tag:theconversation.com,2011:/africa/topics/human-research-3965/articlesHuman research – The Conversation2021-11-17T05:15:01Ztag:theconversation.com,2011:article/1712172021-11-17T05:15:01Z2021-11-17T05:15:01ZCOVID vaccines don’t violate the Nuremberg Code. Here’s how to convince the doubters<p>People opposing vaccine mandates, or COVID vaccines more broadly, <a href="https://www.facebook.com/groups/138599678102481/permalink/184874376808344">have claimed</a> the vaccines violate the Nuremberg Code.</p>
<p>They say COVID vaccines are <a href="https://twitter.com/VigilantFox/status/1458925515205660678">experimental and people have been coerced</a> into vaccination. They say this breaches the ethical code drawn up after the second world war to guide medical research and human clinical trials.</p>
<p>But this argument is flawed. Here’s why the Nuremberg Code doesn’t apply, and how to correct this misunderstanding. </p>
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Read more:
<a href="https://theconversation.com/no-thats-not-the-law-the-danger-of-using-pseudolegal-arguments-against-covid-19-rules-170630">No, that's not the law: the danger of using pseudolegal arguments against COVID-19 rules</a>
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<h2>What is the Nuremberg Code?</h2>
<p>The Nuremberg Code was a direct response to atrocities Nazi doctors performed in concentration camps during WWII. They perpetrated this so-called medical experimentation on people with no capacity to consent, and this frequently led to lifelong disability, or death. </p>
<p>The doctors who performed these experiments <a href="https://www.nejm.org/doi/full/10.1056/nejm199711133372006">were tried</a> in Nuremberg in 1947.</p>
<p>The doctors’ defence argued their experiments were not significantly different to other research practices. So two American doctors working for the prosecution produced a document that aimed to draw together what made for ethical research.</p>
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<p>This document identified <a href="https://www.nejm.org/doi/full/10.1056/nejm199711133372006">three ethical, legal, and scientific requirements</a> for conducting human experiments, which were later expanded to ten. This ten-point document became known <a href="https://jamanetwork.com/journals/jama/fullarticle/2649074">as the Nuremburg Code</a>.</p>
<p>It details the process of seeking legally valid voluntary consent, covers the need to establish the humanitarian nature and purpose of the experiment, as well as ensuring the scientific integrity and obligations of the investigator to the subjects’ welfare. </p>
<p>However, the Nuremberg Code is no longer used to guide research ethics. The World Medical Association’s <a href="https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/">Declaration of Helsinki</a> replaced it in 1964. And there’s been more ethical guidance since.</p>
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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>
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<h2>No, COVID vaccines are not experimental</h2>
<p>Online commentary <a href="https://twitter.com/AbolishtheFeds/status/1428751073448181770">says</a> COVID vaccines are “experimental”.</p>
<p>But COVID vaccines have been thoroughly tested, and they have been <a href="https://theconversation.com/how-well-do-covid-vaccines-work-in-the-real-world-162926">shown to work</a>. Their side-effects have been extensively examined. They have been approved for use around the world and have been credited for <a href="https://theconversation.com/how-many-lives-have-coronavirus-vaccines-saved-we-used-state-data-on-deaths-and-vaccination-rates-to-find-out-169513">saving many lives</a>.</p>
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Read more:
<a href="https://theconversation.com/how-well-do-covid-vaccines-work-in-the-real-world-162926">How well do COVID vaccines work in the real world?</a>
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<p>So COVID vaccines are not “experimental”. Now COVID vaccines are part of standard public health response, it is not appropriate to refer to codes or documents developed to guide clinical trials and other research studies. </p>
<h2>How do you convince someone?</h2>
<p>If you come across someone claiming COVID vaccines are experimental, you can try the “<a href="https://www.independent.co.uk/news/health/coronavirus-vaccines-misinformation-scientists-truth-sandwich-b1783401.html">truth sandwich</a>” to try to <a href="https://medium.com/wehearthealthliteracy/the-truth-sandwich-a-better-way-to-mythbust-8021d2cf8730">myth bust</a>.</p>
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<p>If you imagine two pieces of bread, then the filling in the middle, you are on your way to using the truth sandwich.</p>
<p>First, we take a piece of bread, where we state the truth:</p>
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<p>COVID vaccines have been tested in pre-clinical and clinical trials, and their efficacy and effectiveness has been proven, and their side effects profiles have been extensively examined. </p>
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<p>Then we come to the filling in the middle, where we talk about a false claim and how it relates to the truth:</p>
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<p>You may have heard someone suggest the COVID-19 vaccine program infringes people’s rights under the Nuremberg Code. But the claim that COVID-19 vaccines are experimental is simply not true. Regulatory authorities have approved these vaccines nationally and internationally. Safety monitoring is ongoing, but these processes are routine and commonly used for other vaccines or drugs. Check out <a href="https://ausvaxsafety.org.au/safety-data/covid-19-vaccines">AusVaxSafety</a>.</p>
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<p>Our final piece of bread comes next, repeating the truth:</p>
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<p>The Nuremberg Code focuses on clinical research on humans. Therefore, it is no longer relevant once a vaccine moves beyond the clinical trial phase and has been authorised or approved for use globally. </p>
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<h2>The issue of informed consent</h2>
<p>Online commentary usually cites the <a href="https://www.ushmm.org/information/exhibitions/online-exhibitions/special-focus/doctors-trial/nuremberg-code">first clause</a> of the Nuremberg Code about the need for informed consent in human experiments:</p>
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<p>The voluntary consent of the human subject is absolutely essential.</p>
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<p>This argument is used as evidence there’s something unethical about using COVID vaccines or introducing mandates.</p>
<p>Indeed, voluntary informed consent is an ethical bedrock for clinical research. Any form of compulsion is unacceptable because clinical research has inherent risks and can’t be quantified precisely. Research also may not have any direct benefit for participants, which again requires consent. </p>
<p>To be ethical, therefore, researchers must ensure participants in clinical trials understand potential risks and benefits, and give voluntarily consent to participate.</p>
<h2>How do you convince someone?</h2>
<p>Again, we can use the “truth sandwich” to myth bust. </p>
<p>Take your first piece of bread, stating the truth (the facts): </p>
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<p>The Nuremberg Code relates to research, where the emphasis of informed consent is on “<a href="https://www.usatoday.com/story/news/factcheck/2021/08/10/fact-check-covid-19-vaccine-mandates-nuremberg-code-not-related/5530548001/">preventing research participants from being used as a means to an end</a>”. The need for informed consent is still required for receiving a COVID-19 vaccine (or any vaccine) but the need does not stem from the Nuremberg Code. </p>
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<p>Here’s the filling (the false claim and how it relates to the truth):</p>
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<p>The introduction of a vaccine mandate is not medical research but rather a public health intervention. In every setting where COVID vaccines are mandated, no-one is being forced to be vaccinated against their will or consent. Informed consent is still sought before vaccination, and people retain the right to choose whether to be vaccinated. </p>
<p>However, in these settings, the public health goal of COVID-19 vaccination is seen as outweighing the rights of the individual to remain un-vaccinated. Other people in these settings have a right to health and security. Therefore there are outcomes for those who don’t comply. Exemptions are provided for those who cannot receive the vaccine for medical reasons. </p>
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<p>If you want to expand further:</p>
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<p>Mandates of this nature have previously been used in occupational settings to reduce the risk from vaccine preventable diseases for the employee and for the people they come into contact with, whether they be hospital patients or aged care residents. Beyond these settings, we have accepted vaccines as requirements of travel (such as yellow fever) both to protect ourselves and to reduce any risk of bringing this infection back to Australia. </p>
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<p>Final piece of bread (repeating the truth):</p>
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<p>There has been misinformation about linking COVID-19 vaccination, and/or the requirements within some occupations to the Nuremberg Code. The code relates to research and claims that mandates violate it are not accurate. </p>
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<h2>Why is this important?</h2>
<p>This type of misinformation often thrives in situations <a href="https://fullfact.org/health/how-to-fact-check-coronavirus/">where feelings are manipulated</a>. And emotional posts on social media referring to Nazi doctors and Nuremberg are more likely to be shared.</p>
<p>We can keep fact checking. But it’s also time for every one of us to get out there with our truth sandwiches.</p><img src="https://counter.theconversation.com/content/171217/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Holly Seale is an investigator on research studies funded by NHMRC and has previously received funding for investigator driven research from NSW Ministry of Health, as well as from Sanofi Pasteur and Seqirus. She is the Deputy Chair of the Collaboration on Social Science and Immunisation.</span></em></p><p class="fine-print"><em><span>Ben Harris-Roxas is an investigator on projects funded by the Cancer Institute NSW, the National Health and Medical Research Council (NHMRC), the Sydney Partnership for Health Education Research & Enterprise (SPHERE), and NSW Health. In the past he has received funding from the Australian Research Council, the World Health Organization, the Australian Government Department of Health, the Public Health Agency of Canada, the Heart Foundation, NPS MedicineWise, the Sax Institute, and the City of Gold Coast.</span></em></p><p class="fine-print"><em><span>Bridget Haire has received funding from National Health and Medical Research Council (NHMRC)</span></em></p>Emotive claims, like COVID vaccination being unethical or coercive, are more likely to be shared on social media. But we can fight back.Holly Seale, Associate professor, UNSW SydneyBen Harris-Roxas, Senior Lecturer, UNSW SydneyBridget Haire, Postdoctoral Research Fellow, Kirby Institute, UNSW SydneyLicensed 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>
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<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>
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<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>
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<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>
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<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>
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<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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<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>
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<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/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/398782015-06-11T11:23:07Z2015-06-11T11:23:07ZWhy we shouldn’t always compensate people for historical wrongs<figure><img src="https://images.theconversation.com/files/83854/original/image-20150603-2966-1ulih9h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">In the 1940s and 50s, hundreds of Guatemalan men, women and children were deliberately infected with syphilis and gonorrhoea.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/tfjensen/8079210756/">Thomas Frost Jensen/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>Human research ethics has often been formulated in response to scandals. However, the majority of research ethics cases are actually quite mundane. They involve committees making decisions about the likely balance between risks and benefits of the proposed research. Most researchers are well-intentioned and much research is conducted for public benefit. </p>
<p>But what should we do when things go wrong? What about when evidence of wrongdoing is uncovered long after the event? Are survivors entitled to compensation? A current example of just such a case provides an opportunity to examine the issues involved.</p>
<h2>The Guatemala STD case</h2>
<p>From 1945 and into the 1950s, a series of research activities involving investigations into various sexually transmitted diseases (STDs), took place in Guatemala. The project was a collaboration with support from government agencies of both Guatemala and the United States. </p>
<p>About 1,500 men, women and children <a href="http://www.hhs.gov/1946inoculationstudy/factsheet.html">were deliberately infected</a> with syphilis and gonorrhoea so patterns of disease transmission could be better understood. Survivors are <a href="http://www.theguardian.com/us-news/2015/apr/02/johns-hopkins-lawsuit-deliberate-std-infections-guatemala">now taking legal action against</a> those they hold responsible including Johns Hopkins University (where some researchers held academic appointments) and the Rockefeller Foundation (which supplied some of the funding). </p>
<p>When we look at the case, 75 years later, it’s easy to see what happened as wrong, and the work has been <a href="http://bioethics.gov/node/654">strongly condemned</a> by the US <a href="http://www.bioethics.gov/">Presidential Commission for the Study of Bioethical Issues</a>. But we should take care in reaching such judgements; we should always accept our conclusions for the right reasons. We need to think carefully about what we can learn and what subsequent action is appropriate. </p>
<p>There are three reasons for questioning whether legal action against the institutions involved is the right approach for the survivors of the Guatemala study to take. Because even if the original experimentation was wrong, it’s not clear that legal action, at least in its present form, is justified.</p>
<h2>Interpreting historical cases</h2>
<p>First, we should take care not to judge the case as if it were a contemporary failure. The world has changed a lot in the past 70 years, and we need to look at the case in terms of the values and assumptions about research at the time the actions occurred. </p>
<p>The experimentation began during World War II, when STDs were a major health issue that threatened the war effort. There was little, if any, research regulation in place at the time, and the attitudes of clinicians and researchers were very different from those of today. </p>
<p>Key aspects of contemporary research ethics, such as a strong commitment to informing participants that research is occurring and the risk of harms involved, did not exist at that time. The transformation of the values that guide medicine and research, and the subsequent development of relevant research ethics regulations have been dramatic. We should not judge the 1940s and 1950s by the standards of 2015.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/83857/original/image-20150603-2931-p0jwq1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/83857/original/image-20150603-2931-p0jwq1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/83857/original/image-20150603-2931-p0jwq1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/83857/original/image-20150603-2931-p0jwq1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/83857/original/image-20150603-2931-p0jwq1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/83857/original/image-20150603-2931-p0jwq1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/83857/original/image-20150603-2931-p0jwq1.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">Do the descendants of people driven out of rural Ireland in the 1850s as a result of the potato famines deserve compensation?</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/sackton/7580310736/">Tim Sackton/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<h2>Responsible parties</h2>
<p>Even if I’m wrong on the issue of the relevant standard to use, we still have the problem of how to ascribe responsibility in this case. If individuals, an organisation or even a nation acted wrongly in the past, who is responsible for the consequences of that event? </p>
<p>In this case, it’s almost certain that not a single individual involved in the research is still an active researcher or employed by Johns Hopkins University or the Rockefeller Foundation. Indeed, most active participants will be dead. </p>
<p>So even if we think the actions were wrong, it’s not clear the relevant responsible parties still exist. Any causal chain of responsibility is weak, if not broken. </p>
<p>Surely if anyone should be the focus of legal action, it should be the US government, as they have ultimate responsibility for what their citizens do when acting on the basis of a nationally supported programme as in this case. If no action can be taken against the US government, it’s not clear that any other legal action is justifiable. </p>
<h2>Appropriateness of compensation</h2>
<p>Finally, even if we think we should still be able to go down the route of retrospective compensation, focused perhaps on the US government as having ultimate responsibility when wrongs are inflicted on the citizens of another country, where do we stop in making such claims? </p>
<p>Even when wrongs have clearly been committed in the past, there must be firm limits on retrospective claims. Most jurisdictions have such limits for good reason. Without them, a list of claims for compensation for cases of past injustice will be very long. </p>
<p>For example, part of my family was driven out of rural Ireland in the 1850s as a result of poverty, crop failures and a lack of an adequate response by the British government to the problems of a starving population. Do I, as a result, have some kind of claim against the UK government? Surely not.</p>
<h2>Useful lessons</h2>
<p>The real lesson we should learn from the Guatemala case is that research should be conducted according to appropriate standards, and such standards are, rightly, now much higher than they were in 1945. Indeed, it’s impossible to believe that such research would be carried out in this manner today. </p>
<p>Any research involving deliberate infection with a disease would require the highest level of informed consent. But it’s also essential to acknowledge that STD research is vital to understanding the nature of disease transmission and possible treatments. We all benefit from such public health research, and it should be encouraged, where the appropriate safeguards are in place.</p>
<p>Retrospective lawsuits are problematic because they involve judging the past by today’s standards. We can learn something by looking at them - what not to do today, and how contemporary research regulation might have to change - but it makes no sense to seek compensation for historical wrongs from organisations that were once involved. </p>
<p><strong><a href="https://theconversation.com/us/topics/on-human-experiments">Click here</a> to read more articles in The Conversation’s series <a href="https://theconversation.com/us/topics/on-human-experiments">On Human Experiments</a>.</strong></p><img src="https://counter.theconversation.com/content/39878/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Angus Dawson 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>On Human Experiments - Should there be compensatio when evidence of unethical research is uncovered long after the event?Angus Dawson, Professor of Bioethics and Director of VELiM, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/398762015-06-08T05:27:33Z2015-06-08T05:27:33ZHuman experiments – the good, the bad, and the ugly<figure><img src="https://images.theconversation.com/files/83938/original/image-20150604-13657-ucxhpk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A pioneer at work.</span> <span class="attribution"><a class="source" href="http://en.wikipedia.org/wiki/File:The_cow_pock.jpg">Library of Congress</a></span></figcaption></figure><p>Research involving human subjects is littered with a history of scandal that often shapes people’s views of the ethics of research. Often the earliest cited case is English physician <a href="http://www.ncbi.nlm.nih.gov/pubmed/4592685/">Edward Jenner’s development of the smallpox vaccine</a> in 1796, where he injected an eight-year-old child with the pus taken from a cowpox infection and then deliberately exposed her to an infected carrier of smallpox.</p>
<p>Although Jenner’s experiment was, fortunately, successful, the method of exposing a child to a deadly disease in this way would undoubtedly nowadays be seen as unacceptable. Perhaps the most notorious cases of unethical research were revealed during the Nuremberg trials concerning <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1323276/">Nazi experiments on concentration camp prisoners</a>. This “research” included involuntary sterilisation, inducing hypothermia, and exposing subjects to diseases such as tuberculosis. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/78236/original/image-20150416-5657-1jnb1b5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/78236/original/image-20150416-5657-1jnb1b5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/78236/original/image-20150416-5657-1jnb1b5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=428&fit=crop&dpr=1 600w, https://images.theconversation.com/files/78236/original/image-20150416-5657-1jnb1b5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=428&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/78236/original/image-20150416-5657-1jnb1b5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=428&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/78236/original/image-20150416-5657-1jnb1b5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=538&fit=crop&dpr=1 754w, https://images.theconversation.com/files/78236/original/image-20150416-5657-1jnb1b5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=538&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/78236/original/image-20150416-5657-1jnb1b5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=538&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Mustard gas burns.</span>
<span class="attribution"><a class="source" href="http://commons.wikimedia.org/wiki/File:Mustard_gas_burns.jpg#/media/File:Mustard_gas_burns.jpg">Balcer</a></span>
</figcaption>
</figure>
<p>There are also examples of government-run research that took advantage of the vulnerability of the subjects to ensure their participation and which resulted in the subjects experiencing severe harms, such as the <a href="http://www.tuskegee.edu/about_us/centers_of_excellence/bioethics_center/about_the_usphs_syphilis_study.aspx">Tuskegee Syphilis trials</a> or the UK-run <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1832084/">Porton Down chemical experiments</a> in which 11,000 military personnel <a href="http://www.theguardian.com/politics/2006/jul/15/uk.greenpolitics">were exposed to mustard and nerve gas</a> between 1939 and 1989.</p>
<h2>Human subjects</h2>
<p>Yet, despite the litany of failures to maintain ethical standards in research, these remain the exceptions and a focus on scandals can seriously distort proper discussion about research ethics. </p>
<p>Research involving human subjects is not intrinsically ethically dubious. That is not to say it doesn’t contain ethical challenges, but these concerns can often be met. Nor does it diminish the immense social importance of involving human subjects in experiments and the huge improvement in the quality of lives and number of lives saved through such research.</p>
<p>The most pressing question in research ethics is often not whether we should be doing research but how can we balance or justify exposing individual human subjects to risk for the sake of the advancement of science? </p>
<p>Sometimes, in the case of therapeutic trials, research subjects potentially stand to benefit should the treatment prove successful (some have argued that this <a href="http://www.telegraph.co.uk/news/health/saatchi-bill/">should go even further</a> with the recruitment of the terminally ill for experimental drugs). However, such cases are rare when considered against the time it takes for the results of research to be fully developed. The benefits are therefore often distributed among future populations rather than the individuals taking part in the trial. Matters are made even more complicated in cases where trials are conducted on subjects who are potentially vulnerable or desperate.</p>
<h2>Balancing tensions</h2>
<p>The crucial feature about research ethics is to understand that in order to carry out ethically justified research, we have to be particularly aware of where the imbalances lie between researchers and their subjects and what might be best done to avoid ethical conflict. Much of the ethical conflict is based in the tension that arises between the researcher’s concerns for the interests of the subject on the one hand and the interests of science, society and future patients on the other.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/78235/original/image-20150416-5654-t7vxif.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/78235/original/image-20150416-5654-t7vxif.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/78235/original/image-20150416-5654-t7vxif.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=459&fit=crop&dpr=1 600w, https://images.theconversation.com/files/78235/original/image-20150416-5654-t7vxif.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=459&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/78235/original/image-20150416-5654-t7vxif.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=459&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/78235/original/image-20150416-5654-t7vxif.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=577&fit=crop&dpr=1 754w, https://images.theconversation.com/files/78235/original/image-20150416-5654-t7vxif.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=577&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/78235/original/image-20150416-5654-t7vxif.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=577&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Rotavirus close up.</span>
<span class="attribution"><a class="source" href="http://commons.wikimedia.org/wiki/File:Rotavirus.jpg#/media/File:Rotavirus.jpg">Cell culture</a></span>
</figcaption>
</figure>
<p>Unethical practice can still occur where this hasn’t been properly thought through – especially when it comes to exposing study participants risk through placebos. In 2014, a trial for an experimental vaccine for rotavirus in India <a href="http://www.huffingtonpost.com/michael-carome-md/unethical-clinical-trials_b_5927660.html">was heavily criticised</a> for giving more than 2,000 children a placebo. In 1997, one US government-funded trial into preventing HIV spread from pregnant women to their babies saw them given a placebo instead of a known drug that was effective in prevention. </p>
<h2>The role of the committee</h2>
<p>Abuse can also happen because researchers themselves may, consciously or unconsciously, favour the interests of carrying out research over the interests of the subjects involved in the research. </p>
<p>Research ethics committees (RECs) are widely used to assess and review trial designs. These committees are designed to scrutinise with a broad societal view – including both professional and lay perspectives – as to whether the research is ethically acceptable. In many cases, this involves ensuring that many of the standard safeguards, such as proper consent or anonymising data, are in place to protect research subjects, and ensuring that subjects are not exposed to unnecessary risks.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/78238/original/image-20150416-5615-1vet6n4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/78238/original/image-20150416-5615-1vet6n4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=419&fit=crop&dpr=1 600w, https://images.theconversation.com/files/78238/original/image-20150416-5615-1vet6n4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=419&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/78238/original/image-20150416-5615-1vet6n4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=419&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/78238/original/image-20150416-5615-1vet6n4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=526&fit=crop&dpr=1 754w, https://images.theconversation.com/files/78238/original/image-20150416-5615-1vet6n4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=526&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/78238/original/image-20150416-5615-1vet6n4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=526&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">What will the committee think?</span>
<span class="attribution"><span class="source">Decide by Shutterstock</span></span>
</figcaption>
</figure>
<p>There will inevitably be cases where research cannot meet the usual ethical safeguards, for example, when the very nature of the research requires that the subjects do not know they are participating in research (as in the case of certain kinds of behavioural study, where knowing that you were the subject of research would change your behaviour patterns and render the research useless). </p>
<p>It then becomes a much more demanding question as to whether the potential benefits of the research are sufficiently great to justify overriding standard practices, and whether there are ever limits to the sorts of risks we are willing to allow human subjects to undertake.</p>
<h2>The limits of consent</h2>
<p>We tend to deem it much too risky to allow those those least able to protect their own interests, such as children, adults with cognitive impairments, or those whose circumstances that leave them more open to harm, to participate in research. But it is not unheard of when the research cannot be done on any other subject population other than the vulnerable group. </p>
<p>Research into dementia treatments, for instance, or research into child behavioural disorders would each require at least some involvement of vulnerable groups to be effective. For such research to be ethically acceptable, the methodological necessity of using members of these groups as subjects must also go hand-in-hand with a range of safeguards to protect them from harm. </p>
<p>As these subjects are less able to protect their own interests adequately, these safeguards must also be much more stringent and wide-reaching than might be the case for research involving less vulnerable research subjects. </p>
<p>Even in cases of studying particular conditions, such as childhood diseases, research is usually only seen as ethically justified if it imposes no real risk of harm or is likely to have some direct therapeutic benefit. The drawback, some argue, is that this inhibits drugs being developed that are targeted at specific populations such as children. This has <a href="https://theconversation.com/eu-loophole-means-children-with-cancer-are-denied-drugs-23098">led to changes in law</a> in cancer trials, for example, that make it easier to include children. </p>
<p>When it comes to well-informed, competent adults, some believe that any level of risk is acceptable as long as the subject agrees to it. Others think that the degree of risk needs to be offset by particular gains for the individual taking part – as was the case with the recent use of an <a href="http://www.who.int/medicines/emp_ebola_q_as/en/">experimental Ebola vaccine</a> on healthcare workers exposed to the virus in Africa.</p>
<p>Ultimately, there is no universally accepted position as to how such research should proceed. Laws and codes are far too general for deciding such cases, which is where ethical judgements, committees, and arguments come in that allow agreement to be reached. These can delay research or draw on resources available for a trial, but they are essential if we are to maintain a high level of scrutiny in often complex situations and prevent further scandalous cases from arising. </p>
<p><strong><a href="https://theconversation.com/us/topics/on-human-experiments">Click here</a> to read more articles in The Conversation’s series <a href="https://theconversation.com/us/topics/on-human-experiments">On Human Experiments</a>.</strong></p><img src="https://counter.theconversation.com/content/39876/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Anthony Wrigley 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>The first part of our series On Human Experiments looks at the parameters of human research and its ethical bounds.Anthony Wrigley, Senior Lecturer in Ethics, Keele UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/405282015-06-08T05:27:17Z2015-06-08T05:27:17ZHow national security gave birth to bioethics<figure><img src="https://images.theconversation.com/files/80561/original/image-20150505-966-14ofol0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Exercise Desert Rock I Buster Jangle Dog</span> <span class="attribution"><a class="source" href="http://commons.wikimedia.org/wiki/File%3AExercise_Desert_Rock_I_(Buster-Jangle_Dog)_002.jpg">By Federal Government of the United States [Public domain], via Wikimedia Commons</a></span></figcaption></figure><p>Starting near the end of World War II and continuing until the 1970s, the US government sponsored radiation experiments on human subjects. Some of these experiments were conducted to understand the effects of radiation on atomic bomb workers. Others were to learn about the benefits of radiation for cancer patients. Many of the experiments were conducted in secret or not well understood by the public. </p>
<p>Twenty years ago, a committee appointed by President Bill Clinton <a href="http://biotech.law.lsu.edu/research/reports/ACHRE/summary.html">reported</a> on decades of radiation experiments conducted under the auspices of the federal government. </p>
<p>I was a senior staff member of that committee. Even though I had been teaching bioethics for 15 years, I was stunned to discover that my understanding of my field was drastically incomplete. I failed to appreciate that national security was the reason for many experiments in the history of medicine. After that experience, I published my book <a href="http://www.jonathandmoreno.com/about/undue-risk/">Undue Risk</a> about human experiments and national security.</p>
<p>Unethical incidents often gave rise to ethical standards we now take for granted. But even when ethical standards were in place, there were times when they were grievously violated.</p>
<h2>The Guatemala syphilis experiments</h2>
<p>During World War II, sexually transmitted diseases (STDs) were a huge problem for the US military. Out of 1,000 sailors, as many as 300 could be sick at any given time. It’s likely many of them were infected when they visited prostitutes during shore leave in places such as Sydney, Australia, in spite of movies and posters that warned them about the risk. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/80339/original/image-20150504-8387-1ll9icu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/80339/original/image-20150504-8387-1ll9icu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/80339/original/image-20150504-8387-1ll9icu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=855&fit=crop&dpr=1 600w, https://images.theconversation.com/files/80339/original/image-20150504-8387-1ll9icu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=855&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/80339/original/image-20150504-8387-1ll9icu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=855&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/80339/original/image-20150504-8387-1ll9icu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1075&fit=crop&dpr=1 754w, https://images.theconversation.com/files/80339/original/image-20150504-8387-1ll9icu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1075&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/80339/original/image-20150504-8387-1ll9icu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1075&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">This United States Air Force poster was used to remind servicemen fighting abroad during World War II that venereal disease is not just a local concern, but that VD can be found</span>
<span class="attribution"><span class="source">CDC via Public Health Image Library</span>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>Having so many sick sailors, soldiers and marines could cripple the war effort, so figuring out how to treat servicemen more effectively in the future became a matter of serious military interest. </p>
<p>In 1946, just after World War II, through the cooperation of American and Guatemalan officials, experiments on sexually transmitted diseases began in Guatemala. The goal was to see if the new wonder drug penicillin could cure these STDs.</p>
<p>The experiments involved hundreds of sex workers, prisoners, mental patients, soldiers and even children who were intentionally exposed to STDs. The Guatemala experiment was forgotten, at least in the US, until Wellesley College historian Susan Reverby discovered documents about the experiments in 2010 and reported her find to the US government. </p>
<p>That same year, president Barack Obama personally apologized to the president of Guatemala for the experiments. Obama also ordered his presidential bioethics commission to investigate the experiments and <a href="http://bioethics.gov/node/778">report</a> to him about how such ethical violations could have happened. Once again, I was fortunate to be on the staff of this presidential commission.</p>
<h2>Military research</h2>
<p>Ironically, while the experiments in Guatemala were going on in the late 1940s, three American judges were hearing the arguments in a war crimes trial in Germany. Twenty-three Nazi doctors and bureaucrats were accused of horrific experiments on people in concentration camps. </p>
<p>The judges decided they needed to make the rules around human experiments clear, so as part of their decision they wrote what has come to be known as the Nuremberg Code. The code states that “the voluntary consent of the human subject is absolutely essential.” </p>
<p>The Guatemala experiments clearly violated that code. President Obama’s commission found that the US public health officials knew what they were doing was unethical, so they kept it quiet. Years later, one of those doctors had a key role in the infamous <a href="http://www.cdc.gov/tuskegee/timeline.htm">syphilis experiments in Tuskegee, Alabama</a> that studied the progression of untreated syphilis. None of the 600 men enrolled in the experiments was told if he had syphilis or not. No one with the disease was offered penicillin, the treatment of choice for syphilis. The 40-year experiment finally ended in 1972.</p>
<p>Unlike the Guatemala experiments that were successfully covered up for so long, the syphilis experiments were done in public. What they had in common was exploitation of vulnerable people. Consent isn’t enough to make a research study ethical. It must be an <em>informed</em> consent. There is also the matter of justice. Both the burdens and benefits of science should not be confined to a single group of people. </p>
<h2>Military research and an evolving understanding of ethics</h2>
<p>Military research needs didn’t always lead to the exploitation of people. In some cases, important ethical standards were recognized. </p>
<p>When a yellow fever epidemic threatened American forces in Cuba in 1900, Army doctor Walter Reed wrote what seems to be the first consent form for a human experiment. </p>
<p>Before the Guatemala experiments, American prisoners were asked for their consent to be in another experiment on STDs and penicillin. Although the ethics of prison experiments are complex, many men in federal prisons at that time seem to have genuinely volunteered for malaria experiments at a time when their brothers and fathers might have been in combat. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/81073/original/image-20150508-22785-75ogno.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/81073/original/image-20150508-22785-75ogno.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/81073/original/image-20150508-22785-75ogno.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=752&fit=crop&dpr=1 600w, https://images.theconversation.com/files/81073/original/image-20150508-22785-75ogno.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=752&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/81073/original/image-20150508-22785-75ogno.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=752&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/81073/original/image-20150508-22785-75ogno.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=945&fit=crop&dpr=1 754w, https://images.theconversation.com/files/81073/original/image-20150508-22785-75ogno.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=945&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/81073/original/image-20150508-22785-75ogno.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=945&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">An atomic test at Nevada Test Site, April 15 1955.</span>
<span class="attribution"><a class="source" href="http://upload.wikimedia.org/wikipedia/commons/6/6a/Operation_Teapot_-_MET_%28Military_Effects_Test%29.jpg">Photo courtesy of National Nuclear Security Administration/Nevada Field Office via Wikimedia Commons</a></span>
</figcaption>
</figure>
<p>And in 1953 the Pentagon adopted the Nuremberg Code for its defensive studies of atomic, biological and chemical warfare. They were the first and only US government agency to adopt the code word for word.</p>
<p>The problem is that ethics rules are inconsistently applied. There’s no better example than testing for radiation effects. </p>
<p>More than 200,000 soldiers and marines were exposed to atomic bomb blasts in the 1950s. Hardly any were asked for their consent because it was considered part of their training. Yet it seems a few of the men who were in psychological studies of their reaction to the bomb were asked for consent, perhaps because psychiatrists and psychologists were in charge so it was considered “medical.” Or the information given to the subjects before an experiment was vague, as in LSD experiments with soldiers in the 1950s.</p>
<h2>National security and medical research today</h2>
<p>Medical research related to national security continues to be an important enterprise. For example, there may be as many as 300,000 veterans of the wars in Afghanistan and Iraq with traumatic brain injuries. The federal government is investing a lot of money in neuroscience to improve treatment for these injuries. Inevitably this research will raise ethical issues, such as how well some of these patients can give a fully informed consent. I take up some of these problems in my book <a href="http://www.dana.org/News/Details.aspx?id=42724">Mind Wars</a>.</p>
<p>And human research continues to push forward into new frontiers. At the same time the Pentagon is interested in how to treat injured or sick warfighters, it’s also studying ways to enhance healthy human beings, especially their ability to learn new skills. For the 21st-century military, brains count as much as muscle. But how far should human enhancement go? And who goes first and at what personal cost? These are the questions that must be answered. </p>
<p>Because science is changing at a rapid rate, there must be a common understanding about how to apply the words on paper to new situations. A good place to start is by remembering how easy it is for things to go wrong.</p>
<p>We’ve learned that the finest ethics rules aren’t enough. There must be transparency and accountability so that the public can know what’s going on, and there are clear lines of responsibility if the rules are broken. </p>
<p><strong><a href="https://theconversation.com/us/topics/on-human-experiments">Click here</a> to read more articles in The Conversation’s series <a href="https://theconversation.com/us/topics/on-human-experiments">On Human Experiments</a>.</strong></p><img src="https://counter.theconversation.com/content/40528/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jonathan D Moreno is affiliated with the President's Commission for the Study of Bioethical Issues as a senior advisor and the Center for American Progress as a senior fellow.</span></em></p>On Human Experiments: what lies behind some of the most shocking human experiments in recent history? Here’s a clue: most of it took place during wartime or when war seemed like a real threat.Jonathan D Moreno, Professor of Ethics, University of PennsylvaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/375612015-02-27T11:09:45Z2015-02-27T11:09:45ZIt’s time to fix our outdated guidelines for human vaccine trials<p>Recently, Phase II and III trials of two vaccines for Ebola started in West Africa. The development of possible vaccines is welcome news. Like most vaccine trials, the current Ebola trials are being conducted under ethical guidelines derived from US standards for clinical research in human beings.</p>
<p>Research in humans is a crucial part of our medical system. We need to be able to test that vaccines and drugs are safe and effective in people before they are released to the general public. While standards exist to govern these testing processes, our protections for human subjects of medical experiments are badly outdated. </p>
<p>Vaccines merit public scrutiny especially during the early years of their use and development. Not only are problems most likely to appear while vaccines are being tested, but the volunteers in these early, risky stages often have little political power.</p>
<p>It is useful to look to a vaccine trial conducted 50 years ago where researchers from the US National Institutes of Health studied the effects of a virus called SV40 in human subjects – in this case federal prisoners.</p>
<h2>1960 – scientists discover a contaminated vaccine</h2>
<p>In 1960 scientists discovered that a vaccine culture used throughout the United States had been contaminated with a monkey virus, SV40. Among other things, this vaccine culture had been used to make polio vaccine that had been given to 98 million Americans – more than half the US population at the time.</p>
<p>The discovery raised major concerns. Scientists knew that SV40 caused cancer-like tumors in lab animals and human tissue. But they did not know how it affected living people. In 1963, scientists gathered in La Jolla, California to discuss the “safety of polio and measles vaccines and their possible contamination by viruses capable of causing cancer in lower forms of animals.” </p>
<p>As we report <a href="http://dx.doi.org/10.1016/j.shpsc.2014.07.011">in a recent article</a>, scientists at the time felt that running a controlled clinical trial was the only way to find a definitive answer. But they also felt it would be unethical to experiment on people if one outcome might be cancer. And then an opportunity to do an “ethical” human trial presented itself.</p>
<h2>Using prisoners as guinea pigs</h2>
<p>At the same time that the US National Institutes of Health (NIH) learned about the SV40 contamination, NIH scientists were also developing and testing new vaccines on federal prisoners who had volunteered to take part in an intentional infection program. Using prisoners for clinical research was not uncommon at the time. Prior to the 1970s, almost all Phase I and II drug trials were conducted on prisoners. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/73101/original/image-20150225-1795-1ls4mpo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/73101/original/image-20150225-1795-1ls4mpo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=659&fit=crop&dpr=1 600w, https://images.theconversation.com/files/73101/original/image-20150225-1795-1ls4mpo.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=659&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/73101/original/image-20150225-1795-1ls4mpo.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=659&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/73101/original/image-20150225-1795-1ls4mpo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=828&fit=crop&dpr=1 754w, https://images.theconversation.com/files/73101/original/image-20150225-1795-1ls4mpo.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=828&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/73101/original/image-20150225-1795-1ls4mpo.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=828&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Caption reads: ‘1964-5: Mr. Grey, Assistant Chief, NVP (Normal Volunteer.
Program) poses for picture depicting diet for Fed Prisoners Vols, NIAID cold virus
studies’.</span>
<span class="attribution"><span class="source">Patient Recruitment and Public Liaison Office, NIH</span></span>
</figcaption>
</figure>
<p>J Anthony Morris, a molecular biologist at NIH, was testing a new vaccine for the common cold on prisoners. And SV40, the same virus that had contaminated the polio vaccine, had also stowed away in the experimental vaccine Morris was using. Since the prisoners had already been exposed to SV40 once by mistake, scientists decided they had a rare opportunity. Morris and his team created a controlled study to examine the affects of SV40 in humans.</p>
<p>To their relief they found that while SV40 affected the prisoners’ immune response, it fell beneath the threshold of clinical notice. They felt confident that any accidental low dose of SV40 – in polio vaccine, for example – would not affect people’s long-term health.</p>
<p>Government epidemiologists tracked cancer rates in the US population to be sure there was no spike in the disease for people who had received the contaminated polio vaccine. By the end of the 1960s, epidemiologists had found no observable effect of SV40 at the population level. The polio vaccine was safe, and other contaminated vaccines, too.</p>
<h2>Our ethical standards are better, but not by much</h2>
<p>Our goal here is not to argue about the safety of vaccines routinely given in the US – they are safe – or about the safety of the Ebola vaccines being tested.</p>
<p>Since the 1960s, our knowledge about vaccines has improved, and our standards for vaccine trials have evolved. The people used in the 1960s vaccine research — namely, prisoners — were eventually safeguarded under regulations for the protection of human subjects of medical research, which passed in <a href="http://scholarship.law.georgetown.edu/cgi/viewcontent.cgi?article=1478&context=facpub">the 1970s</a>.</p>
<p>Now almost 50 years later, the US Office of Human Research Protections has stated that these old rules are inadequate to <a href="http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html">protect human subjects</a>. Yet research on human subjects has radically expanded both the numbers of human subjects and the transnational reach of the old rules. The US government knows that at the least they need better ways to track adverse events and inform participants about results. They need earlier warning systems and the resources for more systematic governance of clinical trials. </p>
<p>Despite the deficiencies in our human research protocols, medical researchers in other countries have followed US human subject protections since the 1970s. The regulatory apparatus is lagging to such an extent that in 2011, the US government pledged to <a href="http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html">revise</a> the rules to account for new populations and methods used in 21st century medical experiments. Yet these outdated rules remain unchanged today. </p>
<p>Phase I and II trials are the riskiest, the first tests of new drugs that are done in human beings. In the United States these tests <a href="http://www.ncbi.nlm.nih.gov/pubmed/25601069">tend to be done on people</a> with little money and lots of time out of the workforce – the very people who most need protection. </p>
<p>Turning our eye to the <a href="http://www.nybooks.com/articles/archives/2014/dec/18/ebola-liberia-epidemic-rumors/">Ebola trials</a>, we must ask who is taking part and how they will be protected. Experiments for the Ebola vaccine are at risk of being done with the best of intentions on people susceptible to the disease by virtue of geopolitical location and a history of inequality.</p><img src="https://counter.theconversation.com/content/37561/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>Prior to the 1970s, almost all Phase I and II drug trials were conducted on prisoners. Our standards have gotten better since then, but still need revision.Laura Stark, Assistant professor, Center for Medicine, Health, and Society, Vanderbilt UniversityNancy D Campbell, Associate Dean for Graduate Studies & Research, Rensselaer Polytechnic InstituteLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/123422013-02-21T19:33:47Z2013-02-21T19:33:47ZThe brain race: can giant computers map the mind?<figure><img src="https://images.theconversation.com/files/20482/original/8bbqmv5s-1361417057.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The race to map the human brain may be more political than scientific.</span> <span class="attribution"><span class="source">brewbooks</span></span></figcaption></figure><p>In the past month, we have seen two major announcements of huge projects to map the brain – the <a href="http://www.humanbrainproject.eu/">European Human Brain Project (HBP)</a> and the <a href="http://www.nytimes.com/2013/02/18/science/project-seeks-to-build-map-of-human-brain.html?pagewanted=all&_r=1&">Obama Brain Activity Map (BAM)</a>. </p>
<p>What you may not have noticed is a third, much more promising project announced by the Seattle-based <a href="http://www.alleninstitute.org/">Allen Institute for Brain Science</a> to do similar things – but more on this later on.</p>
<p>Of the first two, the European HBP <a href="http://www.newscientist.com/article/mg21729036.800-why-were-building-a-1-billion-model-of-a-human-brain.html">will give €1 billion</a> to the Lausanne-based research group headed by Henry Markram. Markram is a brilliant salesman whose ambitious plan to make a working computer model of the cerebral cortex (<a href="http://bluebrain.epfl.ch/">“the Blue Brain Project”</a>) has been strongly supported by IBM since about 2005. </p>
<p>The fact the Blue Brain project has not produced any significant breakthroughs in recent years does not seem to have worried the European funding agencies. Apparently they like the idea of Markram building a monster computer to lead Europe into the future of brain research.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/20485/original/zwtz7ng2-1361418024.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/20485/original/zwtz7ng2-1361418024.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/20485/original/zwtz7ng2-1361418024.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/20485/original/zwtz7ng2-1361418024.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/20485/original/zwtz7ng2-1361418024.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/20485/original/zwtz7ng2-1361418024.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/20485/original/zwtz7ng2-1361418024.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/20485/original/zwtz7ng2-1361418024.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption"></span>
<span class="attribution"><span class="source">"lapolab"</span></span>
</figcaption>
</figure>
<p>The US plan is just as ambitious, but its aims seem to be more commercial and political than scientific. Obama <a href="http://slashdot.org/topic/datacenter/u-s-joins-google-microsoft-in-brain-race-report/">hopes</a> that companies such as Google and Microsoft will combine with universities and drug companies to lead the way to curing diseases such as Alzheimer’s. </p>
<p>No start-up funds have so far been allocated, but the plan clearly centres on the building of a massive computer network to simulate brain activity.</p>
<p>Obama sees the project as putting the US first in what he calls the “brain race” – just as Kennedy drove the space race competition with the Russians. Of course, this kind of announcement makes great political sense, but in my opinion it may be another case of the Emperor’s New Clothes.</p>
<h2>Baby steps for the brain</h2>
<p>The harsh truth is that brain research is still in its infancy, and big computers cannot replace our fundamental lack of understanding of how brains work.</p>
<p>I have watched the Markram project over the past five years and have been underwhelmed by the insights it has generated. For a start, Markram’s work focuses on a model of a tiny piece of rat cerebral cortex, which ignores the fact that the most important parts of the brain, in terms of survival, are outside the cerebral cortex. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/20486/original/qh38bc9p-1361418261.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/20486/original/qh38bc9p-1361418261.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/20486/original/qh38bc9p-1361418261.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=480&fit=crop&dpr=1 600w, https://images.theconversation.com/files/20486/original/qh38bc9p-1361418261.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=480&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/20486/original/qh38bc9p-1361418261.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=480&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/20486/original/qh38bc9p-1361418261.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=603&fit=crop&dpr=1 754w, https://images.theconversation.com/files/20486/original/qh38bc9p-1361418261.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=603&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/20486/original/qh38bc9p-1361418261.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=603&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption"></span>
<span class="attribution"><span class="source">_DJ_</span></span>
</figcaption>
</figure>
<p>We know that subcortical structures such as the <a href="http://www.news-medical.net/health/What-is-the-Hypothalamus.aspx">hypothalamus</a> can manage eating, drinking, reproduction, nurturing of offspring and defence all by themselves, but we are not even close to understanding the complex networks that make these basic systems work. </p>
<p>It is true the cerebral cortex of humans is awesomely powerful, but if we cannot even understand the basic survival functions of the brain, I think it’s a very long shot to predict that we can make an electronic cerebral cortex with a big computer.</p>
<h2>Scepticism</h2>
<p>While my own concerns over these two big projects are based in scepticism, others are worried about something much more sinister. Radical commentator <a href="http://www.nomorefakenews.com/">Jon Rappoport</a> sees the US project as a veiled attempt to create a kind of Orwellian Nineteen Eighty-Four society, with <a href="http://www.naturalnews.com/039152_brain_mapping_government_project_DARPA.html">government control of an individual’s brain function</a>.</p>
<p>Rappoport’s views are extreme but recent history shows the US public can easily be seduced into plans such as these. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/20483/original/7y45tf86-1361417174.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/20483/original/7y45tf86-1361417174.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/20483/original/7y45tf86-1361417174.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=677&fit=crop&dpr=1 600w, https://images.theconversation.com/files/20483/original/7y45tf86-1361417174.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=677&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/20483/original/7y45tf86-1361417174.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=677&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/20483/original/7y45tf86-1361417174.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=851&fit=crop&dpr=1 754w, https://images.theconversation.com/files/20483/original/7y45tf86-1361417174.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=851&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/20483/original/7y45tf86-1361417174.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=851&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption"></span>
<span class="attribution"><span class="source">marsmet543</span></span>
</figcaption>
</figure>
<p>Examples include the crazy mind-control ideas of Spanish physiology professor <a href="http://www.wanttoknow.info/650517nytimes">Jose Delgado</a> at Yale in the 1970s (“a program of psychosurgery and political control of our society”), Nixon’s <a href="http://www.socialjusticejournal.org/Pedagogy/Syl-Nixo.html">thwarted plans</a> to carry out psychosurgery on aggressive individuals (mainly African American prisoners), and George Bush’s failed attempt to force early intervention on children to detect mental disorders (the <a href="http://www.teenscreen.org/">Teen Screen project</a>). </p>
<p>Rappoport observes that <a href="http://www.darpa.mil/">DARPA</a> (Defense Advanced Research Project Agency) will be a major player in BAM, and to him this suggests an opportunity for some new-millennium Dr Strangelove to be let loose on the American public.</p>
<h2>Heady possibilities</h2>
<p>I’m less concerned about these dark possibilities, because I think the political hype in HBP and BAM is hundreds of miles ahead of the scientific realities of brain research. But that’s not to say we should not be excited about ambitious projects. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/20492/original/kdmrdc4t-1361418994.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/20492/original/kdmrdc4t-1361418994.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/20492/original/kdmrdc4t-1361418994.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=800&fit=crop&dpr=1 600w, https://images.theconversation.com/files/20492/original/kdmrdc4t-1361418994.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=800&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/20492/original/kdmrdc4t-1361418994.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=800&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/20492/original/kdmrdc4t-1361418994.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1005&fit=crop&dpr=1 754w, https://images.theconversation.com/files/20492/original/kdmrdc4t-1361418994.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1005&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/20492/original/kdmrdc4t-1361418994.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1005&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption"></span>
<span class="attribution"><span class="source">Aidan O'Sullivan</span></span>
</figcaption>
</figure>
<p>I mentioned above that the Allen Institute for Brain Science (formed by Bill Gates’ Microsoft partner Paul Allen in 2003) is also entering the fray. The difference between the Allen Institute proposal and the HBP and BAM projects is that it is much more realistic, and comes from an institute with an outstanding, perhaps unmatched, <a href="http://www.alleninstitute.org/science/publications/index.html">track record</a> in brain research.</p>
<p>Over the past decade, the Allen Institute has mapped <a href="http://mouse.brain-map.org/">all 26,000 genes</a> in the mouse brain, and has mapped the major genes in the embryonic brain. </p>
<p>Among other projects, they are in the midst of <a href="http://human.brain-map.org/">mapping all the genes in the human brain</a>, and creating a library of brain wiring experiments. </p>
<p>All of this is <a href="http://www.brain-map.org/">open to any researcher</a> in the world at no cost – you just need an internet connection.</p>
<p>Paul Allen has announced he is putting around US$300 million into a new 10-year project to map every aspect of the visual cortex in the mouse. Not nearly as ambitious as HBP or BAM, but to me it looks achievable. </p>
<p>If I was investing, I would put my money on the Allen Institute.</p><img src="https://counter.theconversation.com/content/12342/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Charles Watson 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>In the past month, we have seen two major announcements of huge projects to map the brain – the European Human Brain Project (HBP) and the Obama Brain Activity Map (BAM). What you may not have noticed…Charles Watson, John Curtin Distinguished Professor of Health Science, Curtin UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/93432012-10-04T04:37:17Z2012-10-04T04:37:17ZComplexity and consent: the ethics of researching youth<figure><img src="https://images.theconversation.com/files/16116/original/ct7rnkm4-1349238074.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Young people have the right to contribute to research about their lives.</span> <span class="attribution"><span class="source">Anita & Greg/Flickr</span></span></figcaption></figure><p>Ethics by their very nature are tricky – if the morally right thing to do was clear-cut, we wouldn’t need to have ethical deliberations. Perhaps one of the most enduring ethical dilemmas is around questions of how researchers work with teenagers and children. Working with them can raise complex issues of consent; failing to include them can compromise research and shut them out of the benefits that research brings. </p>
<h2>Fine lines around consent</h2>
<p>People tend to assume all research with young people under age 18 requires formal consent from the young person and her parents or guardians. But it’s not that clear cut. Is a young person aged 17 and ten months necessarily less mature and able to consent for herself than a young person aged 18 and one day? And is it always ethical to let parents or guardians have the final say about participation in research if their son or daughter wants to take part?</p>
<p>The key document on research ethics in Australia, the <a href="http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72.pdf">National Statement on Ethical Conduct in Research Involving Humans</a>, has something to say about both these issues. It distinguishes between levels of maturity and vulnerability and says “it is not possible to attach fixed ages to each level”. </p>
<p>It also outlines specific situations where parental or guardian consent is not required for a young person under age 18 to take part in research: when research isn’t especially risky, for instance, and if it aims to benefit the kinds of young people that the participants represent, such as homeless young people.</p>
<h2>Privacy and justice</h2>
<p>For adult participants, the principle of respect includes respect for “the capacity of human beings to make their own decisions”. And professional <a href="http://www.yacwa.org.au/uploads/CodeofEthicsBooklet.pdf">ethics for youth work</a> insist that “young people are competent in assessing and acting on their interests”. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/16047/original/4ws748bp-1349068367.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/16047/original/4ws748bp-1349068367.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/16047/original/4ws748bp-1349068367.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/16047/original/4ws748bp-1349068367.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/16047/original/4ws748bp-1349068367.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/16047/original/4ws748bp-1349068367.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/16047/original/4ws748bp-1349068367.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Requiring parental consent is difficult for research that takes part in unstructured settings, such as skate parks.</span>
<span class="attribution"><span class="source">Ashley Hatch</span></span>
</figcaption>
</figure>
<p>The National Statement says young people should be asked whether they want to take part in research. It even recognises that sometimes it is wrong to give parents or guardians the final say on their child’s behalf. </p>
<p>Parents may coerce their son or daughter, or they may be estranged from them, or it may be against the best interest of the young person to ask her parents for consent. This is particularly a problem when the research is about something personal (such as sexuality or how you get on with your siblings).</p>
<p>According to the principle of justice, all people should have the opportunity to take part in research that affects them. But requiring parental consent arguably contradicts this principle. Take, for instance, research that takes part in unstructured settings, such as skate parks. Would it be fair (or ethical) to exclude young people who want to take part from research because it’s impractical for them to go home, get their parent to sign a consent form, and come back? </p>
<p>The author of <a href="http://www.acys.info/ysa/issues/v.31_n.3_2012/papers">a paper on the subject</a> in a special issue of Youth Studies Australia, which looks at the complexities of youth research, suggests it would been better to allow parents to give verbal consent by phone. </p>
<p>Another ethical dilemma is raised by research using mobile phones. At first glance, using mobile phones for research involving young people makes sense because it’s a research method that suits that demographic. But this also raises ethical concerns around blurring the boundary between public and private information. Young people may use their mobile phones on public transport and at parties where others may overhear their conversations.</p>
<p>Research ethics guidelines such as the National Statement are not directly helpful to such dilemmas as they are unable to quickly respond to such technological changes. Although research involving young people poses ethical challenges, not involving them would be unethical (and produce inaccurate results). Young people have the right to contribute to research about their lives, especially when that research affects policy that impacts them.</p>
<p>So the question is not whether they should take part in research at all but how to facilitate this in respectful and beneficial ways. University ethics committees (and the National Statement that informs their work) are not perfect. But if used well, they can help researchers work with young people.</p><img src="https://counter.theconversation.com/content/9343/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kitty te Riele is a member of the Human Research Ethics Committee in the Faculty of Arts, Education and Human Development at Victoria University. She guest-edited the special issue mentioned in the article.</span></em></p>Ethics by their very nature are tricky – if the morally right thing to do was clear-cut, we wouldn’t need to have ethical deliberations. Perhaps one of the most enduring ethical dilemmas is around questions…Kitty Te Riele, CRN Principal Research Fellow, Victoria UniversityLicensed as Creative Commons – attribution, no derivatives.