professionals in fertility discussions.</span>
<span class="attribution"><span class="source">Damien Riggs</span>, <span class="license">Author provided</span></span>
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</figure>
<p>As a result, transgender men in particular may feel pressured to preserve their fertility. In our <a href="https://twitter.com/DrDamienRiggs/status/985673090964140032">recent study</a> of Australian transgender and non-binary people and fertility preservation, some of our trans masculine participants reported they had been told, in essence, that “if you have a uterus, you should want to use it”. </p>
<p>Certainly <a href="https://transpregnancy.leeds.ac.uk">growing numbers of transgender men are bearing children</a>. It is heartening that <a href="http://www.starobserver.com.au/news/national-news/50-men-australia-given-birth/159965">Medicare now treats pregnancy and birth-related items as non-gender-specific</a>. But this does not mean that all men want to bear children, nor that they should be expected to do so. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/commercial-surrogacy-in-australia-rethinking-notions-of-natural-31423">Commercial surrogacy in Australia: rethinking notions of 'natural'</a>
</strong>
</em>
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<hr>
<p>Some of our participants also reported that medical professionals <a href="https://twitter.com/DrDamienRiggs/status/1004150882282323968">insisted they preserve their fertility</a>. This was an especially concerning form of gatekeeping. Gatekeeping occurs when access to medical care is restricted to transgender people who conform to a standard narrative of what it means to be transgender.</p>
<h2>Facilitating informed consent</h2>
<p>In our work on sexuality education for transgender young people, we highlighted <a href="https://www.theaustralian.com.au/news/nation/call-to-strip-gender-talk-from-sexed-classes/news-story/6605824c8c957ab087889a2178f80707">the importance of gender-neutral language</a>. We suggested that speaking about <a href="https://www.britannica.com/science/gamete">gametes</a>, rather than sperm and eggs, is one way of ensuring that transgender young people do not experience distress. This does not prevent making distinctions between different types of gametes, and how they come together in the process of conception.</p>
<p>In the context of fertility preservation, it is also possible to speak about gametes or reproductive organs. As noted above, it is also important not to presume that all people want to reproduce. Many of our participants reported that, should they wish to become parents in the future, they might do so through adoption or foster care. </p>
<p>Discussions about fertility preservation are important for any person whose fertility may be compromised by particular forms of medical care. But this does not mean that agreeing to fertility preservation should be mandatory in order to access particular forms of medical care. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/transgender-kids-get-their-own-health-care-guidelines-98308">Transgender kids get their own health-care guidelines</a>
</strong>
</em>
</p>
<hr>
<p>Particular care is indicated <a href="https://twitter.com/DrDamienRiggs/status/993271692905648128">with regard to young people</a>. Parents of transgender children may hope to have grandchildren. They may encourage a young person to preserve fertility when that is not necessarily the young person’s desire. For young children unable to give consent, medical professionals should ensure that the family receives adequate counselling prior to a decision being made so as to ensure that children’s voices are heard. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/227060/original/file-20180711-70039-i80p2t.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/227060/original/file-20180711-70039-i80p2t.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/227060/original/file-20180711-70039-i80p2t.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=534&fit=crop&dpr=1 600w, https://images.theconversation.com/files/227060/original/file-20180711-70039-i80p2t.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=534&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/227060/original/file-20180711-70039-i80p2t.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=534&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/227060/original/file-20180711-70039-i80p2t.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=671&fit=crop&dpr=1 754w, https://images.theconversation.com/files/227060/original/file-20180711-70039-i80p2t.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=671&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/227060/original/file-20180711-70039-i80p2t.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=671&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Experiences with clinics when undertaking fertility preservation.</span>
<span class="attribution"><span class="source">Damien Riggs</span>, <span class="license">Author provided</span></span>
</figcaption>
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<h2>Transgender people’s reproductive rights</h2>
<p>The area of fertility preservation represents an important aspect of reproductive rights for transgender people. Transgender people should absolutely have the right to undertake fertility preservation. This should be provided in a timely and affordable manner, mindful of how informed consent may be undermined if medical professionals do not approach the topic in an inclusive way. </p>
<p>At the same time, however, assumptions are not helpful. It should not be assumed that all transgender people want to preserve their fertility. It should also not be assumed that all transgender people want to access forms of medical care that might negatively impact their fertility (i.e., not all transgender people will wish to commence hormone therapies or undertake gender affirming surgeries).</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/more-australian-trans-stories-on-our-tv-screens-please-88556">More Australian trans stories on our TV screens, please</a>
</strong>
</em>
</p>
<hr>
<p>Conversely, it is important to acknowledge that some transgender people might experience infertility unrelated to gender transition, and may wish to access reproductive services – as is true for any person who experiences infertility.</p>
<p>For transgender people who do choose to have children, their rights as parents must be protected. This includes as a society challenging the discrimination that many transgender parents face. More broadly, ensuring transgender people’s reproductive rights must include access to services related to reproductive health (such as pap smears for transgender men), and access to abortion services.</p>
<p>Transgender communities are diverse, and there is no one right outcome for medical care other than ensuring that the individual’s needs are met. Medical professionals must acknowledge the diverse desires and needs of transgender people. This means opening up conversations about reproduction, but also respecting when people do not wish to reproduce. </p>
<hr>
<p><em>The author is presenting <strong><a href="https://adelaidefestivalofideas.com.au/sessions/futurity-and-fertility-in-transgender-peoples-lives/">Futurity and fertility in transgender people’s lives</a></strong> at the 2018 Adelaide Festival of Ideas, Sunday 15 July 2018 (free entry).</em></p><img src="https://counter.theconversation.com/content/99589/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Damien Riggs receives funding from the Australian Research Council for a project focused on family diversity. </span></em></p>Conversations about reproduction should be a routine part of medical care for transgender people – but assumptions and non-inclusive language can act as barriers to informed consent.Damien Riggs, Associate Professor in Social Work, Australian Research Council Future Fellow, Flinders UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/989422018-06-27T05:20:36Z2018-06-27T05:20:36ZHealthEngine may be in breach of privacy law in sharing patient data<figure><img src="https://images.theconversation.com/files/225044/original/file-20180627-112644-16lm4yt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Online users are not able to give totally informed consent if their permission is sought for multiple things at once.</span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/mfB1B1s4sMc">christin hume unsplash</a></span></figcaption></figure><p>This week <a href="http://www.abc.net.au/news/2018-06-25/healthengine-sharing-patients-information-with-lawyers/9894114">it was reported</a> an online medical appointment service, HealthEngine, was sharing patients’ private information with a firm of solicitors specialising in personal injury claims. </p>
<p>As reported, HealthEngine, which boasts 15 million annual users, requested details of the patent’s symptoms and medical conditions as part of their booking process. It then passed this information to law firm Slater and Gordon at an average rate of 200 patients per month. This was called a “referral partnership pilot” program, and operated between March and August of 2017.</p>
<p>HealthEngine denies sharing this information without patient consent, stating consent was provided by way of a <a href="https://www.afr.com/technology/healthengine-admits-client-data-provided-to-law-firms-but-only-with-consent-20180625-h11tvh">“simple pop up”</a>. Despite the company’s best efforts, HealthEngine continues to face queries regarding their treatment of patient information. </p>
<p>On the face of it, it appears several <a href="https://www.oaic.gov.au/individuals/privacy-fact-sheets/general/privacy-fact-sheet-17-australian-privacy-principles">Australian Privacy Principles</a> may have been breached.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-should-australian-companies-be-doing-right-now-to-protect-our-privacy-85247">What should Australian companies be doing right now to protect our privacy</a>
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<h2>Did patients provide informed consent?</h2>
<p>HealthEngine assures <a href="https://healthengine.com.au/">visitors to their website</a> the collection of information is done strictly by consent, and it has provided disclosures of the use of collected information. </p>
<p>For instance, in <a href="https://healthengine.com.au/privacy.php">its Privacy Policy</a>, HealthEngine notes information may be disclosed to third parties “but only for the purpose of providing goods and services to [HealthEngine]”. </p>
<p>HealthEngine also notes disclosure may be made to:</p>
<blockquote>
<p>other persons notified to you at the time we collect your personal information, who you give consent to, or to whom we are authorised or required by law to make such disclosure. </p>
</blockquote>
<p>In their “Collection Notice” - one of three policies to which patients must agree, HealthEngine further states it may disclose personal information to “<a href="https://healthengine.com.au/collection.php">third party providers who may be of interest to the patient</a>”, including health insurance comparison providers, finance companies for credit for cosmetic or dental procedures, and providers of legal services. </p>
<p>This appears to contradict their <a href="https://healthengine.com.au/privacy.php">Privacy Policy</a>, which is itself bound by the <a href="https://www.oaic.gov.au/individuals/privacy-fact-sheets/general/privacy-fact-sheet-17-australian-privacy-principles">Australian Privacy Principles</a>. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/questions-still-need-answering-in-australias-largest-health-data-breach-67916">Questions still need answering in Australia's largest health data breach</a>
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<h2>The Australian Privacy Principles</h2>
<p>The Australian Privacy Principles specify requirements regarding how organisations collect and use patient information. These include how and in what circumstances information is shared with third parties. The principles specify all information collected by HealthEngine must be reasonably necessary for the provision of services. </p>
<p>And they must not collect information unless there is consent, the information is necessary for the function of the organisation, or there’s a “permitted health situation”, which means the information must be necessary to provide services to the patient. </p>
<h2>Click-wraps and bundled consent</h2>
<p>A type of agreement HealthEngine uses to ensure patients using their services agree to the terms and conditions, called the “click-wrap”, involves the patient clicking through the booking process and thereby agreeing to the terms and conditions, links to which are provided. </p>
<p>So the patient is agreeing to three separate sets of agreements (called the <a href="https://www.oaic.gov.au/agencies-and-organisations/app-guidelines/chapter-b-key-concepts">“bundled consent”</a>) — the Terms of Use, the Privacy Policy, and the Collection Notice — in the one action. This also means agreeing to secondary use of patient information and the provision of direct marketing, as found in the Collection Notice.</p>
<p>The privacy principles broadly prohibit direct marketing unless there is informed consent. And they require the patient to be provided with a simple way to opt out of direct marketing. HealthEngine assures patients they’re under “no obligation” to provide their information, though accepting these bundled terms is necessary to complete the booking and there is no option to opt out.</p>
<p>Informed consent requires the individual to be able to have a genuine ability to provide or withhold consent. This means having informed knowledge of the impact of their decision. It’s evident that with contradictory policies, bundled consent, and potentially misleading terms, a patient could not make a truly informed decision of the impact of their choice to use HealthEngine as the provider of this service. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/when-data-privacy-goes-missing-will-the-regulators-hear-it-cry-23367">When data privacy goes missing, will the regulators hear it cry?</a>
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<h2>Where to from here?</h2>
<p>Laws that ought to protect individuals online do exist, but the potential for harm online is neither immediate nor always evident. So, as an immediate recourse to online threats, people need to take greater care with personal information online and ensure they seek recourse when issues arise. This requires being better informed about both the law and and individual’s rights and responsibilities online.</p>
<p>The Australian government also needs to take individual privacy and personal information protection more seriously and crack down on violators. </p>
<p>The establishment of the <a href="https://www.esafety.gov.au/">Office of the eSafety Commissioner</a> was a positive move forward, but effective cuts to funding to the <a href="https://www.smh.com.au/technology/privacy-commissioner-s-small-budget-to-make-policing-new-data-breach-laws-difficult-experts-say-20180223-p4z1dj.html">Office of the Australian Information Commissioner</a> has the potential to hinder progress.</p><img src="https://counter.theconversation.com/content/98942/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Paul Maluga does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>An online medical appointment booking organisation was sharing personal information about the users of their platform with a plaintiff law firm.Paul Maluga, Sessional Academic, Solicitor, Macquarie UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/963532018-05-14T02:28:09Z2018-05-14T02:28:09Z94% of Australians do not read all privacy policies that apply to them – and that’s rational behaviour<figure><img src="https://images.theconversation.com/files/218712/original/file-20180514-34038-10eli61.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It would take the average person 244 hours per year (6 working weeks) to read all privacy policies that apply to them.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/magnifying-glass-document-close-61677337?src=qDUr2eld6uVwGuNH_osd7Q-4-7">Shutterstock</a></span></figcaption></figure><p>Australians are agreeing to privacy policies they are not comfortable with and would like companies only to collect data that is essential for the delivery of their service. That’s according to <a href="http://cprc.org.au/2018/05/13/research-australian-consumers-soft-targets-big-data-economy/">new, nation-wide research</a> on consumer attitudes to privacy policies released by the Consumer Policy Research Centre (CPRC) today. </p>
<p>These findings are particularly important since the government’s announcement last week that it plans to implement “<a href="http://sjm.ministers.treasury.gov.au/media-release/049-2018/">open banking</a>” (which gives consumers better access to and control over their banking data) as the first stage of the proposed “consumer data right” from July 2019. </p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/how-not-to-agree-to-clean-public-toilets-when-you-accept-any-online-terms-and-conditions-81169">How not to agree to clean public toilets when you accept any online terms and conditions</a>
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<p><a href="http://financialrights.org.au/wp-content/uploads/2018/04/180410-FINAL-submission-Draft-Report.pdf">Consumer advocates</a> argue that existing privacy regulation in Australia needs to be strengthened before this new regime is implemented. In many cases, they say, consumers are not truly providing their “<a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3150138">informed consent</a>” to current uses of their personal information.</p>
<p>While some <a href="https://nakedsecurity.sophos.com/2017/07/17/wait-you-didnt-want-to-clean-the-toilets-should-have-read-the-terms/">blame consumers</a> for failing to read privacy policies, I argue that not reading is often rational behaviour under the current consent model. We need improved standards for consent under our Privacy Act as a first step in improving data protection. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"992317056799428608"}"></div></p>
<h2>Australians are not reading privacy policies</h2>
<p>Under the <a href="http://www8.austlii.edu.au/cgi-bin/viewdb/au/legis/cth/consol_act/pa1988108/">Privacy Act</a>, in many cases, the collection, use or disclosure of personal information is justified by the individual’s <a href="https://www.oaic.gov.au/resources/engage-with-us/submissions/discussion-paper-on-consent-and-privacy-submission-to-the-office-of-the-privacy-commissioner-of-canada.pdf">consent</a>. This is consistent with the “<a href="https://scholarship.kentlaw.iit.edu/cgi/viewcontent.cgi?article=1567&context=fac_schol">notice and choice</a>” model for privacy regulation: we receive notice of the proposed treatment of our information and we have a choice about whether to accept.</p>
<p>But according to the CPRC Report, most Australians (94%) do not read all privacy policies that apply to them. While some suggest this is because <a href="https://www.smh.com.au/business/privacys-dead-facebook-chief-20100118-mgs8.html">we don’t care</a> about our privacy, there are four good reasons why people who do care about their privacy don’t read all privacy policies.</p>
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<h3>We don’t have enough time</h3>
<p>There are many privacy policies that apply to each of us and most are lengthy. But could we read them all if we cared enough? </p>
<p>According to international research, it would take the average person <a href="https://kb.osu.edu/dspace/bitstream/handle/1811/72839/ISJLP_V4N3_543.pdf">244 hours per year</a> (six working weeks) to read all privacy policies that apply to them, not including the time it would take to check websites for changes to these policies. This would be an impossible task for most working adults. </p>
<p>Under our current law, if you don’t have time to read the thousands of words in the policy, your consent can be implied by your continued use of the website which provides a link to that policy.</p>
<h3>We can’t understand them</h3>
<p>According to the CPRC, one of the reasons users typically do not read policies is that they are difficult to comprehend.</p>
<p>Very often these policies lead with feel-good assurances “We care about your privacy”, and leave more concerning matters to be discovered later in vague, open-ended terms, such as:</p>
<blockquote>
<p>…we may collect your personal information for research, marketing, for efficiency purposes…</p>
</blockquote>
<p>In fact, the CPRC Report states around one in five Australians:</p>
<blockquote>
<p>…wrongly believed that if a company had a Privacy Policy, it meant they would not share information with other websites or companies.</p>
</blockquote>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/consent-and-ethics-in-facebooks-emotional-manipulation-study-28596">Consent and ethics in Facebook's emotional manipulation study</a>
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</em>
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<h3>We can’t negotiate for better terms</h3>
<p>We generally have no ability to negotiate about how much of our data the company will collect, and how it will use and disclose it. </p>
<p>According to the CPRC Report, most Australians want companies only to collect data that is essential for the delivery of their service (91%) and want options to opt out of data collection (95%).</p>
<p>However, our law allows companies to group into one consent various types and uses of our data. Some are essential to providing the service, such as your name and address for delivery, and some are not, such as disclosing your details to “business partners” for marketing research.</p>
<p>These terms are often presented in standard form, on a take-it-or-leave-it basis. You either consent to everything or refrain from using the service.</p>
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<h3>We can’t avoid the service altogether</h3>
<p>According to the CPRC, over two thirds of Australians say they have agreed to privacy terms with which they are not comfortable, most often because it is the only way to access the product or service in question.</p>
<p>In a 2017 report, the <a href="https://www.pc.gov.au/inquiries/completed/data-access/report/data-access.pdf">Productivity Commission</a> expressed the view that:</p>
<blockquote>
<p>… even in sectors where there are dominant firms, such as social media, consumers can choose whether or not to use the class of product or service at all, without adversely affecting their quality of life.</p>
</blockquote>
<p>However, in many cases, we cannot simply walk away if we don’t like the privacy terms. </p>
<p><a href="http://www.abc.net.au/news/2017-03-13/rise-of-parent-teacher-behaviour-apps-in-australian-classrooms/8340414">Schools</a>, for example, may decide what apps parents must use to communicate about their children. Many jobs require people to have <a href="https://www.vox.com/policy-and-politics/2018/3/21/17144748/case-against-facebook">Facebook</a> or other social media accounts. Lack of transparency and competition in privacy terms also means there is often little to choose between rival providers.</p>
<h2>We need higher standards for consent</h2>
<p>There is frequently no real notice and no real choice in how our personal data is used by companies.</p>
<p>The <a href="https://www.eugdpr.org">EU General Data Protection Regulation</a> (GDPR), which comes into effect on 25 May 2018, provides one model for improved consent. Under the GDPR, consent:</p>
<blockquote>
<p>… should be given by a clear affirmative act establishing a freely given, specific, informed and unambiguous indication of the data subject’s agreement.</p>
</blockquote>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/you-may-be-sick-of-worrying-about-online-privacy-but-surveillance-apathy-is-also-a-problem-86474">You may be sick of worrying about online privacy, but 'surveillance apathy' is also a problem</a>
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<p>The Privacy Act should be amended along these lines to set higher standards for consent, including that consent should be:</p>
<ul>
<li><p>explicit and require action on the part of the customer – consent should not be implied by the mere use of a website or service and there should be no pre-ticked boxes. Privacy should be the default;</p></li>
<li><p>unbundled – individuals should be able to choose to consent only to the collection and use of data essential to the delivery of the service, with separate choices of whether to consent to additional collections and uses;</p></li>
<li><p>revocable – the individual should have the option to withdraw their consent in respect of future uses of their personal data at any time. </p></li>
</ul>
<p>While <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3150138">further improvements</a> are needed, upgrading our standards for consent would be an important first step.</p><img src="https://counter.theconversation.com/content/96353/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Katharine Kemp receives funding from The Allens Hub for Technology, Law and Innovation. She is a Member of the Advisory Board of the Future of Finance Initiative in India, the Centre for Law, Markets & Regulation and the Australian Privacy Foundation.</span></em></p>We need to stop blaming consumers for not reading online privacy policies and fix the system.Katharine Kemp, Lecturer, Faculty of Law, UNSW, and Co-Leader, 'Data as a Source of Market Power' Research Stream of The Allens Hub for Technology, Law and Innovation, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/846182017-09-27T20:02:03Z2017-09-27T20:02:03ZFrom tourism to terrorists, fast-moving space industries create new ethical challenges<figure><img src="https://images.theconversation.com/files/187502/original/file-20170926-17379-1tb7i52.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Medical data from space tourists will be fascinating, but is it ethical? </span> <span class="attribution"><a class="source" href="https://www.nasa.gov/centers/ames/news/releases/2004/moon/moon_images.html">Rick Guidice/NASA</a></span></figcaption></figure><p>It’s an exciting time to be working in the space sector - particularly with Australia’s recently-announced commitment to developing a <a href="https://theconversation.com/yes-australia-will-have-a-space-agency-what-does-this-mean-experts-respond-84588">space agency</a>. </p>
<p>But with advances come new challenges. Similar to technologies such as <a href="https://theconversation.com/downside-of-fitness-trackers-and-health-apps-is-loss-of-privacy-69870">digital communications</a> and <a href="https://theconversation.com/artificial-intelligence-researchers-must-learn-ethics-82754">robotics</a>, advances in space science bring ethical dilemmas. What rights do space tourists have? How can we prevent space terrorism? Who should regulate space activities? </p>
<p>Now is the time to turn the spotlight on concerns about the operations of new and future stakeholders in space. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/artificial-intelligence-researchers-must-learn-ethics-82754">Artificial intelligence researchers must learn ethics</a>
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</em>
</p>
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<h2>A shift in access</h2>
<p>In the not-too-distant-past, operations in space were only available to the world’s superpowers: in particular the <a href="https://theconversation.com/lost-in-space-australia-dwindled-from-space-leader-to-also-ran-in-50-years-83310">USA and Russia</a>. We’ve seen the number of countries with space programs slowly increase over the years.</p>
<p>In recent times the cost of operating in space has dramatically decreased, allowing a large number of countries, and even some private companies, to become involved in space operations on a serious scale. </p>
<p>Unfortunately, the increase in the number of players operating in space brings with it new problems. One issue is that some newcomers might use their new-found abilities in problematic ways, such as space terrorism. </p>
<p>Another is linked to the fact that some of these new space ventures – such as <a href="http://www.virgingalactic.com/">Virgin Galactic</a>, <a href="http://www.spacex.com/">Space X</a> and <a href="http://www.spaceadventures.com/">Space Adventures</a> – are working to create opportunities never seen before, by allowing ordinary people to become space tourists. </p>
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<h2>Space tourists</h2>
<p>We currently do not know what rights space tourists will have. </p>
<p>Undoubtedly they will be exceedingly rich members of our society, as only a very small proportion of the population is likely to be able to afford space travel as a destination in the foreseeable future. However, just because a person is rich does not make them immune to the dangers of space travel. </p>
<p>The risky nature of the launch and re-entry are perhaps the most easily identifiable concerns. However, there are other issues which are not immediately obvious. </p>
<hr>
<p><em><strong>Read more:</strong> <a href="https://theconversation.com/stronger-faster-and-more-deadly-the-ethics-of-developing-supersoldiers-71086">The ethics of developing supersoldiers</a></em> </p>
<hr>
<p>For example, the physical and mental health of astronauts is <a href="https://www.nasa.gov/mission_pages/station/research/experiments/1025.html">assessed very thoroughly</a> during and after space travel. Scientifically it would make sense to extend such monitoring to space tourists, since this will eventually increase the data set considerably.</p>
<p>But can space tourists truly give valid informed consent to such activities? It’s difficult to fully anticipate the long-term effects of space travel, let alone the effects of any medical experimentation that might go alongside it.</p>
<p>This may be a particular concern if becoming a space tourist is made conditional on giving consent to such monitoring, since in such cases the consent would, at the very least, appear to be coerced.</p>
<h2>Space terrorism</h2>
<p>A larger concern to the wider community is the prospect of space terrorism. </p>
<p>Rogue states (and at some point in the future, even non-state groups such as ISIS) could potentially make large political statements through space. </p>
<p>An electromagentic pulse (<a href="https://theconversation.com/i-advised-ncis-la-on-e-bombs-but-theyre-not-a-work-of-fiction-5095">EMP</a>) terrorist attack on a satellite could leave it “dead” in orbit indefinitely. Or, a large debris field could be created through an explosion in space, making a whole range of orbits unusable for both civilian and military purposes for years to come. </p>
<p>The effect of either of these events could be to cripple communication and navigation worldwide, with flow-on effects felt in financial markets, hospitals, transportation, food distribution and many elements of everyday life. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/explainer-why-some-acts-are-classified-as-terrorism-but-others-arent-76013">Explainer: why some acts are classified as terrorism but others aren't</a>
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<p>Efforts to stop terrestrial terrorism involve <a href="https://theconversation.com/australian-authorities-are-doing-all-they-can-to-combat-terrorism-78989">multi-agency and multi-disciplinary approaches</a> through the intelligence and justice systems. </p>
<p>These approaches revolve around intelligence gathering to identify and prevent terrorist attacks, as well as limiting access to raw materials that might be used to effect large numbers of people (force multipliers), such as bomb making materials, bio-weapon ingredients and nuclear weapon components. These approaches have been effective in limiting the amount of damage terrorists are able to inflict, and so reduce the effect of terrorist actions. </p>
<p>The impact of space terrorist actions by rogue states and non-state actors can plausibly be limited by similar approaches, largely through the diplomatic and intelligence community. </p>
<p>A second approach might be to regulate those few countries and companies that have launch capabilities. However, as we have seen in recent times, engaging in diplomatic negotiations to try to limit the actions of states like <a href="https://theconversation.com/as-it-launches-another-missile-we-must-realise-there-are-no-easy-options-for-dealing-with-north-korea-83139">North Korea</a> and Iran is certainly no easy task.</p>
<p>It is important that we start discussing the ethical concerns raised by the entry of new stakeholders into the space community. It is vital that decisions we make now foster innovation, while also mitigating the risks of the dramatic increase in space operations.</p>
<p>This will allow us to ensure that theoretical problems of the present do not become insurmountable, real problems in the future. </p>
<hr>
<p><em>This article is based on a paper presented at the <a href="http://www.iac2017.org/">68th International Astronautical Congress</a> taking place this week in Adelaide, South Australia.</em></p><img src="https://counter.theconversation.com/content/84618/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nikki Coleman does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Space terrorism and testing of space tourists are theoretical problems today. But let’s have conversations right now to make sure they don’t become real problems in the future.Nikki Coleman, Military Space Bioethicist, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/698702016-12-22T19:08:56Z2016-12-22T19:08:56ZDownside of fitness trackers and health apps is loss of privacy<figure><img src="https://images.theconversation.com/files/150842/original/image-20161219-24263-ju0wsz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Do you know how the data from your running app is being used?</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/pic-538639498/stock-photo-jogger-using-smart-phone-female-runner-holding-cell-phone-while-taking-break.html?src=oBtvZ-vItpekJYULp7h_Gw-1-20">from www.shutterstock.com/Artfully Photographer</a></span></figcaption></figure><p>At the touch of an app, Emma tracks her diabetes. She enters food, exercise, weight and blood sugar levels, then sets up medication reminders.</p>
<p>Suzanne uses the latest <a href="https://theconversation.com/au/topics/wearable-technology-5180">wearable device</a> to track her running route and distances walked. As she has not slept too well in the past month, she also records her sleep patterns.</p>
<p>Richard takes his tablet for schizophrenia. The tablet contains a sensor that communicates with central health databases to tell health professionals if he has taken his medication.</p>
<h2>The participatory health revolution</h2>
<p>This is the participatory health revolution, where people use apps and wearable devices, and swallow sensors, to keep track of their health and well-being, to take control in the name of empowerment.</p>
<p><a href="https://cybersecuritystrategy.dpmc.gov.au">Latest figures</a> indicate two in three Australians have a social media account and most spend almost the equivalent of one day a week online. In 2017, 90% of Australians will be online and by 2019 most households will have an average of 24 home devices (like alarms, phones, cars and computers) connected online.</p>
<p>Researchers <a href="http://www.tandfonline.com/doi/full/10.1080/14461242.2016.1228149?src=recsys">say</a> there are currently more than 160,000 medical and health apps; an estimated 485 million wearable devices <a href="http://link.springer.com/article/10.1007/s13347-016-0215-5">are projected</a> to be released a year by 2018.</p>
<p>All of this self-tracking and connectivity has implications for health care delivery. It is also changing how researchers collect and analyse data.</p>
<p>The public have now become the study subjects <em>and</em> the collection tools. People can also share this data in new ways.</p>
<p>Emma’s app data can be used during her health care consultations to guide her diabetes treatment and fill her medical records. So, Emma has become an active partner in how her health care is managed.</p>
<p>Emma could also join an online community to share this personal health information publicly. She can use <a href="https://www.patientslikeme.com">new platforms</a> to donate data for the public good.</p>
<p>The idea is that someone else like Emma, perhaps recently diagnosed with diabetes, or even diabetes researchers, will access this information and use it for the greater good. Yet, the implications of this data sharing have not received much attention.</p>
<h2>Emerging risks</h2>
<p>Emma chooses to upload her personal health information to one of these data sharing websites; she is in control and empowered. As the website promises anonymity, she thinks there’s little risk. But there are risks, some unintended. </p>
<p>Some <a href="http://btlj.org/data/articles2015/vol30/30_3/1741-1806%20Hoffman.pdf">researchers</a> <a href="https://www.ncbi.nlm.nih.gov/pubmed/22473380">suggest</a> publicly available datasets could be combined and analysed to identify negative behaviours linked with particular conditions. These negative behaviours may then be linked with particular social or cultural groups and increase the potential for stigmatisation.</p>
<p>The flow and movement of data is also creating more questions around consent and privacy. Many people remain unaware of where data is going and how it is then used. A <a href="http://www.pc.gov.au/inquiries/current/data-access/draft/data-access-overview-draft.pdf">recent draft report</a> indicates 13% of Australians own a wearable device like the one Suzanne uses to track her running, walking and sleep.</p>
<p>How many people know the well-being and location data these wearable devices collect travels back to the companies that sell them and is used in ways we know little about?</p>
<h2>How participatory is this?</h2>
<p>A <a href="http://www.ey.com/Publication/vwLUAssets/EY_-_Health_reimagined:_a_new_participatory_health_paradigm/$FILE/ey-health-reimagined-2016.pdf">recent report</a> paints a picture of Australians poised to embark on this revolution.</p>
<p>It found 87% of people would make appointments online, 74% would use home diagnostic kits for cholesterol, 70% would order prescriptions using a mobile app, 61% would consult with their doctor by video on their computer and 70% would communicate with a doctor or other health professional by email, text or social media.</p>
<p>But is this for everyone? Researchers <a href="http://www.invent-journal.com/article/S2214-7829(16)30019-7/abstract">argue</a> many health and medical apps are mental health specific but few people use them. People are more likely to download a mental health app when a health professional recommends it rather than download it themselves.</p>
<p>Until now, most <a href="http://www.ey.com/Publication/vwLUAssets/EY_-_Health_reimagined:_a_new_participatory_health_paradigm/$FILE/ey-health-reimagined-2016.pdf">discussion</a> has been on people’s capacity to use apps and wearable devices to promote their autonomy as truly empowered citizens.</p>
<p>But there is equal concern that new digital technologies may erode autonomy. One example is through the data movement to businesses without individual knowledge or consent. </p>
<p>Another example might be in Richard’s case of monitoring his use of schizophrenia medication, with its potential for greater surveillance and control, a form of digital paternalism.</p>
<h2>Ethical guidance</h2>
<p>Ethical guidance is needed to mitigate these emerging risks of participatory health. The unprecedented opportunities for public involvement in tracking and sharing data means we need to ensure participation is more than mere data generation and actually achieves true partnership and empowerment.</p>
<p>Research institutions will need to establish guidelines to determine the trustworthiness and legitimacy of publicly shared data. Research ethics committees and the research community will need to discuss where the boundaries lie between being a data subject and data collector.</p>
<p>We need to think about who owns data and how rights to use that data will be granted.</p>
<p>There also needs to be a better understanding of the impact of mental health apps and new technological sensor devices for people living with mental illness.</p><img src="https://counter.theconversation.com/content/69870/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Victoria J Palmer receives funding from the Victorian Government Mental Illness Research Fund and the National Health and Medical Research Council. </span></em></p>Apps and wearable devices promise greater participation and empowerment in health care. But what are we risking when we take part in this new era of participatory health?Victoria J Palmer, Postdoctoral Researcher Applied Ethics, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/671132016-12-19T02:22:31Z2016-12-19T02:22:31ZObama administration’s big science and tech innovation: Socially engaged policy<figure><img src="https://images.theconversation.com/files/150616/original/image-20161218-26137-6n65ta.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Obama annually welcomed students to the White House with their Science Fair projects.</span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Obama-Science/cdaa4cbaea9e4d03b9c54f898d9da404/2/0">AP Photo/Susan Walsh</a></span></figcaption></figure><p>When President Barack Obama gave his <a href="https://www.whitehouse.gov/blog/2009/01/21/president-barack-obamas-inaugural-address">inaugural address</a> in 2009, he promised to “restore science to its rightful place and wield technology’s wonders to raise health care’s quality and lower its cost.” For the previous eight years, scientists had protested that the Bush administration <a href="http://www.washingtonpost.com/wp-dyn/content/article/2005/08/31/AR2005083101271.html">ignored</a> their expertise and <a href="http://www.livescience.com/9574-scientists-bush-stifles-science-lets-global-leadership-slip.html">restricted</a> research freedoms. So they were heartened when the new president <a href="https://www.whitehouse.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells">removed barriers</a> to federal funding for human embryonic stem cell research and <a href="https://www.whitehouse.gov/the-record/climate">took serious steps</a> to mitigate climate change. </p>
<p>But President Obama should be remembered – and praised – for much more than his renewed support for science. As a scholar of science and technology policy, it is clear to me that this president and his advisers recognized that policy could be carefully crafted to maximize the social and economic benefits of research and innovation. </p>
<p>They designed intellectual property policies, for example, that enhance scientific collaboration and in turn accelerate research progress, and also improve the availability of important technologies. And by including average citizens in developing research projects and priorities, they increased the usefulness and public legitimacy of science and technology. </p>
<h2>Modernizing patents’ power</h2>
<p>For decades, the United States government had <a href="http://www.press.uchicago.edu/ucp/books/book/chicago/P/bo25338584.html">largely accepted</a> the idea that patents were a necessary incentive for innovation. With the promise of a temporary monopoly if they were successful, inventors would work hard to develop new, transformative technologies. The potential benefits were significant: access to technologies that could transform societies for the better. Ultimately new industries, new jobs and economic growth would result.</p>
<p>Over time, though, it became clear that patents can <a href="http://science.sciencemag.org/content/280/5364/698">stifle research</a> and make important new technologies <a href="https://mitpress.mit.edu/books/building-genetic-medicine">prohibitively expensive</a>. The Patent and Trademark Office (PTO) and its traditional stakeholders, such as patent lawyers, <a href="https://www.uspto.gov/web/offices/com/sol/comments/utilguide/index.html">dismissed</a> such problems as minor and temporary, suggesting that only those who misunderstood how the system worked were concerned.</p>
<p>But in 2010, the Obama administration took the unprecedented step of breaking with its own PTO to side with physicians and scientists, as well as civil liberties and patient advocacy groups, who raised these issues in the context of patents covering human genes. A case brought in federal courts focused on whether genes were products of nature, but the plaintiffs <a href="https://www.aclu.org/legal-document/brca-complaint">were clearly motivated</a> by concerns that patents on human genes were stifling important research and limiting access to potentially lifesaving genetic testing.</p>
<p>The Obama administration argued alongside these plaintiffs publicly when the Supreme Court heard the case in 2013. And in a unanimous decision, the Supreme Court agreed with the plaintiffs and the administration. Today, isolated human genes are not patentable. </p>
<p>As a result, there is greater competition in the genetic testing market; more tests are <a href="http://www.nytimes.com/2015/04/21/business/more-accurate-affordable-tests-for-detecting-breast-cancer-genes.html?_r=0">available</a> for common diseases including breast cancer, and at lower costs.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=411&fit=crop&dpr=1 600w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=411&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=411&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=517&fit=crop&dpr=1 754w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=517&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=517&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Announcing the Precision Medicine Initiative, Obama shares the podium with a model of DNA.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Obama-Budget-Precision-Medicine/d3d0e8db587843fb82f29d2fcab56563/11/0">AP Photo/Carolyn Kaster</a></span>
</figcaption>
</figure>
<h2>Removing IP roadblocks</h2>
<p>The Obama administration’s concern that intellectual property could be hurting biomedicine and ultimately patients is also clear in the research programs it established.</p>
<p>Both the <a href="https://www.whitehouse.gov/share/brain-initiative">Brain Initiative</a>, designed to develop a more dynamic understanding of brain function, and the <a href="https://www.whitehouse.gov/precision-medicine">Precision Medicine Initiative</a>, focused on designing individually tailored treatment and prevention strategies, <a href="https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative">emphasize</a> data sharing and collaboration. While previous efforts viewed competition among individuals and proprietary interests as central to the development of biomedicine, the Obama administration has come to see these as potential obstacles. </p>
<p>This <a href="https://medium.com/cancer-moonshot/report-of-the-cancer-moonshot-task-force-executive-summary-e711f1845ec#.xc01cmmi8">skepticism</a> is perhaps clearest in the 2016 <a href="https://www.whitehouse.gov/CancerMoonshot">Cancer Moonshot</a> initiative. </p>
<p>Decades of significant government expenditures for cancer research – from President Nixon’s <a href="https://dtp.cancer.gov/timeline/flash/milestones/M4_Nixon.htm">War on Cancer</a> to an <a href="http://www.healthline.com/health/breast-cancer/state-of-awareness-and-research#3">over 2,000 percent increase</a> in yearly breast cancer research funding since the 1980s – have improved scientists’ understanding of the disease and reduced <a href="http://onlinelibrary.wiley.com/doi/10.3322/caac.21254/full">cancer deaths</a>. But cancer incidence <a href="http://onlinelibrary.wiley.com/doi/10.3322/caac.21254/full">remains high</a>, and there are still significant disparities in <a href="http://link.springer.com/article/10.1007/s10903-014-9991-0">diagnosis</a> and <a href="http://jnci.oxfordjournals.org/content/94/5/334.short">treatment.</a> </p>
<p>The Cancer Moonshot aims to address these problems through increased data sharing. </p>
<p>For example, it includes a first-of-its-kind, open access, public data platform, the <a href="https://www.whitehouse.gov/the-press-office/2016/06/06/fact-sheet-vice-president-biden-launches-open-access-data-resource-part">Genomic Data Commons</a>. This allows researchers not just to store and analyze the genomes of cancer tumors, linking that information to data about how the disease appears and spreads in the body, but also to share all of this information with colleagues. The platform also provides privacy and security protections for patients and researchers. </p>
<p>Before 2008, policymakers seemed to assume that the competitive ethos and monopoly incentives provoked by patent policies were the most likely to stimulate important scientific research. But the Obama administration’s nuanced approach to patents and investment in data-sharing initiatives have created a legacy that emphasizes openness and collaboration as the best avenue for producing scientific progress.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=394&fit=crop&dpr=1 600w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=394&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=394&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=495&fit=crop&dpr=1 754w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=495&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=495&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Protocols for patient consent were ripe for an update.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Informing-Patients/e6d3408332164573b4969bdafc0abe7d/8/0">AP Photo/Brian Kersey</a></span>
</figcaption>
</figure>
<h2>More voices in the research conversation</h2>
<p>The Obama administration also took important steps toward including citizen perspectives in science and technology development.</p>
<p>The Precision Medicine Initiative – which aims to gather data (genomic, medical, metabolic, microbial, environmental and lifestyle) from at least one million Americans to produce better medical diagnostics and therapies – emphasizes transparency, citizen representation and patient autonomy in its core principles. It is dedicated to keeping participants informed throughout the research process, and emphasizes the importance of culturally appropriate interactions.</p>
<p>It has created <a href="https://www.nih.gov/precision-medicine-initiative-cohort-program/infographics">a new model of research</a> that treats informed consent as ongoing and interactive, and gives research subjects the option to withdraw at any time.</p>
<p><a href="http://www.nature.com.proxy.lib.umich.edu/nature/journal/v478/n7369/full/478312a.html">Customarily</a>, participants in similar research projects provide consent only once, at the beginning. This traditional approach has become controversial in recent years because blood and tissue samples are often <a href="https://theconversation.com/if-we-dont-own-our-genes-what-protects-study-subjects-in-genetic-research-56003">used for a variety of projects</a>, and citizens <a href="http://www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all&_r=0">want more control</a> over how their samples are used. </p>
<p>The PMI also includes “<a href="https://www.whitehouse.gov/precision-medicine">substantial participant representation</a>” in all aspects of the process, including program design and implementation. This means research subjects will serve on the policy committees that develop data-sharing, privacy and recruitment guidelines, among others, and also help to determine research priorities. Previous scientific research initiatives have <a href="http://www.lancaster.ac.uk/fss/journals/gsp/docs/volume1number3/mlgspvol1no32005.pdf">included</a> citizen perspectives occasionally in the research process, either in funding decisions or identifying overarching goals. But the PMI approach is more ambitious and systematic. </p>
<p>The Obama administration’s enthusiasm for considering citizen perspectives is not limited to scientific research. We’ve seen this approach in its energy policy as well, including in decisions on the <a href="http://america.aljazeera.com/articles/2015/2/9/how-climate-activists-turned-a-pipeline-into-a-green-movement.html">Keystone XL</a> and <a href="http://www.latimes.com/nation/la-na-dakota-access-deadline-20161204-story.html">Dakota Access</a> pipeline.</p>
<p>After massive protests and millions of citizens <a href="https://www.youtube.com/watch?v=0BdjszfbIDw#t=19">submitting</a> public comments, President Obama <a href="https://www.nytimes.com/video/multimedia/100000004023322/obama-rejects-keystone-pipeline.html">rejected</a> the Keystone XL. Similarly, months of protests in Standing Rock, North Dakota, led the Army Corps of Engineers to halt development of the Dakota Access pipeline and <a href="https://www.theatlantic.com/science/archive/2016/12/the-historic-victory-at-standing-rock/509558/">request an environmental impact statement</a> that would assess the environmental and social implications of the project and provide extensive additional opportunity for public input. </p>
<p>At this moment, when there is great concern that the priorities of scientists and engineers do not align with those of the public, and there is growing <a href="https://www.bostonglobe.com/metro/2016/10/09/the-rise-biorights-donors-are-demanding-control-and-sometimes-cash-exchange-for-genetic-samples/jCbaQ2E5t6c0Qs1kcITMRM/story.html">desire</a> among citizens to be treated as “partners” rather than “subjects” in research, these kinds of initiatives are particularly important. They can lead to the development of science and technology that is more directly beneficial to the population – and also enhance the legitimacy of scientific and technological establishment.</p>
<h2>Will Trump build on the groundwork laid by Obama?</h2>
<p>There is a great deal of <a href="http://www.nature.com/news/the-ultimate-experiment-how-trump-will-handle-science-1.20971">uncertainty</a> about President-elect Trump’s approach to science and technology policy, and so far his cabinet appointments <a href="http://www.freep.com/story/opinion/columnists/stephen-henderson/2016/12/10/betsy-devos-trouble-data/95207844/">do not provide</a> much reassurance to the scientific community. Some of these appointments have <a href="http://www.newyorker.com/tech/elements/donald-trumps-war-on-science">even explicitly denied</a> the scientific consensus on climate change.</p>
<p>But there is a path forward that could allow Trump to remain true to those who voted him into office while building upon President Obama’s approach. Pundits tell us Trump’s victory is largely the <a href="https://www.washingtonpost.com/politics/a-rancorous-campaign-begets-huge-problems-for-the-winner/2016/11/08/0fcea580-a20d-11e6-8d63-3e0a660f1f04_story.html?utm_term=.0b0d12e81ec4">result</a> of a populist wave and deep frustration toward elites; many Americans feel that policymakers do not adequately consider the realities of their everyday lives.</p>
<p>President-elect Trump could address these concerns by bringing the needs and perspectives of rural and working-class Americans explicitly into the development of science and technology policies. His administration could consider <a href="http://delinkage.org/">new kinds of policy frameworks</a>, including intellectual property regimes, that could help to lower drug prices. It could bring these “forgotten” Americans directly into policy discussions about how to tackle the unemployment triggered by <a href="http://www.businessinsider.com/united-tech-ceo-says-trump-deal-will-lead-to-more-automation-fewer-jobs-2016-12">increasing automation</a>. And it could <a href="http://www.bmj.com/content/316/7129/463?variant=full-text">include them</a> in discussions about biomedical research priorities, perhaps leading to increased funding for practical solutions to the <a href="http://aese.psu.edu/directory/smm67/Election16.pdf">opioid epidemic</a>. </p>
<p>Such efforts could ultimately strengthen the legitimacy of the new administration among both the scientific community and the public, while continuing the work towards a socially engaged science and technology policy.</p><img src="https://counter.theconversation.com/content/67113/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Shobita Parthasarathy sits on the Board of Directors for Breast Cancer Action, a health justice advocacy group.</span></em></p>The outgoing president leaves behind some solid accomplishments in the world of science, tech and medicine. But the biggest departure from his predecessors might have been in his approach.Shobita Parthasarathy, Associate Professor of Public Policy and Women's Studies, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/560032016-03-28T10:07:33Z2016-03-28T10:07:33ZIf we don’t own our genes, what protects study subjects in genetic research?<figure><img src="https://images.theconversation.com/files/116093/original/image-20160322-32312-1gz84bk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Who's in charge once your biological material is out of your body?</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/igemhq/4942218397">igemhq</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>On February 25, the <a href="https://www.whitehouse.gov/precision-medicine">White House</a> hosted a forum on the National Institute of Health’s <a href="https://www.nih.gov/precision-medicine-initiative-cohort-program">Precision Medicine Initiative</a>. This is an ambitious research study that aims to develop targeted drugs and treatments that would vary from individual to individual. </p>
<p>To reach the goal of eventually being able to make specific recommendations for patients based on their own combination of genes, environment and lifestyle, researchers plan to collect that kind of information from one million Americans. The study is so large so results can account for diversity among Americans with respect to factors such as ancestry, geography, and social and economic circumstances. </p>
<p><a href="https://www.whitehouse.gov/blog/2016/02/25/precision-medicine-health-care-tailored-you">At the forum</a>, President Obama remarked “I would like to think that if somebody does a test on me or my genes, <a href="https://www.whitehouse.gov/the-press-office/2016/02/25/remarks-president-precision-medicine-panel-discussion">that that’s mine</a>.”</p>
<p>Lots of people would make that same assumption – it seems sensible that we would each “own” our genetic information. But the legal reality is quite different. And that could turn out to be a problem, because research projects like the Precision Medicine Initiative rely on research participants trusting that their information is protected once they agree to share it. </p>
<p>As scholars with expertise in research ethics, informed consent and health law, we’re conducting research to clarify how different laws apply to information used for genomic research. We’ll identify gaps in those protections and suggest changes that may be necessary. </p>
<h2>Do you own your genes?</h2>
<p>Contrary to President Obama’s expectations, the few U.S. courts that have considered research participants’ claims of ownership of their biological materials have rejected them.</p>
<ul>
<li><p>John Moore’s doctor used his cells without his knowledge to develop and patent a cell line (cells that could continue to reproduce indefinitely for research). In 1990, the <a href="https://scholar.google.com/scholar_case?case=14543058709300681513&q=51.Cal.3d+120&hl=en&as_sdt=40000006">California Supreme Court held</a> that Mr. Moore <a href="http://scocal.stanford.edu/opinion/moore-v-regents-university-california-31115">did not own the cells</a> that had been removed from his body. </p></li>
<li><p>The Greenbergs and other families affected by Canavan disease, an inherited, degenerative and fatal brain disease in children, provided a University of Miami researcher with tissue and blood samples, medical information and money to develop a genetic test. The researcher patented the associated gene sequence, limiting families’ access to it without payment. In 2003, a <a href="https://scholar.google.com/scholar_case?case=15803440069702275727&q=264+F.Supp.2d+1064+(S.D.+Fla.+2003)&hl=en&as_sdt=40000006">federal court rejected</a> the parents’ claims that they owned their genetic samples.</p></li>
<li><p>About 6,000 research participants responded to a letter sent by Dr. William Catalona, the developer of the prostate specific antigen test, and asked that their research samples stored at Washington University be transferred to Northwestern University, where Dr. Catalona had a new job. But a <a href="https://scholar.google.com/scholar_case?case=7283524957057325487&q=490+F.3d+667+(8th+Cir.+2007)&hl=en&as_sdt=40000006">court determined</a> that the research participants had no control over who held their specimens after collection.</p></li>
</ul>
<p>The courts that have looked at the question have consistently decided that once we give our biological materials to researchers, the materials and the genetic information they contain belong to the researchers or, more specifically, the institutions that employ them. </p>
<p>A few <a href="http://www.genomicslawreport.com/index.php/2012/03/20/on-genetic-rights-and-states-a-look-at-south-dakota-and-around-the-u-s/">states have adopted statutes</a> concerning ownership of genes, but they may not alter court decisions. A Florida statute certainly did not make a difference in the Greenbergs’ case.</p>
<h2>Short of ownership, what protections exist?</h2>
<p>So you don’t own your genes. But there are other protections for participants in the Precision Medicine Initiative and other research projects.</p>
<p>The primary one comes from the <a href="http://www.hhs.gov/ohrp/humansubjects">Federal Common Rule</a>. It applies to research conducted or funded by 18 federal departments and agencies. Many universities and other institutions apply the Common Rule to their research too. And research on drugs and devices that must be approved by the Food and Drug Administration (FDA) must comply with very similar rules.</p>
<p>Under the Common Rule, with some exceptions, research studies must be reviewed and approved by an Institutional Review Board (IRB): a committee within the university or hospital, for instance, that scrutinizes proposed experiments involving human subjects. In approving a study, the IRB must evaluate, among other things, the adequacy of the consent process and confidentiality protections, whether risks are minimized and are reasonable in relation to the benefits, and whether the selection of subjects is equitable. The IRB provides a check on what researchers can do.</p>
<p>Once the Institutional Review Board approves a study, researchers can start recruiting people to participate. This is where another protection comes in – consent. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/116096/original/image-20160322-23223-17gul8b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/116096/original/image-20160322-23223-17gul8b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/116096/original/image-20160322-23223-17gul8b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/116096/original/image-20160322-23223-17gul8b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/116096/original/image-20160322-23223-17gul8b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/116096/original/image-20160322-23223-17gul8b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/116096/original/image-20160322-23223-17gul8b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/116096/original/image-20160322-23223-17gul8b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Study subjects should understand the potential risks and benefits of participating.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-312419948/stock-photo-closeup-of-a-young-woman-patient-signing-an-informed-consent-at-the-doctors-office.html">Form image via www.shutterstock.com.</a></span>
</figcaption>
</figure>
<p>The researchers must disclose the research’s purpose, procedures and any risks and benefits of participating. In a study like the Precision Medicine Initiative, the primary risks are informational, not physical. For example, if an insurer learned that a research participant had a gene that increases the risk of Alzheimer’s, it might refuse long-term care coverage.</p>
<p>Based on the risks and benefits (if any) discussed in the consent form, participants can decide whether they want to take part. They may decline to participate if they do not trust the researchers or do not want to share their information.</p>
<p>In some circumstances, the Common Rule doesn’t require participant consent. These exceptions are allowed when the study poses little risk to the participant, often because the information cannot be connected to the individual. </p>
<p>In recent years, these exceptions have been called into question as researchers have repeatedly demonstrated that it is possible to identify people whose information has been used in research, but were thought to be unidentifiable. However, such reidentification requires significant effort and technical skills, and, alone, is unlikely to result in harm to participants. Thus, it is not clear that we should forego the benefits of research conducted under these exceptions because of the theoretical threat to confidentiality.</p>
<p>Beyond these exceptions, some research – such as <a href="http://www.nytimes.com/2014/06/30/technology/facebook-tinkers-with-users-emotions-in-news-feed-experiment-stirring-outcry.html?_r=0">Facebook’s 2014 study</a> that manipulated some 700,000 users’ newsfeeds to determine the effect of negative or positive words on their emotions – falls outside the Common Rule altogether. </p>
<p>In general, research that is not federally conducted or funded or subject to FDA regulations is not governed by federal research protections. Some states have adopted laws that apply similar protections to research not subject to either the Common Rule or the FDA regulations, but those laws vary considerably from state to state.</p>
<h2>Additional protections for research participants</h2>
<p>The Health Insurance Portability and Accountability Act’s (HIPAA) privacy rule provides a national standard for protecting the <a href="http://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html">use and disclosure of identifiable health information</a>. The corresponding security rule establishes standards for securing electronic health records which could include results of genetic research.</p>
<p>In addition, the Genetic Information Nondiscrimination Act (<a href="http://www.eeoc.gov/laws/types/genetic.cfm">GINA</a>) prohibits use of genetic information to discriminate against asymptomatic individuals in employment and health insurance decisions. Although it <a href="http://doi.org/10.1056/NEJMp1404776">has recognized gaps</a>, GINA provides some protections against discrimination, should genetic information from a research study be disclosed. </p>
<p>As with the Common Rule, state medical privacy and antidiscrimination laws may supplement these federal protections. Thus, the protections afforded to participants may depend greatly on where they live. Moreover, Institutional Review Boards may be unfamiliar with the myriad laws that could combine to protect research participants and their possible gaps.</p>
<p>Beyond these legal requirements, the Precision Medicine Initiative may provide participants <a href="https://www.whitehouse.gov/precision-medicine">additional controls over their data</a> on a voluntary basis. For example, participants could reevaluate their preferences for how their data are shared or used, withdraw their consent for future use of their data at any time and control the types of communications they receive about their information. </p>
<p>While these types of protections may fall short of full legal ownership rights over your genetic information, they do go beyond current legal requirements and may be the types of controls to which President Obama was alluding. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/116083/original/image-20160322-32285-1cdi522.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/116083/original/image-20160322-32285-1cdi522.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/116083/original/image-20160322-32285-1cdi522.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/116083/original/image-20160322-32285-1cdi522.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/116083/original/image-20160322-32285-1cdi522.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/116083/original/image-20160322-32285-1cdi522.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/116083/original/image-20160322-32285-1cdi522.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/116083/original/image-20160322-32285-1cdi522.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The samples have been collected… now what happens?</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/ntnumedicine/14288468172">Geir Mogen, NTNU</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span>
</figcaption>
</figure>
<h2>What is needed?</h2>
<p>We think it is essential for all those involved in research – IRBs, researchers and study participants – to understand what protections are available and what their limitations are.</p>
<p>That’s why we’ve undertaken a comprehensive analysis of federal and state laws that combine to form what we call the “web of protections.” We want to be able to describe how the laws work together, to identify gaps, and to suggest ways to improve those protections, as well as how all this should be described to prospective research participants.</p>
<p>To the extent that the current laws fall short of the types of protections and controls expected by participants in research studies like the Precision Medicine Initiative, we may be able to propose ways that the laws can be updated or supplemented to address concerns like President Obama’s. In this way, we can maintain the public trust on which this research relies.</p><img src="https://counter.theconversation.com/content/56003/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Leslie E. Wolf receives funding from the National Human Genome Research Institute (R01-HG-007733). The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of NHGRI or the National Institutes of Health.</span></em></p><p class="fine-print"><em><span>Erin Fuse Brown receives funding from the National Human Genome Research Institute (R01-HG-007733). The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of NHGRI or the National Institutes of Health.</span></em></p><p class="fine-print"><em><span>Laura Beskow receives funding from the National Human Genome Research Institute (R01-HG-007733), other NIH institutes and centers, and the federally-funded Patient-Centered Outcomes Research Network. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of NHGRI or the National Institutes of Health.</span></em></p>Next-generation genomic research depends on study participants sharing their biological materials with scientists. But concerns over how that information is protected may hold some people back.Leslie E. Wolf, Professor of Law and Director, Center for Law Health and Society, College of Law, Georgia State UniversityErin Fuse Brown, Assistant Professor of Law, Georgia State UniversityLaura Beskow, Director of the Program for Empirical Bioethics, Associate Professor of Medicine, Duke UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/564762016-03-23T14:02:19Z2016-03-23T14:02:19ZSex education is letting British teenagers down<figure><img src="https://images.theconversation.com/files/115583/original/image-20160318-4415-kqgn6b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Voyagerix/Shutterstock</span></span></figcaption></figure><p>The UK government has been heavily <a href="http://www.pinknews.co.uk/2016/02/19/nick-clegg-says-pm-has-abandoned-duty-by-blocking-sex-education/">criticised</a> after rejecting a recommendation for statutory inclusive sex and relationship education in schools. This comes after <a href="http://www.theguardian.com/uk-news/2016/feb/11/30-of-female-victims-under-16">Office for National Statistics figures</a> recently revealed that in the 12 months to March last year, 30% of female rape victims were aged under 16, a quarter were 14 or younger, and nearly 10% were nine or younger. </p>
<p>Despite <a href="http://www.theguardian.com/education/2015/feb/17/sex-education-mandatory-all-schools-mps-demand">MPs’ calls</a> for sex and relationship education to be mandatory in all schools, its “<a href="https://www.pshe-association.org.uk/curriculum-and-resources/curriculum">non-statutory</a>” status – couple with the fact that many schools are emerging via the process of “<a href="http://www.theguardian.com/commentisfree/2016/mar/22/teachers-osborne-academies-schools">academy-isation</a>” – means that currently schools embrace sex education with varying degrees of enthusiasm. Consequently, it is almost impossible for the subject to be taught at a <a href="http://mancunion.com/2016/03/15/lets-talk-about-sex/">consistent level</a> across the UK. </p>
<p>The case for making sex education compulsory seems to be <a href="http://www.bbc.co.uk/news/magazine-34470205">more compelling</a> than ever. And in the wake of high-profile child abuse cases in <a href="http://www.theguardian.com/uk-news/2016/feb/24/child-sex-abuse-rotherham-guilty-gang-hussain">Rotherham</a> and <a href="http://www.bbc.co.uk/news/uk-england-manchester-35499700">Rochdale</a>, calls have been for a greater discussion of issues of <a href="http://www.express.co.uk/news/weird/649315/Sexual-consent-education-campaign-viral-videos-genitals">consent</a> for all young people, and young women in particular. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/zLC6SxseIKI?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">How should sex education be taught in schools?</span></figcaption>
</figure>
<p>Issues highlighted in recent research undertaken by the <a href="http://www.sexeducationforum.org.uk/">Sex Education Forum</a> into young people’s experience of sexual education shows there needs to be more focus on the safety around the exchanges of digital images between pupils – with discussions needed on the <a href="http://www.bbc.co.uk/news/education-35858169">impact “sexting”</a> has on young people.</p>
<p>It is also important to evolve the understanding of “relationships” to include <a href="http://www.independent.co.uk/news/education/education-news/sex-education-lessons-ignore-gay-and-lesbian-relationships-research-says-a6745351.html">same-sex</a> relations – with young gay and bisexual men particularly poorly served by school sex education classes, in part due to low levels of knowledge around safer behaviour and HIV.</p>
<h2>Facts of life</h2>
<p>Prior to the government’s decision on sex and relationship education, four different chairs of House of Commons Committees – education, health, home affairs and business – wrote to education secretary <a href="http://www.nickymorgan.org/">Nicky Morgan</a>, saying personal, social, health and economic education, which includes sex education, was a “<a href="http://www.huffingtonpost.co.uk/2016/02/10/nicky-morgan-refuses-to-make-pshe-compulsory-in-schools_n_9201786.html">crucial part of preparing young people for life</a>”. </p>
<p>“It can provide them with the knowledge and confidence to make decisions which affect their health, well-being and relationships, now and in the future,” said the joint letter. </p>
<p>In her <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/499338/Nicky_Morgan_to_Education_Select_Committee_-_10_Feb_2016--.pdf">reply to Neil Carmichael</a> – chairman of the education select committee – Nicky Morgan defended the lack of change. She implied schools are either not ready, or do not have the expertise to deliver such classes – with Ofsted <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/413178/Not_yet_good_enough_personal__social__health_and_economic_education_in_schools.pdf">finding</a> that 40% of personal, social, health and economic education teaching in schools is less than good. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/115646/original/image-20160318-4446-k47v1a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/115646/original/image-20160318-4446-k47v1a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/115646/original/image-20160318-4446-k47v1a.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/115646/original/image-20160318-4446-k47v1a.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/115646/original/image-20160318-4446-k47v1a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/115646/original/image-20160318-4446-k47v1a.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/115646/original/image-20160318-4446-k47v1a.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Sex education often ignores gay and lesbian relationships.</span>
<span class="attribution"><span class="source">Dragon Images/Shutterstock</span></span>
</figcaption>
</figure>
<p>But strangely, governments have never held back on <a href="http://www.bbc.co.uk/news/education-13274090">introducing educational initiatives</a> in the past. In fact, the mandatory nature of the changes often provides a powerful imperative for implementation. A good example is the <a href="http://www.educationengland.org.uk/history/timeline.html">curriculum reforms</a> in the 1990s, which foregrounded literacy and numeracy.</p>
<h2>Beyond the banana</h2>
<p>In a lot of ways, sex education is still stuck in the past – when it <a href="http://www.academia.edu/4104142/teaching_pleasure_and_danger_in_sexuality_education">sought to</a> “regulate the moral and sexual behaviour of citizens in accordance with reoccurring social agendas”. This <a href="https://www.lib.utexas.edu/etd/d/2008/elliotts19091/elliotts19091.pdf">includes</a> encouraging a heterosexually envisaged future, stable family life, the prevention of “promiscuity”, and stemming sexually transmissible infections and “unplanned” pregnancies. Unfortunately, this isn’t really representative of the age we live in now.</p>
<p>Influenced by the ideas of the eugenics movement, early sex education also sought to encourage “<a href="http://www.abebooks.co.uk/book-search/title/ethical-sex-relations-or-the-new-eugenics/author/whitehead-c-s-hoff-charles-a/">good breeding</a>” to “strengthen the nationhood”.</p>
<p>As the situation stands, it seems as though Nicky Morgan is caught in a trap between her own personally supportive position and the potential challenges which might emerge from certain <a href="http://www.christian.org.uk/news/school-sex-ed-not-the-answer-to-teen-sexting/">faith groups</a> – who have a vested interest in protecting a more conservative concept of “sexuality”. So if sex education was to become compulsory it could create confrontation and a conflict of values.</p>
<p>We need to look deeper at our society and the moral meanings that are attached to sexuality, sexual behaviour and sex and relationship education. Because it is society at large and young people specifically who continue to pay the price for inadequate, patchy sex education. Instead of being seen as “contaminating knowledge”, sex education should be seen as a facilitator of individual growth and empowerment. Sexuality, arguably, is a central experience of being human after all.</p><img src="https://counter.theconversation.com/content/56476/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Max Biddulph receives funding from National Healthy Schools initiative. </span></em></p>It’s old-fashioned, out of date and varies massively from school to school.Max Biddulph, Associate Professor, Faculty of Social Sciences, University of NottinghamLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/458992015-08-24T03:42:42Z2015-08-24T03:42:42ZInformed consent for stem cell research: why it matters and what you should know<figure><img src="https://images.theconversation.com/files/92601/original/image-20150820-7225-1k3yhc0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p><em>This article is part of a series The Conversation Africa is running on stem cell research and therapy. Read the rest of the series <a href="https://theconversation.com/au/topics/african-stem-cells">here.</a></em></p>
<p>Ongoing developments in stem cell science mean that researchers often have no idea how, one year down the line, they will use specimens of human biological material. </p>
<p>But when a scientist takes a swab of your saliva, a sample of your blood or a piece of your skin to research a particular disease, how do you know that it’s going to be used for the intended purpose? And when it is used for research in a different condition, can you take any action? This is where informed consent comes in.</p>
<p>Informed consent is an important part of medical research. It is the process by which a person agrees to be part of a scientific study and then donates their biological material. The person can either agree for their sample to be used in a specific study or give broad consent for it to be used widely for research. </p>
<p>Medical research involving humans and the collection of their biological material should ideally work towards helping the study’s participants to be cured. And when people participate in research, they must be told all the details of the research in a way that leaves them with no uncertainty about their rights in the study. The content should be clearly explained and translated into simple language.</p>
<p>In reality, researchers often give participants information that is not always understood because complicated scientific language is used. This is a major challenge for patients, medical scientists and medical doctors across the world.</p>
<h2>Different stem cells require different consent</h2>
<p>In stem cell research, there are three different types of stem cells that can be donated which need informed consent from participants. </p>
<ul>
<li><p>Adult stem cells. Typically these are found in the person’s skin or grown from a sample of skin cultured in a laboratory from a skin biopsy and can then be used for treatment, such as burns. Until now, most stem cell research has involved obtaining stem cells from a patient for the treatment of their illness or a medical or clinical condition such as a serious burn.</p></li>
<li><p>Multipotent mesenchymal stem cells. These mesenchymal stem cells are taken from bone marrow, the umbilical cord, foetal tissue and fat tissues. Bone marrow cells have been used for treating blood cancers such as leukaemia and blood disorders such as sickle cell disease. </p></li>
<li><p>Pluripotent stem cells. There are two types: those found in a developing embryo (embryonic stem cells) and induced pluripotent stem cells. Embryonic stem cells have become controversial because the process entails terminating the development of a foetus, created by in vitro <a href="http://stemcells.nih.gov/info/basics/pages/basics3.aspx">fertilisation</a> in the laboratory. </p></li>
</ul>
<p>Induced pluripotent stem cells are adult stem cells that are reprogrammed in the laboratory to behave like embryonic stem cells. In the hands of skilled researchers, they can develop into many cell types. Induced pluripotent cells are used as cellular or biological models of certain diseases, called disease-in-the-dish modelling. The results of this type of research could potentially be used to treat some of diseased or damaged tissue.</p>
<p>The ability of pluripotent cells to become a part of a fully functional normal tissue is still unproven. But many animal studies and some human studies are providing <a href="http://stemcell.childrenshospital.org/newsroom/related-topics/tissue-engineering-growing-bladder-cells/">exciting prospects</a>. These stem cells are the most complex.</p>
<p>While they are not yet being used for treatment, they have great potential for future research and the scope and extent of their use is <a href="https://www.uct.ac.za/dailynews/?id=8432">wide</a>. At <a href="http://stemcells.uct.ac.za/">UCT</a> they are currently used as “disease-in-the-dish” models in the laboratory only. It is impossible to anticipate the full range of their future application.</p>
<p>Getting informed consent for induced pluripotent stem cells in the future will need to be done very carefully to assure participants of the ethical use of their specimens. This is because induced pluripotent stem cells can potentially also be used in reproductive cloning. Currently this is banned in South Africa.</p>
<h2>What’s wrong with the forms</h2>
<p>Before any research can go ahead, a patient must complete a customised form. The way researchers get informed consent is guided by recommendations in the <a href="http://www.wma.net/en/30publications/10policies/b3/">Declaration of Helsinki</a>, a set of ethical principles around human experimentation and research using human biological material. It was drawn up in 1964 and has subsequently been revised by the World Medical Association’s committees seven times, including once in South Africa in 1996 and most recently in Brazil in 2013. It is the ultimate guideline around human research ethics. </p>
<p>Researchers are expected to use simple non-scientific terms in the informed consent forms. But because stem cell research is such a complex topic, it may be difficult for patients to understand the scientists’ research intentions. This is particularly true in a developing technology, which is still often in the realm of the <a href="http://www.humangenetics.uct.ac.za/research/neurodegenerative-disorders/inherited-ataxias/">unknown</a>.</p>
<p>In the past, questions have been raised about whether or not patients understand the complicated and scientific content of consent forms. To overcome this, professionally trained staff are being employed to explain the risks and benefits of stem cell research to participants. But this is still a relatively new practice across the globe and South Africa has less than 20 appropriately trained and registered genetic counsellors. There is an <a href="http://www.uct.ac.za/dailynews/?id=8458">urgent need</a> for more.</p>
<p>Their job would be to:</p>
<ul>
<li>help potential participants to navigate through trials; </li>
<li>explain risks, benefits, and therapeutic alternatives; and </li>
<li>provide information about unproven transplants offered outside the bounds of good clinical practice and ethical <a href="http://www.humangenetics.uct.ac.za/teaching/msc-med-genetic-counselling/genetic-counselling-courses-offered-at-uct/">research</a>.</li>
</ul>
<p>For South Africa to continue to develop the capacity to incorporate new bio-medical technologies, such as those in the stem cell field, it must proactively formulate clear guidelines for the oversight of <a href="http://hmpg.co.za/index.php/sajbl/article/view/8408">informed consent</a>. This should ideally cover future anticipated and potential unanticipated use of stem cells in research.</p>
<p><em>This article is based on a paper published in a special South African Medical Research Council Flagship edition of the South African <a href="http://hmpg.co.za/index.php/sajbl/issue/view/497/showToc">Journal</a> of Bioethics and Law.</em></p><img src="https://counter.theconversation.com/content/45899/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jacquie Greenberg receives funding from the National Research Foundation and SA Medical Research Council for research involving the development of stem cell-based disease-in-the-dish modelling of Inherited Ataxias in Africa.</span></em></p>When it comes to stem cells, the ways that informed consent has been obtained in the past are not sufficient and improvements are needed.Leslie Jacqueline Greenberg, Professor of Human Genetics: Stem Cell Researcher , University of Cape TownLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/459682015-08-24T03:42:35Z2015-08-24T03:42:35ZHow to make sure South Africa’s biobanks balance scientific progress with the law<figure><img src="https://images.theconversation.com/files/92731/original/image-20150821-31386-fv73pv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Empty sample tubes wait to be filled in a blood and urine sample freezer. South Africa has no legislation governing biobanks that deal with human biological material. </span> <span class="attribution"><span class="source">Reuters/Phil Noble</span></span></figcaption></figure><p><em>This article is part of a series The Conversation Africa is running on stem cell research and therapy. Read the rest of the series <a href="https://theconversation.com/au/topics/african-stem-cells">here</a>.</em></p>
<p>When biobanks were created, the idea was that scientists could have quick access to samples they could use without having to get new specimens every time they needed to do research. </p>
<p>But ongoing developments in science and the commercialisation of scientific based products have heightened the need for legislation and guidelines that could specify both the ethical use and legal implications of samples in biobanks. In South Africa there is no legislation around biobanks and the guidelines are not clear enough. </p>
<p>Biobanks are repositories that store large numbers of human biological materials from donors along with their associated data and the information drawn from this <a href="http://www.scielo.org.za/scielo.php?pid=S0256-95742013000400014&script=sci_arttext&tlng=es">analysis</a>. Biobanks should not be confused with tissue banks, which involve services around cells or tissue from living or dead people for transplants.</p>
<h2>The biobank challenge</h2>
<p>There are two broad categories of biobanks. One category is involved in large cohort studies where tens of thousands of participants are required at a minimum. They are referred to as population biobanks and their function is to promote the <a href="http://www.scielo.org.za/scielo.php?pid=S0256-95742013000400014&script=sci_arttext&tlng=es">health of the population</a>. The second category are <a href="http://researchbriefings.files.parliament.uk/documents/POST-PN-473/POST-PN-473.pdf">disease specific</a>. </p>
<p>In South Africa there are just over a dozen <a href="http://hmpg.co.za/index.php/sajbl/article/view/8406/9680">biobanks</a>, which operate on a smaller scale than their international counterparts. Not all are specific to research, and those involved in human health research are from projects within academic institutions. The country’s National Health Laboratory Services tried to establish a population level biobank but this did not materialise.</p>
<p>Currently there is no legislation governing biobanks.
The <a href="http://www.chr.up.ac.za/undp/domestic/docs/legislation_55.pdf">National Health Act</a> and its regulations, which should be providing direction, is silent on the issue of biobanks.
The National Department of Health’s ethics guidelines make some references to biobanks. It requires all new repositories to have <a href="http://www0.sun.ac.za/research/assets/files/Integrity_and_Ethics/DoH%202015%20Ethics%20in%20Health%20Research%20-%20Principles,%20Processes%20and%20Structures%202nd%20Ed.pdf">approval</a> from the research ethics committee before opening their doors. Ideally this committee should establish the procedures to guide this process and the use of the repository.</p>
<p>But there’s a weakness in this process: oversight from the committees on already established biobanks is not mandatory. </p>
<p>Another problem is that of <a href="http://www.scielo.org.za/scielo.phpid=S0256-95742013000400014&script=sci_arttext&tlng=es">informed consent</a> and individual autonomy around specimens. Informed consent is an ethical and legal doctrine and a necessary component of health research.</p>
<p>In classical research, the consent emphasis lies with the individual who decides how their samples will be used and how long they will be stored for. Because biobank research involves the contributions of large numbers of people, its ethical emphasis generally centres on the <a href="http://sro.library.usyd.edu.au/handle/10765/106615">common good</a>. </p>
<p>Here the challenge comes in with the secondary use of specimens. This is because future research may also involve research questions and methods that were not contemplated at the time of sample collection. Because of this, consent for biobank research cannot be truly “informed”. </p>
<h2>An ideal situation</h2>
<p>At the University of the Witwatersrand, the Human Research Ethics Committee (Medical), which is the oldest ethics committee in the country and among the first to be established in the world, set up a Biobanks Ethics Committee in 2013. This committee reviews applications for the establishment of biobanks and all research around the use of specimens from the approved biobanks. It remains the only biobank specific committee in the country.</p>
<p>For biobanks to operate optimally, their governance should be <a href="http://researchbriefings.files.parliament.uk/documents/POST-PN-473/POST-PN-473.pdf%20Accessed%20on%2016/06/2015">harmonised</a>.</p>
<p>Initial and continuous oversight of biobanks should be provided by research ethics committees. This includes the establishment of a biobank and how it is governed, managed and operated. The biobank must also set up protocols and processes for research activities, consulting with the public and other stakeholders, and establish what the criteria is for sampling and <a href="http://www.oecd.org/sti/biotechnologypolicies/44054609.pdf">selecting participants</a>. </p>
<p><em>This article is based on a paper published in a special South African Medical Research Council Flagship edition of the <a href="http://hmpg.co.za/index.php/sajbl/issue/view/497/showToc">South African Journal of Bioethics and Law</a>.</em></p><img src="https://counter.theconversation.com/content/45968/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>South Africa has no legislation setting out the rules for biobanks and the guidelines that do exist are not clear or detailed. This leaves the door wide open for unethical practises.Ames Dhai, Director of the Steve Biko Centre for Bioethics and Adjunct Professor and Head of Department of Bioethics at the Faculty of Health Sciences, University of the WitwatersrandSafia Mahomed, Bcom, LLB, LLM, PhD candidate, Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.