tag:theconversation.com,2011:/africa/topics/human-research-ethics-17506/articles
Human research ethics – The Conversation
2023-07-13T12:37:38Z
tag:theconversation.com,2011:article/208276
2023-07-13T12:37:38Z
2023-07-13T12:37:38Z
Promising assisted reproductive technologies come with ethical, legal and social challenges – a developmental biologist and a bioethicist discuss IVF, abortion and the mice with two dads
<figure><img src="https://images.theconversation.com/files/534595/original/file-20230628-23-se3fkd.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2000%2C1500&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A few days after successful fertilization, an embryo becomes a rapidly dividing ball of cells called a blastocyst.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/blastocyst-embryo-illustration-royalty-free-illustration/1498384521">Juan Gaertner/Science Photo Library via Getty Images</a></span></figcaption></figure><p><em>Assisted reproductive technologies are medical procedures that help people experiencing difficulty having or an inability to have biological children of their own. From in vitro fertilization to genetic screening to creation of viable eggs from the <a href="https://doi.org/10.1038/s41586-023-05834-x">skin cells of two male mice</a>, each new development speaks to the potential of reproductive technologies to expand access to the experience of pregnancy.</em> </p>
<p><em>Translating advances from the lab to the clinic, however, comes with challenges that go far beyond the purely technical.</em></p>
<p><em>Conversations around the ethics and implications of cutting-edge research often happen after the fact, when the science and technology have advanced beyond the point at which open dialogue could best protect affected groups. In the spirit of starting such cross-discipline conversations earlier, we invited developmental biologist <a href="https://scholar.google.com/citations?user=i6SghEMAAAAJ&hl=en">Keith Latham</a> of Michigan State University and bioethicist <a href="https://www.researchgate.net/profile/Mary-Faith-Marshall">Mary Faith Marshall</a> of the University of Virginia to discuss the ethical and technological potential of <a href="https://www.npr.org/sections/health-shots/2023/05/27/1177191913/sperm-or-egg-in-lab-breakthrough-in-reproduction-designer-babies-ivg">in vitro gametogenesis</a> and assisted reproductive technology post-Roe.</em></p>
<h2>How new are the ethical considerations raised by assisted reproductive technologies?</h2>
<p><strong>Keith</strong></p>
<p>Every new technology raises many of the same questions, and likely new ones. On the safety and risk-benefit side of the ethical conversation, there’s nothing here that we haven’t dealt with since the 1970s with other reproductive technologies. But it’s important to keep asking questions, because the benefits are hugely dependent on the success rate. There are potential biological costs, but also possible social costs, financial costs, societal costs and many others.</p>
<p><strong>Mary Faith</strong> </p>
<p>It’s probably been that way even longer. One of my mentors, Joseph Francis Fletcher, a pioneering bioethicist and Episcopal priest, wrote a book called “<a href="https://press.princeton.edu/books/hardcover/9780691635224/morals-and-medicine">Morals and Medicine</a>” in 1954. It was the first non-Roman Catholic treatment of bioethics. And he raised a lot of these issues there, including the <a href="https://theconversation.com/jurassic-world-scientists-still-havent-learned-that-just-because-you-can-doesnt-mean-you-should-real-world-genetic-engineers-can-learn-from-the-cautionary-tale-184369">technological imperative</a> – the idea that because we can develop the technology to do something, we therefore should develop it.</p>
<p>Fletcher also said that the use of artifice, or human-made creations, is supremely human. That’s what we do: We figure out how things work and we develop new technologies like vaccines and heart-lung machines based on evolving scientific knowledge.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Microscopy image of mouse ovum being fertilized by mouse sperm" src="https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=388&fit=crop&dpr=1 600w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=388&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=388&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=487&fit=crop&dpr=1 754w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=487&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=487&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">Scientists were able to create a mouse egg from the skin cells of male mice.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/fertilization-of-mouse-ovum-royalty-free-image/523741410">Clouds Hill Imaging Ltd./Corbis Documentary via Getty Images</a></span>
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<p>I think that in most cases, scientists should be involved in thinking about the implications of their work. But often, researchers focus more on the direct applications of their work than the potential indirect consequences. </p>
<p>Given the evolution of assisted reproductive technology, and the fact that its evolution is going to continue, I think one of the central questions to consider is, what are the goals of developing it? For assisted reproduction, it’s to help infertile people and people in nontraditional relationships have children.</p>
<h2>What are some recent developments in the field of assisted reproductive technology?</h2>
<p><strong>Keith</strong></p>
<p>One recent advance in assisted reproductive technology is the expansion of <a href="https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/03/preimplantation-genetic-testing">pre-implantation genetic testing</a> methods, particularly DNA sequencing. Many genes come in different variants, or alleles, that can be inherited from each parent. Providers can determine whether an embryo bears a “bad” allele that may increase the risk of certain diseases and select embryos with “healthy” alleles.</p>
<p>Genetic screening <a href="https://doi.org/10.1016/j.fertnstert.2022.03.017">raises several ethical concerns</a>. For example, the parents’ genetic profiles could be unwillingly inferred from that of the embryo. This possibility may deter prospective parents from having children, and such knowledge may also have potential effects on any future child. The cost of screening and potential need for additional cycles of IVF may also increase disparities.</p>
<p>There are also considerations about the <a href="https://doi.org/10.1016/j.fertnstert.2022.03.019">accuracy of screening predictions</a> without accounting for environmental effects, and what <a href="https://doi.org/10.1007/s12687-021-00573-w">level of genetic risk</a> is “serious” enough for an embryo to be excluded. More extensive screening also raises concerns about possible misuse for purposes other than disease prevention, such as production of “<a href="https://theconversation.com/an-american-company-will-test-your-embryos-for-genetic-defects-but-designer-babies-arent-here-just-yet-126833">designer babies</a>.”</p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/uhb5gd5B-7g?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">In vitro gametogenesis involves making egg or sperm cells from other adult cells in the body.</span></figcaption>
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<p>At a <a href="https://www.nationalacademies.org/news/2023/02/agenda-for-third-international-summit-on-human-genome-editing-march-6-8">genome-editing conference</a> in March 2023, researchers announced that they were able to <a href="https://doi.org/10.1038/s41586-023-05834-x">delete and duplicate whole chromosomes</a> from the skin cells of male mice to make eggs. This method is one potential way to make eggs that do not carry genetic abnormalities. </p>
<p>They were very upfront that this was done at 1% efficiency in mice, which could be lower in humans. That means something bad happened to 99% of the embryos. The biological world is not typically binary, so a portion of that surviving 1% could still be abnormal. Just because the mice survived doesn’t mean they’re OK. I would say at this point, it would be unethical to try this on people.</p>
<p>As with some forms of genetic screening, using this technique to reduce the risk of one disease could inadvertently increase the risk of another. Determining that it is absolutely safe to duplicate a chromosome would require knowing every allele of every gene on that chromosome, and what each allele could do to the health of a person. That’s a pretty tall order, as that could involve identifying hundreds to thousands of genes, and the effects of all their variants may not be known. </p>
<p><strong>Mary Faith</strong></p>
<p>That raises the issue of efficacy and costs to yet another order of magnitude.</p>
<p><strong>Keith</strong> </p>
<p>Genome editing with <a href="https://theconversation.com/human-genome-editing-offers-tantalizing-possibilities-but-without-clear-guidelines-many-ethical-questions-still-remain-200983">CRISPR technology</a> in people carries similar concerns. Because of potential limitations in how precise the technology can be, it may be difficult for researchers to say they are absolutely 100% certain there won’t be off-target changes in the genome. Proceeding without that full knowledge could be risky. </p>
<p>But that’s where bioethicists need to come into play. Researchers don’t know what the full risk is, so how do you make that risk-benefit calculation?</p>
<p><strong>Mary Faith</strong></p>
<p>There’s the option of a voluntary global moratorium on using these technologies on human embryos. But somebody somewhere is <a href="https://theconversation.com/did-he-jiankui-make-people-better-documentary-spurs-a-new-look-at-the-case-of-the-first-gene-edited-babies-196714">still going to do it</a>, because the technology is just sitting there, waiting to be moved forward.</p>
<h2>How will the legal landscape affect the development and implementation of assisted reproductive technologies?</h2>
<p><strong>Mary Faith</strong></p>
<p>Any research that involves human embryos is in some ways politicized. Not only because the <a href="https://doi.org/10.1038/d41586-020-00127-z">government provides funding</a> to the basic science labs that conduct this research, but because of the wide array of beliefs that members of the public at large have about <a href="https://theconversation.com/defining-when-human-life-begins-is-not-a-question-science-can-answer-its-a-question-of-politics-and-ethical-values-165514">when life begins</a> or <a href="https://theconversation.com/what-is-personhood-the-ethics-question-that-needs-a-closer-look-in-abortion-debates-182745">what personhood means</a>.</p>
<p>The <a href="https://theconversation.com/roe-overturned-what-you-need-to-know-about-the-supreme-court-abortion-decision-184692">Dobbs decision</a>, which overturned the constitutional right to an abortion, has implications for assisted reproduction and beyond. Most people who are pregnant don’t even know they’re pregnant at the earliest stages, and somewhere around <a href="https://theconversation.com/most-human-embryos-naturally-die-after-conception-restrictive-abortion-laws-fail-to-take-this-embryo-loss-into-account-187904">60% of those pregnancies end naturally</a> because of genetic aberrations. Between 1973 and 2005, <a href="https://doi.org/10.1215/03616878-1966324">over 400 women were arrested for miscarriage in the U.S.</a>, and I think that number is going to grow. The implications for reproductive health care, and for assisted reproduction in the future, are challenging and frightening.</p>
<p>What will abortion restrictions mean for people who have <a href="https://www.cdc.gov/art/key-findings/multiple-births.html">multiple-gestation pregnancies</a>, in which they carry more than one embryo at the same time? In order to have one healthy child born from that process, the other embryos often need to be removed so they don’t all die. In the past 40 years, the number of twin births doubled and triplet and higher-order births quadrupled, primarily because of fertility treatments. </p>
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<a href="https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Needle touching eggs in petri dish under microscope in IVF" src="https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.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">IVF may involve transferring more than one embryo at a time.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/in-vitro-fertilization-royalty-free-image/1272954210">Antonio Marquez lanza/Moment via Getty Images</a></span>
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<p><strong>Keith</strong> </p>
<p>IVF may transfer one, two, or sometimes three embryos at a time. The <a href="https://doi.org/10.1016/j.jpeds.2022.11.038">cost of care for preterm birth</a>, which is one possible outcome of multiple-gestation pregnancies, can be high. That’s in addition to the <a href="https://doi.org/10.1016/j.ajog.2013.10.005">cost of delivery</a>. IVF clinics are increasingly transferring just one embryo to mitigate such concerns.</p>
<p>The life-at-conception bills that have been put forth in some U.S. state legislatures and Congress may contain language claiming they are not meant to prevent IVF. But the language of the bills could be extended to affect procedures such as IVF with pre-implantation genetic testing to detect chromosomal abnormalities, particularly when single-embryo transfer is the goal. Pre-implantation genetic testing has been increasing, with one study estimating that <a href="https://doi.org/10.1001/jama.2022.1892">over 40% of all IVF cycles</a> in the U.S. in 2018 involved genetic screening. </p>
<p>Could life-at-conception bills criminalize clinics that don’t transfer embryos known to be genetically abnormal? Freezing genetically abnormal embryos could avoid destroying them, but that raises questions of, to what end? Who would pay for the storage, and who would be responsible for those embryos?</p>
<h2>How can we determine whether the risks outweigh the benefits when so much is unknown?</h2>
<p><strong>Keith</strong></p>
<p>Conducting studies in animal models is an important first step. In some cases, it either hasn’t been done or hasn’t been done extensively. Even with animal studies, you have to recognize that mice, rabbits and monkeys are not human. Animal models may reduce some risks before a technology is used in people, but they won’t eliminate all risks, because of biological differences between species.</p>
<p><strong>Mary Faith</strong> </p>
<p>We could look to the example of <a href="https://www.genome.gov/25520302/online-education-kit-1972-first-recombinant-dna">early recombinant DNA research in the U.S.</a> The federal government created the <a href="https://doi.org/10.1089%2Fhum.2013.2524">Recombinant DNA Advisory Committee at the National Institutes of Health</a> to oversee animal and early-phase human research involving synthetic or hybrid genetic material. </p>
<p>The <a href="https://doi.org/10.1126/science.307.5712.1028b">death of Jesse Gelsinger</a>, who was a participant in a gene therapy clinical trial in 1999, led to a halt in all gene therapy clinical trials in the U.S. for a time. When the Food and Drug Administration investigated what went wrong, they found huge numbers of adverse events in both humans and animals that should have been reported to the advisory committee but weren’t. Notably, the principal investigator of the trial was also the <a href="https://sciencehistory.org/stories/magazine/the-death-of-jesse-gelsinger-20-years-later/">primary shareholder</a> of the biotech company that made the drug being tested. That raises questions about the reality of oversight.</p>
<p>I think something like that earlier NIH advisory committee but for reproductive technologies would still be advisable. But researchers, policymakers and regulators need to learn from the lessons of the past to try to ensure that – especially in early-phase research – we’re very thoughtful about the potential risks and that research participants really understand what the implications are for participation in research. That would be one model for translating research from the animal into the human.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Child looking into a slip lamp microscope for an eye exam with a doctor" src="https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.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 FDA approved a gene therapy for a form of congenital vision loss in 2017. The child in this photo, then 8, first received gene therapy at age 4.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/BlindnessTreatmentPrice/c567cc3a2b244cac8afc2b5ae2c62ca3">Bill West/AP Photo</a></span>
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<p><strong>Keith</strong></p>
<p>A process to make sure that the people conducting studies don’t have a conflict of interest, like having the potential to commercially profit from the technology, would be useful. </p>
<p>Caution, consensus and cooperation should not take second place to profit motives. Altering the human genome in a way that allows human-made genetic changes to be <a href="https://doi.org/10.1089/crispr.2020.0096">propagated throughout the population</a> has a potential to alter the genetics of the human species as a whole. </p>
<p><strong>Mary Faith</strong></p>
<p>That raises the question of how long it will take for long-term effects to show. It’s one thing for an implanted egg not to survive. But how long will it take to know whether there are effects that aren’t obvious at birth?</p>
<p><strong>Keith</strong> </p>
<p>We’re still collecting long-term outcome data for people born using different reproductive technologies. So far there have been no obviously horrible consequences. But some abnormalities could take decades to manifest, and there are many variables to contend with. </p>
<p>One can arguably say that there’s substantial good in helping couples have babies. There can be a benefit to their emotional well-being, and reproduction is a natural part of human health and biology. And a lot of really smart, dedicated people are putting a lot of energy into making sure that the risks are minimized. We can also look to some of the practices and approaches to oversight that have been used over the past several decades.</p>
<p><strong>Mary Faith</strong></p>
<p>And thinking about international guidelines, such as from the <a href="https://cioms.ch">Council for International Medical Science</a> and other groups, could provide guidance on protecting human research subjects.</p>
<p><strong>Keith</strong></p>
<p>You hate to advocate for a world where the automatic response to anything new is “no, don’t do that.” My response is, “Show me it’s safe before you do it.” I don’t think that’s unreasonable.</p>
<p>Some people have a view that scientists don’t think about the ethics of research and what’s right and wrong, advisable or inadvisable. But we do think about it. I co-direct a research training program that includes teaching scientists how to responsibly and ethically conduct research, including speakers who specifically address the ethics of reproductive technologies. It is valuable to have a dialogue between scientists and ethicists, because ethicists will often think about things from a different perspective. </p>
<p>As people go through their scientific careers and see new technologies unfold over time, these discussions can help them develop a deeper appreciation and understanding of the broader impact of their research. It becomes our job to make sure that each generation of scientists is motivated to think about these things. </p>
<p><strong>Mary Faith</strong></p>
<p>It’s also really important to include stakeholders – people who are nonscientists, people who experience barriers to reproduction and people who are opposed to the idea – so they have a voice at the table as well. That’s how you get good policies, right? You have everyone who should be at the table, at the table.</p><img src="https://counter.theconversation.com/content/208276/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>
Scientists can create viable eggs from two male mice. In the wake of CRISPR controversies and restrictive abortion laws, two experts start a dialogue on ethical research in reproductive biology.
Keith Latham, Professor of Animal Science, Adjunct Professor of Obstetrics, Gynecology and Reproductive Biology, Michigan State University
Mary Faith Marshall, Professor of Biomedical Ethics, University of Virginia
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/208416
2023-06-29T15:01:08Z
2023-06-29T15:01:08Z
Researchers can learn a lot with your genetic information, even when you skip survey questions – yesterday’s mode of informed consent doesn’t quite fit today’s biobank studies
<figure><img src="https://images.theconversation.com/files/534693/original/file-20230628-29-j4a0gl.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1999%2C1499&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Participants in biobank studies are often asked for broad consent to use their data.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/genetic-research-royalty-free-image/136810911">Science Photo Library - TEK IMAGE/Brand X Pictures via Getty Images</a></span></figcaption></figure><p>Imagine you agreed to be part of a new and exciting long-term research study to better understand human health and behavior. For the past few years, you’ve been visiting a collection site where you fill out some questionnaires about your health and daily activities. Research assistants take your height, weight and some other physical characteristics about you. Because you agreed to contribute your genetic data to the study, you also provided a saliva sample during your first visit.</p>
<p>Later, you see a news article reporting that researchers analyzing data from the study you’re participating in have <a href="https://www.vox.com/science-and-health/2018/8/23/17527708/genetics-genome-sequencing-gwas-polygenic-risk-score">found genetic variants</a> that predict the likelihood of someone completing college. You remember reading a long form when you consented to giving your data, but you can’t quite remember all the details. You know the study was about health, but how do these findings about genes and education have anything to do with health? Did they analyze your data specifically? What did they find? </p>
<h2>What are biobanks?</h2>
<p>Many scientific research studies collect data meant to answer a specific research question. For example, to study the genetics of diabetes, researchers might collect data on your blood pressure and lipid levels in addition to genetic data. But increasingly, scientists are collecting large amounts of data to be <a href="https://doi.org/10.1186/s12967-019-1922-3">kept in biobanks</a> – repositories that store genetic data and other biospecimens like blood, urine or tumor tissue to be used in a wide number of future studies.</p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/sOP8WacfBM8?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Biobank data is often used to conduct genome-wide association studies, or GWAS.</span></figcaption>
</figure>
<p>Some biobanks, like the <a href="https://www.ukbiobank.ac.uk">UK Biobank</a>, link biospecimen data to other collected data, such as sexual behavior, medical history, weight, diet and lifestyle. Private companies <a href="https://theconversation.com/how-a-south-african-communitys-request-for-its-genetic-data-raises-questions-about-ethical-and-equitable-research-166940">like 23andMe</a> also obtain consent from their customers to have their data used in research efforts.</p>
<p><a href="https://scholar.google.com/citations?user=zCedU50AAAAJ&hl=en&oi=ao">As a researcher</a> interested in the intersection between <a href="https://www.robbeewedow.com">social behaviors and genetics</a>, I frequently have conversations with people who weren’t aware of how their genetic data is being used. They’re often surprised that the genetic data they consented to be used for research at a private company by using a DNA testing kit or at a biobank while visiting their local clinic might be used to study the genetics of <a href="https://doi.org/10.1126/science.aat7693">same-sex sexual behavior</a> or <a href="https://doi.org/10.1038/s41588-018-0309-3">risk-taking</a>. </p>
<p>In our newly published research, my colleagues and I found that even <a href="https://www.nature.com/articles/s41562-023-01632-7">choosing not to respond to survey questions</a> can reveal information about the population (we found that not responding to survey questions is correlated with a person’s education, health and income levels) if genetic data is available.</p>
<h2>Genetic data and informed consent</h2>
<p>The research that can be done with biobank data might sound scary, but it shouldn’t be. Genetic data, like the data used in our study, is de-identified. This means that it cannot be linked back to individual research participants, who remain anonymous. Further, genetic data for these sorts of genetic studies is used <a href="https://doi.org/10.1038/s43586-021-00056-9">at the aggregate level</a>, meaning it isn’t used to predict or evaluate any one particular individual’s responses or behaviors.</p>
<p>Researchers aren’t using genetic data to target individuals with certain genetic profiles. Almost all genetic research is used to better understand how health behaviors and other factors affect health and to figure out ways to improve outcomes. This goal is why most research participants agree to contribute their data to research in the first place: to help the world through science.</p>
<figure>
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<figcaption><span class="caption">Many developments in human subject protections arose in response to unethical research.</span></figcaption>
</figure>
<p>The problem is whether research participants really understand how their data can be used. Many of the original ideas around the development of the <a href="https://doi.org/10.1186/s12910-019-0414-6">informed consent process and Institutional Review Boards</a>, or IRBs, intended to protect research participants from direct harm or privacy violations were based on the expectation that research studies would be addressing particular questions about a single subject, like cardiovascular disease or lung cancer. This focus was so as not to repeat unethical research atrocities like the infamous <a href="https://www.cdc.gov/tuskegee/timeline.htm">Tuskegee Syphilis Study</a>, where researchers did not tell participants, who were all Black men, that they had syphilis and withheld treatment that was already widely available and known to be highly effective.</p>
<p>But since genetic data is de-identified, it is <a href="https://www.hhs.gov/ohrp/node/4350/index.html">often considered exempt from full IRB review</a>, which is a protocol to ensure studies meet ethical standards and institutional policies. And the broad number of research questions that can be explored with biobanks, along with the amount and types of data collected, has made these original protections to ensure truly informed consent insufficient.</p>
<h2>Improving informed consent</h2>
<p>To be clear, biobanks are enormously important for public health research. They allow researchers to <a href="https://theconversation.com/people-dont-mate-randomly-but-the-flawed-assumption-that-they-do-is-an-essential-part-of-many-studies-linking-genes-to-diseases-and-traits-194793">link many different outcomes and variables</a> together to paint a critical overall picture of human health and behavior. And in contrast with the <a href="https://theconversation.com/most-americans-dont-realize-what-companies-can-predict-from-their-data-110760">personally identifiable online or phone data</a> that companies collect to show you targeted ads, biobanks collect de-identified data that is evaluated in aggregate.</p>
<p>In the age of vast data collection, ensuring that participants are aware of how their data can and cannot be used is necessary to ensure that biobanks are a transparent tool for global good. Biobanks can’t predict how a participant’s data will be used in the future, so it can be difficult for researchers and ethicists to bring back the “informed” part of “informed consent.” Even so, more needs to be done to earn the trust of the valuable research participants who contribute the data to improve science and the world.</p><img src="https://counter.theconversation.com/content/208416/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Robbee Wedow is a research fellow at AnalytiXIN, which is a consortium of health-data organizations, industry partners and university partners in Indiana primarily funded through the Lilly Endowment, IU Health and Eli Lilly and Company.</span></em></p>
Biobanks collect and store large amounts of data that researchers use to conduct a wide range of studies. Making sure participants understand what they’re getting into can help build trust in science.
Robbee Wedow, Assistant Professor of Sociology and Data Science, Purdue University
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/205557
2023-05-15T15:01:09Z
2023-05-15T15:01:09Z
You shed DNA everywhere you go – trace samples in the water, sand and air are enough to identify who you are, raising ethical questions about privacy
<figure><img src="https://images.theconversation.com/files/525993/original/file-20230512-24221-4caajm.png?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A casual stroll on the beach can leave enough intact DNA behind to extract identifiable information.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/human-footprint-on-the-sand-royalty-free-image/1030780262">Comezora/Moment via Getty Images</a></span></figcaption></figure><p>Human DNA can be sequenced from small amounts of water, sand and air in the environment to <a href="https://www.nature.com/articles/s41559-023-02056-2">potentially extract identifiable information</a> like genetic lineage, gender, and health risks, according to our new research.</p>
<p>Every cell of the body <a href="https://calteches.library.caltech.edu/2687/1/bonner.pdf">contains DNA</a>. Because each person has a unique genetic code, DNA can be <a href="https://theconversation.com/genetic-paparazzi-are-right-around-the-corner-and-courts-arent-ready-to-confront-the-legal-quagmire-of-dna-theft-178866">used to identify individual people</a>. Typically, medical practitioners and researchers obtain human DNA through direct sampling, such as blood tests, swabs or biopsies. However, all living things, including animals, plants and microbes, <a href="https://doi.org/10.1016/j.biocon.2014.11.019">constantly shed DNA</a>. The water, soil and even the air contain microscopic particles of biological material from living organisms.</p>
<p>DNA that an organism has shed into the environment is known as <a href="https://doi.org/10.1093/biosci/biab027">environmental DNA, or eDNA</a>. For the last couple of decades, scientists have been able to collect and sequence eDNA from soil or water samples to <a href="https://theconversation.com/fishing-for-dna-free-floating-edna-identifies-presence-and-abundance-of-ocean-life-75957">monitor biodiversity, wildlife populations</a> and <a href="https://theconversation.com/environmental-dna-how-a-tool-used-to-detect-endangered-wildlife-ended-up-helping-fight-the-covid-19-pandemic-158286">disease-causing pathogens</a>. Tracking rare or elusive endangered species <a href="https://doi.org/10.1007/s00114-019-1605-1">through their eDNA</a> has been a boon to researchers, since traditional monitoring methods such as observation or trapping can be difficult, often unsuccessful and intrusive to the species of interest.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/q7mp1wxLoyA?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The authors and their colleagues use environmental DNA to study sea turtles.</span></figcaption>
</figure>
<p>Researchers using eDNA tools usually focus only on the species they’re studying and disregard DNA from other species. However, humans <a href="https://theconversation.com/genetic-paparazzi-are-right-around-the-corner-and-courts-arent-ready-to-confront-the-legal-quagmire-of-dna-theft-178866">also shed</a>, cough and <a href="https://theconversation.com/who-sees-what-you-flush-wastewater-surveillance-for-public-health-is-on-the-rise-but-a-new-survey-reveals-many-us-adults-are-still-unaware-193007">flush DNA</a> into their surrounding environment. And as our team of geneticists, <a href="https://scholar.google.com/citations?user=czRqHV4AAAAJ&hl=en&oi=ao">ecologists</a> and <a href="https://scholar.google.com/citations?user=3cQ6umoAAAAJ&hl=en">marine biologists</a> in the <a href="https://scholar.google.com/citations?hl=en&user=LtNEh9gAAAAJ">Duffy Lab</a> at the University of Florida found, <a href="https://www.nature.com/articles/s41559-023-02056-2">signs of human life can be found everywhere</a> but in the most isolated locations. </p>
<h2>Animals, humans and viruses in eDNA</h2>
<p>Our team uses environmental DNA to study <a href="https://doi.org/10.1111/1755-0998.13617">endangered sea turtles and the viral tumors</a> to which they are susceptible. Tiny hatchling sea turtles shed DNA as they crawl along the beach on their way to the ocean shortly after they are born. <a href="https://doi.org/10.1111/1755-0998.13617">Sand scooped from their tracks</a> contains enough DNA to provide valuable insights into the turtles and the chelonid herpesviruses and <a href="https://theconversation.com/could-human-cancer-treatments-be-the-key-to-saving-sea-turtles-from-a-disfiguring-tumor-disease-98140">fibropapillomatosis tumors that afflict them</a>. Scooping a liter of <a href="https://doi.org/10.1038/s42003-021-02085-2">water from the tank</a> of a recovering sea turtle under veterinary care equally provides a wealth of genetic information for research. Unlike blood or skin sampling, collecting eDNA causes no stress to the animal.</p>
<p><a href="https://theconversation.com/genomic-sequencing-heres-how-researchers-identify-omicron-and-other-covid-19-variants-172935">Genetic sequencing technology</a> used to decode DNA has improved rapidly in recent years, and it is now possible to easily sequence the DNA of every organism in a sample from the environment. Our team suspected that the sand and water samples we were using to study sea turtles would also contain DNA from a number of other species – including, of course, humans. What we didn’t know was <a href="https://www.nature.com/articles/s41559-023-02056-2">just how informative</a> the human DNA we could extract would be. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/525991/original/file-20230512-33762-xb83ft.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two people on a boat collecting water samples from a river" src="https://images.theconversation.com/files/525991/original/file-20230512-33762-xb83ft.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/525991/original/file-20230512-33762-xb83ft.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=800&fit=crop&dpr=1 600w, https://images.theconversation.com/files/525991/original/file-20230512-33762-xb83ft.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=800&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/525991/original/file-20230512-33762-xb83ft.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=800&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/525991/original/file-20230512-33762-xb83ft.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1005&fit=crop&dpr=1 754w, https://images.theconversation.com/files/525991/original/file-20230512-33762-xb83ft.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1005&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/525991/original/file-20230512-33762-xb83ft.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">The researchers were able to collect intact human DNA in water samples from a river in Florida.</span>
<span class="attribution"><span class="source">Todd Osborne</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>To figure this out, we took samples from a variety of locations in Florida, including the ocean and rivers in urban and rural areas, sand from isolated beaches and a remote island never usually visited by people. We found human DNA in all of those locations except the remote island, and these samples were high quality enough for analysis and sequencing. </p>
<p>We also tested the technique in Ireland, tracing along a river that winds from a remote mountaintop, through small rural villages and into the sea at a larger town of 13,000 inhabitants. We found human DNA everywhere but in the remote mountain tributary where the river starts, far from human habitation.</p>
<p>We also collected air samples from a room in our wildlife veterinary hospital in Florida. People who were present in the room gave us permission to take samples from the air. We recovered DNA matching the people, the animal patient and common animal viruses present at the time of collection.</p>
<p>Surprisingly, the human eDNA found in the local environment was intact enough for us to identify mutations associated with disease and to determine the genetic ancestry of people who live in the area. Sequencing DNA that volunteers left in their footprints in the sand even yielded part of their sex chromosomes.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/526004/original/file-20230513-16755-kheuum.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram depicting eDNA collection sources and analysis workflow" src="https://images.theconversation.com/files/526004/original/file-20230513-16755-kheuum.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/526004/original/file-20230513-16755-kheuum.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=420&fit=crop&dpr=1 600w, https://images.theconversation.com/files/526004/original/file-20230513-16755-kheuum.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=420&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/526004/original/file-20230513-16755-kheuum.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=420&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/526004/original/file-20230513-16755-kheuum.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=528&fit=crop&dpr=1 754w, https://images.theconversation.com/files/526004/original/file-20230513-16755-kheuum.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=528&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/526004/original/file-20230513-16755-kheuum.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=528&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Human eDNA can be collected and analyzed from a variety of sources.</span>
<span class="attribution"><span class="source">Liam Whitmore/Created with BioRender.com</span>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<h2>Ethical implications of collecting human eDNA</h2>
<p>Our team dubs inadvertent retrieval of human DNA from environmental samples <a href="https://www.nature.com/articles/s41559-023-02056-2">“human genetic bycatch.”</a> We’re calling for deeper discussion about how to ethically handle human environmental DNA. </p>
<p>Human eDNA could present significant advances to research in fields as diverse as conservation, epidemiology, forensics and farming. If handled correctly, human eDNA could help archaeologists <a href="https://theconversation.com/who-owned-this-stone-age-jewellery-new-forensic-tools-offer-an-unprecedented-answer-204797">track down undiscovered ancient human settlements</a>, allow biologists to <a href="https://doi.org/10.1038/s42003-021-01656-7">monitor cancer mutations in a given population</a> or provide law enforcement agencies <a href="https://doi.org/10.1016/j.forsciint.2023.111599">useful forensic information</a>.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/525989/original/file-20230512-7632-rct90g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Footprints in the sand at a beach" src="https://images.theconversation.com/files/525989/original/file-20230512-7632-rct90g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/525989/original/file-20230512-7632-rct90g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=899&fit=crop&dpr=1 600w, https://images.theconversation.com/files/525989/original/file-20230512-7632-rct90g.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=899&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/525989/original/file-20230512-7632-rct90g.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=899&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/525989/original/file-20230512-7632-rct90g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1130&fit=crop&dpr=1 754w, https://images.theconversation.com/files/525989/original/file-20230512-7632-rct90g.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1130&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/525989/original/file-20230512-7632-rct90g.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1130&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 researchers extracted identifiable genetic information from footprints in the sand.</span>
<span class="attribution"><span class="source">David Duffy</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>However, there are also myriad ethical implications relating to the inadvertent or deliberate collection and analysis of human genetic bycatch. Identifiable information can be extracted from eDNA, and accessing this level of detail about individuals or populations comes with <a href="https://theconversation.com/how-a-south-african-communitys-request-for-its-genetic-data-raises-questions-about-ethical-and-equitable-research-166940">responsibilities relating to consent and confidentiality</a>.</p>
<p>While we conducted our study with the approval of our <a href="https://doi.org/10.2146/ajhp070066">institutional review board</a>, which ensures that studies on people adhere to ethical research guidelines, there is no guarantee that everyone will treat this type of information ethically. </p>
<p>Many questions arise regarding human environmental DNA. For instance, who should have access to human eDNA sequences? Should this information be made publicly available? Should consent be required before taking human eDNA samples, and from whom? Should researchers remove human genetic information from samples originally collected to identify other species?</p>
<p>We believe it is vital to implement regulations that ensure collection, analysis and data storage are carried out ethically and appropriately. Policymakers, scientific communities and other stakeholders need to take human eDNA collection seriously and balance consent and privacy against the possible benefits of studying eDNA. Raising these questions now can help ensure everyone is aware of the capabilities of eDNA and provide more time to develop protocols and regulations to ensure appropriate use of eDNA techniques and the ethical handling of human genetic bycatch.</p><img src="https://counter.theconversation.com/content/205557/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jessica Alice Farrell received funding from the Gumbo Limbo Nature Center d/b/a Friends of Gumbo Limbo (a 501c3 non-profit organization) through a generous donation through their Graduate Research Grant programme</span></em></p><p class="fine-print"><em><span>Jenny Whilde does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>
Environmental DNA provides a wealth of information for conservationists, archaeologists and forensic scientists. But the unintentional pickup of human genetic information raises ethical questions.
Jenny Whilde, Adjunct Research Scientist in Marine Bioscience, University of Florida
Jessica Alice Farrell, Postdoctoral associate, University of Florida
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/200983
2023-03-08T12:06:26Z
2023-03-08T12:06:26Z
Human genome editing offers tantalizing possibilities – but without clear guidelines, many ethical questions still remain
<figure><img src="https://images.theconversation.com/files/513790/original/file-20230306-28-k1tc0y.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1936%2C1547&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">DNA editing has the capacity to treat many diseases, but how to do this safely and equitably remains unclear.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/molecules-illustration-royalty-free-image/1148113002">KTSDESIGN/Science Photo Library via Getty Images</a></span></figcaption></figure><p><a href="https://royalsociety.org/science-events-and-lectures/2023/03/2023-human-genome-editing-summit/">The Third International Summit on Human Genome Editing</a>, a three-day conference organized by the Royal Society, the U.K. Academy of Medical Sciences, the U.S. National Academies of Sciences and Medicine and The World Academy of Sciences, was held this week in March 2023 at the Francis Crick Institute in London. Scientists, bioethicists, physicians, patients and others gathered to discuss the latest developments on this technology that lets researchers modify DNA with precision. And a major topic at the summit was <a href="https://royalsociety.org/-/media/events/2023/03/human-genome-editing-summit/third-international-summit-on-human-genome-editing-programme-booklet.pdf?la=en-GB&hash=16DB894FBD02A549B2F090D575C3E92D">how to enforce</a> research policies and ethical principles for human genome editing.</p>
<p>One of the first agenda items was how to regulate human genome editing in China in light of its <a href="https://theconversation.com/crispr-babies-raise-an-uncomfortable-reality-abiding-by-scientific-standards-doesnt-guarantee-ethical-research-108008">misuse in 2018</a>, when scientists modified the DNA of two human embryos before birth to have resistance against HIV infection. The controversy stems from the fact that because the technology is relatively early in its development, and its potential risks have not been reduced or eliminated, editing human embryos in ways they could pass on to their own offspring could lead to a variety of known and unknown adverse complications. The <a href="https://www.statnews.com/2023/03/06/genome-editing-summit-experts-worry-rule-changes-in-china-fall-short/">summit speakers noted</a> that while China has updated its guidelines and laws on human genome editing, it failed to address privately funded research – an issue other countries also face. Many countries, including the U.S., <a href="https://doi.org/10.1038/d41586-023-00625-w">do not have sufficiently robust regulatory frameworks</a> to prevent a repeat of the 2018 scandal.</p>
<p>We are a <a href="https://www.rit.edu/hudsonlab/">biochemist</a> and a <a href="https://www.rit.edu/directory/grssbi-gary-skuse">geneticist</a> who teach and conduct research in genomics and ethics at the Rochester Institute of Technology. As in our classrooms, debate about genome editing continues in the field.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/E8vi_PdGrKg?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Listening to different perspectives about CRISPR could lead to more balanced discussions about how to regulate it.</span></figcaption>
</figure>
<h2>What is genome editing?</h2>
<p>The <a href="https://theconversation.com/the-human-genome-project-pieced-together-only-92-of-the-dna-now-scientists-have-finally-filled-in-the-remaining-8-176138">human genome</a> typically consists of 23 pairs of chromosomes made of approximately 3.2 billion nucleotides – the building blocks of DNA. There are four nucleotides that make up DNA: adenine (A), thymine (T), guanine (G) and cytosine (C). If the genome were a book, each chromosome would be a chapter, each gene on a particular chromosome would be a paragraph and each paragraph would be made of individual letters (A, T, G or C). </p>
<p>One can imagine a book with over 3 billion characters might need editing to correct mistakes that occurred during the writing or copying processes. </p>
<p>Genome editing is a way for scientists to make specific changes to the DNA in a cell or in an entire organism by adding, removing or swapping in or out one or more nucleotides. In people, these changes can be done in somatic cells, those with DNA that cannot be inherited by offspring, or in gamete cells, those containing DNA that can be passed on to offspring. Genome editing of gamete cells, which includes egg or sperm, is controversial, as any changes would be passed on to descendants. Most <a href="https://doi.org/10.1089/crispr.2020.0082">existing guidelines and policies</a> prohibit its use at this time.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/TdBAHexVYzc?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Geneticist Jennifer Doudna is one of the co-inventors of CRISPR/Cas9.</span></figcaption>
</figure>
<h2>How CRISPR works</h2>
<p>In 2012, scientists published a <a href="https://doi.org/10.1126/science.1225829">groundbreaking study</a> demonstrating how CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, can be used to accurately change specific DNA sequences.</p>
<p>CRISPR’s natural origins are as a kind of immune response for bacteria. Bacteria that can be infected with viruses have evolved mechanisms to combat them. When a bacterium is infected with a particular virus, it keeps a small piece of the viral DNA sequence called a “spacer” in its own genome. This spacer is an exact match to the viral DNA. Upon subsequent infection, the bacterium is able to use the spacer to recruit a scissorlike protein called Cas9 that can sever new viral DNA attempting to integrate into the bacterium’s genome. This cut to the genetic material prevents the virus from replicating and killing its bacterial host.</p>
<p>After this discovery, scientists were able to fine-tune the system in the lab to be highly precise. They can sever DNA from a variety of cells, including human cells, at a specific location in the genome and subsequently edit it by adding, removing or swapping nucleotides. This is similar to adding or removing letters and words from a book. </p>
<p>This technology has the potential to treat diseases that have genetic origins. One of the summit’s sessions covered CRISPR’s ongoing experimental use to treat patients with <a href="https://doi.org/10.1056/NEJMoa2031054">sickle cell anemia and beta-thalassemia</a>, two blood disorders caused by mutations in the genes. Notably, genetic modification to treat sickle cell anemia and beta-thalassemia involves editing somatic cells, not germline cells. But as the summit speakers noted, whether these likely expensive therapies will be <a href="https://www.statnews.com/2023/03/07/crispr-sickle-cell-access/">accessible to the people who need them most</a>, especially in low- and middle-income countries, is a problem that requires changes to how treatments are sold.</p>
<figure>
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<figcaption><span class="caption">Scientists have been testing ways to use CRISPR/Cas9 to treat sickle cell anemia.</span></figcaption>
</figure>
<h2>Ethics of human genome editing</h2>
<p><a href="https://doi.org/10.1016%2Fj.jmb.2018.05.044">Many questions remain</a> concerning the safety of genome editing, along with its potential to promote eugenics and exacerbate inequities and inequality.</p>
<p>A number of the summit’s sessions involved discussion on the ethics and regulation of the use of this tool. While the landmark 1979 <a href="https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html">Belmont Report</a> outlined several ethical pillars to guide human research in the U.S., it was published before human genome editing was developed. In 2021, the World Health Organization <a href="https://www.who.int/news/item/12-07-2021-who-issues-new-recommendations-on-human-genome-editing-for-the-advancement-of-public-health">issued recommendations on human genome editing</a> as a tool to advance public health. There is <a href="https://doi.org/10.1146/annurev-genom-111320-091930">no current international law</a> governing human genome editing. </p>
<p>There is <a href="https://www.pewresearch.org/internet/2022/03/17/americans-are-closely-divided-over-editing-a-babys-genes-to-reduce-serious-health-risk/">still a debate</a> regarding how to use this technology. Some people equate genome editing to interfering with the work of God and argue that it shouldn’t be used at all, while others recognize its potential value and weigh that against its potential risks. The latter focuses on the fundamental question of <a href="https://www.scientificamerican.com/article/the-dark-side-of-crispr/">where to draw the line</a> between which applications are considered acceptable and which are not. For example, some people will agree that using genome editing to modify a defective gene that may lead to an infant’s death if untreated is acceptable. But these same people may frown upon the use of genome editing to ensure that an unborn child has specific physical features such as blue eyes or blond hair.</p>
<p>Nor is there consensus about <a href="https://doi.org/10.1001/jama.2022.13468">what diseases</a> are desirable targets. For example, it may be acceptable to modify a gene to prevent an infant’s death but not acceptable to modify one that prevents a disease later in life, such as the gene responsible for <a href="https://www.mayoclinic.org/diseases-conditions/huntingtons-disease/symptoms-causes/syc-20356117">Huntington’s disease</a>.</p>
<p>The potential for positive applications of human genome editing is both numerous and tantalizing. But establishing informed regulatory legislation everyone can agree on is and will continue to be a challenge. Conferences such as the human genome editing summit are one way to continue important discussions and educate the scientific community and the public on the benefits and risks of genome editing.</p><img src="https://counter.theconversation.com/content/200983/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andre Hudson receives funding from the National Institutes of Health</span></em></p><p class="fine-print"><em><span>Gary Skuse has received funding from the National Science Foundation. </span></em></p>
Following the controversial births of the first gene-edited babies, a major focus of the Third International Summit on Human Genome Editing was responsible use of CRISPR.
André O. Hudson, Interim Dean/Professor-College of Science, Rochester Institute of Technology
Gary Skuse, Professor of Bioinformatics, Rochester Institute of Technology
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/166940
2022-04-19T12:20:59Z
2022-04-19T12:20:59Z
How a South African community’s request for its genetic data raises questions about ethical and equitable research
<figure><img src="https://images.theconversation.com/files/447331/original/file-20220218-43570-jbyp9t.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2941%2C1959&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Many researchers are interested in the genetic history of the Khoe-San.</span> <span class="attribution"><span class="source">Dana Al-Hindi</span>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span></figcaption></figure><p>Scientists believe Africa is where <a href="https://www.pbs.org/newshour/science/cradle-of-modern-human-life-found-in-botswana-maybe">modern humans first emerged</a>. For the past decade, our team of <a href="https://scholar.google.com/citations?user=sDUNh9UAAAAJ&hl=en">genetic</a> <a href="http://hennlab.ucdavis.edu/dana-al-hindi.html">researchers</a> from the <a href="http://hennlab.ucdavis.edu/">Henn Lab</a> have worked among the Khoe-San and self-identified “<a href="https://www.semanticscholar.org/paper/What%27s-in-a-name-Racial-categorisations-under-and-Posel/81e1ad38d1f37b37fe1cddd8a81081b378242217">Coloured</a>” communities in South Africa, which comprise multiple ethnic groups in the region, requesting DNA and generating genetic data to help unravel the history and prehistory of southern Africans and their relationship to populations around the world. </p>
<p>While we have learned a great deal from these communities, we have been unable to fulfill a common request: providing them their individual genetic ancestry results. In our attempts to overcome the logistical challenges of providing this information, we’ve grappled with the common question of how to ensure an equitable balance of benefits between researchers and the community they study. What we’ve found is that there is no easy answer. </p>
<h2>The history of the Khoe-San</h2>
<p>Community member requests to see their genetic results came as no surprise. Many South African groups were stripped of their identities and collapsed into one overarching racial category known as “<a href="https://doi.org/10.1016/S1090-9524(03)00007-X">Coloured</a>” during the early 1900s. Early <a href="https://muse.jhu.edu/book/35209">European colonizers</a> initially used this term to refer to indigenous Khoekhoe and San groups long before it was codified by the apartheid government in 1948. It persists today as an ethnic category, broadly encompassing Khoe-San groups, various East African, Indian and Southeast Asian populations brought by the slave trade, and people of mixed ancestry. </p>
<p><a href="https://doi.org/10.1534/genetics.116.187369">We</a> and <a href="https://doi.org/10.1126/science.1227721">other</a> research groups have shown that some Coloured communities are largely descendants of the Khoe and San peoples. Other ancestries present in Coloured communities are from Bantu-speaking populations that migrated into the region from <a href="https://doi.org/10.1093/hmg/ddaa274">western Africa</a> around 1,500 years ago and from <a href="https://doi.org/10.1186/s12915-020-0746-1">Europe</a> a little under 400 years ago. <a href="https://doi.org/10.1186/s12915-020-0746-1">Asian ancestry</a> is also present as a result of the aforementioned slave trade.</p>
<p>The Khoe and San are considered the most <a href="https://doi.org/10.1073/pnas.1017511108">genetically diverse</a> human populations currently known, meaning they have a large amount of genetic differences within and between each community. Though they are distinct groups, they share genetic similarities with each other. As a result, geneticists collectively refer to them as <a href="https://doi.org/10.1038/464487a">Khoe-San</a>, using a hyphen to acknowledge their cultural distinction.</p>
<p>Today, few people identify as Khoe or San in South Africa. Rather, many people call themselves Coloured, though they are deeply aware of the term’s racist legacy. </p>
<h2>Logistical challenges and potential risks</h2>
<p>In our 12 years of fieldwork, we have returned to South Africa on a nearly annual basis to update community-level genetic results. At each visit, most of our participants ask about their personal genetic ancestry results. </p>
<p>But there are several hurdles we face in trying to fulfill their requests. For one, we need to be able to translate scientifically complex data into an accessible and digestible form, a skill that researchers are not always equipped with. Additionally, we must work within restrictions set by <a href="http://www.sun.ac.za/english/faculty/healthsciences/rdsd/Documents/Ethics/DoH%202015%20Ethics%20in%20Health%20Research%20-%20Principles,%20Processes%20and%20Structures%202nd%20Ed.pdf">the local government</a>, which is mediated by the Health Research Ethics Committee at our collaborators’ academic institution, as well as restrictions set by the <a href="http://trust-project.eu/wp-content/uploads/2017/03/San-Code-of-RESEARCH-Ethics-Booklet-final.pdf">South African San Council</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/449876/original/file-20220303-4451-15ykg4f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Enrolled research participant holding the spitkit during saliva collection" src="https://images.theconversation.com/files/449876/original/file-20220303-4451-15ykg4f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/449876/original/file-20220303-4451-15ykg4f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=612&fit=crop&dpr=1 600w, https://images.theconversation.com/files/449876/original/file-20220303-4451-15ykg4f.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=612&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/449876/original/file-20220303-4451-15ykg4f.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=612&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/449876/original/file-20220303-4451-15ykg4f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=770&fit=crop&dpr=1 754w, https://images.theconversation.com/files/449876/original/file-20220303-4451-15ykg4f.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=770&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/449876/original/file-20220303-4451-15ykg4f.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=770&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Researchers extracted DNA from saliva samples.</span>
<span class="attribution"><span class="source">Dana Al-Hindi</span>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>There are also <a href="https://www.ncbi.nlm.nih.gov/books/NBK525077/">potential risks</a> to the participant. Group-level results provide a protective blanket from potential legal or social issues that can arise from individual ancestry results. For example, a participant may learn that their biological father is not who they believed they were, which could sow conflict in the family and unease for the participant. More generally, the participant faces the social risk of being included or excluded from different communities depending on the outcome of the results.</p>
<p>We discussed these potential problems with past participants and found that most community members care little about the risks. Our participants have consistently viewed the option to receive their personal ancestry results as a benefit of taking part in research. They simply want to know who their forefathers were.</p>
<h2>Helicopter research and exploitation</h2>
<p>To fulfill these requests, we’ve partnered with <a href="https://www.23andme.com/">23andMe Inc.</a>, a U.S.-based company that provides at-home genetic testing. One of us previously worked for 23andMe on its ancestry team and continues to maintain a relationship with scientists at the company. When 23andMe launched a <a href="https://blog.23andme.com/23andme-research/23andmes-populations-collaborations/">program in 2018</a> to improve genetic data on underrepresented communities in biomedical and genetic research, we were excited to see an emphasis on local partnerships and community grants. We submitted a successful application, and 23andMe has provided us with funding to conduct this research.</p>
<p>As academic researchers, we don’t always have the right expertise on how to best communicate personal results. Nor do we often have the funds to successfully execute this task. Research grants do not typically provide support for community development, and graduate and postdoctoral researchers lack protected time to do this on top of their other responsibilities. 23andMe, on the other hand, already has the resources and the experience to accessibly communicate personal genomic results to lay people, because that’s its commercial product. Thus, collaborations with for-profit organizations is not uncommon. Along with <a href="https://doi.org/10.1101/2022.02.07.478793">23andMe</a>, academic researchers have also worked with genetic testing companies <a href="https://www.forbes.com/sites/tommywilliams1/2020/02/29/meet-54gene-changing-the-landscape-of-global-dna-by-including-africa/?sh=6a92cbc55abd">54gene</a> and <a href="https://medium.com/variantbio/variant-bio-launches-new-partnership-on-kidney-disease-in-south-africa-ef3657fb4f3d">Variant Bio</a>.</p>
<p>With approval from the research ethics committee of the local university we work with, 23andMe will fund the expenses of our fieldwork and a community grant, in addition to processing our DNA samples in exchange for data access. They plan to use the data to improve African ancestry results for their customers and for their own research projects. </p>
<p>The company made <a href="https://www.bloomberg.com/news/features/2021-11-04/23andme-to-use-dna-tests-to-make-cancer-drugs">over US$50 million</a> in 2021, and its plans to use the genetic data it has accumulated from its customers to develop pharmaceuticals has not been without <a href="https://www.nytimes.com/2021/09/20/opinion/23andme-dna.html">controversy</a> in the U.S. The samples collected in our partnership with 23andMe, however, would not be used to develop new drugs. While our research focuses primarily on broadening scientific knowledge, and 23andMe does make an effort to follow an <a href="https://blog.23andme.com/23andme-research/an-ethical-framework-for-international-research/">ethical framework</a> for collaborations like these, our developing partnership has heightened our concerns about exploitation and what’s known as <a href="https://doi.org/10.1038/d41586-021-01795-1">helicopter research</a>.</p>
<p>Scientists conduct helicopter research when they collect data from developing countries and marginalized communities with little to no involvement from local researchers and community members. Helicopter research also occurs when researchers take data out of the country they collected it from without either providing benefit to or sharing the results with the community.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/HOBlWaH-Owo?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Informed consent is not enough to prevent research from being exploitative.</span></figcaption>
</figure>
<p>San communities are <a href="https://www.smithsonianmag.com/smart-news/san-people-south-africa-issue-code-ethics-researchers-180962615/">no strangers</a> to helicopter research. For example, <a href="https://doi.org/10.1007/978-90-481-3123-5_6">hoodia</a> is a cactus San communities use to suppress appetite during long hunts or famine. Pharmaceutical companies researched and patented this cultural knowledge in 1995 to develop and sell an anti-obesity pill, initially all without San recognition or involvement. If the San were acknowledged at all, they were referred to as a <a href="https://uwapress.uw.edu/book/9780295742175/reinventing-hoodia/">population that no longer existed</a>. After several legal disputes, the San were promised benefits from any production that came out of the project. Though they received <a href="https://www.unl.edu/rhames/courses/current/hoodia.htm">some compensation</a>, it was a fraction of the value they funneled toward the research and <a href="https://uwapress.uw.edu/book/9780295742175/reinventing-hoodia/">nowhere near what was promised</a>.</p>
<p>This has been a recurring issue for the Khoe and San communities, most recently involving the <a href="https://doi.org/10.1038/d41586-019-03374-x">rooibos tea industry</a>. Companies conducted over a century of commercial rooibos farming benefiting from Khoe and San cultural knowledge before finally agreeing to pay 1.5% of what farmers make for unprocessed rooibos to the communities. Because of this, gaining approval from the local university’s ethics committee for our project has been difficult, and understandably so.</p>
<p>To build a more active and transparent relationship with the local community, we are working closely with 23andMe to develop an advisory board of members from local communities. We have held town halls and conducted interviews with locals to ask if they’d still be interested in being a part of this research project if a company became involved. The majority expressed little concern about 23andMe’s involvement and potentially profiting from their genetic information. But history has shown that for study participants around the globe, <a href="https://doi.org/10.1017/S0963180111000259">informed consent</a> has its limitations. It is still difficult to communicate and gauge whether participants, or the <a href="https://www.vox.com/recode/2019/12/13/20978024/genetic-testing-dna-consequences-23andme-ancestry">millions of Americans</a> who have paid 23andMe for genetic testing, fully understand the full extent of the risks involved with giving away their genetic data, both to 23andMe and to us academic researchers.</p>
<p>The company has offered to provide small community grants to help meet local needs, and has also expanded our ability to “<a href="https://www.un.org/en/academic-impact/capacity-building">capacity-build</a>” – that is, to make sure that the knowledge and skills we gain are shared with local institutions. But the question remains whether there is an equitable balance of benefits. Other companies have already promised <a href="https://54gene.com/we-have-launched-a-trust-to-reinvest-5-of-proceeds-from-commercial-drug-discovery-programs-on-african-scientists-and-communities/">long-term benefits</a> by <a href="https://www.variantbio.com/faq">sharing equity and profit</a> with participating communities. Are individual ancestry results and community grants a sufficient and fair exchange against the profits the company will gain from this collaboration?</p>
<h2>Where does this leave us?</h2>
<p>Academic researchers are faced with navigating the many trade-offs that come with industry collaborations. While 23andMe’s participation provides a means to return individual results to the community, it also raises questions about sufficiently equitable benefits. Our research team, local collaborators and 23andMe are all concerned about how to best address the risk of helicopter research, coercion and any unknown risks that may arise from disclosing personal ancestry results. </p>
<p>In an ideal world, researchers would be able to return benefits to the community without involving nonacademic external parties. Integrating practices like returning results to communities within <a href="https://doi.org/10.1371/journal.pcbi.1009277">research grant requirements</a> is one way to ensure that participants are also benefiting from research. Nonprofit small grants dedicated to returning results and community benefit are another. Until then, researchers will continue to make do with the limited resources they have.</p>
<p><em>This article was updated to more accurately reflect how 23andMe will use the collected data.</em></p><img src="https://counter.theconversation.com/content/166940/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dana Al-Hindi intends to use Dr. Henn's awarded funds from 23andMe Inc. to complete fieldwork and return of results to sampled communities. </span></em></p><p class="fine-print"><em><span>Brenna Henn is a former employee of 23andMe, Inc. and retains shares in the organization. She has received funding from 23andMe to complete research described in this article. </span></em></p>
The South African Khoe-San communities are no strangers to exploitative research. One research team is trying to provide genetic ancestry results to community members. But they still face many challenges.
Dana Al-Hindi, PhD Candidate in Anthropology, University of California, Davis
Brenna Henn, Associate Professor of Anthropology, University of California, Davis
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/171217
2021-11-17T05:15:01Z
2021-11-17T05:15:01Z
COVID 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>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1435603579646132226"}"></div></p>
<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>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1330728487938904064"}"></div></p>
<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>
</blockquote>
<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>
<blockquote>
<p>The voluntary consent of the human subject is absolutely essential.</p>
</blockquote>
<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>
<blockquote>
<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>
</blockquote>
<p>Here’s the filling (the false claim and how it relates to the truth):</p>
<blockquote>
<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>
</blockquote>
<p>If you want to expand further:</p>
<blockquote>
<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>
</blockquote>
<p>Final piece of bread (repeating the truth):</p>
<blockquote>
<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>
</blockquote>
<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 Sydney
Ben Harris-Roxas, Senior Lecturer, UNSW Sydney
Bridget Haire, Postdoctoral Research Fellow, Kirby Institute, UNSW Sydney
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/169284
2021-10-20T15:29:37Z
2021-10-20T15:29:37Z
Why scholars have created global guidelines for ancient DNA research
<figure><img src="https://images.theconversation.com/files/425679/original/file-20211011-17-e8rw09.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Ancient DNA holds a great deal of valuable information - but it must be researched ethically.</span> <span class="attribution"><span class="source">© Max Planck Institute for Evolutionary Anthropology</span></span></figcaption></figure><p>The field of <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/ancient-dna">ancient DNA</a> has grown rapidly in recent years, largely thanks to technological advancements. This work involves sampling human remains from long ago and analysing the DNA to understand human and population history, origins and evolution. </p>
<p>As with any scientific research, there are ethical questions to navigate. Some are fairly modern concerns. DNA contains all our genetic and biological information; these data, if unregulated, can be misused for medical and scientific research by anyone, including but not limited to scientists, governments, and big pharmaceutical companies. Other ethical concerns are rooted in history. For centuries, scientists have tested and obtained data on African people as though they were merely <a href="https://jacana.co.za/product/darwins-hunch-science-race-and-the-search-for-human-origins/">specimens, objects and subjects</a>. <a href="https://www.bbc.com/news/world-europe-52151722">These attitudes persist</a>.</p>
<p>These, then, are the key questions for anyone engaged in ancient DNA research: how can Africa’s genomes (and those from other places, especially elsewhere in the global South) be protected while its researchers contribute to <a href="https://www.ft.com/content/eed0555c-5e2b-11ea-b0ab-339c2307bcd4">the human story and understanding human history</a>? What is the most ethical way to do this research? How do scientists, for instance, proceed with obtaining consent from a community or families whose ancestors’ remains are being tested? What should they do when it’s not clear who the human remains descendants or communities are? And, crucially, how can the African continent’s ancient DNA be protected?</p>
<p>This last question is important because of humanity’s origin and deep historical roots in Africa. <a href="https://www.researchgate.net/publication/338960012_DNA_is_the_key_to_unlocking_our_ancient_African_past">African DNA</a> is found in all humans. Studying ancient DNA in Africa is valuable for understanding human evolution, population migrations, and human history locally, regionally and globally. </p>
<p>These questions of ethics have led to a diverse set of 64 scholars from 24 countries who are actively involved in ancient DNA research – myself among them – to develop a set of ethical guidelines for the discipline. These are outlined in our <a href="https://www.nature.com/articles/s41586-021-04008-x">new article</a> in the journal Nature.</p>
<p>Appropriate approaches to working with human ancient DNA differ across world contexts. That’s why so many specialists from varying regions and countries came together to develop these guidelines. They are not so detailed that they can’t be adapted for specific contexts, but are specific enough to offer a level of protection. The countries include Germany, India, Mexico and the US. From the African continent, researchers from Sudan, Kenya and South Africa contributed ideas and suggestions.</p>
<h2>Five guidelines</h2>
<p>My colleagues and I believe that the set of guidelines we’ve created are strong and universally applicable. We’ve committed to applying them in our own work.</p>
<p>The guidelines call for researchers to:</p>
<ol>
<li><p>abide by all regulations in the places where they work and from which the human remains originate </p></li>
<li><p>prepare a detailed plan prior to beginning any study </p></li>
<li><p>minimise damage to human remains </p></li>
<li><p>ensure data are made available following publication to allow critical re-examination of scientific findings </p></li>
<li><p>engage with other stakeholders and ensure respect and sensitivity to stakeholder perspectives.</p></li>
</ol>
<p>Our hope is that these guidelines will ensure ancient DNA research is always conducted to the highest ethical standards. We have also designed them in a way that will, we believe, address the issue of <a href="https://theconversation.com/how-a-partnership-is-closing-the-door-on-parachute-research-in-africa-102217">parachute research</a>. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/425685/original/file-20211011-19-p7qbcg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/425685/original/file-20211011-19-p7qbcg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/425685/original/file-20211011-19-p7qbcg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/425685/original/file-20211011-19-p7qbcg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/425685/original/file-20211011-19-p7qbcg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/425685/original/file-20211011-19-p7qbcg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/425685/original/file-20211011-19-p7qbcg.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">No matter where it’s done, ancient DNA research must be done ethically.</span>
<span class="attribution"><span class="source">© Max Planck Institute for Evolutionary Anthropology</span></span>
</figcaption>
</figure>
<p>This refers to scientists from wealthy nations swooping into developing ones, collecting samples and data, then heading straight back home to analyse them. There is poor to little coordination with local researchers, scientists and community groups in the country the samples come from – and, ultimately, the resulting research predominantly benefits those in the global North. Historically this is well documented, and <a href="https://theconversation.com/global-health-still-mimics-colonial-ways-heres-how-to-break-the-pattern-121951">today</a> these ideas of testing on Africans are still pervasive. With the rise of ancient DNA research, there’s a risk of parachute research. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/ancient-dna-unearths-fascinating-secrets-but-what-about-the-ethics-85186">Ancient DNA unearths fascinating secrets. But what about the ethics?</a>
</strong>
</em>
</p>
<hr>
<h2>A starting point</h2>
<p>My contributions to the subject follow on from <a href="https://doi.org/10.1038/s41576-020-00285-w">a paper</a> I published in 2020 explaining the robust rules and regulations for DNA studies on the living. I highlighted the gaps in South Africa’s heritage legislation with ancient DNA research and argued they should mirror each other. DNA, whether from the living or the dead, provides a lot of information about both – the implications for this research are far reaching.</p>
<p>In my own research, I hope the guidelines we’ve created will improve communication structures and respect for local community consultation processes and understanding the need for regular feedback and results returning in tangible ways back into community groups. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/skeletons-and-closets-how-one-university-reburied-the-dead-126607">Skeletons and closets: How one university reburied the dead</a>
</strong>
</em>
</p>
<hr>
<p>The guidelines capture the values of transparency and open access data, engagement, respect, dignity and sensitivity that must be central to ancient DNA research.</p>
<p>The hope is that these principles will provide a starting point from which African countries can begin to improve consultation, prevent or lessen parachute research and develop strong local legislation to enshrine ethical ancient DNA research. It is critical that all ancient DNA researchers are held accountable: researchers in African countries need to be careful and responsible with the continent’s genetic material in the same way that those from wealthier countries need to avoid conducting parachute research.</p>
<p>The paper has been translated into more than 20 languages – among them Swahili, isiXhosa, Afrikaans, Arabic, French, German and Portuguese – to ensure that the guidelines are widely accessible.</p><img src="https://counter.theconversation.com/content/169284/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Victoria Gibbon receives funding from the National Research Foundation (NRF) of South Africa their financial assistance towards this research is hereby acknowledged. Opinions expressed, and conclusions arrived at, are those of the author and are not necessarily
attributed to these funding bodies.</span></em></p>
Studying ancient DNA in Africa is valuable for understanding human evolution, population migrations, and human history locally, regionally and globally.
Victoria Gibbon, Associate Professor in Biological Anthropology, Division of Clinical Anatomy and Biological Anthropology, University of Cape Town
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/148904
2020-10-29T19:07:29Z
2020-10-29T19:07:29Z
First, do no harm: education research should answer to the same standards as medicine
<figure><img src="https://images.theconversation.com/files/365678/original/file-20201027-23-n76gnh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/teacher-giving-lesson-technology-classroom-441374218">Shutterstock</a></span></figcaption></figure><p>Australia has one of the <a href="https://www.health.gov.au/health-topics/medical-research">highest-quality systems</a> of <a href="https://www.natureindex.com/news-blog/ten-best-countries-life-sciences-research-rankings">medical research</a> in the world. It has helped underpin the high standing of Australia’s health system — it’s <a href="https://www.bloomberg.com/news/articles/2018-09-19/u-s-near-bottom-of-health-index-hong-kong-and-singapore-at-top">ranked</a> as one of the finest in the world. </p>
<p>Strong principles to protect safety and prevent harm underpin medical research. These <a href="https://www.nybooks.com/articles/2015/11/19/medical-research-dangers-human-subjects/">have been developed</a> due to a history of sometimes well intentioned, but ultimately harmful, medical interventions over the course of the 20th century. </p>
<p>Australia’s <a href="https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018">National Statement on Ethical Conduct in Human Research</a> is the primary guidance not only for medical research in Australia but for most research involving people, which includes education. But the harm and impact of educational programs — that are, on the surface, deemed important to educational improvements and well-being — face far less scrutiny in the applications process than do those of medical research.</p>
<p>No-one wants our children to be used as research guinea pigs. High standards of ethical oversight are needed to ensure no child is exposed to possible harm. While the medical research ethics model was developed to provide exactly this level of protection, perversely, in education, it may be exposing our children to harm. </p>
<h2>Differences between medical and education research</h2>
<p>There is a critical difference between medicine and education that impacts research. While drug and surgical therapies are administered to individuals, education is a shared activity. Students are taught in classes and schools. </p>
<p>Research ethics <a href="https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018">require individual signed consent</a> from parents for their child to participate in any research project. This makes it difficult to study classroom teaching and class- and school-based programs. While few parents oppose educational research, families have busy lives, and notes home from school are easily overlooked or forgotten.</p>
<p>Studies show <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/j.1753-6405.2009.00387.x">the requirement to sign a consent form</a> results in research participation rates of between 30% and 60%. In this case, the educational intervention being studied can be altered to only be delivered to some of the students in the class. This can lead to <a href="https://bera-journals.onlinelibrary.wiley.com/doi/full/10.1002/berj.3137">biased findings</a>. Or the study may not go ahead if only some parents sign the form. It is no wonder many programs used in schools lack an evidence base informed by rigorous educational research.</p>
<p>As one example, most of the more than 200 mental health programs recommended by the <a href="https://beyou.edu.au/resources/programs-directory">Beyond Blue Be You national education initiative</a> have not actually been tested in Australian schools.</p>
<p>A <a href="https://www.pc.gov.au/inquiries/completed/education-evidence/report">Productive Commission report</a> noted the largest gaps in Australia’s education evidence base relate to </p>
<blockquote>
<p>the evaluation of policies, programs and education practices in Australian schools and early childhood education and care services to identify what works best, for whom and in what circumstances.</p>
</blockquote>
<p>While educational research ethics are guided by the National Statement on Ethical Conduct in Human Research, there is another critical difference between health and education. A new medical therapy <a href="https://www.nps.org.au/consumers/how-medicines-are-approved-for-use-in-australia">can only be approved</a> for the Medicare or Pharmaceutical Benefits Scheme if it has been proven to be safe, effective, and more cost effective than existing therapies. There is no such requirement in education. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/not-every-schools-anti-bullying-program-works-some-may-actually-make-bullying-worse-116163">Not every school's anti-bullying program works – some may actually make bullying worse</a>
</strong>
</em>
</p>
<hr>
<p>Schools and teachers are given wide latitude to adopt untested educational programs and strategies based on their professional judgements. Some programs such as <a href="https://visible-learning.org">Visible Learning</a>, which helps teachers evaluate their own practices, have been <a href="https://bera-journals.onlinelibrary.wiley.com/doi/abs/10.1111/j.1467-8535.2012.01347_7.x">developed to rigorous standards</a>. But the implementation of such programs is less scrutinised, and questions are seldom raised about their potential harms. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/365698/original/file-20201027-15-1xbpoly.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/365698/original/file-20201027-15-1xbpoly.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/365698/original/file-20201027-15-1xbpoly.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=407&fit=crop&dpr=1 600w, https://images.theconversation.com/files/365698/original/file-20201027-15-1xbpoly.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=407&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/365698/original/file-20201027-15-1xbpoly.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=407&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/365698/original/file-20201027-15-1xbpoly.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=512&fit=crop&dpr=1 754w, https://images.theconversation.com/files/365698/original/file-20201027-15-1xbpoly.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=512&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/365698/original/file-20201027-15-1xbpoly.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=512&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A new medical therapy must be proven to be safe, effective, and more cost effective than existing therapies.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/group-scientists-working-laboratory-71245138">Shutterstock</a></span>
</figcaption>
</figure>
<p>Research into the <a href="https://www.tandfonline.com/doi/abs/10.1080/0969594X.2011.592972">high stakes NAPLAN</a> test shows several negative effects. These include <a href="https://eprints.qut.edu.au/63662/">teachers limiting the scope</a> of what they teach and concentrating only on what will be in the test, and <a href="https://theconversation.com/too-many-adjectives-not-enough-ideas-how-naplan-forces-us-to-teach-bad-writing-133068">encouraging students to write badly</a>, to a formula that will get them higher marks. But despite this, not much has changed in terms of the way the testing is implemented.</p>
<h2>Whose interests are being served?</h2>
<p>The requirement by university ethics committees for individual signed consent for research studies sounds prudent. Yet is it ethical not to evaluate the impacts of programs that are actually being taught in schools? And how can it be ethical to teach a program in schools that has not been rigorously evaluated? </p>
<p>Ethics committees ought to routinely ask questions about whose interests are being served. Rather than a focus on harm minimisation, a <a href="https://www.tandfonline.com/doi/full/10.1080/0725686042000315740">focus on who benefits from the research</a> might be more appropriate. </p>
<p>Children don’t generally die from poor quality teaching. However, high quality education is one of the main drivers of economic opportunity and increased choices throughout life. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/too-many-adjectives-not-enough-ideas-how-naplan-forces-us-to-teach-bad-writing-133068">Too many adjectives, not enough ideas: how NAPLAN forces us to teach bad writing</a>
</strong>
</em>
</p>
<hr>
<p>Some educational programs are <a href="https://link.springer.com/chapter/10.1007/978-3-319-58689-2_11">evaluated and assessed</a> for the outcomes they produce, as well as the methodologies they use. But a database of evidence of these studies, similar to the <a href="https://www.cochrane.org">Cochrane Collaboration</a> which summarises previous medical studies about one topic, could be used to inform educational policy and decision making. It could also offer conclusive evidence about these programs and interventions.</p>
<p>In the main, educational projects that intend to help schools respond to policy objectives, such as improving national or international test scores, are rarely evaluated for the potential harm that might arise. For example, the <a href="https://www.education.gov.au/year-1-phonics-check">Australian government is investing $10.8</a> million to develop free phonics checks for Year 1 students to improve literacy levels. While there is mention of research that may help children, there is not, as yet, any adequate evidence-base for phonics testing.</p>
<h2>Funding differences</h2>
<p>Educational research in Australia is also underfunded compared with medical research. The Australian government provided $1.2 billion through the <a href="https://www.nhmrc.gov.au/funding/new-grant-program/overview">Medical Research Endowment Fund</a> and the <a href="https://www.finance.gov.au/government/australian-government-investment-funds/medical-research-future-fund">Medical Research Future Fund</a> in 2019 — <a href="https://www.pc.gov.au/research/ongoing/report-on-government-services/2020/health">roughly 1%</a> of the $103 billion Australian governments spend annually on health care. While the $11.2million of education funding provided by the <a href="https://www.arc.gov.au/grants-and-funding/apply-funding/grants-dataset">Australian Research Council</a> in 2019 is only <a href="https://www.pc.gov.au/research/ongoing/report-on-government-services/2020/child-care-education-and-training/school-education">0.02% of the $58 billion</a> Australian governments spend annually on school education. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/gaps-in-education-data-there-are-many-questions-for-which-we-dont-have-accurate-answers-65241">Gaps in education data: there are many questions for which we don't have accurate answers</a>
</strong>
</em>
</p>
<hr>
<p>Without research to guide what we invest in, we fail to learn from the experiences of the past and lack the information to guide improvements in our schools and education systems. Although researchers do question and contest educational policies, the impact of this research remains in our peripheral vision.</p>
<p>Australia needs to improve the education evidence base by systematically evaluating the effectiveness of policies, programs and practices. It must also evaluate and their implementation strategies within a cycle of learning, feedback and continuous improvement.</p><img src="https://counter.theconversation.com/content/148904/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>David Lawrence receives funding from the National Health and Medical Research Council and the Medical Research Future Fund. </span></em></p><p class="fine-print"><em><span>Tanya Fitzgerald 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>
No-one wants our children to be used as research guinea pigs. High standards of ethical oversight are needed to ensure no child is exposed to possible harm.
David Lawrence, Principal Research Fellow, The University of Western Australia
Tanya Fitzgerald, Professor and Dean, The University of Western Australia
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/113138
2019-04-11T04:41:28Z
2019-04-11T04:41:28Z
When science is put in the service of evil
<figure><img src="https://images.theconversation.com/files/262675/original/file-20190307-82665-1o7jut6.jpg?ixlib=rb-1.1.0&rect=14%2C0%2C1902%2C1281&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Nazi leadership saw medical and pharmaceutical research as a front-line tool to contribute to the war effort.</span> <span class="attribution"><a class="source" href="https://pixabay.com/photos/auschwitz-birkenau-war-holocaust-2559070/">Akanbatt / Pixabay</a></span></figcaption></figure><p>The Holocaust is one of the worst collective crimes in the history of humanity – and medical science <a href="http://ediberun.com/delta/inicio/50-cuando-la-medicina-no-cura.html">was complicit in the horrors</a>.</p>
<p>After World War II, evidence was given at the <a href="https://www.ncbi.nlm.nih.gov/pubmed/17223241">Nuremberg Trials</a> of reprehensible research carried out on humans. This includes subjects being frozen, infected with tuberculosis, or having limbs amputated. </p>
<p>There was also <a href="https://www.ncbi.nlm.nih.gov/pubmed/19125905">specific research into pharmacology</a> <a href="https://www.ncbi.nlm.nih.gov/pubmed/18848972">that is less well-known</a>, as can be seen from the <a href="https://scholar.google.com/citations?user=IbuwtWgAAAAJ&hl=es">articles we have published</a> over the past 15 years.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/is-it-ethical-to-use-data-from-nazi-medical-experiments-39928">Is it ethical to use data from Nazi medical experiments?</a>
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</em>
</p>
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<h2>The prestige of German medicine</h2>
<p>German pharmacology and chemistry enjoyed great international prestige from the second half of the 19th century. </p>
<p>This golden age ended with the Nazi Party’s rise to power in 1933 and was replaced with <a href="https://www.cambridge.org/core/journals/acta-neuropsychiatrica/article/psychotropic-drugs-research-in-nazi-germany-the-triumph-of-de-principle-of-malfeasance/72702C7C6B9607759A0CFB639BBA5599">institutionalised criminal behaviour</a> in public health and human research.</p>
<p>At the beginning of World War II, Nazi leadership saw medical and pharmaceutical research as a front-line tool to contribute to the war effort and reduce the impact of injury, disease and epidemics on troops. </p>
<p>Nazi leaders believed concentration camps were a source of “inferior beings” and “degenerates” who could (and should) be used as research subjects.</p>
<p>German pharmacology and medicine lost all dignity. <a href="https://books.google.es/books?id=ju0XAwAAQBAJ&pg=PA5&lpg=PA5&dq=louis+falstein+%2B+nazis+made+doctors+murderers&source=bl&ots=mV82A4pDNs&sig=ACfU3U0y2-k_Q-cPgVUdih3F0Jr_TeGv9w&hl=en&sa=X&ved=2ahUKEwjpu7mF_qTgAhVIrxoKHbprBn4Q6AEwDHoECAUQAQ#v=onepage&q=louis%20falstein%20%2B%20nazis%20made%20doctors%20murderers&f=false">As Louis Falstein pointed out</a>:</p>
<blockquote>
<p>the Nazis prostituted law, perverted education and corrupted the civil service, but they made killers out of physicians.</p>
</blockquote>
<p>The rise of eugenics in central Europe at the beginning of the 20th century paved the way for the Nazi government to implement a <a href="http://germanhistorydocs.ghi-dc.org/sub_document.cfm?document_id=449">disastrous</a> policy of “racial hygiene”. </p>
<h2>The Aktion T4 Programme</h2>
<p>The Nazi ideology promoted the persecution of those who were considered “abnormal”, as part of the Aktion T4 program.</p>
<p>September 1, 1939 – the date of the start of World War II – <a href="https://encyclopedia.ushmm.org/content/es/article/euthanasia-progra">marked the beginning of the mass extermination</a> of patients with “deficiencies” or mental conditions, who were deemed to be “empty human shells”. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/257498/original/file-20190206-174867-z2fol0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/257498/original/file-20190206-174867-z2fol0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=411&fit=crop&dpr=1 600w, https://images.theconversation.com/files/257498/original/file-20190206-174867-z2fol0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=411&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/257498/original/file-20190206-174867-z2fol0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=411&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/257498/original/file-20190206-174867-z2fol0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=516&fit=crop&dpr=1 754w, https://images.theconversation.com/files/257498/original/file-20190206-174867-z2fol0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=516&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/257498/original/file-20190206-174867-z2fol0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=516&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Aktion 4 patients getting on a bus, 1941.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Aktion_T4_(Diakonie_Neuendettelsau).jpg">Wikimedia Commons</a></span>
</figcaption>
</figure>
<p>At first, the crimes were carried out via carbon monoxide poisoning. </p>
<p>In 1941, a second phase was launched: so-called “discrete euthanasia” via a lethal injection of drugs such as opiates and scopolamine (anti-neausea medication), or the use of low-doses of barbiturates to cause terminal pneumonia.</p>
<p>These techniques were combined with food rations and turning off the hospital heating during winter. </p>
<p>These euthanasia programmes led to what amounted to psychiatric genocide, with the murder of more than 250,000 patients. This is possibly the most heinous criminal act in the history of medicine.</p>
<h2>Experimenting with healthy subjects</h2>
<p>Medical experimentation became another tool of political power and social control, over both sick people from the T4 Program, as well as healthy people. </p>
<p>Those in good health were recruited in the concentration camps of ostracised ethnic or social groups such as Jews, Gypsies, Slavs and homosexuals.</p>
<p>A number of experiments were undertaken, including the study of:</p>
<ul>
<li>the effect of sulfonamides (antibiotics) on induced gas gangrene (Ravensbrück)</li>
<li>the use of the toxic chemical formalin for female sterilisation (Auschwitz-Birkenau)</li>
<li>the use of vaccines and other drugs to prevent or treat people intentionally infected with malaria (Dachau)</li>
<li>the effects of methamphetamine in extreme exercise (Sachsenhausen)</li>
<li>the anaesthetic properties of hexobarbital (a barbiturate derivative) and chloral hydrate (a sedative) in amputations (Buchenwald)</li>
<li>the use of barbiturates and high doses of mescaline (a hallucinogenic drug) in “brainwashing” studies (Auschwitz and Dachau).</li>
</ul>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/257620/original/file-20190206-174870-1eglovp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/257620/original/file-20190206-174870-1eglovp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=649&fit=crop&dpr=1 600w, https://images.theconversation.com/files/257620/original/file-20190206-174870-1eglovp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=649&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/257620/original/file-20190206-174870-1eglovp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=649&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/257620/original/file-20190206-174870-1eglovp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=816&fit=crop&dpr=1 754w, https://images.theconversation.com/files/257620/original/file-20190206-174870-1eglovp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=816&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/257620/original/file-20190206-174870-1eglovp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=816&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Block 10 of the Auschwitz concentration camp, where medical experiments with prisoners were carried out.</span>
<span class="attribution"><span class="source">Francisco López Muñoz</span></span>
</figcaption>
</figure>
<p>Faced with all this evidence, how it is possible that up to 45% of German doctors joined the Nazi party? No other profession reached these figures of political affiliation. </p>
<p>What were the reasons and circumstances that led to these perverse abuses?</p>
<h2>The banality of evil in medicine</h2>
<p>The answer is difficult. Many doctors argued that regulations were designed for the benefit of the nation and not the patient. They invoked such misleading concepts as “force majeure” or “sacred mission”.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/two-steps-forward-one-step-back-how-world-war-ii-changed-how-we-do-human-research-39929">Two steps forward, one step back: how World War II changed how we do human research</a>
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</p>
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<p>Some believed everything was justified by science, even the inhumane experiments carried out in the camps, while others considered themselves patriots and their actions were justified by the needs of wartime.</p>
<p>Some were followers of the perverse Nazi ethos and others, the more ambitious, became involved in these activities as a means of promoting their professional and academic careers.</p>
<p>Lastly, avoiding association with the Nazi apparatus may have been difficult in a health sector where fear had become a system of social pressure and control.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/257497/original/file-20190206-174887-14su5kh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/257497/original/file-20190206-174887-14su5kh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=456&fit=crop&dpr=1 600w, https://images.theconversation.com/files/257497/original/file-20190206-174887-14su5kh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=456&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/257497/original/file-20190206-174887-14su5kh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=456&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/257497/original/file-20190206-174887-14su5kh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=573&fit=crop&dpr=1 754w, https://images.theconversation.com/files/257497/original/file-20190206-174887-14su5kh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=573&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/257497/original/file-20190206-174887-14su5kh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=573&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A monument by Richard Serra in Berlin honouring of the victims of the Aktion 4 programme.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Serra,_Berlin_Curves,_Stahl,_1986.jpg">Wikimedia Commons</a></span>
</figcaption>
</figure>
<p>Arturo Pérez-Reverte, in his book Purity of Blood, defines this type of motivation very well: </p>
<blockquote>
<p>… although all men are capable of good and evil, the worst are always those who, when they administer evil, do so on the authority of others or on the pretext of carrying out orders.</p>
</blockquote>
<p>However, as has happened in many moments of history, sometimes tragedies bring positive posthumous effects. </p>
<p>After the trial of the Nazi doctors, the first international code of ethics for research with human beings was enacted, the <a href="http://www.bioeticanet.info/documentos/Nuremberg.pdf">Nuremberg Code</a>, under the Hippocratic precept “<a href="https://es.wikipedia.org/wiki/Primum_non_nocere">primun non nocere</a>”. This code has had immense influence on human rights and bioethics.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/two-steps-forward-one-step-back-how-world-war-ii-changed-how-we-do-human-research-39929">Two steps forward, one step back: how World War II changed how we do human research</a>
</strong>
</em>
</p>
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<img src="https://counter.theconversation.com/content/113138/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Francisco López-Muñoz 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>
Medical research has a dark history of human experimentation in Nazi Germany. And we’re still uncovering the extent of the horrors.
Francisco López-Muñoz, Profesor Titular de Farmacología y Director de la Escuela Internacional de Doctorado, Universidad Camilo José Cela
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/113463
2019-03-13T19:11:18Z
2019-03-13T19:11:18Z
Experts call for halt to CRISPR editing that allows gene changes to pass on to children
<figure><img src="https://images.theconversation.com/files/263553/original/file-20190313-86713-uwtcri.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">CRISPR is a gene editing tool that can create permanent changes in the human genome. </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/newborn-baby-first-many-small-hospital-1103569475">from www.shutterstock.com</a></span></figcaption></figure><p>Remember the global outrage four months ago at world-first claims a researcher had used the gene editing tool CRISPR to <a href="https://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">edit the genomes of twin girls</a>? </p>
<p>The molecular scissors known as CRISPR (<a href="https://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">CRISPR/cas9</a> in full) allow scientists to modify DNA with high precision and greater ease than previous technologies.</p>
<p>Now researchers from the USA, Europe, China and New Zealand have published a prominent call for <a href="https://www.nature.com/articles/d41586-019-00726-5">a moratorium</a>, or temporary freeze, on the clinical use of germline gene editing technology in humans. (Germline editing means the genes that are edited are included in eggs and sperm, the “germ” cells, and can be passed on to following generations). </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">What is CRISPR gene editing, and how does it work?</a>
</strong>
</em>
</p>
<hr>
<p>The authors on the Nature report include some leaders in the development of CRISPR technologies, as well as bioethicists.</p>
<p>They propose a framework in which nations commit to not approve any clinical use of heritable gene editing unless some conditions are met on technical, societal, medical and ethical grounds. </p>
<p>In that process, they also argue that there should be an initial period during which no clinical use of germline editing is allowed at all. Research would still be allowed, provided embryos are used only in the very early stages in laboratory studies, and not transferred to a woman’s uterus to develop further. They suggest this period could last five years.</p>
<p>After this initial period, any participating country could allow a particular application of germline editing by following three steps: </p>
<ol>
<li>public notice of intent</li>
<li>transparent evaluation and justification of the application (considering not only the scientific and medical aspects, but also the related societal and ethical issues)</li>
<li>achievement of a broad consensus in the nation that this is an acceptable application.</li>
</ol>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">Researcher claims CRISPR-edited twins are born. How will science respond?</a>
</strong>
</em>
</p>
<hr>
<h2>It’s about more than just science</h2>
<p>It is important that the evaluation considers not only the science of germline genetic modifications, but also the broader societal context. The authors mention the risk of discrimination, peer and marketing pressure, and unequal access to the technology if gene editing became available as a tool, for example in IVF clinics.</p>
<p>This moratorium would be limited to human germline editing only. This means modifying human sperm, eggs or embryos to make children whose DNA has been altered. Such changes pass through the generations, which is why germline editing is a particular area of concern. </p>
<p>The moratorium would not apply to changes in human cells not capable of reproduction (called somatic gene editing). <a href="https://www.nature.com/articles/d41587-018-00003-2">Current efforts to treat blindness, sickle cell disease or cancer using CRISPR</a> would not be affected by the moratorium. </p>
<h2>Implications in Australia</h2>
<p>In Australia, germline genetic modification is not allowed, and is illegal.</p>
<p>According to the <a href="https://www.legislation.gov.au/Details/C2017C00306">Prohibition of Human Cloning for Reproduction Act (2002)</a> researchers can face up to 15 years in jail for modifying “the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered”. Therefore the implications for Australia will be limited, and applying the initial five-year freeze on any clinical use of germline editing would be seamless. </p>
<p>If Australia wishes to allow any clinical application of germline editing at some point in the future, this act would need to be revised. </p>
<p>The framework proposed in the moratorium call provides a basis for how such a revision could then be discussed: public notice, transparent and comprehensive consideration of the application, and national discussion. </p>
<h2>Voluntary and pragmatic</h2>
<p>The proposed moratorium is voluntary. This is a pragmatic approach. It would be very difficult to get international agreement on a ban. </p>
<p>As the authors note, <a href="https://www.nature.com/articles/palcomms201719">discussions on a legally binding convention to outlaw human cloning are not making much progress</a>. </p>
<p>In the absence of a binding agreement, a voluntary pledge can start to move the main stakeholders towards a workable solution. Other issues such as climate change have shown the limitations of international agreements, but even getting a limited number of countries on board would be a positive first step.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/designer-babies-wont-be-common-anytime-soon-despite-recent-crispr-twins-108342">'Designer' babies won't be common anytime soon – despite recent CRISPR twins</a>
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</p>
<hr>
<h2>Change requires commitment</h2>
<p>The authors also call on those who work in fields where CRISPR is used, including the leaders of research institutes as well as individual researchers, to publicly pledge to the principles of the framework they have outlined. </p>
<p>It will be interesting to see how some other stakeholders respond. For instance, will funding agencies and scientific publishers come on board? One objection to moratoriums is that they do not prevent “rogue” entities or individuals from operating outside their framework. </p>
<p>If it was clear that no study would be funded or published unless it adhered to the principles of advance notice, full transparency and national approval, it would remove some of the incentives that sometimes turn scientific research into a race.</p>
<p>Ultimately, in each country, society as a whole will have to decide whether germline editing is acceptable, and under which circumstances. A meaningful consensus will only be achieved if an informed discussion takes place. </p>
<p>To date, issues around gene editing have been <a href="http://www.nationalacademies.org/gene-editing/2nd_summit/">mostly discussed among experts</a>. More than ever, engagement and education that includes diverse members of our society around advanced biotechnologies is crucial.</p><img src="https://counter.theconversation.com/content/113463/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dimitri Perrin has received funding from the Australian Research Council (ARC), the Australian-French Association for Innovation and Research (AFRAN), and the Advance Queensland programme.</span></em></p><p class="fine-print"><em><span>Gaetan Burgio receives funding from the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), the National Collaborative Research Infrastructure Strategy (NCRIS) via the Australian Phenomics Network (APN) and the Natural Science Foundation in China (NSFC). </span></em></p>
Four months ago a researcher claimed he had used the tool CRISPR to edit the genomes of twin girls. Now prominent researchers and ethicists are calling for a temporary halt to this sort of work.
Dimitri Perrin, Senior Lecturer, Queensland University of Technology
Gaetan Burgio, Geneticist and Group Leader, The John Curtin School of Medical Research, Australian National University
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/108077
2019-02-05T19:17:29Z
2019-02-05T19:17:29Z
Whose hearts, livers and lungs are transplanted in China? Origins must be clear in human organ research
<figure><img src="https://images.theconversation.com/files/248605/original/file-20181204-23267-p3ouw7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It's not always clear where human organs come from in research papers. </span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/U4FyCp3-KzY">Piron Guillaume/unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>Scientist He Jiankui’s claimed use of the genetic tool CRISPR to <a href="https://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">edit the genomes of twin girls</a> led to <a href="https://www.theatlantic.com/science/archive/2018/12/15-worrying-things-about-crispr-babies-scandal/577234/">international condemnation</a>. His actions have focused a spotlight on research ethics – and what the consequences should be when scientists “<a href="https://apnews.com/13303d99c4f849829e98350301e334a9">go rogue</a>”.</p>
<p>The Chinese Academy of Science initially <a href="https://qz.com/1474814/the-cripsr-baby-news-was-carefully-orchestrated-pr-until-it-all-went-wrong/">looked into He’s conduct</a>, and a subsequent <a href="https://www.nytimes.com/2019/01/21/world/asia/china-gene-editing-babies-he-jiankui.html#click=https://t.co/XGWuV3PP4T">internal government investigation</a> has allegedly identified multiple violations of state laws. He has now been <a href="https://uk.reuters.com/article/us-china-health-babies/chinese-scientist-who-gene-edited-babies-fired-by-university-idUKKCN1PF0RA">fired by his university</a>. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/tension-as-scientist-at-centre-of-crispr-outrage-speaks-at-genome-editing-summit-107807">Tension as scientist at centre of CRISPR outrage speaks at genome editing summit</a>
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</p>
<hr>
<p>But beyond just this example, what does happen when scientists fail to comply with globally-accepted guidelines for ethical medical research? We examined this issue focusing on published research involving recipients of organ transplants performed in the People’s Republic of China.</p>
<p><a href="https://www.tts.org/index.php?option=com_content&view=article&id=11&Itemid=223">International professional standards</a> ban publication of research that:</p>
<ol>
<li>involves any biological material from executed prisoners</li>
<li>lacks human research ethics committee approval</li>
<li>lacks consent of donors.</li>
</ol>
<p>But as described in our <a href="https://bmjopen.bmj.com/content/9/2/e024473">new paper</a>, we found that research which does not comply with these standards is regularly accepted for publication in international peer-reviewed journals.</p>
<h2>Human organ transplants in China</h2>
<p>Using a scoping review methodology, we examined 445 studies published in peer reviewed English language journals between January 2000 and April 2017. The papers reported research involving recipients of human organ transplants (limited to hearts, livers or lungs) taking place in China. The data included 85,477 transplants.</p>
<p>We found that 92.5% of the publications failed to state whether or not the transplanted organs were obtained from executed prisoners. Nearly all of them (99%) failed to report whether organ donors gave consent. In contrast, 73% of papers reported approval from an institutional ethics committee for the research reported in the paper.</p>
<p>Widespread ethical concerns over the <a href="https://optn.transplant.hrsa.gov/resources/ethics/the-ethics-of-organ-donation-from-condemned-prisoners/">inability of condemned prisoners to give informed consent</a> for organ donation are exacerbated in the People’s Republic of China. Here, the <a href="https://www.amnestyusa.org/files/no-end-in-sight_torture-and-forced-confessions-in-china.pdf">judicial and police system lacks safeguards against procedural abuses</a>. <a href="https://www.springer.com/us/book/9783662460832">Faulty convictions are extensively documented and extremely difficult to redress</a>.</p>
<p>In addition, a <a href="https://endtransplantabuse.org/an-update/">growing body of credible evidence</a> suggests that organ harvesting is <a href="https://www.youtube.com/watch?v=ofQA7FVCoPc">not limited to condemned prisoners</a>, but also <a href="https://chinatribunal.com/draft-interim-judgement-and-closing-statement-by-sir-geoffrey-nice-dec-10-2018/">includes prisoners of conscience</a>. It is possible therefore — though not verifiable in any particular case — that peer reviewed publications may contain data obtained from prisoners of conscience killed for the purpose of organ acquisition.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/real-bodies-controversy-how-australian-museums-regulate-the-display-of-human-remains-95644">Real Bodies controversy: how Australian museums regulate the display of human remains</a>
</strong>
</em>
</p>
<hr>
<p>Who is responsible for ensuring that data based on research involving organs harvested from non-consenting prisoners is banned from publication? We argue in our paper that reviewers and journal editors have a role to play.</p>
<h2>Where do the organs come from?</h2>
<p>In 19 papers involving 2,688 organs transplanted prior to 2010, the source of organs was reported as voluntary donors. But as widely known in the transplantation community, there was no volunteer deceased organ donor program in China before a pilot started in 2010. It therefore seems reasonable to assume that organs may have been sourced from prisoners, making claims about volunteer donation unreliable.</p>
<p>The two journals that published the greatest number of Chinese transplant papers identified in our study are Transplantation Proceedings, with 65 of the total 445 papers, and PLOS ONE, with 20. Other journals with papers identified by this study include the American Journal of Transplantation, and Transplantation (the official journal of the peak international body, The Transplantation Society). These journals both have policies that explicitly prohibit the publication of research based on organ transplants from non-consenting and/or prisoner donors.</p>
<p>We argue that, if they are not already doing so, reviewers and medical journals should demand information about the source of organs in Chinese transplant research before these are published for the broader public and scientific communities. If they are demanding such information, the responses to those demands should be published. And if they are not satisfied with the responses, they should refuse to publish the research.</p>
<p>When a paper is published without identifying the source of the transplanted organs, it risks sending the message that ethical standards may be ignored or breached. This undermines the incentive to comply with these standards in the future.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/heres-what-australia-can-do-to-help-end-the-chinese-organ-trade-63701">Here's what Australia can do to help end the Chinese organ trade</a>
</strong>
</em>
</p>
<hr>
<h2>We’re all responsible</h2>
<p>Our findings raise important and disturbing questions about ethical oversight on the part of all of those involved in the process of reviewing and publishing transplantation research.</p>
<p>In response, we propose large-scale retractions of the papers identified by our research that are not consistent with international standards regarding organ donation. </p>
<p>We also propose a moratorium on all clinical transplant publications from China pending an international summit. The summit of transplantation community members and other stakeholders could develop appropriate policies and processes for handling future research.</p>
<p>Our hopes for these retractions are, however, not high. As one of us (Rogers) found, <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/liv.13244">securing a retraction</a> can be a prolonged process even where there is evidence of overt falsehood in the paper.</p>
<hr>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/250182/original/file-20181212-76974-27hzoo.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/250182/original/file-20181212-76974-27hzoo.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=480&fit=crop&dpr=1 600w, https://images.theconversation.com/files/250182/original/file-20181212-76974-27hzoo.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=480&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/250182/original/file-20181212-76974-27hzoo.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=480&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/250182/original/file-20181212-76974-27hzoo.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=603&fit=crop&dpr=1 754w, https://images.theconversation.com/files/250182/original/file-20181212-76974-27hzoo.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=603&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/250182/original/file-20181212-76974-27hzoo.png?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">
<figcaption>
<span class="caption">An article retracted due to concerns about the source of organs used for donation.</span>
<span class="attribution"><a class="source" href="https://onlinelibrary.wiley.com/doi/abs/10.1111/liv.13244">Screen shot captured on Dec 12 2018.</a></span>
</figcaption>
</figure>
<hr>
<p>Journals are reluctant to retract articles, and even <a href="https://retractionwatch.com/the-retraction-watch-leaderboard/top-10-most-highly-cited-retracted-papers/">retracted articles continue to be widely cited</a>.</p>
<p>Nevertheless, there is <a href="https://www.statnews.com/2018/11/21/research-misconduct-journals-hiring-research-integrity-czars/">growing interest in trying to uphold the integrity of published research</a>, as well as initiatives to <a href="http://www.alltrials.net/">demand the publication of all clinical trial data</a>. These initiatives offer some hope that breaches such as the ones we discovered will become less common.</p>
<p>As for the authors involved in retracted or ethically non-compliant research, there is little information about the impact on their careers. Being the author on a paper that is retracted may lead to a ban by the journal, trigger an institutional investigation, or have no effect.</p>
<p>Academic misconduct investigations by universities <a href="https://retractionwatch.com/2018/11/06/its-time-to-end-the-code-of-silence-at-universities/#more-76579">are rarely reported in the public domain</a>. Apart from high profile cases like that of He, the nature and extent of the consequences for researchers who breach ethical standards is largely unknown.</p><img src="https://counter.theconversation.com/content/108077/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Wendy Rogers is affiliated with the International Coalition to End Transplant Abuse in China (ETAC) which is an NGO. She is Chair of ETAC's International Advisory Committee. </span></em></p><p class="fine-print"><em><span>Matthew Robertson occasionally consults on a voluntary basis for End Transplant Abuse in China, a Sydney-based non-profit advocacy group concerned with abuses of organ transplantation in the People's Republic of China.</span></em></p>
International standards ban publication of research that involves any biological material from executed prisoners, that lacks human research ethics committee approval and that lacks consent of donors.
Wendy Rogers, Professor in Clinical Ethics, Macquarie University
Matthew P. Robertson, Doctoral student, Australian National University
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/108008
2018-12-03T11:33:25Z
2018-12-03T11:33:25Z
CRISPR babies raise an uncomfortable reality – abiding by scientific standards doesn’t guarantee ethical research
<figure><img src="https://images.theconversation.com/files/248287/original/file-20181202-194922-5bsecs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">What does oversight really ensure?</span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/gKUC4TMhOiY">Ousa Chea/Unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>Uncertainty continues to swirl around scientist He Jiankui’s gene editing experiment in China. Using CRISPR technology, He modified a gene related to immune function in human embryos and transferred the embryos to their mother’s womb, producing twin girls.</p>
<p>Many <a href="https://theconversation.com/rogue-science-strikes-again-the-case-of-the-first-gene-edited-babies-107684">questions about the ethical acceptability</a> of the experiment have focused on ethical oversight and informed consent. These are important issues; compliance with established standards of practice is crucial for public trust in science.</p>
<p>But public debate about the experiment should not make the mistake of equating ethical oversight with ethical acceptability. Research that follows the rules is not necessarily good by definition. As He pushed ahead with human gene editing, how much he skirted the rules may not be his primary ethical failing.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/248320/original/file-20181202-194944-xmxzmd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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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>
<figcaption>
<span class="caption">A man included in a syphilis study has blood drawn by a doctor in Tuskegee, Alabama.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Tuskegee-Syphilis-Study-Legacy/06764fabc735439db3dc0c99fed01732/7/0">National Archives via AP</a></span>
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<p>The ethical acceptability of research is contingent on an <a href="https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm">institutional review board’s judgment</a> that the procedure has the potential for benefit that counterbalances risk of harm. Institutional review boards are typically internal to research institutions but are meant to be independent of investigators. The board also works to ensure the process of informed consent is robust, such that participants are appropriately educated about the relevant risks of participation, are free from coercion to participate and are aware of their ability to decline to participate without penalty.</p>
<p>Funders of research will also conduct scientific peer review of a protocol to ensure the quality of the research design. Poorly designed research is ethically problematic since it wastes financial, human and other resources that could be allocated to better justified research. </p>
<p>Journal editors play an important gatekeeper role, as well. Studies conducted without appropriate ethical oversight may not be reviewed for publication in journals that abide by the <a href="http://www.icmje.org/recommendations/">Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals</a> adopted by the International Committee of Medical Journal Editors.</p>
<p>Concerns at any of these steps along the way can prevent health research from proceeding or from contributing to the scientific and medical literature. </p>
<h2>Passing ethical review doesn’t mean it’s ethical</h2>
<p><a href="https://theconversation.com/tension-as-scientist-at-centre-of-crispr-outrage-speaks-at-genome-editing-summit-107807">When He presented his work</a> at a session of the <a href="http://www.nationalacademies.org/gene-editing/2nd_summit/index.htm">Second International Summit on Genome Editing</a> in Hong Kong, many people raised questions about the informed consent process. Important as they are, the queries also seemed to be groping for a smoking gun – some clear violation of existing standards – in order to declare what people already felt: that the research was unethical.</p>
<p>Having those standards and discovering a violation of them makes judgments of ethical responsibility feel straightforward and objective. A rule was broken, the research was unethical. Case closed. There are certainly questions about the adequacy of the processes He’s research went through. Were collaborators kept in the dark about its nature and aims? Was the experimental protocol and the informed consent process subjected to rigorous review by an independent oversight body? Was the consent process itself robust and not compromised by the interests of the researchers?</p>
<p>But by focusing heavily on these still-open questions, the scientific community risks implying that mere compliance with routines of oversight would have made it ethical. That approach fails to ask what is being overseen, what is being overlooked and whether that matters to how we judge the ethical acceptability of an experiment.</p>
<p>It’s important to ask not only whether there was ethical oversight, but what it consisted in. Just because there has been a process does not mean that it is thorough or sufficient.</p>
<p>This is particularly important in the case of germline editing, because it’s so unlike most conventional therapies. <a href="http://nuffieldbioethics.org/project/genome-editing-human-reproduction">As the U.K. Nuffield Council has pointed out</a>, it is incorrect to call it a therapy. If one were undertaking gene therapy in a baby, or even a fetus, to address a life-threatening genetic disease, it would be appropriate to accept a certain amount of risk, because the alternative is much worse: living with a life-threatening disease.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/248322/original/file-20181202-194928-10b3fua.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<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>
</figcaption>
</figure>
<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 University
Jason Scott Robert, Director of the Lincoln Center for Applied Ethics, Arizona State University
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/90892
2018-01-31T15:42:01Z
2018-01-31T15:42:01Z
Diesel monkey tests: can harmful corporate research ever be justified?
<figure><img src="https://images.theconversation.com/files/204253/original/file-20180131-131744-hrdtsx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/animal-testing-94008682?src=mRaHt26UlMrfSsspmzaWDA-1-78">Shutterstock</a></span></figcaption></figure><p>The <a href="https://www.nytimes.com/2018/01/25/world/europe/volkswagen-diesel-emissions-monkeys.html">recent allegations</a> that researchers funded by the German car industry tested the effects of diesel fumes on humans and monkeys has raised serious questions about research ethics in the corporate world. </p>
<p>These tests were carried out by scientists on behalf of the now-disbanded European Research Group of Environment and Health in the Transport Sector (EUGT), which was funded by Volkswagen, Daimler and BMW. The aim was to observe and record the pollutant effect of emissions from diesel cars using modern exhaust-cleaning technology.</p>
<p>Yet, even if the aim of the research was to show that diesel fumes are less harmful than previously considered, there still exists <a href="http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2017-0049&language=EN#title2">substantial evidence</a> that diesel fumes are harmful to health. No one, not even car manufacturers, is claiming that diesel exhaust fumes are entirely harmless.</p>
<p>Ethically sound research brings huge benefits to society, saves lives and advances knowledge. But research always comes at a cost, ranging from resources and time used through to the direct risk of harm for subjects. So, the central ethical question is always: are these costs justified by the potential benefits of the research? When these costs become skewed too far, particularly where people have been exposed to unjustifiable harm, we end up with research scandal.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/human-experiments-the-good-the-bad-and-the-ugly-39876">Human experiments – the good, the bad, and the ugly</a>
</strong>
</em>
</p>
<hr>
<p>In the case of the diesel fume tests, the most pressing question is whether exposing monkeys and humans to harm can be justified against the benefits of the research. When administering substances known to be dangerous, the potential benefits would have to be significant in order justify such exposure. This can happen, for example, in cases where the research is therapeutic. Exposing volunteers to <a href="https://theconversation.com/testing-drugs-on-animals-could-soon-be-a-thing-of-the-past-58183">newly developed drugs</a> that might end up hurting them can be justified on the basis that they might also benefit, or that society more generally will.</p>
<p>But in purely <a href="http://annals.org/aim/article-abstract/2023019/corporate-research-ethics-whose-responsibility?doi=10.7326%2fM14-1669">corporate research</a>, these therapeutic aims are often absent. Instead, they often are replaced with a central aim of advancing profits. This does not necessarily mean there are not secondary social benefits in some cases. With diesel fume emissions, developing and testing technologies to reduce harmful emissions might be considered to have these secondary benefits in terms of improving public health and the environment. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/204276/original/file-20180131-157488-yk1qe5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/204276/original/file-20180131-157488-yk1qe5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/204276/original/file-20180131-157488-yk1qe5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/204276/original/file-20180131-157488-yk1qe5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/204276/original/file-20180131-157488-yk1qe5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/204276/original/file-20180131-157488-yk1qe5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/204276/original/file-20180131-157488-yk1qe5.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">Humans can volunteer. Animals can’t.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/young-man-testing-breathing-function-by-723861829?src=MJbW5jVcafmD4bWUlTBJ6A-1-4">Shutterstock</a></span>
</figcaption>
</figure>
<p>The amount of risk and the severity of the potential harm are also important factors. Even a significant future benefit might not offset serious harm. And in the case of the diesel tests, there are <a href="http://www.who.int/ipcs/emergencies/diesel.pdf">very real and severe risks</a> associated with exposure to fumes. </p>
<p>Whether the tests exposed subjects to greater levels of fumes than they might otherwise experience (such as walking down the street in daily life) would be important to know in order to assess these levels of potential harm. A greater than normal exposure requires proportionally greater potential benefits. But given what we know about the harm from diesel fumes, it is unlikely that such extra risk could be justified by a modest potential improvement in public health.</p>
<p>Another way of justifying the exposure to risks and harms in research is to appeal to the <a href="https://ec.europa.eu/research/science-society/document_library/pdf_06/textbook-on-ethics-report_en.pdf">consent given by the research subject</a>. If you volunteer and you are properly informed about the risks then why shouldn’t you take part, despite the potential harm? You might see any payment you receive for volunteering as more valuable than being free from the risk. Or you might simply want to altruistically contribute to a greener world.</p>
<p>Yet in cases where potential harm is particularly severe, we might still want to limit people’s freedom to consent. There may be limits that we think we should not cross in society and that to ask someone to expose themselves to significant risks for the sake of research is a step too far. In corporate research, where participants motivated by <a href="http://onlinelibrary.wiley.com/doi/10.1111/1467-8519.00078/pdf">how much reward</a> they are offered rather than potential therapy or social benefit, allowing people to undergo harm may even be seen as <a href="http://onlinelibrary.wiley.com/doi/10.1111/1467-8519.00136/pdf">devaluing them as human beings</a>.</p>
<p>Corporate research is very demanding upon our system of ethical decision-making because of the lack of focus on benefit to individuals or society. When the research involves substances that are known to be severely dangerous, it is extremely difficult to justify exposing people to them, even with all of the ethical arguments about benefiting the greater good and the right to consent. And because animal subjects can’t give consent, the research would have to have even more worthwhile aims to justify exposing them to risk and harm.</p><img src="https://counter.theconversation.com/content/90892/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>
Researchers funded by VW, Daimler and BMW are accused of testing diesel fumes on monkeys and humans.
Anthony Wrigley, Senior Lecturer in Ethics, Keele University
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/56003
2016-03-28T10:07:33Z
2016-03-28T10:07:33Z
If 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 University
Erin Fuse Brown, Assistant Professor of Law, Georgia State University
Laura Beskow, Director of the Program for Empirical Bioethics, Associate Professor of Medicine, Duke University
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/45626
2015-08-25T04:11:33Z
2015-08-25T04:11:33Z
The justice factor must be improved when carrying out health research
<figure><img src="https://images.theconversation.com/files/91058/original/image-20150806-5263-19anb4a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The concept of benefit sharing ensures that all who take part in research have sone form of gain from it. </span> </figcaption></figure><p><em>This article is part of a series The Conversation Africa is running on stem cell research and therapy. Read the rest of the series <a href="https://theconversation.com/au/topics/african-stem-cells">here</a>.</em></p>
<p>Research in the health sector is particularly notorious for its <a href="http://link.springer.com/article/10.1007/s11673-014-9604-6">exploitation</a> of the developing world. Despite the increased developments in the scientific arena, the concept of benefit sharing still remains relatively unexplored. </p>
<p><a href="http://www.wits.ac.za/academic/researchsupport/1911%20/ethics_application_%20forms_guidance_%20notes_and_policy_documents.html">Benefit sharing</a> ensures that everyone who participates in research gains from it. This does not imply a monetary transaction only. It can be any form of advantage, assistance or upliftment to the participant, community or institution.</p>
<p>The philosophical principle behind it is a matter of justice. Those who contribute to scientific research ought to share in its <a href="http://link.springer.com/chapter/10.1007/978-94-007-6205-3_2">benefits</a>. But it is not always clear how and with whom benefits should be shared, especially when research is funded by outside sources. The concept is sometimes questioned or resisted when developed countries perform and fund research activities in the developing world. </p>
<h2>Bad - and good - examples</h2>
<p>Traditionally, developed - or affluent - countries have argued that participating in scientific research should be altruistic in nature. But there are serious concerns about exploitation if this notion is exported into <a href="http://link.springer.com/chapter/10.1007/978-94-007-6205-3_5">developing countries</a>. </p>
<p>In one instance of exploitation, in the 1990s, a <a href="https://books.google.co.za/books?hl=en&lr=&id=Ge72AwAAQBAJ&oi=fnd&pg=PA3&dq=Kruger+M+et+al.+Research+Ethics+in+Africa,+a+Resource+for+Research+Ethics+Committees,+African+SUN+MeDIA+2014+Chapter+2:+Ndebele+P+et+al.+History+of+Research+Ethics+Review+in+Africa+&ots=tYJXrypnEp&sig=Rfu7EgHacWFr5WBBrWcX1mM6mZc#v=onepage&q&f=false">British anaesthetist</a> was arrested and charged with murder for carrying out dangerous human experiments on 500 patients in Zimbabwe without their knowledge or approval from any relevant authorities. Up to six patients allegedly died because of his experiments. </p>
<p>In another case of participant exploitation, in 2001, pharmaceutical giant <a href="https://books.google.co.za/books?hl=en&lr=&id=Ge72AwAAQBAJ&oi=fnd&pg=PA3&dq=Kruger+M+et+al.+Research+Ethics+in+Africa,+a+Resource+for+Research+Ethics+Committees,+African+SUN+MeDIA+2014+Chapter+2:+Ndebele+P+et+al.+History+of+Research+Ethics+Review+in+Africa+&ots=tYJXrypnEp&sig=Rfu7EgHacWFr5WBBrWcX1mM6mZc#v=onepage&q&f=false">Pfizer</a> was sued by 30 Nigerian families as a result of trials of the antibiotic Trovan, intended to treat meningitis. </p>
<p>About 200 children were given the drug without informed consent or approval by a local ethics committee. Eleven children died while some survivors suffered permanent brain damage and paralysis. In this case an out of court settlement was reached.</p>
<p>There are at least two benefit sharing agreements and arrangements which were successfully implemented in Africa to the advantage of the communities involved. The first is the case of participants in <a href="http://www.africanslumjournal.com/tag/majengo/">Majengo</a>, a slum in Mombasa, Kenya. The second is the case of the San in South Africa.</p>
<p>In Majengo, follow up studies were conducted on 850 female sex workers in Kenya for research which could contribute to the development of a vaccine against <a href="https://www.uclan.ac.uk/research/explore/projects/assets/cpe_genbenefit_nairobi_case.pdf">HIV</a>. </p>
<p>Here the main benefit for the women was access to non-discriminatory health care. The research team set up a clinic for them to freely access. Until then they were forced to use a local treatment centre where services were poor and they were discriminated against. They also received indirect benefits in the form of a “safe haven” by accessing the clinic. This enabled the women to form new relationships, social networks and a sense of solidarity, creating a community environment. </p>
<p>Research publications also gave the women international exposure. This could safeguard their rights to benefits that may accrue from ongoing research activities. </p>
<p>In specific response to the Majengo case, national guidelines for research and development of HIV/AIDS vaccines were <a href="https://www.globalgiving.org/pfil/1108/projdoc.pdf">developed</a>. These guidelines provided a framework to address issues of financial compensation for research participants.</p>
<p>In the case of the <a href="http://www.san.org.za/history.php">San people</a>, they were acknowledged for their traditional knowledge about the use of <a href="http://www.drugs.com/hoodia.html">hoodia gordonii</a>. This is a moist plant found in the Kalahari desert, which the San people customarily used to limit hunger on their tiring journeys.</p>
<p>At first the San people were unaware that an appetite suppressant was being patented and commercialised using the hoodia plant without their consent. But in 2003, with the help of a non-governmental organisation, one of the first benefit sharing <a href="http://www.ipngos.org/NGO%20Briefings/Hoodia%20case%20of%20benefit%20sharing.pdf">agreements</a> was negotiated. As part of the agreement the San people were provided with a share of the royalties derived from the sale of products containing hoodia. </p>
<p>The agreement is an example of how one of the first benefit sharing agreements was negotiated in South Africa in the absence of an enabling domestic legal environment. Although far from perfect and criticised to some extent, this agreement is an example for future ones where communities are allowed to receive recognition and share in the commercialisation of products based on their traditional knowledge.</p>
<h2>Benefit sharing laws and guidelines</h2>
<p>There are many international protocols on benefit sharing. These include the <a href="https://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf">Nagoya protocol</a> declaration on the human genome and <a href="http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genome-and-human-rights">human rights</a>, the Council for International Organisations and Medical Sciences’ international ethical guidelines for biomedical research involving <a href="http://www.cioms.ch/publications/layout_guide2002.pdf">human subjects</a> and the Declaration of <a href="http://www.wma.net/en/30publications/10policies/b3">Helsinki</a>. </p>
<p>In South Africa, the only legal document that defines and describes benefit sharing and benefit sharing agreements is the <a href="http://ship.mrc.ac.za/biodiversity.pdf">Biodiversity Act</a>. It stipulates that the agreement must be approved by the Minister. It also sets out how the agreement should explain the extent to which resources should be used and the benefits shared and provides for regular review of the agreement. </p>
<p>But the Act excludes the use of human material and the benefits that should be derived from it.
In addition, the South African National Department of Health’s ethics in health research <a href="http://www.mrc.ac.za/ethics/DOHEthics.pdf">guidelines</a> also mentions benefit sharing. Although the guidelines refer to human material, they are not legally binding. </p>
<p>Most African countries are signatories to the international ethical guidelines that place a huge emphasis on benefit sharing.</p>
<h2>Bridging the gap</h2>
<p>To assist researchers with benefit sharing, in 2014 the University of the Witwatersrand approved a comprehensive Material Transfer Agreement template for human biological materials to be used by its researchers.</p>
<p>In this agreement benefits include (but are not limited to): </p>
<ul>
<li>the sharing of information, </li>
<li>use of research results, </li>
<li>royalties, </li>
<li>acknowledging the provider as the source of the materials, </li>
<li>publication rights, </li>
<li>transfer of technology or materials, and </li>
<li>capacity building. </li>
</ul>
<p>Other institutions and the Department of Science and Technology in South Africa have shown interest in the template and its use is open access.</p>
<p>Providing adequate benefit sharing mechanisms will enhance confidence and trust in the research process, which will in turn attempt to restore a balance and ensure a sustainable research environment for research participants, researchers and institutions. </p>
<p><em>This article is based on a paper published in a special South African Medical Research Council Flagship edition of the <a href="http://hmpg.co.za/index.php/sajbl/issue/view/497/showToc">South African Journal of Bioethics and Law</a>.</em></p><img src="https://counter.theconversation.com/content/45626/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ian Sanne received funding from the National Institute of Health in the United States and is the CEO of Right to Care, a non profit organisation that supports and delivers prevention, care, and treatment services for HIV and associated diseases. </span></em></p><p class="fine-print"><em><span>Safia Mahomed 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>
Research should not only benefit the researchers. People who participate in research should also be compensated for the contributions.
Safia Mahomed, Bcom, LLB, LLM, PhD candidate, Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand
Ian Sanne, Associate Professor and Director of the Clinical HIV Research Unit at the Department of Medicine in the Faculty of Health Science , University of the Witwatersrand
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/39878
2015-06-11T11:23:07Z
2015-06-11T11:23:07Z
Why 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 Sydney
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/39929
2015-06-10T05:19:09Z
2015-06-10T05:19:09Z
Two steps forward, one step back: how World War II changed how we do human research
<figure><img src="https://images.theconversation.com/files/83828/original/image-20150603-2946-6di6df.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The Nazis subjected Jews, political prisoners and other 'undesirables' to a range of experiments that resulted in death and disability.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/tsaiproject/6927486111/in/photolist-byabgH-p7AWHV-4YQnTQ-4aj26j-4aeZ8T-YWKXc-PUSB8-aDKL8C-rFtqaX-rHKJP7-4af5cz-a4mmLe-4AdZYW-4S5qBN-4aj4Qo-gyjo1-61bfoC-nx9Nj2-nxa4ff-nPmmP6-bQn1BP-8nNcn7-7XhQZZ-nxaria-nxaqSF-nxa3T3-nPmnJ2-nMASBm-nPuj1q-nx9PDB-nx9NWK-nxa47Q-nx9PxK-nxapza-9PAcrB-4af5UZ-5zDsgG-nPmkJk-nxap6p-nx9Kvf-dsuUVc-nPDsCF-ouwfgS-oLKgF4-nRqYQX-oLZ84s-oM2acp-ouwXVF-ouwUsP-oJZg6L">tsaiproject/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>It’s easy, in retrospect, to portray World War II as a major turning point in the history of medical ethics. But it’s a portrayal we should resist because it blinds us to the troubles that persist to this day in matters of informed consent.</p>
<p>When Germany surrendered in May 1945, the victors’ worst fears were confirmed: the Nazis had committed innumerable and horrific war crimes, including the attempt to annihilate the Jewish people. So severe were the depredations of Hitler and his henchmen and women that new words were invented to describe their actions: <a href="http://www.ushmm.org/wlc/en/article.php?ModuleId=10007043">genocide</a> (the obliteration of an entire people) and <a href="http://www.britannica.com/EBchecked/topic/589963/thanatology">thanatology</a> (the science of producing death).</p>
<p>As the extermination camps in Nazi-occupied Poland and the concentration camps in Germany were liberated, the scale of human destruction wrought by Nazi ideology both confounded and shocked. But, in their efforts to reap the benefits of Nazi scientific research, intelligence officers rapidly discovered the devastation of human medical experimentation. </p>
<h2>Nuremberg trials</h2>
<p>Jews, political prisoners and other “undesirables” were subjected to a range of experiments that resulted in death and disability. The Luftwaffe, for instance, wished to know how to protect and revive pilots shot down in the sea who suffered from hypothermia. The Nazi solution was to immerse experimental subjects in freezing water to the point of death and beyond.</p>
<p>Following the assassination of high-ranking Nazi <a href="http://www.historylearningsite.co.uk/reinhard_heydrich.htm">Reinhard Heydrich</a>, a cry went out to experiment more boldly with <a href="http://www.drugs.com/drug-class/sulfonamides.html">sulphanomides</a> (drugs that curb the growth of bacteria) since Heydrich had died of wound infection. The solution: scarify the legs of experimental subjects, infect the wounds and see what happens with or without drugs.</p>
<p>These examples are the tip of the iceberg. Experiments with transplants, bacteria, gases and other chemical agents were carried out on thousands of hapless prisoners. Worst of all was <a href="http://www.ushmm.org/wlc/en/article.php?ModuleId=10005200">the T4 programme</a>, which paved the way for the destruction of all “life unworthy of life” between 1939 and 1941. Thousands of disabled and mentally ill people were “euthanased” using a variety of techniques including mass gassing, a method that was later transferred to the extermination camps.</p>
<p>As part of trying to find out how Germany, one of the most scientifically sophisticated and humanistic cultures had become so perverted, a military tribunal was established as a corollary to the 13 <a href="http://www.history.com/topics/world-war-ii/nuremberg-trials">Nuremberg trials</a>. And between December 1946 and August 1947, <a href="http://law2.umkc.edu/faculty/projects/ftrials/nuremberg/NurembergDoctorTrial.html">23 medical doctors were tried</a> for war crimes and crimes against humanity.</p>
<p>The defence mounted by the doctors was founded on three points: first was the classic Nuremberg defence of only obeying orders in a time of national emergency. The second was that war was a time of national emergency where sacrifices had to be made for the greater good of the population, particularly troops. </p>
<p>But the most interesting was the final defence, which claimed what the Nazi doctors had done was little different from experiments carried out by the allies on their own prison populations, inmates of mental asylums, conscientious objectors and troops.</p>
<p>This final point was undeniable: in both the United States and Britain, experiments had been carried out on vulnerable groups. In 1941, for instance, patients at a Michigan state mental hospital were <a href="http://history.amedd.army.mil/booksdocs/historiesofcomsn/section2.html">deliberately infected with the influenza virus</a>. And in the early 1940s, predominantly African-American prisoners at the Statesville Penitentiary were <a href="http://www.nbcnews.com/id/41811750/ns/health-health__care/t/ugly-past-us-human-experiments-uncovered/%20were%20deliberately%20infected%20with%20malaria">deliberately infected with malaria</a>.</p>
<p>These are only two of the many experiments carried out on vulnerable populations; people who could not be said to have the freedom to consent.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/84230/original/image-20150608-8674-95khjf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/84230/original/image-20150608-8674-95khjf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/84230/original/image-20150608-8674-95khjf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=766&fit=crop&dpr=1 600w, https://images.theconversation.com/files/84230/original/image-20150608-8674-95khjf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=766&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/84230/original/image-20150608-8674-95khjf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=766&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/84230/original/image-20150608-8674-95khjf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=962&fit=crop&dpr=1 754w, https://images.theconversation.com/files/84230/original/image-20150608-8674-95khjf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=962&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/84230/original/image-20150608-8674-95khjf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=962&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Adolf Hitler’s personal physician Karl Brandt, later sentenced to death for participation and consent to medical experiments on concentration camp inmates.</span>
<span class="attribution"><a class="source" href="http://commons.wikimedia.org/wiki/File:Karl_Brandt_SS-Arzt.jpg">USHMM, courtesy of Hedwig Wachenheimer Epstein</a></span>
</figcaption>
</figure>
<p>It was apparent a general code of ethics developing standards for informed consent in human research needed to come out of the trial so the judges formulated the Nuremberg Code as part of their judgement. They used the work of <a href="http://www.the-aps.org/fm/presidents/introaci.html">Andrew Ivy</a>, the American Medical Association representative, and psychiatrist and neurologist <a href="http://www.nytimes.com/1985/07/24/us/dr-leo-alexander-79-nuremberg-trial-aide.html">Leo Alexander</a> who was appointed to the prosecution team, both of whom had supplied the trial with their own ethical codes.</p>
<p>The code is generally regarded as the foundation of the <a href="http://www.wma.net/en/30publications/10policies/b3/17c.pdf">World Medical Association’s Helsinki Declaration</a> (1964), which has become the bedrock of ethical standards for human experimentation and informed consent. But the story doesn’t have as happy an ending as all this would suggest. </p>
<h2>Things stay the same</h2>
<p>Despite the impact of the Nazi doctors’ trial and the promulgation of the new code of ethics, neither the United States nor its European allies, adhered to the code until a series of scandals suggested the need for a closer look at how medicine was conducting itself.</p>
<p>The existence of the code was not enough to halt the <a href="http://www.sciencemuseum.org.uk/broughttolife/techniques/tuskegee.aspx">Tuskegee syphilis study</a> in which 400 African-American men with syphilis were simply observed though treatment was available. Or to prevent the <a href="http://www.hhs.gov/1946inoculationstudy/factsheet.html">Guatemala syphilis experiments</a>, which involved about 1,500 children, prisoners, soldiers, sex workers and psychiatric patients. </p>
<p>Neither did it impact the deliberate exposure of military personnel and civilians <a href="http://www.carnegiecouncil.org/publications/ethics_online/0032.html">to radioactive fallout from atomic testing</a>. Or the testing of nerve agents and other chemicals on conscripts at <a href="http://www.bbc.co.uk/insideout/west/series1/porton-down.shtml">Porton Down in the United Kingdom</a>. Clearly, the dictats of the Cold War overrode the post-Nuremberg ethical regime.</p>
<p>And when the Helsinki Declaration was finally released, key principals of the Nuremberg Code and its tight legal language had been watered down, giving more leeway to those conducting human experiments. Still, we are considerably better off today because of it, and should not forget the price that was paid for the institution of an effective ethics regime.</p>
<p>Perhaps there was a pragmatism in the actions of the United States that undermined their insistence on the prosecution of Nazi medical war crimes. In the Asian theatre of the war, the scale of human medical experimentation carried out by <a href="http://www.japanfocus.org/-Tsuneishi-Keiichi/2194/article.html">Japan’s Unit 731</a> was also staggering and brutal. </p>
<p>Hundreds of thousands of lives are thought to have been lost to experiments that tested germ and chemical weapons. But not a single Japanese medical practitioner was held accountable for his actions.</p>
<p>Had the defendants at the Nuremberg doctors’ trial known this, the force of <a href="http://chinesejil.oxfordjournals.org/content/3/1/87.full.pdf">their third, tu quoque (appeal to hypocrisy) defence</a> would have been immeasurably strengthened. As it was, the disparity between Japan and Germany might explain why, at most, only lip service was paid to the Nuremberg Code. It might also explain how it was that the code became diluted in the Helsinki Declaration. </p>
<p>The judges and the prosecutors at Nuremberg were fully aware of the high stakes. But the implementation of their ethical vision required a political will that was sadly lacking.</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>
<p><em>An error was introduced into the article during the editorial process that confused the Guatemalan syphilis experiment, in which subjects were deliberately infected with syphilis, with the Tuskegee syphilis experiment in which the natural progression of untreated syphilis was studied in a group in the US. This has been corrected.</em></p><img src="https://counter.theconversation.com/content/39929/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>James Bradley 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 horror of the human experiments by Nazi doctors led to the Nuremberg Code but the international declaration it inspired was watered down for political purposes.
James Bradley, Lecturer in History of Medicine/Life Science, The University of Melbourne
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/39876
2015-06-08T05:27:33Z
2015-06-08T05:27:33Z
Human 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>
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<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>
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</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>
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<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>
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<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>
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</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>
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</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 University
Licensed as Creative Commons – attribution, no derivatives.
tag:theconversation.com,2011:article/40528
2015-06-08T05:27:17Z
2015-06-08T05:27:17Z
How 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>
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<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>
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<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 Pennsylvania
Licensed as Creative Commons – attribution, no derivatives.