tag:theconversation.com,2011:/ca/topics/precision-medicine-iniative-28871/articlesPrecision Medicine Iniative – The Conversation2017-01-26T00:49:00Ztag:theconversation.com,2011:article/715232017-01-26T00:49:00Z2017-01-26T00:49:00ZThe privacy debate over research with your blood and tissue<p>Many people don’t realize that their leftover tissue, blood or other samples – otherwise known as “biospecimens” – taken during a visit to the doctor or hospital might be stripped of identifying information and used in research <a href="https://www.nytimes.com/2015/12/30/opinion/your-cells-their-research-your-permission.html">without their consent</a>.</p>
<p>This <a href="https://dx.doi.org/10.1111/jlme.12211">makes some people uncomfortable</a>. </p>
<p>So when the federal government decided to <a href="https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf">revise</a> its “Common Rule” regulations governing federally funded research involving humans for the first time in decades, the <a href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/nprm-2015-summary/index.html">draft revision</a> included a proposal to require consent for all research with biospecimens, whether they have <a href="https://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf">identifying information accompanying them or not</a>. The original regulations <a href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.102">required a person’s consent</a> for research with biospecimens only if they had information with them that made them identifiable. </p>
<p>But when the <a href="https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects">updated Common Rule</a> was released on Jan. 18, there was no change to this part of the regulation.</p>
<p>Human research regulations need to keep up with major advances in technology. They also need to balance enabling scientific progress with attempting to ensure safety and privacy for human participants in research. </p>
<p>So why wasn’t the proposal requiring consent for all biospecimen research adopted, and how do the new regulations recognize people’s concern in what happens to pieces of themselves in the future? </p>
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<img alt="" src="https://images.theconversation.com/files/154328/original/image-20170125-23858-vxiv4j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/154328/original/image-20170125-23858-vxiv4j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/154328/original/image-20170125-23858-vxiv4j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/154328/original/image-20170125-23858-vxiv4j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/154328/original/image-20170125-23858-vxiv4j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/154328/original/image-20170125-23858-vxiv4j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/154328/original/image-20170125-23858-vxiv4j.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">Research with nonidentified biospecimens doesn’t require consent.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/245509936?size=huge_jpg">Blood vials via www.shutterstock.com</a></span>
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<h2>Why we need human biospecimens for research</h2>
<p>Exciting new research projects, like the <a href="https://www.nih.gov/research-training/allofus-research-program">Precision Medicine Initiative</a> (PMI), aim to personalize medical interventions and therapies for things like cancer care. </p>
<p>But knowing how to personalize treatment requires <a href="https://theconversation.com/why-you-should-worry-about-the-privatization-of-genetic-data-62591">comparing data</a> from thousands of biospecimens to discover the relationship between genetic variation, health behaviors and medical outcomes. The PMI itself is trying to build a <a href="https://www.nih.gov/research-training/allofus-research-program">million-person biospecimen collection</a> to support its research. The goal is not to just order the treatment that is best for most people – but best for you.</p>
<p>The steps required to collect those specimens are critical.</p>
<p>The <a href="https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf">Common Rule</a> requires publicly funded researchers get informed consent for two kinds of work. The first is research that involves intervention or interaction with a person, like a blood draw. The second is research done with identifiable private information or identifiable biospecimens. </p>
<p>But if biospecimens don’t have any identifying data with them, like a name, <a href="http://www.npr.org/sections/health-shots/2017/01/18/510442240/scientists-neednt-get-a-patients-consent-to-study-blood-or-dna">consent is not required</a>. Hospitals and clinics are major sources of these nonidentified biospecimens. People “donate” these samples when they, for example, <a href="http://www.forbes.com/sites/michellemeyer/2015/12/31/no-donating-your-leftover-tissue-to-research-is-not-like-letting-someone-rifle-through-your-phone/#6ee14c3319df">have a biopsy at a hospital</a>. These nonidentified biospecimens or information derived from them may then be made available to researchers, at the hospital and elsewhere.</p>
<p>Technological advances have made it possible to generate and <a href="http://www.nature.com/news/stop-the-privatization-of-health-data-1.20268">share massive amounts of data</a>. Large research collaborations can accomplish impressive scientific advancements, like the recent research into the <a href="https://www.technologyreview.com/s/602052/23andme-pulls-off-massive-crowdsourced-depression-study/">genetic causes of depression</a>. But data access can also create problems. For example, there have been cases where “nonidentifiable” information is <a href="http://science.sciencemag.org/content/339/6117/321">reidentified</a> later. </p>
<p>As a matter of <a href="http://www.npr.org/sections/health-shots/2017/01/18/510442240/scientists-neednt-get-a-patients-consent-to-study-blood-or-dna">self-determination</a>, people are concerned about having control over their person. Generally, they want a say in <a href="https://theconversation.com/americans-want-a-say-in-what-happens-to-their-donated-blood-and-tissue-in-biobanks-60681">what happens to their biospecimens</a> – including what research is done with them.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/154092/original/image-20170124-16070-1nitlgx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/154092/original/image-20170124-16070-1nitlgx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/154092/original/image-20170124-16070-1nitlgx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=1545&fit=crop&dpr=1 600w, https://images.theconversation.com/files/154092/original/image-20170124-16070-1nitlgx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=1545&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/154092/original/image-20170124-16070-1nitlgx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=1545&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/154092/original/image-20170124-16070-1nitlgx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1942&fit=crop&dpr=1 754w, https://images.theconversation.com/files/154092/original/image-20170124-16070-1nitlgx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1942&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/154092/original/image-20170124-16070-1nitlgx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1942&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">Henrietta Lacks around 1945.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/oregonstateuniversity/4446362464/in/photolist-7LULDN-niGgFN-9uNbR4-7LULDq-niGexw-nAbMd8-ny986J-niGeJF-niGfx7-nzTQQt-nzTQyB-niG6AD-niGgHG-nAbMA2-ny98Eu-nAc4c1-nAc5jb-ny98r3-9AvTUX-niGf5y-niGh4y-niG7tv-nBXPhR-nzWXcw-nzWWFS-nAc4hG-nzTRw8-niGf8Q-9kcRan-niG6DV-nAc42b-9kcR72-nBXPWB-niGgSj-nAbNoe-ny9887-niGeRY-9AvPMv-9AvMRk-9AyCEy-7HE3v7-32BDe6-e4fjDB-dCA4Q8-nAc6Co-niGdiV-niGgYb-niG7uT-nBXPSt-niGemu">Oregon State University</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
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<p>These issues were raised in the 2010 book “<a href="http://rebeccaskloot.com/the-immortal-life/">The Immortal Life of Henrietta Lacks</a>.” Henrietta Lacks was treated for cervical cancer at Johns Hopkins Hospital in the 1950s. Cells taken from a cervical biopsy before she died were used to create one of the most important cell lines in research. These cells, called the HeLa line, <a href="http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html">are still in use</a>, and have lead to many scientific discoveries. But Henrietta Lacks never consented to, nor even knew, her cells were being used for research.</p>
<p>Research indicates that the <a href="https://theconversation.com/americans-want-a-say-in-what-happens-to-their-donated-blood-and-tissue-in-biobanks-60681">majority of Americans are willing to donate</a> their blood and tissue to advance research. But their willingness to do so <a href="http://lsspjournal.springeropen.com/articles/10.1186/s40504-016-0036-4">hinges on trust</a>. A lack of trust in scientists and scientific research is the <a href="https://theconversation.com/americans-want-a-say-in-what-happens-to-their-donated-blood-and-tissue-in-biobanks-60681">strongest predictor</a> of whether a person will be unwilling to donate to a biobank. People also want to know the specific kind of research being done. </p>
<p>As President Obama <a href="https://www.whitehouse.gov/the-press-office/2016/02/25/remarks-president-precision-medicine-panel-discussion">put it</a>, “I would like to think that if somebody does a test on me or my genes…that’s mine.”</p>
<h2>Concerns about consent for all biospecimen research</h2>
<p>More than 2,100 commenters <a href="http://www.cogr.edu/COGR/files/ccLibraryFiles/Filename/000000000346/Analysis%20of%20Common%20Rule%20Comments.pdf">voiced their opinions</a> on the proposed regulations during the recent comment period. Most discussed whether informed consent should be required for research with “nonidentified” biospecimens. And <a href="https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects">80 percent opposed</a> that proposal.</p>
<p>This change <a href="https://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf">had been considered</a> because regulators believed that the majority of participants preferred to be asked whether their biospecimen could be involved in research. But the preamble of <a href="https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf">the new rule</a> argued that the comments on the proposal raised questions about whether that is in fact the case.</p>
<p>Apparently more commenters <a href="https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects">were worried</a> that the proposal would mean <a href="http://www.nejm.org/doi/full/10.1056/NEJMp1700736">fewer biospecimens would be available</a> for research because some institutions wouldn’t (or couldn’t) implement the <a href="http://www.wsj.com/articles/how-not-to-end-cancer-in-our-lifetimes-1459811684">expensive administrative process required</a> for getting consent. That would mean fewer people are asked for consent in the first place, and fewer biospecimens would be available for research – slowing potential advances.</p>
<p>In addition, some commenters were concerned that the revision could have implications for the <a href="https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects">diversity of samples available</a> for research. Community clinics and hospitals may have <a href="http://www.slideshare.net/petrieflom/mark-barnes-biospecimens-and-the-nprm">faced greater affordability challenges</a> than larger medical centers. Large medical centers are likely to collect samples from their – <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5089703/">often homogeneous</a> – geographic community.</p>
<p>Diversity is already an issue in genetic research. For instance, recent research on genetic studies found that people of African and Latin American ancestry, Hispanic people and indigenous peoples <a href="http://www.nature.com/news/genomics-is-failing-on-diversity-1.20759">represent only 5 percent</a> of participants involved in studies searching for associations between genes and disease.</p>
<p>If samples are collected only from medical centers that can afford to implement the extra consent requirement, that could potentially weaken efforts to gain samples from more diverse groups of people. In turn, that could dampen <a href="http://www.nejm.org/doi/full/10.1056/NEJMp1511294">potential transformational effects</a> of precision medicine research across race and ethnicity. </p>
<p>It’s worth noting, however, these comments don’t necessarily reflect how a majority of Americans feel about requiring consent for research with nonidentified biospecimens, just the majority of people commenting on the proposed rule.</p>
<h2>Other regulations may address some concerns</h2>
<p>While the proposal requiring consent for research with deidentified biospecimens was not adopted in the final rule, many other updates, including several regarding informed consent, were.</p>
<p>For example, the Common Rule <a href="https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf">updates the consent requirement</a> for “secondary research” with identifiable data and biospecimens taken from a biobank, and not directly from a participant. These changes allow for broad consent, which would give the participant a general description of the types of research that may be conducted and information generated at the time of donation.</p>
<p>Another change is that the agencies that implement the Common Rule are now required to consider what an “identifiable biospecimen” means <a href="https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf">at least every four years</a>. They also have to publish a list of what new technologies could generate “<a href="https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf">identifiable private information</a>” from otherwise nonidentified biospecimens. This could mean that researchers might not be able to use technologies that could generate such information without consent from the subject. That could, perhaps, <a href="https://twitter.com/MichelleNMeyer/status/821819537318408192">achieve some of the goals of the original proposal</a>.</p>
<p>Also, the new rule adds to existing research informed consent disclosure requirements. One addition is that prospective subjects must be told that their <a href="https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf">deidentified biospecimens might be used for future research</a> that they don’t specifically consent to, if that’s a possibility. </p>
<p>Many are still fully processing the <a href="https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf">543-page</a> updated Common Rule. But initial indications are that it is a thoughtful document – particularly considering potential changes in government rule-making going forward.</p>
<h2>Where are we now?</h2>
<p>It’s unclear what the Trump administration will do with these regulations now that they’ve been published.</p>
<p>The House has passed legislation that would allow Congress to <a href="http://blogs.harvard.edu/billofhealth/2017/01/18/final-common-rule-revisions-just-published/">disapprove or eliminate new regulations</a>. The House Freedom Caucus (cofounded by Representative Mick Mulvaney, <a href="https://www.nytimes.com/2016/12/16/us/politics/mick-mulvaney-office-management-budget-trump.html">President Trump’s pick for budget director</a>) had placed these research policy revisions specifically <a href="https://morningconsult.com/wp-content/uploads/2016/12/Meadows_Rules_and_Regulations.pdf">on the chopping block</a> for Trump’s first 100 days, although that was in response to the <a href="https://morningconsult.com/wp-content/uploads/2016/12/Meadows_Rules_and_Regulations.pdf">proposed revisions</a>.</p>
<p>But while regulations may be dismantled quickly, big-picture policy concerns – like public trust in science – remain to be grappled with. </p>
<p>Science remains critical to our national interests, and biospecimens will remain critical to science. </p>
<p>Whether the new administration allows these revisions to stand or pulls them, clearly there is still work to be done.</p><img src="https://counter.theconversation.com/content/71523/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kayte Spector-Bagdady works for the University of Michigan, where representatives of the research program publicly commented on the proposed revisions to the Common Rule. She was also Associate Director for President Obama's Presidential Commission for the Study of Bioethical Issues from 2010-2015 where she worked on issues related to human subjects research (but not revisions to the Common Rule).</span></em></p>New regulations for research with human blood and tissue try to balance scientific progress with patient privacy.Kayte Spector-Bagdady, Research Investigator, Obstetrics and Gynecology, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/671132016-12-19T02:22:31Z2016-12-19T02:22:31ZObama administration’s big science and tech innovation: Socially engaged policy<figure><img src="https://images.theconversation.com/files/150616/original/image-20161218-26137-6n65ta.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Obama annually welcomed students to the White House with their Science Fair projects.</span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Obama-Science/cdaa4cbaea9e4d03b9c54f898d9da404/2/0">AP Photo/Susan Walsh</a></span></figcaption></figure><p>When President Barack Obama gave his <a href="https://www.whitehouse.gov/blog/2009/01/21/president-barack-obamas-inaugural-address">inaugural address</a> in 2009, he promised to “restore science to its rightful place and wield technology’s wonders to raise health care’s quality and lower its cost.” For the previous eight years, scientists had protested that the Bush administration <a href="http://www.washingtonpost.com/wp-dyn/content/article/2005/08/31/AR2005083101271.html">ignored</a> their expertise and <a href="http://www.livescience.com/9574-scientists-bush-stifles-science-lets-global-leadership-slip.html">restricted</a> research freedoms. So they were heartened when the new president <a href="https://www.whitehouse.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells">removed barriers</a> to federal funding for human embryonic stem cell research and <a href="https://www.whitehouse.gov/the-record/climate">took serious steps</a> to mitigate climate change. </p>
<p>But President Obama should be remembered – and praised – for much more than his renewed support for science. As a scholar of science and technology policy, it is clear to me that this president and his advisers recognized that policy could be carefully crafted to maximize the social and economic benefits of research and innovation. </p>
<p>They designed intellectual property policies, for example, that enhance scientific collaboration and in turn accelerate research progress, and also improve the availability of important technologies. And by including average citizens in developing research projects and priorities, they increased the usefulness and public legitimacy of science and technology. </p>
<h2>Modernizing patents’ power</h2>
<p>For decades, the United States government had <a href="http://www.press.uchicago.edu/ucp/books/book/chicago/P/bo25338584.html">largely accepted</a> the idea that patents were a necessary incentive for innovation. With the promise of a temporary monopoly if they were successful, inventors would work hard to develop new, transformative technologies. The potential benefits were significant: access to technologies that could transform societies for the better. Ultimately new industries, new jobs and economic growth would result.</p>
<p>Over time, though, it became clear that patents can <a href="http://science.sciencemag.org/content/280/5364/698">stifle research</a> and make important new technologies <a href="https://mitpress.mit.edu/books/building-genetic-medicine">prohibitively expensive</a>. The Patent and Trademark Office (PTO) and its traditional stakeholders, such as patent lawyers, <a href="https://www.uspto.gov/web/offices/com/sol/comments/utilguide/index.html">dismissed</a> such problems as minor and temporary, suggesting that only those who misunderstood how the system worked were concerned.</p>
<p>But in 2010, the Obama administration took the unprecedented step of breaking with its own PTO to side with physicians and scientists, as well as civil liberties and patient advocacy groups, who raised these issues in the context of patents covering human genes. A case brought in federal courts focused on whether genes were products of nature, but the plaintiffs <a href="https://www.aclu.org/legal-document/brca-complaint">were clearly motivated</a> by concerns that patents on human genes were stifling important research and limiting access to potentially lifesaving genetic testing.</p>
<p>The Obama administration argued alongside these plaintiffs publicly when the Supreme Court heard the case in 2013. And in a unanimous decision, the Supreme Court agreed with the plaintiffs and the administration. Today, isolated human genes are not patentable. </p>
<p>As a result, there is greater competition in the genetic testing market; more tests are <a href="http://www.nytimes.com/2015/04/21/business/more-accurate-affordable-tests-for-detecting-breast-cancer-genes.html?_r=0">available</a> for common diseases including breast cancer, and at lower costs.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=411&fit=crop&dpr=1 600w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=411&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=411&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=517&fit=crop&dpr=1 754w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=517&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/150617/original/image-20161218-28140-gfw353.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=517&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Announcing the Precision Medicine Initiative, Obama shares the podium with a model of DNA.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Obama-Budget-Precision-Medicine/d3d0e8db587843fb82f29d2fcab56563/11/0">AP Photo/Carolyn Kaster</a></span>
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<h2>Removing IP roadblocks</h2>
<p>The Obama administration’s concern that intellectual property could be hurting biomedicine and ultimately patients is also clear in the research programs it established.</p>
<p>Both the <a href="https://www.whitehouse.gov/share/brain-initiative">Brain Initiative</a>, designed to develop a more dynamic understanding of brain function, and the <a href="https://www.whitehouse.gov/precision-medicine">Precision Medicine Initiative</a>, focused on designing individually tailored treatment and prevention strategies, <a href="https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative">emphasize</a> data sharing and collaboration. While previous efforts viewed competition among individuals and proprietary interests as central to the development of biomedicine, the Obama administration has come to see these as potential obstacles. </p>
<p>This <a href="https://medium.com/cancer-moonshot/report-of-the-cancer-moonshot-task-force-executive-summary-e711f1845ec#.xc01cmmi8">skepticism</a> is perhaps clearest in the 2016 <a href="https://www.whitehouse.gov/CancerMoonshot">Cancer Moonshot</a> initiative. </p>
<p>Decades of significant government expenditures for cancer research – from President Nixon’s <a href="https://dtp.cancer.gov/timeline/flash/milestones/M4_Nixon.htm">War on Cancer</a> to an <a href="http://www.healthline.com/health/breast-cancer/state-of-awareness-and-research#3">over 2,000 percent increase</a> in yearly breast cancer research funding since the 1980s – have improved scientists’ understanding of the disease and reduced <a href="http://onlinelibrary.wiley.com/doi/10.3322/caac.21254/full">cancer deaths</a>. But cancer incidence <a href="http://onlinelibrary.wiley.com/doi/10.3322/caac.21254/full">remains high</a>, and there are still significant disparities in <a href="http://link.springer.com/article/10.1007/s10903-014-9991-0">diagnosis</a> and <a href="http://jnci.oxfordjournals.org/content/94/5/334.short">treatment.</a> </p>
<p>The Cancer Moonshot aims to address these problems through increased data sharing. </p>
<p>For example, it includes a first-of-its-kind, open access, public data platform, the <a href="https://www.whitehouse.gov/the-press-office/2016/06/06/fact-sheet-vice-president-biden-launches-open-access-data-resource-part">Genomic Data Commons</a>. This allows researchers not just to store and analyze the genomes of cancer tumors, linking that information to data about how the disease appears and spreads in the body, but also to share all of this information with colleagues. The platform also provides privacy and security protections for patients and researchers. </p>
<p>Before 2008, policymakers seemed to assume that the competitive ethos and monopoly incentives provoked by patent policies were the most likely to stimulate important scientific research. But the Obama administration’s nuanced approach to patents and investment in data-sharing initiatives have created a legacy that emphasizes openness and collaboration as the best avenue for producing scientific progress.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=394&fit=crop&dpr=1 600w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=394&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=394&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=495&fit=crop&dpr=1 754w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=495&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/150618/original/image-20161218-26089-1ympjzi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=495&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Protocols for patient consent were ripe for an update.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Informing-Patients/e6d3408332164573b4969bdafc0abe7d/8/0">AP Photo/Brian Kersey</a></span>
</figcaption>
</figure>
<h2>More voices in the research conversation</h2>
<p>The Obama administration also took important steps toward including citizen perspectives in science and technology development.</p>
<p>The Precision Medicine Initiative – which aims to gather data (genomic, medical, metabolic, microbial, environmental and lifestyle) from at least one million Americans to produce better medical diagnostics and therapies – emphasizes transparency, citizen representation and patient autonomy in its core principles. It is dedicated to keeping participants informed throughout the research process, and emphasizes the importance of culturally appropriate interactions.</p>
<p>It has created <a href="https://www.nih.gov/precision-medicine-initiative-cohort-program/infographics">a new model of research</a> that treats informed consent as ongoing and interactive, and gives research subjects the option to withdraw at any time.</p>
<p><a href="http://www.nature.com.proxy.lib.umich.edu/nature/journal/v478/n7369/full/478312a.html">Customarily</a>, participants in similar research projects provide consent only once, at the beginning. This traditional approach has become controversial in recent years because blood and tissue samples are often <a href="https://theconversation.com/if-we-dont-own-our-genes-what-protects-study-subjects-in-genetic-research-56003">used for a variety of projects</a>, and citizens <a href="http://www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all&_r=0">want more control</a> over how their samples are used. </p>
<p>The PMI also includes “<a href="https://www.whitehouse.gov/precision-medicine">substantial participant representation</a>” in all aspects of the process, including program design and implementation. This means research subjects will serve on the policy committees that develop data-sharing, privacy and recruitment guidelines, among others, and also help to determine research priorities. Previous scientific research initiatives have <a href="http://www.lancaster.ac.uk/fss/journals/gsp/docs/volume1number3/mlgspvol1no32005.pdf">included</a> citizen perspectives occasionally in the research process, either in funding decisions or identifying overarching goals. But the PMI approach is more ambitious and systematic. </p>
<p>The Obama administration’s enthusiasm for considering citizen perspectives is not limited to scientific research. We’ve seen this approach in its energy policy as well, including in decisions on the <a href="http://america.aljazeera.com/articles/2015/2/9/how-climate-activists-turned-a-pipeline-into-a-green-movement.html">Keystone XL</a> and <a href="http://www.latimes.com/nation/la-na-dakota-access-deadline-20161204-story.html">Dakota Access</a> pipeline.</p>
<p>After massive protests and millions of citizens <a href="https://www.youtube.com/watch?v=0BdjszfbIDw#t=19">submitting</a> public comments, President Obama <a href="https://www.nytimes.com/video/multimedia/100000004023322/obama-rejects-keystone-pipeline.html">rejected</a> the Keystone XL. Similarly, months of protests in Standing Rock, North Dakota, led the Army Corps of Engineers to halt development of the Dakota Access pipeline and <a href="https://www.theatlantic.com/science/archive/2016/12/the-historic-victory-at-standing-rock/509558/">request an environmental impact statement</a> that would assess the environmental and social implications of the project and provide extensive additional opportunity for public input. </p>
<p>At this moment, when there is great concern that the priorities of scientists and engineers do not align with those of the public, and there is growing <a href="https://www.bostonglobe.com/metro/2016/10/09/the-rise-biorights-donors-are-demanding-control-and-sometimes-cash-exchange-for-genetic-samples/jCbaQ2E5t6c0Qs1kcITMRM/story.html">desire</a> among citizens to be treated as “partners” rather than “subjects” in research, these kinds of initiatives are particularly important. They can lead to the development of science and technology that is more directly beneficial to the population – and also enhance the legitimacy of scientific and technological establishment.</p>
<h2>Will Trump build on the groundwork laid by Obama?</h2>
<p>There is a great deal of <a href="http://www.nature.com/news/the-ultimate-experiment-how-trump-will-handle-science-1.20971">uncertainty</a> about President-elect Trump’s approach to science and technology policy, and so far his cabinet appointments <a href="http://www.freep.com/story/opinion/columnists/stephen-henderson/2016/12/10/betsy-devos-trouble-data/95207844/">do not provide</a> much reassurance to the scientific community. Some of these appointments have <a href="http://www.newyorker.com/tech/elements/donald-trumps-war-on-science">even explicitly denied</a> the scientific consensus on climate change.</p>
<p>But there is a path forward that could allow Trump to remain true to those who voted him into office while building upon President Obama’s approach. Pundits tell us Trump’s victory is largely the <a href="https://www.washingtonpost.com/politics/a-rancorous-campaign-begets-huge-problems-for-the-winner/2016/11/08/0fcea580-a20d-11e6-8d63-3e0a660f1f04_story.html?utm_term=.0b0d12e81ec4">result</a> of a populist wave and deep frustration toward elites; many Americans feel that policymakers do not adequately consider the realities of their everyday lives.</p>
<p>President-elect Trump could address these concerns by bringing the needs and perspectives of rural and working-class Americans explicitly into the development of science and technology policies. His administration could consider <a href="http://delinkage.org/">new kinds of policy frameworks</a>, including intellectual property regimes, that could help to lower drug prices. It could bring these “forgotten” Americans directly into policy discussions about how to tackle the unemployment triggered by <a href="http://www.businessinsider.com/united-tech-ceo-says-trump-deal-will-lead-to-more-automation-fewer-jobs-2016-12">increasing automation</a>. And it could <a href="http://www.bmj.com/content/316/7129/463?variant=full-text">include them</a> in discussions about biomedical research priorities, perhaps leading to increased funding for practical solutions to the <a href="http://aese.psu.edu/directory/smm67/Election16.pdf">opioid epidemic</a>. </p>
<p>Such efforts could ultimately strengthen the legitimacy of the new administration among both the scientific community and the public, while continuing the work towards a socially engaged science and technology policy.</p><img src="https://counter.theconversation.com/content/67113/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Shobita Parthasarathy sits on the Board of Directors for Breast Cancer Action, a health justice advocacy group.</span></em></p>The outgoing president leaves behind some solid accomplishments in the world of science, tech and medicine. But the biggest departure from his predecessors might have been in his approach.Shobita Parthasarathy, Associate Professor of Public Policy and Women's Studies, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/625912016-09-08T10:17:06Z2016-09-08T10:17:06ZWhy you should worry about the privatization of genetic data<figure><img src="https://images.theconversation.com/files/136822/original/image-20160906-25249-1nbliwh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Privatized. </span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-43195603/stock-photo-dna-research-of-science-genetic-data-background.html?src=c8oK7zJIznToLoS-3eZMdg-2-20">DNA image via www.shutterstock.com.</a></span></figcaption></figure><p>President Obama has <a href="https://www.whitehouse.gov/precision-medicine">promised to support</a> a bold future for medicine where diagnostic testing and treatments aren’t just what’s best for most people – they’re what’s best for you. </p>
<p>This “<a href="https://ghr.nlm.nih.gov/primer/precisionmedicine/definition">precision medicine</a>” takes individual variations in our genes and environments into account. Getting there will require <a href="http://www.sciencedirect.com/science/article/pii/S0140673605676015">genetic and health data</a> from as many people as possible to uncover the relationship between genetic differences and medical outcomes.</p>
<p>This is why Obama’s <a href="https://www.whitehouse.gov/precision-medicine">Precision Medicine Initiative</a> (PMI) includes the creation of <a href="https://www.nih.gov/precision-medicine-initiative-cohort-program/precision-medicine-initiative-cohort-program-frequently-asked-questions">a million-person research cohort</a>. Participants will provide blood and urine samples, share information from their electronic health records and answer questions about health and lifestyle. The hope is that this trove of data will reveal the genetic underpinnings for a variety of diseases, leading to personalized diagnostics and treatments.</p>
<p>It’s a bold goal, and one that private companies have a head start on. For instance, <a href="https://www.23andme.com/">23andMe</a>, a direct-to-consumer genetic testing company, already has a <a href="https://www.technologyreview.com/s/601506/23andme-sells-data-for-drug-search/">1.2 million</a> person genetic database. </p>
<p>But genetic data banks amassed by private companies don’t necessarily have to follow the same regulations regarding access to their data that federally funded researchers do. And a recent proposal <a href="http://www.hhs.gov/ohrp/regulations-and-policy/regulations/nprm-home/">to change consent regulations</a> for human research <a href="http://www.annalsofepidemiology.org/article/S1047-2797(16)30154-5/abstract">may make it cheaper</a> for private companies to collect and use this data than public ones.</p>
<p>As bioethicists (<a href="http://www.annalsofepidemiology.org/article/S1047-2797(16)30154-5/abstract">myself included</a>) have warned, we need to pay attention to concerns about how these private genetic data banks are <a href="http://www.nature.com/ejhg/journal/v21/n6/full/ejhg2012217a.html">used and accessed</a> before we enable a system where the future of public genetic research lies in private hands. </p>
<h2>Who can access genetic data?</h2>
<p>If you go to a clinic or a hospital to have your blood drawn for a diagnostic test or tissue removed, many will <a href="http://www.nytimes.com/2006/04/16/magazine/taking-the-least-of-you.html">keep that biospecimen</a>, and put it or the data derived from it into a “bio-” or “data bank” for future research. </p>
<p>As long as future research with your specimen or associated data doesn’t include any information that links it back to you (like your name), researchers <a href="http://www.nytimes.com/2015/12/30/opinion/your-cells-their-research-your-permission.html">don’t need your consent</a> to do their work (though this <a href="http://www.hhs.gov/ohrp/regulations-and-policy/regulations/nprm-home/">may change</a>). </p>
<p>If researchers receive federal funding, they often have to submit their data to a public data bank such as the National Institutes of Health’s <a href="http://www.ncbi.nlm.nih.gov/gap">dbGaP</a>, which charges other researchers <a href="http://www.ncbi.nlm.nih.gov/pubmed/12383027">little to nothing</a> to access this data for future work. Open accessibility is also the <a href="https://www.nih.gov/precision-medicine-initiative-cohort-program/precision-medicine-initiative-cohort-program-frequently-asked-questions">goal</a> for the PMI Cohort. </p>
<p>In contrast, private companies like 23andMe, the breast cancer testing company <a href="https://www.myriad.com/">Myriad</a> or the carrier-screening company <a href="https://www.counsyl.com/my/orders/new/clinical-information/family-prep-screen/">Counsyl</a> generally get their biospecimens and health data from paying customers who buy <a href="https://www.23andme.com/service/">genetic tests</a> from them. </p>
<p>Some of these private companies are sharing data with other researchers. For instance, 23andMe <a href="https://www.technologyreview.com/s/602052/23andme-pulls-off-massive-crowdsourced-depression-study">collaborated</a> with researchers at Pfizer and Massachusetts General Hospital on the largest-ever study about the genetic causes of <a href="http://dx.doi.org/10.1038/ng.3623">major depression</a>. The company also collaborated with Stanford School of Medicine on a study about <a href="http://dx.doi.org/10.1038/ncomms12048">skin cancer</a>. Both studies were made possible by data from the company’s consumers (the financial details of these arrangements are unclear). </p>
<p>Also recently, Counsyl, collaborating with a researcher at Columbia University Medical Center, published a large study on <a href="https://www.genomeweb.com/molecular-diagnostics/counsyl-study-finds-expanded-carrier-screening-more-effective-standard-testing">expanded carrier screening</a> (the genetic test <a href="https://www.counsyl.com/">it sells</a>).</p>
<p>It’s great that these research collaborations are happening, but collaboration isn’t the same thing as open access. Private companies are still the ultimate gatekeeper for their data. They choose <a href="http://www.fastcompany.com/3062731/most-innovative-companies/23andmes-consumer-dna-data-gold-mine-is-starting-to-pay-off">whom they share their data with</a>. And researchers generally don’t have the same level of access to private data banks that they do from existing “public” data banks or (hopefully) the future PMI Cohort.</p>
<p>When research is done using genetic data that aren’t accessible, it is <a href="http://dx.doi.org/10.1038/ejhg.2012.238">harder for other researchers to check scientific claims</a> – a concern most recently brought up in an <a href="http://dx.doi.org/10.1001/jama.2016.10888">editorial</a> accompanying the research based on <a href="http://dx.doi.org/10.1001/jama.2016.11139">Counsyl’s private data bank</a>.</p>
<h2>Some companies can sell genetic data</h2>
<p>23andMe can <a href="https://www.fastcompany.com/3040356/what-23andme-is-doing-with-all-that-dna">keep and sell</a> its customers’ genetic information to others because consumers consent to the sale of their anonymous and aggregate information just by purchasing the product and agreeing to its <a href="https://www.23andme.com/about/privacy/#Full">privacy statement</a>. The company can also sell deidentified individual-level data if you sign the <a href="https://www.23andme.com/about/consent/">research consent document</a> – which 80 percent of consumers do. </p>
<p>These data are valuable: 23andMe recently announced that the drug company Genetech offered to pay <a href="http://www.forbes.com/sites/matthewherper/2015/01/06/surprise-with-60-million-genentech-deal-23andme-has-a-business-plan/#6b74de179274">up to US$60 million</a> to use its database to conduct Parkinson’s research. </p>
<p>And the fact 23andMe can sell data puts a worrying spin on the proposed changes to consent for federally funded human research.</p>
<p>At the moment, federally funded researchers and private companies have the same standards for consent: If human biospecimens are not “identifiable,” they don’t have to ask for consent to use them for research.</p>
<p>However, the government recently proposed revisions to the federal <a href="http://www.hhs.gov/ohrp/regulations-and-policy/regulations/nprm-home/">human subjects research regulations</a> that would require federally funded researchers to get what is called “broad consent” from people to use their biospecimens (it is unclear what effect this would have on private/public collaborations at the moment). This would apply even if researchers won’t know who the specimens came from. Broad consent would include a general description of types of research that might be conducted with the biospecimen.</p>
<p>While many reasonably argue that this is the <a href="https://theconversation.com/americans-want-a-say-in-what-happens-to-their-donated-blood-and-tissue-in-biobanks-60681">right thing to do</a>, it will be expensive. One medical school recently estimated that it would cost them an additional <a href="http://www.wsj.com/articles/how-not-to-end-cancer-in-our-lifetimes-1459811684">$4 million a year</a> to spend the predicted extra 10 minutes per participant to get informed consent and track who said what. But there are other potential unintended consequences.</p>
<p>For example, these new requirements won’t necessarily apply to private companies. This difference in consent standards could encourage a system (as I <a href="http://www.annalsofepidemiology.org/article/S1047-2797(16)30154-5/abstract">recently argued</a>) where private companies bring in biospecimens and data, deidentify them, and sell them back to publicly funded researchers – for less than it would cost for the researchers to collect samples and donor consent themselves.</p>
<h2>The future of genetic research</h2>
<p>If the future of medicine is being launched from biospecimens and related data, we need to think through their storage and access thoughtfully. It’s all too easy to create monopolies, which can have dire implications for equitable access.</p>
<p>Take Myriad Genetics. It provides the best diagnostic testing for uncommon genetic variants associated with breast and ovarian cancer (BRCA1 and BRCA2). Myriad held a patent on these genes for over a decade, <a href="https://www.aclu.org/cases/association-molecular-pathology-v-myriad-genetics">until 2013</a>, preventing anyone else from doing this type of testing. Even though its patents were invalidated, Myriad still has the biggest BRCA database on the market and remains the <a href="http://www.ncbi.nlm.nih.gov/pubmed/25544836">leader in the field</a>. </p>
<p>The advantage of Myriad’s monopoly is cyclical: The patents allowed it to accumulate the best data, the best data allow it to offer the best results and the best results mean people keep contributing their data. In this cycle, genetic data with incredible health research potential become <a href="http://www.forbes.com/sites/matthewherper/2015/01/06/surprise-with-60-million-genentech-deal-23andme-has-a-business-plan/#2b5d7a977927">just another business asset</a>.</p>
<p>Private industry partnerships can and should <a href="http://www.nature.com/news/stop-the-privatization-of-health-data-1.20268">play a critical and helpful role</a> in the future of medical research. But our medical information is more than a business asset for private leverage. We need to make sure that public genetics researchers are private industry’s partners, not dependents, and that we enable public banks so private ones do not become monopolies.</p>
<p>The future of precision medicine must come from pieces and data from us all – and we need to ensure a data banking system that will be able to benefit us all in return.</p><img src="https://counter.theconversation.com/content/62591/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kayte Spector-Bagdady 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>We should heed concerns about how private genetic data banks are used and accessed before we enable a system where the future of public genetic research lies in private hands.Kayte Spector-Bagdady, Postdoctoral Research Fellow, Center for Bioethics & Social Sciences in Medicine, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/606812016-07-13T23:17:54Z2016-07-13T23:17:54ZAmericans want a say in what happens to their donated blood and tissue in biobanks<p>The last time you went to a hospital, you probably had to fill out forms listing the medications you are taking and updating your emergency contacts. You also might have been asked a question about what is to be done with “excess tissues or specimens” that may be removed during diagnosis or treatment. Are you willing to donate these leftover bits of yourself (stripped of your name, of course) for medical research? </p>
<p>If you are inclined to answer, “Sure, why not?” <a href="http://www.nature.com/gim/journal/v13/n9/abs/gim2011135a.html">you will join the majority of Americans who would agree to donate</a>, allowing your leftovers, such as blood or unused bits from biopsies or even embryos, to be sent to a “biobank” that collects specimens and related medical information from donors. </p>
<p>But what, exactly, will be done with your donation? Can the biobank guarantee that information about your genetic destiny will not find its way to insurance companies or future employers? Could, for example, a pharmaceutical company use it to develop and patent a new drug that will be sold back to you at an exorbitant price? </p>
<p>These questions may soon become a lot more real for many of us. </p>
<p>Precision medicine, a promising new approach to treating and preventing disease, will require thousands, or even millions, of us to provide samples for genetic research. So how much privacy are we willing to give up in the name of cutting-edge science? And do we care about the kinds of research that will be done with our donations?</p>
<h2>Precision medicine needs you</h2>
<p>In January 2015, <a href="https://www.whitehouse.gov/precision-medicine">President Obama announced</a> his “Precision Medicine Initiative” (PMI), asking for <a href="https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative">US$215 million</a> to move medical care from a “one size fits all” approach to one that tailors treatments to each person’s genetic makeup. In <a href="https://www.whitehouse.gov/the-press-office/2015/01/30/remarks-president-precision-medicine">his words</a>, precision medicine is “one of the greatest opportunities for new medical breakthroughs that we have ever seen,” allowing doctors to provide “the right treatments at the right time, every time, to the right person.”</p>
<p>The PMI is <a href="https://www.nih.gov/precision-medicine-initiative-cohort-program/pmi-news">now being implemented</a>, and a critical part of the initiative is the creation of a “<a href="https://www.nih.gov/precision-medicine-initiative-cohort-program/precision-medicine-initiative-cohort-program-frequently-asked-questions">voluntary national research cohort</a>” of one million people who will provide the “data” researchers need to make this big jump in medical care. And yes, those “data” will include blood, urine and information from your electronic health records, all of which will help scientists find the link between genes, illness and treatments. </p>
<p>Recognizing that there may be some reluctance to donate, the drafters of the initiative bent over backwards to assure future donors that their privacy will be “rigorously protected.” But privacy is not the only thing donors are worrying about.</p>
<p>Together with our colleagues at the <a href="http://cbssm.med.umich.edu/">Center for Bioethics and Social Sciences in Medicine</a> at the University of Michigan and the <a href="http://www.bioethics.msu.edu/">Center for Ethics and Humanities in the Life Sciences</a> at Michigan State University, we asked the American public about their willingness to donate blood and tissue to researchers.</p>
<p>Data from our national survey – published in the <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4443895/">Journal of the American Medical Association</a> – reveal that while most Americans are willing to donate to biobanks, they have serious concerns about how we ask for their consent and about how their donations may be used in future research. </p>
<h2>What are you consenting to?</h2>
<p>We asked our respondents – a sample representative of the U.S. population – if they would be willing to donate to a biobank using the current method of “blanket consent” where donors are asked to agree that their tissue can be used for any research study approved by the biobank, “without further consent from me.” </p>
<p>A healthy majority – 68 percent – agreed. But when we asked if they would still be willing to give blanket consent if their specimens might be used “to develop patents and earn profits for commercial companies,” that number dropped to 55 percent. Only 57 percent agreed to donate if there was a possibility their donation would be used to develop vaccines against biological weapons, research that might first require <em>creating</em> biological weapons. And less than 50 percent of our sample agreed to donate if told their specimen may be used “to develop more safe and effective abortion methods.”</p>
<p>You may think that some of these scenarios are far-fetched, but we consulted with a biobank researcher who reviewed all of our scenarios and confirmed that such research could be done with donations to biobanks, or associated data. And some scenarios are real. For instance, biobanked <a href="http://www.ncbi.nlm.nih.gov/pubmed/27001000">human embryos have been used</a> to confirm how <a href="http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm">mifepristone</a>, a drug which is used to induce miscarriages, works.</p>
<h2>Trust in science is important</h2>
<p>Should we take these moral concerns about biobank research seriously? Yes, because progress in science and medicine depends on public trust in the research enterprise. If scientists violate that trust they risk losing public support – including funding – for their work. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/129895/original/image-20160708-24105-6mdccm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/129895/original/image-20160708-24105-6mdccm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/129895/original/image-20160708-24105-6mdccm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=1548&fit=crop&dpr=1 600w, https://images.theconversation.com/files/129895/original/image-20160708-24105-6mdccm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=1548&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/129895/original/image-20160708-24105-6mdccm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=1548&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/129895/original/image-20160708-24105-6mdccm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1946&fit=crop&dpr=1 754w, https://images.theconversation.com/files/129895/original/image-20160708-24105-6mdccm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1946&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/129895/original/image-20160708-24105-6mdccm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1946&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">Henrietta Lacks.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/oregonstateuniversity/4446362464/in/photolist-7LULDN-niGgFN-9uNbR4-7LULDq-niGexw-nAbMd8-ny986J-niGeJF-niGfx7-nzTQQt-nzTQyB-niG6AD-niGgHG-ny98Eu-nAbMA2-nAc4c1-nAc5jb-ny98r3-niGf5y-niGh4y-nBXPhR-niG7tv-9AvTUX-nzWXcw-nzWWFS-nAc4">Oregon State University/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>Witness the story of the <a href="http://www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all&_r=0">Havasupai tribe of Arizona</a>. Researchers collected DNA from members of the tribe in an effort to better understand their high rate of diabetes. That DNA was then used, without informing those who donated, for a study tracing the migration of Havasupai ancestors. The findings of that research undermined the tribal story of its origins. The result? The tribe banished all researchers. </p>
<p>Rebecca Skloot’s best-seller, <a href="http://rebeccaskloot.com/the-immortal-life/">“The Immortal Life of Henrietta Lacks,”</a> revealed the way tissues and blood taken for clinical uses can be used for purposes unknown to the donors. </p>
<p>In the early 1950s, <a href="http://www.chicagotribune.com/lifestyles/books/chi-the-immortal-life-of-henrietta-111710-story.html">Ms. Lacks</a> was unsuccessfully treated for cervical cancer. Researchers harvested her cells without her knowledge, and after her death they used these cells to develop the HeLa cell line. Because of their unique properties, Hela cells have become critical to medical research. They have been used to secure more than 17,000 patents, but neither she nor her family members were compensated. </p>
<p>In a similar case, <a href="http://articles.latimes.com/2001/oct/13/local/me-56770">blood cells from the spleen of a man named John Moore</a>, taken as part of his treatment for leukemia, were used to create a patented cell line for fighting infection. Moore sued for his share of the profits generated by the patent, but his suit was dismissed by local, state and federal courts. As a result of these and similar cases, nearly all biobank consent forms now include a clause indicating that donations might be used to develop commercial products and that the donor has no claim on the proceeds. </p>
<p>Researchers can ill afford to undermine public trust in their work. In our sample we found that <a href="http://dx.doi.org/10.1186/s40504-016-0036-4">lack of trust</a> in scientists and scientific research was the strongest predictor of unwillingness to donate to a biobank. </p>
<p>Those who ask you to donate some of yourself must remember that it is important not only to protect your privacy but also to ensure that your decision to do good for others does not violate your sense of what is good.</p>
<p>The “<a href="https://www.whitehouse.gov/sites/default/files/docs/pmi_privacy_and_trust_principles_july_2015.pdf">Proposed Privacy and Trust Principles</a>” issued by the PMI in 2015 are a hopeful sign. They call for transparency about “how [participant] data will be used, accessed, and shared,” including “the types of studies for which the individual’s data may be used.” The PMI soon will be asking us to <a href="https://www.nih.gov/news-events/news-releases/nih-awards-55-million-build-million-person-precision-medicine-study">donate bits of ourselves</a>, and if these principles are honored, they will go a long way toward building the trust that biobanks – and precision medicine – need to succeed.</p><img src="https://counter.theconversation.com/content/60681/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Raymond G. De Vries receives funding from The National Institutes of Heath. </span></em></p><p class="fine-print"><em><span>Tom Tomlinson 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>How much privacy are we willing to give up in the name of cutting-edge science? And do we care about the kinds of research that will be done with our donations?Raymond G. De Vries, Co-Director, Center for Bioethics and Social Sciences in Medicine, University of MichiganTom Tomlinson, Chair Professor, Michigan State UniversityLicensed as Creative Commons – attribution, no derivatives.