tag:theconversation.com,2011:/us/topics/national-institutes-of-health-37219/articlesNational Institutes of Health – The Conversation2022-09-16T12:18:50Ztag:theconversation.com,2011:article/1907322022-09-16T12:18:50Z2022-09-16T12:18:50ZARPA-H: High-risk, high-reward health research is the mandate of new, billion-dollar US agency<figure><img src="https://images.theconversation.com/files/484955/original/file-20220915-40896-6nr6ho.jpg?ixlib=rb-1.1.0&rect=1014%2C127%2C4311%2C3154&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The Advanced Research Projects Agency for Health is meant to bring forward-thinking nimbleness to health innovation.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/health-care-icon-pattern-medical-innovation-royalty-free-illustration/861104740?adppopup=true">Pixtum/iStock via Getty Images</a></span></figcaption></figure><p>A new multibillion-dollar federal agency was <a href="https://www.statnews.com/2022/09/12/renee-wegrzyn-former-government-scientist-appointed-first-arpa-h-leader/">created with a goal</a> of supporting “the next generation of moonshots for health” in science, logistics, diversity and equality. And the agency now has it’s first leader, as President Joe Biden announced Renee Wegrzyn as <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/12/president-biden-announces-intent-to-appoint-dr-renee-wegrzyn-as-inaugural-director-of-advanced-research-projects-agency-for-health-arpa-h/">director of the Advanced Research Projects Agency for Health</a>, or ARPA-H, on Sept. 12, 2022. </p>
<p>Since <a href="https://doi.org/10.1126/science.abj8547">the announcement of the intention to establish ARPA-H</a> two years ago, this new agency has sparked interest and questions within both academia and industry. </p>
<p>I have been a <a href="https://www.iths.org/about/leadership/tong-sun-mba/">director of innovation-driven health institutes</a> for decades and have worked with many of the government agencies that fund science. I and many of my colleagues hope ARPA-H will become an agency that can quickly turn scientific discoveries into real-world advances to detect, prevent and treat diseases like cancer, diabetes and Alzheimer’s. But questions still remain surrounding how it will work and what makes it different from other government-funded agencies such as the National Institutes of Health and the National Science Foundation.</p>
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<a href="https://images.theconversation.com/files/484956/original/file-20220915-25774-cfjq9n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A large complex of brick buildings." src="https://images.theconversation.com/files/484956/original/file-20220915-25774-cfjq9n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/484956/original/file-20220915-25774-cfjq9n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/484956/original/file-20220915-25774-cfjq9n.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/484956/original/file-20220915-25774-cfjq9n.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/484956/original/file-20220915-25774-cfjq9n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/484956/original/file-20220915-25774-cfjq9n.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/484956/original/file-20220915-25774-cfjq9n.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">ARPA-H will act independently even though it sits within the National Institutes of Health, which is headquartered in Bethesda, Maryland.</span>
<span class="attribution"><a class="source" href="http://www.media.nih.gov/imagebank/display.aspx?ID=392">National Institutes of Health</a></span>
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<h2>What is ARPA-H?</h2>
<p>ARPA-H is the <a href="https://www.hhs.gov/about/news/2022/05/25/hhs-secretary-becerra-establishes-arpa-h-within-nih-names-adam-h-russell-phil-acting-deputy-director.html">newest entity established within</a> the National Institutes of Health. ARPA-H was explicitly set up as an independent agency within NIH, in theory allowing it to benefit from the NIH’s vast scientific and administrative expertise and resources while still being nimble and forward-thinking. </p>
<p>ARPA-H was inspired by and modeled after the <a href="https://www.darpa.mil/about-us/about-darpa">Defense Advanced Research Projects Agency</a>, or DARPA, to rapidly develop cutting-edge technologies. DARPA is small compared to other federal research and development agencies, but has long been hugely successful. It played a critical role in spawning many technologies ranging from the internet to GPS, and even funded Moderna to <a href="https://www.prnewswire.com/news-releases/darpa-awards-moderna-therapeutics-a-grant-for-up-to-25-million-to-develop-messenger-rna-therapeutics-226115821.html">develop mRNA vaccine technology in 2013</a>.</p>
<p>ARPA-H is not the only DARPA spinoff. In 2006, the federal government created the Intelligence Advanced Research Projects Activity to <a href="https://www.iarpa.gov/who-we-are/about-us">tackle difficult challenges in the intelligence community</a>, and in 2009, the Advanced Research Projects Agency for Energy was launched. Though its budget is small compared to the Department of Energy, ARPA-E has been <a href="https://doi.org/10.1038/d41586-021-01878-z">incredibly effective in funding ambitious research into fighting climate change</a>. By funding ambitious mid- and long-term projects, IARPA, ARPA-E and now ARPA-H are meant to operate in between slow, government-funded basic research and short-term, profit-driven private sector venture capital.</p>
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<a href="https://images.theconversation.com/files/484957/original/file-20220915-1785-x4qsyq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Three old personal computers sitting on a table." src="https://images.theconversation.com/files/484957/original/file-20220915-1785-x4qsyq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/484957/original/file-20220915-1785-x4qsyq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=280&fit=crop&dpr=1 600w, https://images.theconversation.com/files/484957/original/file-20220915-1785-x4qsyq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=280&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/484957/original/file-20220915-1785-x4qsyq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=280&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/484957/original/file-20220915-1785-x4qsyq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=352&fit=crop&dpr=1 754w, https://images.theconversation.com/files/484957/original/file-20220915-1785-x4qsyq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=352&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/484957/original/file-20220915-1785-x4qsyq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=352&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">ARPA-H is modeled after the Defense Advanced Research Projects Agency, which played a key role in developing many modern technologies, including personal computers.</span>
<span class="attribution"><a class="source" href="https://en.wikipedia.org/wiki/Personal_computer#/media/File:Trinity77.jpg">Tim Colegrove/Wikimedia Commons</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<h2>How will the agency function?</h2>
<p>Biden wants ARPA-H to replicate the success of DARPA, but in the health care realm, by providing “leadership for high-risk, high-reward biomedical and health research to speed <a href="https://www.federalregister.gov/documents/2022/05/27/2022-11519/establishment-of-the-advanced-research-projects-agency-for-health">application and implementation of health breakthroughs equitably</a>.”</p>
<p>Established federal agencies like the NIH and the National Science Foundation prefer to fund more basic research and less risky projects compared to the high-risk, high-reward, applied science approach of DARPA. If ARPA-H wants to achieve the success of its predecessor, it will need to <a href="https://www.nature.com/articles/d41586-021-01878-z">operate differently from NIH and NSF</a>. </p>
<p>DARPA employs about 100 program managers who are “borrowed” from academia or industry for three to five years. These managers travel across the nation to meet with scientists and experts in different fields in order to generate ideas and start projects. These managers make funding decisions and work closely with their funded teams to overcome problems, but will cut funding if teams cannot deliver promised milestones on time. Many DARPA projects don’t produce spectacular successes, yet they pushed the boundaries of science and technology.</p>
<p>Many years ago, I had the privilege of working with a DARPA program manager alongside numerous experts in various scientific and medical fields. After several months of meetings, the program manager came up with the idea to develop “<a href="https://www.wired.com/2008/05/darpas-new-medi/">fracture putty</a>” – a puttylike material that could be applied to the shattered bones of a wounded soldier in the battlefield. The material would support weight, prevent infection, expedite healing and bone regeneration and eventually dissolve away. The program launched in 2008, and our team of chemists, nanomaterials experts, bioengineers, mathematical modelers and surgeons was one of the funded teams in this program.</p>
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<a href="https://images.theconversation.com/files/484958/original/file-20220915-33289-t2toxh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A photo of a middle-aged white woman." src="https://images.theconversation.com/files/484958/original/file-20220915-33289-t2toxh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/484958/original/file-20220915-33289-t2toxh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/484958/original/file-20220915-33289-t2toxh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/484958/original/file-20220915-33289-t2toxh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/484958/original/file-20220915-33289-t2toxh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/484958/original/file-20220915-33289-t2toxh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/484958/original/file-20220915-33289-t2toxh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">President Joe Biden appointed Renee Wegrzyn, a former DARPA project manager and biotech industry expert, to lead ARPA-H.</span>
<span class="attribution"><a class="source" href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/12/president-biden-announces-intent-to-appoint-dr-renee-wegrzyn-as-inaugural-director-of-advanced-research-projects-agency-for-health-arpa-h/">White House Photo</a></span>
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<h2>Who is the new director?</h2>
<p><a href="https://www.linkedin.com/in/renee-wegrzyn-ba00643/details/experience/">Wegrzyn</a> holds a Ph.D. in molecular biology and bioengineering from Georgia Tech. She is currently a vice president of business development at Ginkgo Bioworks, a U.S. biotech company. Wegrzyn spent four and half years as a program manager in DARPA’s Biological Technologies Office, where she managed projects that focused on using genetic engineering and gene editing for biosecurity and public health. She also worked for another <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/12/president-biden-announces-intent-to-appoint-dr-renee-wegrzyn-as-inaugural-director-of-advanced-research-projects-agency-for-health-arpa-h/">DARPA-inspired agency</a>, Intelligence Advanced Research Projects Activity. </p>
<p>At this moment, we don’t know yet the exact plan and progress in hiring APAR-H program managers and where APAR-H’s headquarters will be located. <a href="https://ssti.org/blog/pitch-secure-arpa-h-headquarters-location-begins">Several cities have expressed interest.</a>.</p>
<h2>What should people look for as ARPA-H gets started?</h2>
<p>DARPA is driven by talented, ambitious and risk-taking program managers. They are the ones who generate ideas and turn lofty goals into executable projects. It will be interesting to see how many and what kind of program managers ARPA-H hires in its early days, as these decisions will give an indication of which areas within health care the agency will be prioritizing.</p>
<p>I’ll also be watching to see how well ARPA-H and its program managers work within the NIH, which has an unbelievable depth of resources and expertise in all health care related fields that ARPA-H can tap into. But the NIH has very different funding mechanisms and culture from DARPA. </p>
<p>The final question is money. Biden wants <a href="https://www.whitehouse.gov/ostp/advanced-research-projects-agency-for-health-arpa-h/">US$6.5 billion in funding for ARPA-H</a>, and he’s only gotten <a href="https://www.statnews.com/2022/03/16/arpa-h-chaotic-road-ahead/">$1 billion from Congress so far</a>. This is its first, biggest challenge. Finding political unity for funding may have to be this new agency’s first big breakthrough if it is to reach its goals.</p><img src="https://counter.theconversation.com/content/190732/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Tong Sun owns stock and serves as a Board member of biotech company BrYet US, Inc.</span></em></p>Renee Wegrzyn will lead the new Advanced Research Projects Agency for Health, which is tasked with speeding up how fast basic science is translated into real-world applications.Tong Sun, Assistant Dean of Translational Health Sciences, School of Medicine, University of WashingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1788692022-03-24T12:16:23Z2022-03-24T12:16:23ZNew data-sharing requirements from the National Institutes of Health are a big step toward more open science – and potentially higher-quality research<figure><img src="https://images.theconversation.com/files/453967/original/file-20220323-27-6bf2wz.jpg?ixlib=rb-1.1.0&rect=137%2C0%2C5251%2C3074&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">In order to get funding from the National Institutes of Health, researchers now need a plan for sharing and managing their data.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/learning-from-the-scholar-royalty-free-illustration/453408843?adppopup=true">Exdez/Digital Vision Vectors via Getty Images</a></span></figcaption></figure><p>Starting on Jan. 25, 2023, many of the 2,500 institutions and 300,000 researchers that the U.S. <a href="https://www.nih.gov/">National Institutes of Health</a> supports will need to provide a formal, detailed plan for publicly sharing the data generated by their research. For many in the scientific community, this new NIH <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html">Data Management and Sharing Policy</a> sounds like a no-brainer. </p>
<p>The incredibly quick development of rapid tests and vaccines for COVID-19 demonstrate the success that can follow the open sharing of data within the research community. The importance and impact of that data even drove a White House <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/21/executive-order-ensuring-a-data-driven-response-to-covid-19-and-future-high-consequence-public-health-threats/">Executive Order</a> mandating that “the heads of all executive departments and agencies” share “COVID-19-related data” publicly last year.</p>
<p>I am the Director of the Rochester Institute of Technology’s Open Programs Office. At <a href="https://openr.it/">Open@RIT</a>, my colleagues and I work with faculty and researchers to help them openly share their research and data in a manner that provides others the rights to access, reuse and redistribute that work with as few barriers or restrictions a possible. In the sciences, these practices are often referred to as open data and open science.</p>
<p>The journal Nature has called the impact of the NIH’s new data management policy “seismic,” saying that it <a href="https://doi.org/10.1038/d41586-022-00402-1">could potentially create a “global standard” for data sharing</a>. This type of data sharing is likely to produce many benefits to science, but there also are some concerns over how researchers will meet the new requirements.</p>
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<a href="https://images.theconversation.com/files/453701/original/file-20220322-23-1ovxpxf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="The large, brown building that houses the NIH." src="https://images.theconversation.com/files/453701/original/file-20220322-23-1ovxpxf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/453701/original/file-20220322-23-1ovxpxf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/453701/original/file-20220322-23-1ovxpxf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/453701/original/file-20220322-23-1ovxpxf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/453701/original/file-20220322-23-1ovxpxf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/453701/original/file-20220322-23-1ovxpxf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/453701/original/file-20220322-23-1ovxpxf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The National Institutes of Health has had data-sharing guidelines in place for years, but the new rules are by far the most comprehensive.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:NIH_Clinical_Research_Center_aerial.jpg#/media/File:NIH_Clinical_Research_Center_aerial.jpg">NIH</a></span>
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<h2>What to share and how to share it</h2>
<p>The NIH’s new policy around data sharing replaces <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html">a mandate from 2003</a>. Even so, for some scientists, the new policy will be a big change. Dr. Francis S. Collins, then Director of the NIH, said in the 2020 statement <a href="https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-final-nih-policy-data-management-sharing">announcing the coming policy changes</a> that the goal is to “shift the culture of research” so that data sharing is the norm, rather than the exception.</p>
<p>Specifically, the policy requires two things. First, that researchers share all the scientific data that other teams would need in order to “validate and replicate” the original research findings. And second, that researchers include a two-page <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.html">data management plan</a> as part of their application for any NIH funding.</p>
<p>So what exactly is a data management plan? Take an imaginary study on heat waves and heatstroke, for example. All good researchers would collect measurements of temperature, humidity, time of year, weather maps, the health attributes of the participants and a lot of other data. </p>
<p>Starting next year, research teams will need to have determined what reliable data they will use, how the data will be stored, when others would be able to get access to it, whether or not special software would be needed to read the data, where to find that software and many other details – all before the research even begins so that these things can be included in the proposal’s data management plan. </p>
<p>Additionally, researchers applying for NIH funding will need to ensure that their data is available and stored in a way that persists long after the initial project is over. </p>
<p>The NIH has stated that it will support – with additional funding – the costs related to the <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-015.html">collection, sharing</a> and <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-016.html">storing of data</a>.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/453959/original/file-20220323-13-rtceks.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="The logo of the Human Genome Project" src="https://images.theconversation.com/files/453959/original/file-20220323-13-rtceks.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/453959/original/file-20220323-13-rtceks.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=596&fit=crop&dpr=1 600w, https://images.theconversation.com/files/453959/original/file-20220323-13-rtceks.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=596&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/453959/original/file-20220323-13-rtceks.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=596&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/453959/original/file-20220323-13-rtceks.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=749&fit=crop&dpr=1 754w, https://images.theconversation.com/files/453959/original/file-20220323-13-rtceks.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=749&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/453959/original/file-20220323-13-rtceks.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=749&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 open sharing of data has a history of promoting scientific excellence and was central to the Human Genome Project that first mapped the entire human genome.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Logo_HGP.jpg#/media/File:Logo_HGP.jpg">U.S. Department of Energy, Human Genome Project via Wikimedia Commons</a></span>
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<h2>Sharing data promotes open science</h2>
<p>The NIH’s case for the new policy is that it will be “<a href="https://osp.od.nih.gov/2020/10/29/nih-releases-new-policy-data-management-and-sharing/">good for science</a>” because it maximizes availability of data for other researchers, addresses problems of reproducibility, will lead to better protection and use of data and increase transparency to ensure public trust and accountability.</p>
<p>The first big change in the new policy – to specifically share the data needed to validate and replicate – seems aimed at the <a href="https://doi.org/10.1038/533452a">proliferation of research that can’t be reproduced</a>. Arguably, by ensuring that all of the relevant data from a given experiment is available, the scientific world would be better able to evaluate and validate through replication the quality of research much more easily.</p>
<p>I strongly believe that requiring data-sharing and management plans addresses a big challenge of open science: being able to <a href="https://doi.org/10.1007/s10502-020-09330-3">quickly find the right data, as well as access, and apply it</a>. The NIH says, and I agree, that the requirement for data management plans will help make the use of open data faster and more efficient. From the Human Genome Project in the 1990s to the recent, rapid development of tests and vaccines for COVID-19, the benefits of greater openness in science have been borne out.</p>
<h2>Will the new requirements be a burden?</h2>
<p>At its core, the goal of the new policy is to make science more open and to fight bad science. But as beneficial as the new policy is likely to be, it’s not without costs and shortfalls. </p>
<p>First, replicating a study – even one where the data is already available – still consumes expensive human, computing and material resources. The system of science <a href="https://theconversation.com/real-crisis-in-psychology-isnt-that-studies-dont-replicate-but-that-we-usually-dont-even-try-47249">doesn’t reward the researchers who reproduce an experiment’s results</a> as highly as the ones who originate it. I believe the new policy will improve some aspects of replication, but will only address a few links in the overall chain.</p>
<p>Second are concerns about the increased workload and financial challenges involved in meeting the requirements. Many scientists aren’t used to preparing a detailed plan of what they will collect and how they will share it as a part of asking for funding. This means they may need training for themselves or the support of trained staff to do so.</p>
<h2>Part of a global trend toward open science</h2>
<p>The NIH isn’t the only federal agency pursuing more open data and science. In 2013, the Obama administration mandated that all agencies with a budget of $100 million or more must provide open access to their publications and data. The National Science Foundation <a href="https://obamawhitehouse.archives.gov/blog/2013/02/22/expanding-public-access-results-federally-funded-research">published their first open data policy</a> two years earlier. Many European Union members are crafting national policies on open science – most notably France, which has already <a href="https://www.ouvrirlascience.fr/second-national-plan-for-open-science/">published it’s second</a>. </p>
<p>The cultural shift in science that NIH Director Collins mentioned in 2020 has been happening – but for many, like me, who support these efforts, the progress has been painfully slow. I hope that the new NIH open data policy will help this movement gain momentum.</p>
<p>[<em>Get fascinating science, health and technology news.</em> <a href="https://memberservices.theconversation.com/newsletters/?nl=science&source=inline-science-fascinating">Sign up for The Conversation’s weekly science newsletter</a>.]</p><img src="https://counter.theconversation.com/content/178869/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Stephen Jacobs directs, Open@RIT, part of the Rochester Institute of Technology. Open@RIT has been funded in part by the Alfred P. Sloan Foundation to provide services in support of Open Work to their faculty. He is a volunteer member of the Steering Committee of the ToDo Group, a member organization of the Linux Foundation that supports Open Source Program Offices in industry.</span></em></p>Starting in 2023, all research proposals funded by the NIH will need to include a data sharing and management plan. An expert on open science explains the requirements and how they might improve science.Stephen Jacobs, Professor of Interactive Games and Media, Rochester Institute of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1720082021-11-18T20:16:48Z2021-11-18T20:16:48ZWhy Moderna won’t share rights to the COVID-19 vaccine with the government that paid for its development<figure><img src="https://images.theconversation.com/files/432489/original/file-20211117-9381-40y1m2.jpg?ixlib=rb-1.1.0&rect=87%2C40%2C4265%2C2961&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The U.S. government funded a significant portion of the R&D behind the Moderna vaccine. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/march-2021-saxony-leipzig-a-hand-with-disposable-gloves-news-photo/1231919693">Peter Endig/picture alliance via Getty Images</a></span></figcaption></figure><p>A quiet <a href="https://www.thedenverchannel.com/news/national/moderna-us-government-at-odds-over-covid-19-vaccine-patent">monthslong legal fight</a> between the U.S. National Institutes of Health and drugmaker Moderna over COVID-19 vaccine patents recently burst into public view. The outcome of the battle has important implications, not only for efforts to contain the pandemic but more broadly for drugs and vaccines that could be critical for future public health crises. </p>
<p><a href="https://www.slu.edu/law/faculty/ana-santos-rutschman.php">I teach drug regulation</a> and patent law at Saint Louis University’s <a href="https://www.slu.edu/law/health/index.php">Center for Health Law Studies</a>.</p>
<p>Moderna recently <a href="https://www.cbsnews.com/news/moderna-covid-vaccine-patent-dispute-national-institutes-health/">offered to share ownership</a> of its main patent with the government to resolve the dispute. Whether or not this is enough to satisfy the government’s claims, I believe the dispute points to serious problems in the ways U.S. companies bring drugs and vaccines to market. </p>
<h2>US was a major funder of the Moderna vaccine</h2>
<p>Vaccines have <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines">played a crucial role</a> in the response to the pandemic.</p>
<p>In December 2020, Moderna became the second pharmaceutical company after Pfizer to <a href="https://www.raps.org/news-and-articles/news-articles/2020/12/fda-issues-eua-for-moderna-covid-vaccine">obtain authorization</a> from the Food and Drug Administration to market a COVID-19 vaccine in the United States. People have since grown so used to talking about the “<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/french-health-authority-advises-against-moderna-covid-19-vaccine-under-30s-2021-11-09/">Moderna vaccine</a>” that a crucial element in the history of how it was developed risks being overshadowed: Moderna was <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-covid-19-vaccine-patent-dispute-headed-court-us-nih-head-says-2021-11-10/">not the sole developer</a> of the vaccine.</p>
<p>Unlike many of the other pharmaceutical companies involved in the <a href="https://openscholarship.wustl.edu/law_journal_law_policy/vol64/iss1/12/">COVID-19 vaccine race</a>, Moderna is a newcomer to drug and vaccine commercialization. Founded in Massachusetts in 2010, the company had <a href="https://fortune.com/2020/11/19/moderna-vaccine-distribution-lonza-swiss/">never brought a product to market</a> until the FDA authorized its COVID-19 vaccine last year.</p>
<p>Throughout the 2010s, Moderna focused on the development of <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mRNA.html">mRNA technology</a>, attracting over <a href="https://www.science.org/content/article/mysterious-2-billion-biotech-revealing-secrets-behind-its-new-drugs-and-vaccines">US$2 billion in funding</a> from pharmaceutical companies and other investors. <a href="https://www.marketwatch.com/story/moderna-ipo-5-things-to-know-about-what-could-be-the-largest-biotech-ipo-in-history-2018-12-05">It went public</a> in 2018.</p>
<p>Even <a href="https://direct.mit.edu/qss/article/1/4/1381/96111/Coronavirus-research-before-2020-is-more-relevant">before the pandemic</a>, research on both coronaviruses and vaccine candidates against emerging pathogens was a priority for agencies operating in the public health space. In 2015, the <a href="https://www.niaid.nih.gov">National Institute of Allergy and Infectious Diseases</a>, an institute within the NIH, <a href="https://www.documentcloud.org/documents/6935295-NIH-Moderna-Confidential-Agreements.html">signed a cooperative R&D agreement</a> with Moderna on basic research, including the development of new vaccines. The agreement resulted in an <a href="https://www.usatoday.com/story/news/factcheck/2020/11/24/fact-check-donations-research-grants-helped-fund-moderna-vaccine/6398486002/">undisclosed amount of funding</a> and assistance with research. </p>
<p>In addition, after the COVID-19 outbreak began Moderna also <a href="https://www.reuters.com/article/us-health-coronavirus-moderna-funding/moderna-gets-further-472-million-u-s-award-for-coronavirus-vaccine-development-idUSKCN24R0IN">received almost $1 billion</a> in <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-award-us-government-agency-barda-483-million">funding</a> from the <a href="https://www.phe.gov/about/barda/Pages/default.aspx">Biomedical Advanced Research and Development Authority</a>, which operates within the Department of Health and Human Services. This funding was specifically targeted to the development of a COVID-19 vaccine candidate. </p>
<p>Researchers have calculated that, collectively, the U.S. government <a href="https://www.usatoday.com/story/news/factcheck/2020/11/24/fact-check-donations-research-grants-helped-fund-moderna-vaccine/6398486002/">has provided $2.5 billion</a> toward the development and commercialization of Moderna’s COVID-19 vaccine. </p>
<h2>US, Moderna scientists working side by side</h2>
<p>In addition to providing financial support, the federal government was instrumental in the development of Moderna’s vaccine for other reasons. Namely, federal scientists worked alongside Moderna scientists on different components of the vaccine.</p>
<p>These contributions included <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-covid-19-vaccine-patent-dispute-headed-court-us-nih-head-says-2021-11-10/">working on dosing mechanisms</a>, and the NIH said federal scientists created the <a href="https://www.documentcloud.org/documents/6956323-NIH-Statement-to-Axios.html">stabilized spike proteins</a> that are a key component of the vaccine made by Moderna.</p>
<p>The importance of the role played by federal scientists in their work with Moderna would soon become apparent. A <a href="https://www.documentcloud.org/documents/6935295-NIH-Moderna-Confidential-Agreements.html#document/p105/a568569">2019 agreement</a> with a third party explicitly acknowledged this, alluding to mRNA vaccine candidates “developed and jointly owned by NIAID and Moderna.” And by late 2020, the U.S. government was calling it the “<a href="https://www.nih.gov/news-events/news-releases/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine">NIH-Moderna COVID-19 vaccine</a>.”</p>
<p>While the U.S. government has spent money on <a href="https://www.nytimes.com/2020/07/22/us/politics/pfizer-coronavirus-vaccine.html">COVID-19 vaccines</a> <a href="https://www.aha.org/news/headline/2021-03-10-federal-government-purchase-additional-100-million-doses-johnson-johnsons">made by other companies</a>, its close involvement in the R&D stages of Moderna’s sets it apart. </p>
<h2>How it became a patent dispute</h2>
<p>As development of the vaccine progressed, Moderna applied for <a href="https://www.modernatx.com/patents">several patents</a>, each one covering different components of the vaccine. U.S. law allows inventors to apply for patents on products or methods that are <a href="https://www.uspto.gov/patents/basics/general-information-patents">new, not obvious and useful</a>. While some early modern vaccines – like the <a href="https://www.history.com/this-day-in-history/salk-announces-polio-vaccine">polio vaccine</a> developed by Jonas Salk’s team – were <a href="https://slate.com/technology/2014/04/the-real-reasons-jonas-salk-didnt-patent-the-polio-vaccine.html">not covered</a> by patents, from the late 20th century onward <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3437006">it became very common</a> for one or multiple patents to cover a newly developed vaccine.</p>
<p>In applying for some patents related to its vaccine, Moderna named National Institute of Allergy and Infectious Diseases scientists as co-inventors alongside Moderna scientists. This was the case, for example, in a <a href="https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021159130">patent application</a> dated May 2020 for a relatively minor component of the vaccine. </p>
<p>However, in July 2021, Moderna made it clear that it would not name government scientists as co-inventors in a <a href="https://patentscope.wipo.int/search/docs2/wipocase/505ZsMDTUgVOqJF7T5XENxyO6tAyZyhu2VjKp25wWCc1G0VAtPuhbCFZOpp-d79HpUrKxDRzhZhLRGVvlDiE3NgLw3QMAP3mkUwKxrJkQHVT7e0ImBPSldyY2tt3-Whp1e5VI8D_InSWK-6CzQMToUJHq4SPXkX1vxlWCT95M8EOIXzWRp_Hq3nTwgotDaOmMXdDoeh8LkRUic82FMd7qN7ymc8Hgg_Rr94szG4fhkaukT6ahB2kq3Lf3fRyk06ellqMDBIo3z4aSa1jfU2VuBXr0Gd4_VguMOcIGyYWGHcTvAjdLob5BFLOj9ZE8HIGI4AtqeOF0idCAgbhj10sNw?filename=Letter_specifying_the_conditions_for_filing_under_37CFR1.97.pdf">patent application</a> covering a much more significant component of the vaccine: the mRNA sequence used to produce the vaccine, known as mRNA-1273.</p>
<p>Moderna’s position was that <a href="https://www.nytimes.com/2021/11/09/us/moderna-vaccine-patent.html">Moderna scientists alone</a> had selected the sequence. The <a href="https://patentscope.wipo.int/search/docs2/wipocase/505ZsMDTUgVOqJF7T5XENxyO6tAyZyhu2VjKp25wWCc1G0VAtPuhbCFZOpp-d79HpUrKxDRzhZhLRGVvlDiE3NgLw3QMAP3mkUwKxrJkQHVT7e0ImBPSldyY2tt3-Whp1e5VI8D_InSWK-6CzQMToUJHq4SPXkX1vxlWCT95M8EOIXzWRp_Hq3nTwgotDaOmMXdDoeh8LkRUic82FMd7qN7ymc8Hgg_Rr94szG4fhkaukT6ahB2kq3Lf3fRyk06ellqMDBIo3z4aSa1jfU2VuBXr0Gd4_VguMOcIGyYWGHcTvAjdLob5BFLOj9ZE8HIGI4AtqeOF0idCAgbhj10sNw?filename=Letter_specifying_the_conditions_for_filing_under_37CFR1.97.pdf">company informed</a> the Patent and Trademark Office of its position in a 2020 statement.</p>
<p>In November 2021, government officials publicly challenged the company’s decision after months of <a href="https://www.nytimes.com/2021/11/09/us/moderna-vaccine-patent.html">failed negotiations</a> with the company. Moderna then <a href="https://twitter.com/moderna_tx/status/1458896909008048131?s=20">took to social media</a> to defend its position, tweeting:</p>
<p>“Just because someone is an inventor on one patent application relating to our COVID-19 vaccine does not mean they are an inventor on every patent application relating to the vaccine.”</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1458896909008048131"}"></div></p>
<p>By contrast, the National Institutes of Health <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-covid-19-vaccine-patent-dispute-headed-court-us-nih-head-says-2021-11-10/">argued that three NIAID scientists</a> – Kizzmekia Corbett, Barney Graham and John Mascola – had meaningfully contributed to the invention, though <a href="https://www.yahoo.com/now/dr-kizzy-breaks-silence-us-010000004.html">they’ve declined</a> to <a href="https://www.nytimes.com/2021/11/09/us/moderna-vaccine-patent.html">publicly specify how</a>. If true, patent law says they <a href="https://www.uspto.gov/web/offices/pac/mpep/s2109.html">should be named co-inventors</a>. </p>
<p>But this dispute is not merely about scientific principles or technical aspects of the law. While patents are also regarded as proxies for measuring scientific reputation, their most immediate and powerful effect is to give patent holders a <a href="https://www.wipo.int/patents/en/">significant amount of control</a> over the covered technology – in this case, the main component of the vaccine made by Moderna.</p>
<p>From a practical perspective, excluding federal scientists from the application means that Moderna alone gets to decide how to use the vaccine, whether to license it and to whom. If, by contrast, the government co-owns the vaccine, <a href="https://www.law.cornell.edu/uscode/text/35/262">federal patent law allows</a> each of the joint owners to engage in a variety of actions – from making and selling the vaccine to licensing it – without the consent of the other owners.</p>
<p>This is especially relevant in cases of product scarcity or potential pricing issues in connection with the commercialization of the vaccine. For instance, the U.S. <a href="https://www.law.cornell.edu/uscode/text/35/262">would have the ability</a> to allow more manufacturers to produce vaccines using the mRNA-1273 technology. In addition, it could direct vaccine doses wherever it likes, including to <a href="https://ourworldindata.org/covid-vaccinations">lower-income countries that have received few vaccines so far</a>.</p>
<h2>Broader implications</h2>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A graphic shows how its mRNA technology works" src="https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=968&fit=crop&dpr=1 600w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=968&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=968&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1216&fit=crop&dpr=1 754w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1216&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/432677/original/file-20211118-23-42dxde.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1216&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Moderna explains its mRNA technology.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/ModernaAnnouncesFundingAwardfromBARDAfor8MillionwithPotentialofupto125MilliontoAccelerateDevelopmentofZikaMessengerRNAmRNAVaccine/4b1115aa7055e766289234593ca164bb/photo?Query=mrna&mediaType=photo&sortBy=arrivaldatetime:asc&dateRange=Anytime&totalCount=23&currentItemNo=4">Business Wire</a></span>
</figcaption>
</figure>
<p>The ongoing battle between the government and an emerging star in the pharmaceutical industry is yet another episode in a complicated relationship between actors with complementary yet distinct roles in the production of drugs and vaccines.</p>
<p>On the one hand, the federal government <a href="https://www.science.org/content/article/data-check-us-government-share-basic-research-funding-falls-below-50">has long played a critical role</a> in both performing and funding basic research. On the other, it does not have the resources and capacity to bring most types of new drugs and vaccines to market on its own. </p>
<p>The pharmaceutical industry thus plays an important and necessary role in drug innovation, which I believe should be rewarded – although not boundlessly.</p>
<p>If the NIH is correct about co-ownership of the vaccine, then Moderna is unduly using a legal tool to achieve a position of market control – a reward it does not deserve. This position of sole control becomes even more problematic in light of the significant amounts of public money that funded the development of this vaccine. This offset some of Moderna’s financial risk, even as the <a href="https://investors.modernatx.com/static-files/24613a26-607a-4012-b0c2-df415ca09e36#page=6">company projects</a> to make $15 billion to $18 billion in revenue from vaccine sales in 2021 alone, with much more expected in 2022. </p>
<p>[<em>More than 140,000 readers get one of The Conversation’s informative newsletters.</em> <a href="https://memberservices.theconversation.com/newsletters/?source=inline-140K">Join the lists today</a>.]</p>
<p>However, even if the NIH prevails in the patent dispute, it is important to understand the limitations of such a “win.” The U.S. would be in a position to license the vaccine, for example, and could do so by requiring that licensees agree to equitable distribution of vaccine doses. </p>
<p>But co-ownership would not enable the government to fix any of the <a href="https://www.nature.com/articles/d41586-021-02383-z">other problems</a> that currently affect the manufacturing and distribution of COVID-19 vaccines, such as scaling up production or building infrastructure to deliver vaccine doses.</p>
<p>In my view, the dispute is a reminder of the <a href="https://healthcareglobal.com/procurement-and-supply-chain/challenges-vaccine-distribution-affecting-everyone">many</a> <a href="https://www.forbes.com/sites/edwardsegal/2021/01/26/new-vaccine-supply-and-distribution-problems-slow-fight-against-covid---and-provide-more-crisis-management-lessons/">problems</a> embedded in how vaccines are made and delivered in the U.S. And it shows that when taxpayers fund basic research of a drug, they deserve more of the control – and rewards – when that drug succeeds.</p><img src="https://counter.theconversation.com/content/172008/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ana Santos Rutschman 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>Moderna claims its scientists alone invented the mRNA sequence used to produce its COVID-19 vaccine. The US government, which helped fund the drug, disagrees.Ana Santos Rutschman, Assistant Professor of Law, Saint Louis UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1685522021-10-12T12:07:43Z2021-10-12T12:07:43ZReporting all biosafety errors could improve labs worldwide – and increase public trust in biological research<figure><img src="https://images.theconversation.com/files/424277/original/file-20211001-23-1442y9w.jpg?ixlib=rb-1.1.0&rect=0%2C10%2C7252%2C5004&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some institutions publish information about their mishaps, while others do not.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/february-2021-bavaria-munich-soldiers-of-the-german-armed-news-photo/1231180728">Peter Kneffel/picture alliance via Getty Images</a></span></figcaption></figure><p>The <a href="https://doi.org/10.1016/S0140-6736(21)02019-5">origin of SARS-CoV-2</a> remains a mystery. One theory is that the coronavirus that causes COVID-19 was transmitted from animals to humans – <a href="https://www.cdc.gov/onehealth/basics/zoonotic-diseases.html">a fairly common occurrence</a>. Another is that it came from a laboratory accident – a <a href="https://my.absa.org/LAI">more infrequent circumstance</a>. </p>
<p>Around the world, scientists conduct many kinds of biological research experiments – from basic studies exploring how living systems operate to synthesizing novel organisms. Applications range from developing medical treatments to protecting the food supply to modifying bacteria to cleaning up oil spills and much more. A subset of experiments may also involve <a href="https://theconversation.com/why-gain-of-function-research-matters-162493">gain-of-function research</a>, which involves modifying an organism to gain a new property or ability.</p>
<p>The idea that a pathogen could escape from a laboratory and infect the entire world is the stuff of horror movies. Working with biological materials does have inherent risks, and <a href="https://www.liebertpub.com/doi/pdf/10.1177/153567601502000103">laboratory incidents will happen</a> – the goal is to minimize risks to laboratory personnel, the community and the environment. </p>
<p>We are <a href="https://scholar.google.com/citations?hl=en&user=CcisQ1kAAAAJ">biosafety</a> <a href="https://scholar.google.com/citations?hl=en&user=sNOHbC4AAAAJ">and</a> <a href="https://scholar.google.com/citations?user=YkYvOhoAAAAJ">biosecurity</a> professionals with expertise in mitigating risks associated with biological research. Without a standardized, international framework for reporting laboratory incidents and responses, the task of mitigating such risks is quite difficult. If laboratories were more open about when things go wrong, others could learn from their mistakes and lessen the chances of a future accident.</p>
<h2>Science and technology mishaps</h2>
<p>In 1984, <a href="https://www.theatlantic.com/photo/2014/12/bhopal-the-worlds-worst-industrial-disaster-30-years-later/100864/">30 tons of a highly toxic gas</a> were released in Bhopal, India. Considered one of the <a href="https://www.theguardian.com/cities/2019/dec/08/bhopals-tragedy-has-not-stopped-the-urban-disaster-still-claiming-lives-35-years-on">world’s worst industrial accidents</a>, the explosion killed several thousand people. </p>
<p>When one of Chernobyl’s radioactive nuclear cores had a meltdown in 1986, the Soviet government hid details and <a href="https://www.reuters.com/world/unsealed-soviet-archives-reveal-cover-ups-chernobyl-plant-before-disaster-2021-04-26/">spread misinformation</a> about the event, even though the heat from the reactor could be <a href="https://www.epa.gov/radnet/chernobyl-epas-radiological-monitoring">seen from space</a>.</p>
<p>By contrast, when an accident occurs with a biological material, it is not a spectacular event like an explosion or meltdown. A disease caused by a biological organism takes time to appear. It may take days or weeks for symptoms to present after infection. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/425344/original/file-20211007-15-wff7l1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A woman stands in front of an area cordoned off with caution tape and a sign saying 'Keep Out.'" src="https://images.theconversation.com/files/425344/original/file-20211007-15-wff7l1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/425344/original/file-20211007-15-wff7l1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/425344/original/file-20211007-15-wff7l1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/425344/original/file-20211007-15-wff7l1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/425344/original/file-20211007-15-wff7l1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/425344/original/file-20211007-15-wff7l1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/425344/original/file-20211007-15-wff7l1.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">Investigators found laboratory security breaches at the heart of a foot-and-mouth outbreak in Britain, 2007.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/government-official-stands-near-signs-warning-of-an-news-photo/76685039">Peter Macdiarmid/Getty Images News via Getty Images</a></span>
</figcaption>
</figure>
<p>The <a href="https://doi.org/10.1126/science.7973702">1979 Sverdlovsk Anthrax Outbreak in the Soviet Union</a> and the <a href="https://www.newscientist.com/article/dn12615-faulty-pipe-blamed-for-uk-foot-and-mouth-outbreak/">2007 Pirbright Institute’s foot-and-mouth incident in the U.K.</a> are examples where biological materials unintentionally escaped the laboratory. People got sick and farm animals died. </p>
<p>Laboratory-related infections are frequently tied to the breakdown of a particular laboratory safety procedure, equipment or organizational process. </p>
<p>Here in the U.S., several well-documented laboratory errors have resulted in potential exposures, including the <a href="https://www.cdc.gov/labs/pdf/Final_Anthrax_Report.pdf">2014 unintentional release of potentially viable anthrax bacteria</a>, the <a href="https://www.cdc.gov/labs/pdf/Investigation-into-Dec-22-2014-CDC-Ebola-event.pdf">2014 potential exposure of a laboratory technician to Ebola virus</a> and the <a href="https://www.usatoday.com/story/news/2016/09/21/gao-inactivation-failures-high-containment-labs/90776218/">2015 discovery of improperly inactivated anthrax bacteria</a> that was shipped around the globe. <a href="https://www.cdc.gov/media/releases/2014/p0711-lab-safety.html">In</a> <a href="https://www.cdc.gov/media/releases/2015/s0204-ebola-lab.html">each</a> <a href="https://www.cdc.gov/media/releases/2014/s0619-anthrax.html">case</a>, medical care was provided and no one became ill. </p>
<h2>Biological incident reporting</h2>
<p>In the U.S., a <a href="https://www.aappublications.org/news/2019/03/08/mmwr030819">standardized system to report</a> all biological incidents and potential exposures does not exist. </p>
<p>The U.S. <a href="https://osp.od.nih.gov/biotechnology/nih-guidelines/">National Institutes of Health</a> has requirements for reporting any <a href="https://osp.od.nih.gov/biotechnology/faqs-on-incident-reporting/">significant problems, accidents and illnesses</a> involving experiments with altered genetic material. If a research institution receives U.S. government funding, failure to comply with NIH rules can result in a loss of this funding, no matter where in the world the lab is located. </p>
<p>But private, corporate or <a href="https://www.brookings.edu/blog/techtank/2017/10/09/do-it-yourself-biology-shows-safety-risks-of-an-open-innovation-movement/">DIY biology laboratories</a> operate with even less government oversight and fewer reporting requirements – though many have adopted their own <a href="https://www.genspace.org/community-biology-biosafety-handbook">biosafety practices</a> and follow local requirements and best management practices. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/424281/original/file-20211001-23-18xjcsn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A woman in full body PPE reaches for a beaker containing a murky liquid." src="https://images.theconversation.com/files/424281/original/file-20211001-23-18xjcsn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/424281/original/file-20211001-23-18xjcsn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=422&fit=crop&dpr=1 600w, https://images.theconversation.com/files/424281/original/file-20211001-23-18xjcsn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=422&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/424281/original/file-20211001-23-18xjcsn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=422&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/424281/original/file-20211001-23-18xjcsn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=530&fit=crop&dpr=1 754w, https://images.theconversation.com/files/424281/original/file-20211001-23-18xjcsn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=530&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/424281/original/file-20211001-23-18xjcsn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=530&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Numerous biolabs operate around the world.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/laboratory-technician-works-in-the-production-plant-of-the-news-photo/1231378210">Yamil Lage/AFP via Getty Images</a></span>
</figcaption>
</figure>
<p>Outside the U.S., the <a href="http://doi.org/10.1177/1535676016661772">robustness of biosafety and biosecurity oversight</a> varies significantly from country to country. </p>
<p>[<em>Over 110,000 readers rely on The Conversation’s newsletter to understand the world.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=100Ksignup">Sign up today</a>.]</p>
<h2>Sharing information</h2>
<p>Although reporting to the U.S. government is required in certain circumstances, the information contained in the reports may never reach the public. </p>
<p>Some institutions openly publish information about their incidents, while others keep that data private. Reasons may include concerns about reputation, protection of personal health information or even sensationalism in the media. Some fear reprisal from a disgruntled employee, a competitor or even a nation-state. Others are concerned about the spread of misinformation by <a href="https://www.bostonmagazine.com/2006/05/15/fear-in-the-air/">individuals who fear biological labs</a> or those who seek to <a href="https://time.com/5550654/crispr-gene-editing-human-embryos-ban/">end human genetic engineering research</a> or <a href="https://www.cbsnews.com/news/peta-complaint-lab-animals-pitt-research-lab-university-of-pittsburgh/">ban animal experiments</a>. </p>
<p>Even with these concerns, we believe a more transparent and comprehensive system of reporting biological incidents to a neutral third party would help reduce the number of laboratory incidents – and could improve public trust in the scientific enterprise. If this type of system had been in place prior to COVID-19, more data would presumably have been available to help evaluate the Wuhan laboratory leak hypothesis and cut down on speculation.</p>
<p>In the U.S., a possible way to do this is to expand the American Biological Safety Association’s <a href="https://my.absa.org/LAI">Laboratory Acquired Infection database</a>. Currently, it contains incident data only from published research papers. But it could be broadened to include all kinds of incident data. In our opinion, an international version of such a reporting system would also help reduce the number and severity of laboratory incidents, both locally and worldwide. The more information available about the root cause of incidents, the more it could be used to help improve training, procedures and controls – and prevent future problems. It would also suggest how safety systems break down and what systems might be at risk. </p>
<p>Biosafety and biosecurity professionals have been discussing this topic for a <a href="https://www.nature.com/articles/nm0811-919">long time</a>, including at a <a href="https://www.phe.gov/Preparedness/legal/boards/biosafetytaskforce/meetings/Documents/agenda-081208.pdf">U.S. Trans-Federal Task Force on Optimizing Biosafety and Biocontainment</a> and by a <a href="https://www.phe.gov/s3/Documents/fesap.pdf">Federal Experts Security Advisory Panel</a>. But to make a centralized reporting system a reality, key players will need to commit and act. They include governments, international agencies, industry partners and the scientific community.</p><img src="https://counter.theconversation.com/content/168552/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>David Gillum is the past president of the American Biological Safety Association (ABSA) International. He is a past-judge and member of the safety and security committee for the International Genetically Engineered Machine Competition.</span></em></p><p class="fine-print"><em><span>Kathleen Vogel receives funding from the U.S. National Science Foundation, Carnegie Corporation of New York, U.S. Department of Defense, U.S. Department of State, Ploughshares Fund. </span></em></p><p class="fine-print"><em><span>Rebecca Moritz is the 2021 President-Elect of the American Biological Safety Association</span></em></p>A centralized reporting system for laboratory incidents involving dangerous pathogens in biological research does not exist in the US or internationally.David Gillum, Executive Director of Environmental Health and Safety and Chief Safety Officer, Arizona State UniversityKathleen Vogel, Interim Director and Professor of the School for the Future of Innovation in Society, Arizona State UniversityRebecca Moritz, Biosafety Director and Responsible Official, Colorado State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1657452021-09-03T12:35:59Z2021-09-03T12:35:59ZDance and movement therapy holds promise for treating anxiety and depression, as well as deeper psychological wounds<figure><img src="https://images.theconversation.com/files/418934/original/file-20210901-13-ojgvbu.jpg?ixlib=rb-1.1.0&rect=584%2C121%2C6776%2C4933&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Dance and movement therapy not only holds promise for treatment of trauma, anxiety and depression but can also contribute lifelong coping skills.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/mother-and-kids-dancing-royalty-free-image/1080443848?adppopup=true">kate_sept2004/E+ via Getty Images</a></span></figcaption></figure><p>A few years ago, framed by the skyline of Detroit, a group of about 15 children resettled as refugees from the Middle East and Africa leapt and twirled around, waving blue, pink and white streamers through the air. </p>
<p>The captivating scene was powerfully symbolic. Each streamer held a negative thought, feeling or memory that the children had written down on the streamers. On cue and in unison, the children released their streamers into the air, then sat down nearby. Then they gathered up the fallen streamers, which carried their collective struggles and hardships, threw them in a trash can and waved goodbye. </p>
<p>The children were participating in a dance therapy activity as part of our team’s research program exploring body-based approaches to mental health treatment in people resettled as refugees.</p>
<p>In 2017, our lab – the <a href="https://www.starclab.org">Stress, Trauma and Anxiety Research Clinic</a> – began <a href="https://doi.org/10.1016/j.jaac.2019.07.007">piloting movement therapies</a> to help address trauma in refugee families. We are learning that movement may not only provide a way to express oneself, but also offer a path toward healing and lifelong strategies for managing stress. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/418924/original/file-20210901-17-138fwa0.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Silhouette image of a participant engaging in streamers activity described in story" src="https://images.theconversation.com/files/418924/original/file-20210901-17-138fwa0.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/418924/original/file-20210901-17-138fwa0.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/418924/original/file-20210901-17-138fwa0.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/418924/original/file-20210901-17-138fwa0.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/418924/original/file-20210901-17-138fwa0.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/418924/original/file-20210901-17-138fwa0.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/418924/original/file-20210901-17-138fwa0.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Dance and movement therapy offers a self-empowering mind-body approach to mental health treatment.</span>
<span class="attribution"><span class="source">David Dalton</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>On average, every year about <a href="https://doi.org/10.1177/1363461515612933">60,000 children are resettled</a> as refugees in Western nations. Now, the refugee crisis resulting from the U.S. withdrawal from Afghanistan is bringing renewed attention to their needs. The UN Refugee Agency estimates that <a href="https://www.unrefugees.org/news/afghanistan-refugee-crisis-explained/">6 million Afghans</a> have been displaced over the past 40 years, and <a href="https://www.axios.com/afghanistan-withdrawal-refugee-crisis-us-europe-42e8c1ca-63b4-41a0-b5b8-eb4832799150.html">a new wave of tens of thousands</a> are now fleeing from Taliban rule. </p>
<p><a href="https://scholar.google.com/citations?user=JxIoO1sAAAAJ&hl=en&authuser=1">I am a neuroscientist</a> who specializes in understanding how trauma reshapes the nervous system of developing youth. I use this information to explore creative arts and movement-based therapies to treat stress and anxiety. <a href="https://dx.doi.org/10.1111%2Fj.1469-7580.2009.01160.x">The instinct to move the body in expressive ways is as old as humanity</a>. But movement-based strategies such as dance therapy have only recently been given much attention in mental health treatment circles. </p>
<p>As a dancer myself, I always found the nonverbal emotional expression offered through movement to be incredibly therapeutic – especially when I was experiencing significant anxiety and depression in high school and college. Now, through my neuroscience research, I am joining a growing number of scholars working to bolster the evidence base supporting movement-based interventions. </p>
<h2>One mind and body</h2>
<p>During the COVID-19 pandemic, the incidence of anxiety and depression <a href="https://doi.org/10.1001/jamapediatrics.2021.2482">doubled in youth</a>. As a result, many people are searching for <a href="https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/insights-on-utilization-of-behavioral-health-services-in-the-context-of-covid-19">new ways to cope with</a> and handle emotional turmoil. </p>
<p>On top of the pandemic, <a href="https://www.mccaininstitute.org/the-global-refugee-crisis-continuing-challenges/">conflicts around the world</a>, as well as <a href="https://www.unhcr.org/en-us/climate-change-and-disasters.html">climate change and natural disasters</a>, have contributed to the growing <a href="https://doi.org/10.1111/sipr.12028">global refugee crisis</a>. This demands resources for resettlement, education and occupation, physical health and – importantly – mental health. </p>
<p>Interventions that offer physical activity and creativity components at a time when children and people of all ages are likely to be sedentary and with reduced environmental enrichment can be <a href="https://doi.org/10.1016/j.jaac.2021.06.017">beneficial during the pandemic</a> and beyond. Creative arts and movement-based interventions may be well-suited to address not just the emotional but also the physical aspects of mental illness, such as pain and fatigue. These factors often <a href="https://dx.doi.org/10.4088%2Fpcc.v07n0405">contribute to the significant distress and dysfunction</a> that drive individuals to seek care. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/418927/original/file-20210901-15-1g6e8h3.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Neuroscientist Lana Ruvolo Grasser does a tension-and-release exercise with study participants." src="https://images.theconversation.com/files/418927/original/file-20210901-15-1g6e8h3.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/418927/original/file-20210901-15-1g6e8h3.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=597&fit=crop&dpr=1 600w, https://images.theconversation.com/files/418927/original/file-20210901-15-1g6e8h3.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=597&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/418927/original/file-20210901-15-1g6e8h3.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=597&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/418927/original/file-20210901-15-1g6e8h3.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=750&fit=crop&dpr=1 754w, https://images.theconversation.com/files/418927/original/file-20210901-15-1g6e8h3.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=750&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/418927/original/file-20210901-15-1g6e8h3.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=750&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">With outstretched arms, neuroscientist Lana Ruvolo Grasser performs a tension-and-release exercise with her study participants.</span>
<span class="attribution"><span class="source">David Dalton</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<h2>Why dance and movement therapy?</h2>
<p>Body movement in and of itself is known to have a multitude of benefits – including <a href="https://doi.org/10.1007/s11892-008-0003-4">reducing perceived stress</a>, <a href="https://doi.org/10.1038/nri3041">lowering inflammation in the body</a> and even <a href="https://theconversation.com/the-exercise-pill-how-exercise-keeps-your-brain-healthy-and-protects-it-against-depression-and-anxiety-155848">promoting brain health</a>. In fact, researchers understand that the <a href="https://www.psychologytoday.com/us/blog/beyond-words/201109/is-nonverbal-communication-numbers-game">majority of our daily communication is nonverbal</a>, and traumatic memories are encoded, or stored, in <a href="https://doi.org/10.1300/J146v04n02_02">nonverbal parts of the brain</a>. We also know that <a href="https://doi.org/10.3389/fpsyg.2021.704974">stress and trauma live in the body</a>. So it makes sense that, through guided practices, movement can be leveraged to tell stories, embody and release emotions and help people “move” forward. </p>
<p>Dance and movement therapy sessions place an emphasis on fostering creativity and adaptability in order to help people <a href="https://books.google.com/books?hl=en&lr=&id=BgMXDQAAQBAJ&oi=fnd&pg=PR1&dq=thinking+with+the+dancing+brain&ots=lMsipkiKJF&sig=L1F_sz-mZkAxamUmGWgS5jl6--M#v=onepage&q=thinking%20with%20the%20dancing%20brain&f=false">develop greater cognitive flexibility</a>, self-regulation and <a href="https://press.uchicago.edu/ucp/books/book/distributed/B/bo18074343.html">self-direction</a>. This is especially important because research shows that early-life experiences and how children learn to cope with them can <a href="https://doi.org/10.1016/j.chiabu.2019.104089">have a lasting impact</a> on their health into adulthood. </p>
<p>According to the <a href="https://childmind.org/our-impact/childrens-mental-health-report/2018report/">Child Mind Institute Children’s Mental Health Report</a>, 80% of children with anxiety disorders are not receiving the treatment they require. This might be due to barriers such as clinician availability and cultural literacy, cost and accessibility, and stigma surrounding mental health conditions and treatment. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/418928/original/file-20210901-17-oyhxys.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="An ice-breaker exercise involving tossing strings of yarn to one another" src="https://images.theconversation.com/files/418928/original/file-20210901-17-oyhxys.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/418928/original/file-20210901-17-oyhxys.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=630&fit=crop&dpr=1 600w, https://images.theconversation.com/files/418928/original/file-20210901-17-oyhxys.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=630&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/418928/original/file-20210901-17-oyhxys.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=630&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/418928/original/file-20210901-17-oyhxys.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=792&fit=crop&dpr=1 754w, https://images.theconversation.com/files/418928/original/file-20210901-17-oyhxys.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=792&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/418928/original/file-20210901-17-oyhxys.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=792&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">In this ice-breaker exercise, study participants created a dream catcher by tossing strings of yarn to one another, introducing themselves and then tossing the string to another child across the room.</span>
<span class="attribution"><span class="source">David Dalton</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>We are finding that dance and movement therapy and other group behavioral health programs can help fill important gaps. For instance, these strategies can be used in combination with services people are already receiving. And they can provide an accessible and affordable option in school and community settings. Dance and movement therapy can also instill coping skills and relaxation techniques that, once learned, can last a lifetime. </p>
<h2>But does it work?</h2>
<p>Our research and that of others are showing that dance and movement therapy can build up children’s <a href="https://digitalcommons.colum.edu/cgi/viewcontent.cgi?article=1041&context=theses_dmt">sense of self-worth</a>, improve their ability to <a href="https://doi.org/10.1007/s10465-013-9152-3">regulate their emotions and reactions</a> and <a href="https://doi.org/10.1016/j.aip.2017.02.010">empower them to overcome obstacles</a>. </p>
<p>Much like yoga and meditation, dance and movement therapy has, at the root of its practice, a focus on deep breathing through the diaphragm. This intentional breathing movement physically pushes on and activates the vagus nerve, which is a large nerve that coordinates a number of <a href="https://doi.org/10.3949/ccjm.76.s2.17">biological processes in the body</a>. When I work with kids, I call this form of breathing and nerve activation their “superpower.” Whenever they need to calm down, they can take a deep breath, and by engaging their vagus nerve, they can bring their bodies to a more restful and less reactive state. </p>
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<p>An analysis of <a href="https://doi.org/10.1016/0197-4556(96)00027-5">23 clinical research studies</a> indicated that dance and movement therapy may be an effective and appropriate method for child, adult and elderly patients experiencing a wide array of symptoms – including psychiatric patients and those with developmental disorders. And for both healthy individuals and patients, the authors concluded that dance and movement therapy was most effective for reducing the severity of anxiety compared with other symptoms. Research from our team has also <a href="https://doi.org/10.1016/j.jaac.2019.07.007">shown promise</a> for the benefits of dance and movement therapy in reducing symptoms of post-traumatic stress disorder and anxiety in youth who resettle as refugees. </p>
<p>We have scaled up these programs and brought them <a href="https://doi.org/10.1016/j.jaac.2021.06.017">into the virtual classroom</a> for six schools throughout the metro Detroit region during the pandemic.</p>
<p>Perhaps the most promising evidence for dance and movement therapy isn’t, as the saying goes, what the eyes cannot see. In this case, it is what the eyes can see: children releasing their streamers, their negative emotions and memories, waving goodbye to them and looking ahead to a new day.</p><img src="https://counter.theconversation.com/content/165745/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lana Ruvolo Grasser receives funding from the National Institute of Mental Health (F31MH120927). She is affiliated with the International Society for Traumatic Stress Studies, Anxiety and Depression Association of America, the National Science Policy Network and SciPol Detroit, the National Honor Society for Neuroscience--Nu Rho Psi--Wayne State Chapter, and Samaritas. </span></em></p>The COVID-19 pandemic and a growing global refugee crisis have shone a light on the ever-increasing need for new approaches to mental health treatment.Lana Ruvolo Grasser, Ph.D. Candidate and Graduate Research Fellow, Wayne State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1542602021-02-24T13:27:42Z2021-02-24T13:27:42ZBlack biomedical scientists still lag in research funding – here’s why that matters to all Americans<figure><img src="https://images.theconversation.com/files/381430/original/file-20210129-19594-193tb8b.jpg?ixlib=rb-1.1.0&rect=972%2C1130%2C3905%2C1936&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Black biomedical researchers receive less funding than their white counterparts.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/an-unfair-concept-of-wage-discrimination-miniature-royalty-free-image/971224314?adppopup=true">hyejin kang/iStock via Getty Images Plus</a></span></figcaption></figure><p>The statistics tell the story. People of color are more likely to be <a href="https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-race-ethnicity.html">infected, hospitalized and killed by COVID-19</a> than white, non-Hispanic people. This grim reality is just one more illustration of an unacceptable truth: Science does not benefit all Americans equally. </p>
<p>While part of the solution lies in making access to health care more equitable, I believe the key to real change is more fundamental. If science is to benefit all Americans, science first must be done by all Americans. </p>
<p>As a Black woman in America and an <a href="http://cheresearch.engin.umich.edu/eniola/">academic biomedical engineering researcher</a>, I have encountered racial, ethnic and gender discrimination and systemic racism at every stage of my life and career. Through these lived experiences, I have become deeply committed to addressing the “diversity problem” in the academic research enterprise. </p>
<h2>What is the cause of the health care disparity problem?</h2>
<p>White Americans continue to perform the vast majority of scientific research that leads to treatments and therapies for all Americans. Among my profession’s 1,700 biomedical engineering faculty – a group responsible for innovating medical technology – <a href="https://ira.asee.org/wp-content/uploads/2021/01/Binder1.pdf">only 34 are Black</a>. </p>
<p>More broadly, Black people account for only about <a href="https://ncses.nsf.gov/pubs/nsf19304/data">3% of U.S. scientific faculty</a>, despite representing over <a href="https://data.census.gov/cedsci/profile?q=United%20States&g=0100000US">13% of the U.S. population</a>.</p>
<h2>Why did prior diversification efforts fail biomedical researchers?</h2>
<p>Attempts to <a href="https://doi.org/10.1002/msj.21310">diversify biomedical</a> professions through better recruitment in federal programs like the <a href="https://www.nigms.nih.gov/training/RISE/Pages/RISEFAQ.aspx">Research Initiative for Scientific Enhancement</a> programs are laudable. Still, minority students remain <a href="https://doi.org/10.1371/journal.pone.0114736">40% to 50% less interested in an academic career</a> after graduation. </p>
<p>These “filling the pipeline” approaches have failed to answer an equally vital question: How is our country taking care of the underrepresented minorities already involved in science? The answer, in my opinion, is not very well. And the proof can be summarized in one word: funding. </p>
<p>A survey of funding from the National Institutes of Health, by far the largest funder of scientific research in the United States, found that <a href="https://doi.org/10.1126/science.1196783">Black applicants were 10% less likely to be awarded grants</a> than their white counterparts when controlling for other factors, such as educational background and publication record. This active discrimination leaves <a href="https://doi.org/10.1126/sciadv.aaz4868">Black faculty with less money for their research</a>. </p>
<p>In a <a href="https://doi.org/10.1016/j.cell.2021.01.011">recently published commentary</a> in the journal Cell, led by <a href="https://bioe.uw.edu/portfolio-items/kelly-stevens/">Dr. Kelly Stevens</a> and me, we highlight that this funding disparity between Black and white biomedical scientists remains unchanged despite every effort dedicated to <a href="https://doi.org/10.1126/sciadv.aaz4868">understanding the gap</a>.</p>
<p>We argue that the <a href="https://doi.org/10.7554/eLife.65697">NIH leadership has failed to fix</a> this discriminatory funding practice. As a result, Black scientists commonly do not reach the research funding required for promotion and tenure and <a href="https://doi.org/10.1089/jwh.2007.0582">are pushed out of academia</a>. </p>
<figure class="align-center ">
<img alt="Black woman writing formulas on a board." src="https://images.theconversation.com/files/385073/original/file-20210218-15-6m7dpv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/385073/original/file-20210218-15-6m7dpv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/385073/original/file-20210218-15-6m7dpv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/385073/original/file-20210218-15-6m7dpv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/385073/original/file-20210218-15-6m7dpv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/385073/original/file-20210218-15-6m7dpv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/385073/original/file-20210218-15-6m7dpv.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">Black students need to see scientists who look like themselves to know that they can enter those professions.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/writing-mathematical-formulas-on-transparent-wipe-royalty-free-image/925114826?adppopup=true">Pekic/E+/Getty Images</a></span>
</figcaption>
</figure>
<h2>Why should you care?</h2>
<p>When Black scientists leave, their perspective is lost from the conversation. They can’t contribute questions that researchers from other ethnic backgrounds wouldn’t ask. And they aren’t able to find treatments for diseases that predominantly affect their own Black families or challenge the prevalent racist ideas and policies that continue to persist in science.</p>
<p>The cycle is vicious. The real-world consequences of Black faculty absence in biomedical research go far beyond the lab – and can be lethal. Take the case of <a href="https://theconversation.com/more-health-inequality-black-people-are-3-times-more-likely-to-experience-pulse-oximeter-errors-152359">pulse oximeters</a> used for at-home monitoring during COVID-19. <a href="https://www.nytimes.com/2020/12/22/health/oximeters-covid-black-patients.html">Among Blacks, these devices are three times more likely to inaccurately</a> measure blood oxygen levels than among white people.</p>
<p>In addition, consider a New York state investigation into a discriminatory algorithm that <a href="https://www.wsj.com/articles/researchers-find-racial-bias-in-hospital-algorithm-11571941096?mod=article_inline">recommended higher-quality care to white patients than to Black ones who were sicker</a>. </p>
<p>It is no wonder that Black people <a href="https://time.com/5925074/black-americans-covid-19-vaccine-distrust/">often distrust health care and science</a> and their lifesaving products – such as the COVID-19 vaccine. </p>
<p>There’s more. When Black scientific faculty leave institutions, they aren’t in the classroom to show Black students that they too belong in the prestigious work of science and medicine. <a href="https://www.sciencedaily.com/releases/2019/04/190416170914.htm">Minorities persist in science</a> when they see people like themselves.</p>
<p>[<em>Deep knowledge, daily.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=deepknowledge">Sign up for The Conversation’s newsletter</a>.]</p>
<p>Instead, these students leave the science and engineering classroom, are left out of high-paying professions and, as a result, turn to lower-paying, front-line jobs that are more vulnerable to COVID-19. The lower wage fuels the racial wealth gap that can force Blacks into violent police encounters, as <a href="https://www.nytimes.com/2020/05/31/us/george-floyd-investigation.html">George Floyd</a> experienced. </p>
<h2>What are the new ways society can fix the problem?</h2>
<p>The NIH has known about the funding disparity bias against Black researchers since 2011, and still, it persists. <a href="https://doi.org/10.1016/j.cell.2021.01.011">In our commentary in Cell</a>, we implore the NIH to admit its system upholds structural racism and pursue funding equity immediately. We estimate, based on the <a href="https://advances.sciencemag.org/content/6/23/eaaz4868">fraction of Black scientists in the NIH applicant pool</a>, that it will cost the NIH only US$32 million of its $40 billion annual budget to close the funding gap. We are still waiting to hear NIH leadership’s response to the commentary.</p>
<p>President Joe Biden has tasked the country’s <a href="https://science.sciencemag.org/content/371/6528/452.full">new scientific leadership</a> with determining how government can guarantee that the fruits of science and technology are shared across America and among all Americans. To realize this goal, public and private entities must take a simple first step: fund Black scientists.</p>
<p>Fortunately Black biomedical engineering faculty don’t need to wait for the wheels of justice to turn through sluggish federal agencies. <a href="https://www.cnbc.com/2020/06/11/companies-are-making-bold-promises-about-greater-diversity-theres-a-long-way-to-go.html">Businesses made big promises</a> to do more over the summer to build a more equal and just society. Here’s one thing the private sector can do: Take immediate action and provide that $32 million to offset the racial disparity in NIH funding.</p>
<p>Biotech company Genentech has stepped up to this challenge by funding a $500,000 <a href="https://www.gene.com/stories/giving-for-a-more-just-healthcare-system">grant</a> to the University of Michigan toward closing the racial gap in NIH research funding to our nationwide network of U.S. biomedical engineering faculty. This is innovative leadership.</p>
<p>The health of millions of Americans and the vibrancy of the science-based economy are at stake.</p><img src="https://counter.theconversation.com/content/154260/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Omolola Eniola-Adefeso receives funding from the National Science Foundation; National Institutes of Health, and the American Heart Association. She serves as the Chief Technology Officer for Asalyxa Bio, Inc.</span></em></p>There aren’t just health care disparities between white and Black people. There are funding disparities too that make it harder for Black scientists to succeed in academia.Omolola Eniola-Adefeso, University Diversity and Social Transformation Professor of Chemical Engineering, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1343192020-03-26T12:16:19Z2020-03-26T12:16:19ZLabs are experimenting with new – but unproven – methods to create a coronavirus vaccine fast<figure><img src="https://images.theconversation.com/files/323031/original/file-20200325-168907-39lsn8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">There are many ways to make a vaccine. In a time of crisis, the more paths towards success the better</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/close-up-of-gloved-hands-holding-syringe-and-virus-royalty-free-image/1212577954?adppopup=true">Adriana Duduleanu / EyeEm via Getty Images</a></span></figcaption></figure><p><em>Leer en <a href="https://theconversation.com/que-tipo-de-vacunas-estan-desarrollando-los-laboratorios-contra-el-coronavirus-135592">español</a></em></p>
<p>The coronavirus has ground social, economic and educational exchanges to a halt around the world. For now, public health officials are relying on tools like social distancing to minimize the harm of the virus, but in the long term, a COVID-19 vaccine is the best hope of a return to normalcy.</p>
<p>It <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/zika-virus-response-updates-fda">normally takes a few years to development a vaccine</a>, but in the face of the coronavirus, biotechnology companies and regulatory agencies are taking aggressive steps to make a COVID-19 vaccine widely available sooner than that. </p>
<p>I <a href="https://peccoud.org/">study biomanufacturing and synthetic biology</a>, and it is fascinating to watch this unprecedented effort push at the limits of vaccine development. Public and private labs around the world are pursuing cutting-edge vaccine engineering strategies that have never been tested on such a large scale. If these efforts succeed, the vaccine would become an essential tool to fight or prevent future COVID epidemics. </p>
<h2>How vaccines work</h2>
<p>The first time the body is exposed to a new virus, <a href="https://www.cdc.gov/flu/prevent/keyfacts.htm">it takes weeks to build antibodies and other defense mechanisms</a> that will fight it off. This gives the virus plenty of time to replicate and make someone sick.</p>
<p>However, the immune system has memory. If it has encountered a virus before, the body can quickly deploy its defenses against the invader and neutralize the virus before a full infection develops.</p>
<p>This is the idea behind vaccines: give the body an opportunity to build defenses against a virus it may encounter in the future. Not all vaccines produce the <a href="https://www.ncbi.nlm.nih.gov/pubmed/9855432">same level of immunological preparedness</a> – the stronger the initial immune response, the better the vaccine – but some preparation is better than none.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/323043/original/file-20200325-168889-1r37mj7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/323043/original/file-20200325-168889-1r37mj7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/323043/original/file-20200325-168889-1r37mj7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=458&fit=crop&dpr=1 600w, https://images.theconversation.com/files/323043/original/file-20200325-168889-1r37mj7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=458&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/323043/original/file-20200325-168889-1r37mj7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=458&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/323043/original/file-20200325-168889-1r37mj7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=576&fit=crop&dpr=1 754w, https://images.theconversation.com/files/323043/original/file-20200325-168889-1r37mj7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=576&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/323043/original/file-20200325-168889-1r37mj7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=576&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Vaccines have been around for nearly 150 years, and until recently, the science hasn’t fundamentally changed.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Vaccine-Opposition-History/30ff2f6680e941ee9c6dd66c1cb9c951/1/0">AP Photo/File</a></span>
</figcaption>
</figure>
<p>The traditional way of developing a vaccine is to grow and inject patients with inactivated viruses. These don’t make you sick, but once exposed to these “dead” viruses, the immune system will have the weapons to fight off that virus in the future, if it needs to.</p>
<p>Unfortunately, figuring out how to grow a new virus on an industrial scale is complicated, and once done, the process itself is often slow, difficult and potentially risky. For example, the flu vaccine is produced by growing the virus in millions of chicken eggs. The process takes four months. In addition, when dealing with a virus for which there is no drug or vaccine, it is safer to avoid growing it in large quantities for fear that it might accidentally leak out of the factory and make the situation even worse than it already is.</p>
<p>With the coronavirus literally making time a matter of life and death, <a href="https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker">nearly 50 public and private labs</a> are turning to newer, safer and faster methods to develop a coronavirus vaccine. </p>
<h2>Protein-based vaccines</h2>
<p>Rather than injecting the whole virus, it is possible to vaccinate a person with a single virus component. The pieces most commonly used are proteins from the surface of a virus. If a live virus enters the body, these surface proteins are easily recognized by the immune system. This approach is easier, faster and safer because the virus protein can be produced in cell cultures.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/323024/original/file-20200325-168918-dqvp4t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/323024/original/file-20200325-168918-dqvp4t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/323024/original/file-20200325-168918-dqvp4t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/323024/original/file-20200325-168918-dqvp4t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/323024/original/file-20200325-168918-dqvp4t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/323024/original/file-20200325-168918-dqvp4t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/323024/original/file-20200325-168918-dqvp4t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/323024/original/file-20200325-168918-dqvp4t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">By using proteins from the surface of the virus, it is possible to vaccinate a person without going through the complicated process of growing a dangerous virus.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/coronavirus-3d-realistic-model-isolated-on-royalty-free-illustration/1211861940?adppopup=true">ayvengo/iStock/Getty Images Plus via Getty Images</a></span>
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<p>Two companies, <a href="http://www.pharmatimes.com/news/sanofi_to_repurpose_sars_vaccine_candidate_for_coronavirus_1326473">Sanofi</a> and <a href="https://ir.novavax.com/news-releases/news-release-details/novavax-advances-development-novel-covid-19-vaccine">Novawax</a>, are both developing <a href="https://science.sciencemag.org/content/367/6483/1260">protein vaccines based on the SARS-CoV-2 spike</a> protein, the tower-shaped structures on the surface of the new coronavirus that causes COVID-19.</p>
<p>Protein-based vaccines, also known as recombinant vaccines, are already used to <a href="https://www.who.int/biologicals/vaccines/human_papillomavirus_HPV/en/">vaccinate against viral infections like HPV</a>. They are far simpler to produce compared to traditional whole-virus vaccines, but it can still take a year to develop a new process and several weeks to produce the vaccine after the manufacturing process has been developed. The world needs something faster.</p>
<h2>Gene-based vaccines</h2>
<p>Theoretically, the simplest and fastest way to make a vaccine would be to have a person’s own cells produce minute quantities of the viral protein that trigger an immune response. To do that researchers are turning to genetics.</p>
<p>The first genetic approach uses DNA. A single gene that codes for a protein from the coronavirus is injected into the patient’s cells in the hopes that a small fraction of the DNA molecules will find their way into the cell nucleus. There they would be copied into an RNA molecule which is then read by the cell to produce the viral protein. But it is difficult to get the human body to produce enough protein using this approach. Frequently, very little DNA makes it to the cell nucleus and the cell does not produce the protein in sufficient quantity to trigger a strong enough immune response. </p>
<p>As of yet, there are <a href="https://dx.doi.org/10.3390%2Fijms19113605">no DNA vaccines currently approved by the FDA</a> for human use and the success of this method has been limited. But there is promise. In 2016, several groups developed candidate <a href="https://www.technologyreview.com/s/602073/us-government-starts-test-of-zika-vaccine-in-humans/?set=602081">Zika vaccines using this technology</a> and at least one company, <a href="http://ir.inovio.com/news-and-media/news/press-release-details/2020/INOVIO-Receives-New-5-Million-Grant-to-Accelerate-Scale-Up-of-Smart-Delivery-Device-for-Its-COVID-19-Vaccine/default.aspx">INOVIO Pharmaceuticals, Inc.</a> is developing <a href="https://www.researchsquare.com/article/rs-16261/v1">INO-4800</a>, a DNA vaccine candidate for the coronavirus.</p>
<p>The bottleneck of DNA vaccines is getting the DNA to the nucleus to be transcribed into RNA. Vaccines that use RNA directly might be able to overcome this problem. Since RNA is translated into proteins as soon as it enters the cell, this approach <a href="https://doi.org/10.1038/nrd.2017.243">results in stronger immune responses</a> than DNA vaccines. However, RNA breaks down faster than DNA.</p>
<p>This has not deterred a number of companies from trying it though. <a href="https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19">Notable in the U.S. is Moderna</a>, and on March 16, the National Institutes of Health <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participant-dosed-nih-led-phase-1-study">started a clinical trial</a> of Moderna’s lead coronavirus vaccine candidate, mRNA-1273.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/323048/original/file-20200325-168894-1itau83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/323048/original/file-20200325-168894-1itau83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/323048/original/file-20200325-168894-1itau83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/323048/original/file-20200325-168894-1itau83.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/323048/original/file-20200325-168894-1itau83.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/323048/original/file-20200325-168894-1itau83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/323048/original/file-20200325-168894-1itau83.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/323048/original/file-20200325-168894-1itau83.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">On March 16, 2020, Jennifer Haller of Seattle, Wash., became the first person to try Moderna’s experimental RNA vaccine.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/APTOPIX-Virus-Outbreak-Vaccine/6edb4126639e4c1b970ba42a45a4c226/18/0">AP Photo/Ted S. Warren</a></span>
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<p>Manufacturing DNA and RNA relies on standardized and fairly simple processes. <a href="https://doi.org/10.1089/hum.2017.159">DNA vaccines are produced in bacteria</a> that grow overnight while <a href="https://doi.org/10.1016/j.smim.2013.05.001">RNA vaccines are produced in test tubes</a> using a biochemical reaction that only takes hours. Gene-based vaccines could be produced extremely quickly compared to traditional or protein-based vaccines. </p>
<h2>Friendly virus vaccines</h2>
<p>The main issue with gene-based vaccines is getting the DNA or RNA to where it needs to be. One elegant way to solve this challenge is to use a harmless virus as a delivery system. Viruses are extremely good at penetrating cells; once inside, a virus with genes from SARS-CoV-2 could use the machinery of the cell to produce proteins to trigger an immune response for the coronavirus. </p>
<p>This technique is being pursued by a few companies around the world. For example, Hong Kong-based <a href="https://gmpnews.net/2020/03/cansino-bio-is-starting-human-testing-of-a-recombinant-vaccine-against-covid-19/">CanSino Biologics</a> is inserting the coronavirus gene that codes for the spike protein into an <a href="https://www.cdc.gov/adenovirus/index.html">adenovirus</a>. They used this strategy to produce the <a href="https://dx.doi.org/10.1080%2F21645515.2018.1473698">first government-approved Ebola vaccine</a>, and clinical trials of an engineered adenovirus that would protect against the coronavirus have already started in China.</p>
<p>The production of vaccines delivered by harmless viruses is slower than producing DNA or RNA vaccines because it involves the culture of slow-growing mammal cells. However, like the production of gene-based vaccines, they rely on existing processes that take advantage of viruses that have been optimized for manufacturing.</p>
<h2>Containing the epidemic with imperfect vaccines</h2>
<p>While the pace of COVID-19 vaccine development is unprecedented, the timeline to mass vaccination still remains uncertain. While the large number of approaches being pursued may give the impression of desperation and confusion, it is actually reassuring. This multipronged approach is a way to hedge the vaccine development bet.</p>
<p>It is unlikely the first vaccines developed will be 100% effective and easy to produce on a massive scale. Realistically, researchers will develop a number of good-enough vaccines that can be produced using different kinds of manufacturing infrastructures. While these vaccines <a href="https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm">may at first have a limited efficacy</a>, the diversity in manufacturing processes will allow companies to make and distribute them quickly, buying time and helping <a href="https://doi.org/10.1093/cid/cir007">contain the current epidemic and prevent future outbreaks</a>.</p>
<p>[<em>Get facts about coronavirus and the latest research.</em> <a href="https://theconversation.com/us/newsletters?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=upper-coronavirus-facts">Sign up for our newsletter.</a>]</p><img src="https://counter.theconversation.com/content/134319/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jean Peccoud holds an equity stake in GenoFAB Inc., a company that may benefit or may be perceived to benefit from the publication of this article. He receives funding from the National Institutes of Health and the National Science Foundation. </span></em></p>Under pressure to develop a coronavirus vaccine, researchers have turned to protein synthesis, genetics and hybrid viruses. It is likely a mix of these approaches will be used to fight the coronavirus.Jean Peccoud, Professor, Abell Chair in Synthetic Biology, Colorado State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1000582018-07-18T18:23:20Z2018-07-18T18:23:20ZNew treatment in the works for disfiguring skin disease, vitiligo<figure><img src="https://images.theconversation.com/files/227851/original/file-20180716-44082-1mly053.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">This African woman suffers from an autoimmune disease called vitiligo which causes the loss of skin pigment.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/beautiful-african-girl-studio-skin-problems-1017272866">By andreonegin/shutterstock.com</a></span></figcaption></figure><p>In many parts of the world there is great shame and stigma tied to vitiligo, an autoimmune disease of the skin that causes disfiguring white spots, which can appear anywhere on the body. In some societies, individuals with vitiligo, and even their family members, are shunned and excluded from arranged marriages. The rejection is so crippling that one person suffering from the disease even requested an <a href="http://doi.org/10.1016/S0140-6736(14)60763-7">amputation of his forearm affected by vitiligo</a> because he could marry with only one arm, but could not with vitiligo.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/228080/original/file-20180717-44088-1899kjq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/228080/original/file-20180717-44088-1899kjq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/228080/original/file-20180717-44088-1899kjq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=428&fit=crop&dpr=1 600w, https://images.theconversation.com/files/228080/original/file-20180717-44088-1899kjq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=428&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/228080/original/file-20180717-44088-1899kjq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=428&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/228080/original/file-20180717-44088-1899kjq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=538&fit=crop&dpr=1 754w, https://images.theconversation.com/files/228080/original/file-20180717-44088-1899kjq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=538&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/228080/original/file-20180717-44088-1899kjq.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">John Harris and his team engineered mice that developed vitiligo so that they can test new treatments for the disease. Depigmentation is visible on the mouse’s ears, feet, and tail.</span>
<span class="attribution"><span class="source">John Harris</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>I am a physician-scientist and director of the <a href="https://www.umassmed.edu/vitiligo/">Vitiligo Clinic and Research Center</a> at the University of Massachusetts Medical School and I’ve witnessed my patients’ suffering and depression. Some are so ashamed of how they look; they refuse to leave their homes in daylight, they quit their jobs, and they lose relationships. Some of those afflicted with vitiligo have committed suicide. </p>
<p>I began studying vitiligo in 2008 because this devastating condition affects about one percent of all people – over 75 million worldwide – and patients deserve better treatments. In a recent report published in Science Translational Medicine <a href="http://doi.org/10.1126/scitranslmed.aam7710">we describe a new therapy</a> that is showing particular promise in mice with this disease.</p>
<h2>Your skin has a memory</h2>
<p>Existing treatments such as topical steroids and light therapy, which are used “off-label” because they have not been FDA-approved to treat vitiligo, can be effective for patients. These treatments reverse the disease by stimulating brown spots to appear around hair follicles within the affected white patches of skin. As these brown spots increase in number and size they merge until the white patch is replaced with normal skin color. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/228079/original/file-20180717-44091-1ody9jz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/228079/original/file-20180717-44091-1ody9jz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/228079/original/file-20180717-44091-1ody9jz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/228079/original/file-20180717-44091-1ody9jz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/228079/original/file-20180717-44091-1ody9jz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/228079/original/file-20180717-44091-1ody9jz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/228079/original/file-20180717-44091-1ody9jz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/228079/original/file-20180717-44091-1ody9jz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Current treatments for vitiligo involve stimulating pigment cell regrowth from the hair follicles, which results in brown dots around the hairs. As these brown dots grow and merge, the white patches disappear.</span>
<span class="attribution"><span class="source">John Harris</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>This takes between one and two years, depending on the location of the body being treated. However, in most cases the white spots reappear at the same location, often within just one year after stopping the treatments. This recurrence can be just as devastating as when the white patches first appeared.</p>
<p>We wanted to find out why these spots reappear. Our research team suspected that “memory” forms within the skin when the white spots first appear, so that the spots “know” where to return when treatments are stopped. Working separately, we and three other laboratories led by <a href="https://ki.se/en/people/liveid">Liv Eidsmo</a>, <a href="https://geiselmed.dartmouth.edu/faculty/facultydb/view.php/?uid=2872">Mary Jo Turk</a>, and <a href="http://u1035-inserm.fr/en/profile/julien-seneschal">Julien Seneschal</a> searched for the source of this memory in the skin. </p>
<p>These <a href="http://doi.org/10.1016/j.immuni.2017.01.009">three </a><a href="http://doi.org/10.1126/sciimmunol.aam6346">other</a> <a href="http://doi.org/10.1016/j.jid.2017.08.038">labs</a> first found cells in vitiligo skin from mice or humans that looked a lot like the memory cells that protect the skin from a second exposure to a viral infection, suggesting that the body “thinks” it is fighting a viral infection when it “misfires” at the patient’s normal cells, killing the pigment-producing cells in the skin called melanocytes and causing vitiligo. These cells are called “resident memory T cells.” </p>
<p>Because immune responses to a virus act in a similar way to immune responses that cause autoimmune diseases, it seemed reasonable that these cells might also be the source of this remaining disease memory in the skin. </p>
<h2>Disease memory can be erased with new treatment</h2>
<p>We used a technique called <a href="http://doi.org/10.1016/j.jaad.2016.12.021">skin blistering</a> to isolate skin and skin fluid directly from the spots of my vitiligo patients and isolate the disease-causing memory cells so we could analyze them more closely. Similar to the other labs, we also found the virus-like memory cells, and we were able to also determine that these cells specifically targeted the melanocytes. We hypothesized that if we could remove these memory cells from the skin using a new treatment, then treatments to repigment the skin would be long-lasting and possibly permanent. </p>
<p>We then tested our hypothesis on mice we specifically engineered to develop vitiligo. Like humans, mice also have memory T-cells so we looked for their “Achilles heel” to see if we could knock them out without harming other cells. Our team figured out that the vitiligo-causing memory cells require a special protein called “IL-15” to survive. We injected the vitiligo mice with an antibody that blocks the IL-15 protein from interacting with the memory cells.</p>
<p>After just a few weeks we <a href="http://doi.org/10.1126/scitranslmed.aam7710">discovered</a> that the treatment wiped out the memory cells from the mouse skin, allowing the brown pigment to return in a spotty pattern, just as we see in patients who respond to therapy. Importantly, just two weeks of antibody treatments caused repigmentation that lasted for months, suggesting this strategy, unlike existing treatments, might provide long-term benefit for vitiligo patients. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/228081/original/file-20180717-44079-oa5rwf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/228081/original/file-20180717-44079-oa5rwf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/228081/original/file-20180717-44079-oa5rwf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=138&fit=crop&dpr=1 600w, https://images.theconversation.com/files/228081/original/file-20180717-44079-oa5rwf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=138&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/228081/original/file-20180717-44079-oa5rwf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=138&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/228081/original/file-20180717-44079-oa5rwf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=174&fit=crop&dpr=1 754w, https://images.theconversation.com/files/228081/original/file-20180717-44079-oa5rwf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=174&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/228081/original/file-20180717-44079-oa5rwf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=174&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">On the left is a mouse with vitiligo that received control antibody. After 12 weeks the tail remained white, without pigment. The mouse on the right also had vitiligo but was treated with the antibody to block IL-15 signaling. Twelve weeks later the tail was largely repigmented.</span>
<span class="attribution"><span class="source">John Harris</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<h2>Human clinical trials may begin next summer</h2>
<p>During our study we also found that the vitiligo-causing memory T-cells in both mouse and human skin seem to require IL-15 more than other types of T cells – which means they are more sensitive to levels of this protein. This is important because it means we might be able to selectively remove the vitiligo-causing cells without harming other important immune cells too. In the treated mice, the vitiligo-causing cells became undetectable, but the other T-cells responsible for fighting infection remained unharmed and present, suggesting that our antibody therapy might be safer for the immune system than first thought. </p>
<p>Based on these results, we are working with the National Institutes of Health-funded <a href="https://www.immunetolerance.org">Immune Tolerance Network</a> (ITN) to develop a <a href="https://www.umassmed.edu/vitiligo/">clinical trial</a> to test this antibody treatment in human patients. We are hopeful that we can begin recruiting patients next summer. </p>
<p>Although this antibody drug has only been proven to work in mice with vitiligo, we are excited to <a href="https://www.umassmed.edu/vitiligo/">test it in humans</a> because it could represent a significant advance over existing treatments. The partnership with the ITN will allow us not only to test whether it works for vitiligo patients, but also how it works. This will help us know when and in whom to use this new therapy.</p><img src="https://counter.theconversation.com/content/100058/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>John Harris receives funding from the National Institutes of Health (NIH).</span></em></p>An autoimmune disease called vitiligo causes white spots to appear on the body, in some cases completely erasing an individual’s pigmentation. But a new therapy is on the horizon.John Harris, Associate Professor of Dermatology, UMass Chan Medical SchoolLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/778382017-05-19T01:00:45Z2017-05-19T01:00:45ZTrump’s global gag order: 5 questions answered<figure><img src="https://images.theconversation.com/files/169611/original/file-20170516-11920-18ugjes.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Community health workers like these visit patients’ homes in Malawi to help prevent mother-to-child transmission of HIV. </span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/usaid_images/14929179975/in/photolist-fpbMUp-aQMAYZ-dCxeUD-aSur7V-b3R1Rt-b3R2oX-dEVMyy-b3R27a-dRQPAZ-6ZtchW-hgsjEG-5bwcvw-9Ew4ZB-9Ui5Dt-dAYLds-oKeX3F-dU2Dh3-qFoYn-dw9Hnp-dEBboS-fgvYov-aQMAZ6-bEyXDR-aMxvhD-fgLeJY-qbViAL-cni9zU-hHrpg9-hHqXKb-c2XNWA-aRwNcx-oERaPx-u7rF96-hHrKFM-945Zp6-fokQm2-oFmDXh-9W2YA2-4v8yRi-cE9xzJ-oKeX5K-fEQHxX-9VxEus-hHqCbR-dw9fng-cE9bkd-bmCsUq-9VuPrz-dEQncT-kXqimY/">Baylor College of Medicine Children's Foundation–Malawi/Chris Cox</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span></figcaption></figure><p><em>Editor’s note: President Donald Trump recently signed an executive order that media reports say could obstruct nearly US$8.8 billion the U.S. spends annually to <a href="http://khn.org/morning-breakout/trumps-abortion-gag-rule-will-block-8-8b-in-aid-to-fight-malaria-aids-and-other-diseases/">fight deadly diseases abroad</a>. Here, Maureen Miller, a Columbia University Medical Center professor and infectious disease epidemiologist with training in medical anthropology, answers five questions about this move, including what it has to do with abortion.</em></p>
<h2>1. What’s at stake?</h2>
<p>Three of the biggest killers in the developing world are AIDS, tuberculosis and malaria. Currently 36.7 million people are <a href="http://www.unaids.org/sites/default/files/media_asset/global-AIDS-update-2016_en.pdf">living with HIV/AIDS</a>, a third of the world’s population is <a href="https://www.cdc.gov/tb/statistics/">infected with tuberculosis</a> and more than one million people <a href="https://www.unicef.org/health/files/health_africamalaria.pdf">die from malaria</a> each year.</p>
<p>Trump’s executive order endangers $6.8 billion in annual funding for the <a href="https://www.pepfar.gov/funding/budget/index.htm">President’s Emergency Plan for AIDS Relief</a>. Former President George W. Bush created this initiative, known as PEPFAR, to help save the lives of people suffering from HIV/AIDS. </p>
<p>The U.S. put <a href="http://kff.org/global-health-policy/fact-sheet/u-s-federal-funding-for-hivaids-trends-over-time/">$1.35 billion</a> of that money into the the Global Fund to Fight AIDS, Tuberculosis and Malaria last year. This independent organization is the largest entity dedicated to preventing and treating these diseases. The U.S., its top donor, covers half <a href="http://kff.org/global-health-policy/fact-sheet/the-u-s-the-global-fund-to-fight-aids-tuberculosis-and-malaria/">the Global Fund’s operating costs</a>, but that represents only a quarter of what our nation spends to fight these diseases internationally. Some $600 million in family planning aid is affected, as is <a href="https://theconversation.com/will-trumps-global-family-planning-cuts-cause-side-effects-75813">other spending</a> slated for global health. </p>
<p>Although I follow these issues closely, I have been unable to find a complete breakdown of the widely reported <a href="http://khn.org/morning-breakout/trumps-abortion-gag-rule-will-block-8-8b-in-aid-to-fight-malaria-aids-and-other-diseases/">$8.8 billion affected</a>.</p>
<p>Women compose <a href="http://Aidsinfo.unaids.org">51 percent of the people living with HIV/AIDS</a> worldwide. Since 60 percent of the people with the virus in sub-Saharan Africa are women, they may bear the brunt of this move. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/169610/original/file-20170516-11945-en0mnh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/169610/original/file-20170516-11945-en0mnh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/169610/original/file-20170516-11945-en0mnh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/169610/original/file-20170516-11945-en0mnh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/169610/original/file-20170516-11945-en0mnh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=425&fit=crop&dpr=1 754w, https://images.theconversation.com/files/169610/original/file-20170516-11945-en0mnh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=425&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/169610/original/file-20170516-11945-en0mnh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=425&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Eunice Adhiambo, an HIV-positive Kenyan woman, and her HIV-negative daughter Jyll.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/usaidafrica/9451379699/in/photolist-fpbMUp-aQMAYZ-dCxeUD-aSur7V-b3R1Rt-b3R2oX-dEVMyy-b3R27a-dRQPAZ-6ZtchW-hgsjEG-5bwcvw-9Ew4ZB-9Ui5Dt-dAYLds-oKeX3F-dU2Dh3-qFoYn-dw9Hnp-dEBboS-fgvYov-aQMAZ6-bEyXDR-aMxvhD-fgLeJY-qbViAL-cni9zU-hHrpg9-hHqXKb-c2XNWA-aRwNcx-oERaPx-u7rF96-hHrKFM-945Zp6-fokQm2-oFmDXh-9W2YA2-4v8yRi-cE9xzJ-oKeX5K-fEQHxX-9VxEus-hHqCbR-dw9fng-cE9bkd-bmCsUq-9VuPrz-dEQncT-kXqimY">Riccardo Gangale/USAID Kenya</a></span>
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<h2>2. How does the US support global efforts to fight and treat HIV/AIDS?</h2>
<p>PEPFAR, primarily implemented through USAID, the National Institutes of Health and the Centers for Disease Control and Prevention, emphasizes improving the health of women, newborns and children. Among its biggest achievements has been integrating AIDS relief and reproductive health services, since HIV is transmitted primarily through unprotected sex. </p>
<p>Until now, PEPFAR has commanded broad bipartisan support, perhaps due to its well-documented success. For the first time since the HIV/AIDS epidemic began in the 1980s, new HIV infections in sub-Saharan Africa – which accounts for <a href="http://aidsinfo.unaids.org/">almost two-thirds</a> of all people living with HIV/AIDS – <a href="http://www.unaids.org/sites/default/files/media_asset/global-AIDS-update-2016_en.pdf">are decreasing</a>. Former President Bush, who <a href="http://www.reuters.com/article/us-africa-bush-idUSKBN1761LJ">traveled to Botswana and Namibia</a> in April, still champions the program.</p>
<h2>3. How is global health aid connected to abortion?</h2>
<p>An estimated <a href="http://kff.org/global-health-policy/fact-sheet/the-u-s-government-and-international-family-planning-reproductive-health-efforts/">303,000 women</a>, primarily in developing countries, die yearly from complications due to pregnancy, childbirth and abortion, and those are the <a href="http://www.who.int/mediacentre/news/releases/2017/yearly-adolescent-deaths/en/">leading causes of death</a> among adolescent girls globally. Approximately one-third of maternal deaths could be prevented if all women had access to effective contraception.</p>
<p>The U.S. is the <a href="http://kff.org/global-health-policy/fact-sheet/the-u-s-government-and-international-family-planning-reproductive-health-efforts/">world’s largest supporter</a> of family planning and reproductive health services. It is also one of the largest purchasers and distributors of contraceptives. <a href="http://kff.org/global-health-policy/fact-sheet/the-u-s-government-and-international-family-planning-reproductive-health-efforts/">No federal funds have paid for abortions</a>, however, since 1973 – either internationally or at home. All nongovernmental organizations receiving U.S. support must agree to this policy.</p>
<p>In 1984, the Reagan administration expanded those restrictions by denying U.S. family-planning money to entities that performed abortions or promoted the practice. Subsequent Democratic presidents lifted this restriction, known either as the “<a href="http://kff.org/global-health-policy/fact-sheet/mexico-city-policy-explainer/">Mexico City policy</a>” or the “global gag rule,” while Republican presidents reinstated it.</p>
<p>Trump framed his new order as “<a href="https://www.state.gov/r/pa/prs/ps/2017/05/270866.htm">Protecting Life in Global Health Assistance</a>,” but it’s unlikely to reduce the number of abortions performed in poor countries. A <a href="http://www.who.int/bulletin/volumes/89/12/11-091660/en/">2011 study by Stanford University researchers</a> found that abortion rates in sub-Saharan African countries rose when the standard restrictions were in force from 2001 to 2008. </p>
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<h2>4. How does Trump’s action stray from Republican precedents?</h2>
<p>The Trump administration has expanded the policy’s reach, broadening it to encompass all foreign health care providers that receive U.S. funding rather than only those that get family planning dollars. For example, any group that does sexual health education to prevent the spread of HIV and also informs women that abortion is legal where they live will <a href="https://www.statnews.com/2017/05/16/mexico-city-policy-global-health-funding/">lose their U.S. support</a>. They would have remained eligible for that money had Trump followed the pattern set by the past three Republican administrations.</p>
<p>The exact repercussions are unknown. The <a href="https://www.state.gov/r/pa/prs/ps/2017/05/270879.htm">State Department</a>, under Rex Tillerson’s leadership, plans to review the impact within six months.</p>
<h2>5. Can other donors bridge the gaps?</h2>
<p>It’s unclear which organizations will agree to these new restrictive terms or what will happen to spending. The administration says it <a href="https://www.state.gov/r/pa/prs/ps/2017/05/270879.htm">will redistribute funds</a> from organizations that refuse to comply to those that will. </p>
<p>But those other groups may not exist. As Johnathan Rucks of the <a href="https://www.nytimes.com/2017/05/15/us/politics/trump-gag-rule-abortion.html?rref=collection%2Fbyline%2Fgardiner-harris&action=click&contentCollection=undefined&region=stream&module=stream_unit&version=latest&contentPlacement=2&pgtype=collection">global health group PAI</a> told The New York Times: “It’s not like we have an influx of providers in places like West Africa.” </p>
<p>Given the limited alternatives, the number of unmet health needs will surely rise, particularly for women and children. In March, other governments and private funders announced they had raised <a href="http://www.npr.org/sections/goatsandsoda/2017/03/02/517959453/-190-million-raised-to-fill-aid-gap-left-by-trumps-abortion-rule">$190 million for international family planning</a> to narrow the anticipated gap caused by the Trump administration’s policies. Now, that’s probably just a drop in the bucket of what will be needed.</p>
<p><a href="https://www.theguardian.com/global-development/2017/feb/14/bill-and-melinda-gates-trumps-global-gag-rule-endangers-millions-women-girls-us-funding">Bill Gates</a>, a philanthropist who with his wife Melinda gives more than <a href="http://www.gatesfoundation.org/Who-We-Are/General-Information/Foundation-Factsheet">$4 billion</a> away every year, mostly to improve global health and fight poverty, told The Guardian that Trump’s expansion of the policy could “create a void that even a foundation like ours can’t fill.”</p><img src="https://counter.theconversation.com/content/77838/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Maureen Miller 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>All recent Republican presidents have cut off foreign aid tied to abortion. Trump’s expansive version of those restrictions endangers billions slated for HIV/AIDS, malaria and other diseases.Maureen Miller, Adjunct Associate Professor of Epidemiology, Columbia UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/751192017-03-30T02:19:52Z2017-03-30T02:19:52ZWho feels the pain of science research budget cuts?<figure><img src="https://images.theconversation.com/files/162959/original/image-20170328-3788-186tgbd.jpg?ixlib=rb-1.1.0&rect=532%2C491%2C2625%2C2110&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Not much science will get done without the money to fund people and equipment.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/beigephotos/2282318205">Michael Pereckas</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>Science funding is intended to support the production of <a href="http://faculty.ucmerced.edu/awhalley/web/Kantor_Whalley_Proximity.pdf">new knowledge</a> and ideas that <a href="http://dx.doi.org/10.3386/w20889">develop new technologies</a>, improve medical treatments and strengthen <a href="http://doi.org/10.1162/REST_a_00357">the economy</a>. The idea <a href="https://nsf.gov/od/lpa/nsf50/vbush1945.htm">goes back to influential engineer Vannevar Bush</a>, who headed the U.S. Office of Scientific Research and Development during World War II. And the evidence is that science funding does <a href="http://dx.doi.org/10.2139/ssrn.2097842">have these effects</a>.</p>
<p>But, at a practical level, science funding from all sources supports research projects, the people who work on them and the businesses that provide the equipment, materials and services used to carry them out. Given current <a href="http://dx.doi.org/10.1126/science.aal0921">proposed cuts to federal science funding</a> – the Trump administration has, for instance, proposed a <a href="https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/budget/fy2018/2018_blueprint.pdf">20 percent reduction for the National Institutes of Health</a> – it’s important to know what types of people and businesses are touched by sponsored research projects. This information provides a window into the likely effects of funding cuts.</p>
<p>Most existing research into the effects of science funding tries to quantify research artifacts, such as publications and patents, rather than tracking people. I’ve helped to start an emerging project called the <a href="http://iris.isr.umich.edu">UMETRICS initiative</a> which takes a novel approach to thinking about innovation and science. At its core, UMETRICS views people as key to understanding science and innovation – people conduct research, people are the vectors by which ideas move around and, ultimately, people are one of the primary “products” of the research enterprise.</p>
<p>UMETRICS identifies people employed on scientific projects at universities and the purchases made to carry out those projects. It then tracks people to the businesses and universities that hire them, and purchases to the vendors from which they come. Since UMETRICS relies entirely on administrative data provided by <a href="http://iris.isr.umich.edu/membership/contactus/">member universities</a> (now around 50), the U.S. Census Bureau and other naturally occurring data, there are no reporting errors, sample coverage concerns or burden for people. It covers essentially all federal research funding as well as some funding from private foundations.</p>
<h2>Who does research funding support?</h2>
<p>Our administrative data allow us to identify everyone employed on research projects, not just those who appear as authors on research articles. This is valuable because we’re able to identify students and staff, who may be less likely to author papers than faculty and postdocs but who turn out to be an important part of the workforce on funded research projects. It’s like taking into account everyone who works in a particular store, not just the manager and owner.</p>
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<p>We <a href="http://doi.org/10.1126/science.1250055">compared the distribution of people</a> supported on research projects at some of the largest National Science Foundation (NSF) Divisions and National Institutes of Health (NIH) Institutes and Centers. Together, the NSF and NIH support <a href="https://www.nsf.gov/statistics/2016/nsb20161/#/report/chapter-5/expenditures-and-funding-for-academic-r-d">close to 70 percent of federally funded academic R&D</a>.</p>
<p>The striking thing is that the majority of people employed on research projects are somewhere in the training pipeline, whether undergraduates; graduate students, who are particularly prevalent at NSF; or postdocs, who are more prevalent at NIH. Staff frequently constitute 40 percent of the NIH-supported workforce, but faculty are a relatively small portion of the workforce at all NIH Institutes and NSF Divisions.</p>
<p>Based on these results, it seems likely that changes in federal research funding will have substantial effects on trainees, which would naturally have implications for the future STEM workforce.</p>
<h2>What happens to STEM doctoral recipients?</h2>
<p>Given the importance of trainees in the research workforce, we have <a href="http://doi.org/10.1126/science.aac5949">focused much of our research on graduate students</a>. </p>
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<p>We mapped the universities in our sample and the share of the graduate students in each state one year after graduation. Our data show that many grad students contribute to local economies – 12.7 percent are within 50 miles of the universities where they trained. For six of our eight universities, more people stayed in state than went to any other single state. At the same time, graduate students fan out nationally, with both coasts, Illinois and Texas all being common destinations.</p>
<p>The doctoral recipients in our sample are also more likely to take jobs at establishments that are engines of the <a href="https://www.elsevier.com/books/the-age-of-discontinuity/drucker/978-0-434-90395-5?start_rank=1&sortby=sortByRelevance&imprintname=Butterworth-Heinemann&q=the%20age%20of%20discontinuity">knowledge economy</a>. They are heavily overrepresented in industries such as electronics, semiconductors, computers and pharmaceuticals, and underrepresented in industries such as restaurants, grocery stores and hotels. Doctoral degree recipients are almost four times as likely as the average U.S. worker to be employed by an R&D-performing firm (44 percent versus 12.6 percent). And, the establishments where the doctoral degree recipients work have a median payroll of over US$90,000 per worker compared to $33,000 for all U.S. establishments and $61,000 for establishments owned by R&D performing firms. </p>
<p>We also studied initial earnings by field and find that earnings of doctoral degree recipients are highest in engineering; math and computer science; and physics. Among the STEM fields, the lowest earnings are in biology and health, but our data also suggest that many of the people in these fields take postdoc positions that have low earnings, which may improve long-run earnings prospects. Interestingly, we find that women have substantially lower earnings than men, but these differences are entirely accounted for by <a href="http://doi.org/10.1257/aer.p20161124">field of study, marital status and presence of children</a>.</p>
<p>Taken as a whole, our research indicates that the workers trained on research projects play a critical role in the industries and at companies critical for our new, knowledge economy. </p>
<h2>What purchases do research projects drive?</h2>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/162759/original/image-20170327-3283-1yekf1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/162759/original/image-20170327-3283-1yekf1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/162759/original/image-20170327-3283-1yekf1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=763&fit=crop&dpr=1 600w, https://images.theconversation.com/files/162759/original/image-20170327-3283-1yekf1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=763&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/162759/original/image-20170327-3283-1yekf1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=763&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/162759/original/image-20170327-3283-1yekf1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=959&fit=crop&dpr=1 754w, https://images.theconversation.com/files/162759/original/image-20170327-3283-1yekf1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=959&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/162759/original/image-20170327-3283-1yekf1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=959&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">Researchers need to buy the equipment they use to do their science.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/beigephotos/6561743">Michael Pereckas</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
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<p>Another way in which sponsored research projects affect the economy in the short run is through purchases of equipment, supplies and services. Economist Paula Stephan writes eloquently of <a href="http://www.hup.harvard.edu/catalog.php?isbn=9780674088160">these transactions</a>, which range from purchasing computers and software, to reagents, medical imaging equipment or telescopes, even to lab mice and rats.</p>
<p>Still unpublished work studying the <a href="http://doi.org/10.3386/w23018">vendors who sell to sponsored research projects at universities</a> shows that many of the firms selling to sponsored research projects are frequently high-tech and often local. Moreover, firms that are vendors to university research projects are more likely to open new establishments near their campus customers. Thus, there is some evidence that research projects directly stimulate local economies.</p>
<p>So while the goal of sponsored research projects is to develop new knowledge, they also support the training of highly skilled STEM workers and support activity at businesses. The UMETRICS initiative allows us to see just which people and businesses are touched by sponsored research projects, providing a window into the short-run effects of research funding as well as hinting at its long-run value.</p><img src="https://counter.theconversation.com/content/75119/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bruce Weinberg's work has been supported by the National Institutes of Health (NIA and OBSSR), National Science Foundation (EHR/DGE and SciSIP) and the Kauffman and Sloan Foundations. He also receives funding from the Institute for Research on Innovation and Science which is home to the UMETRICS initiative. He is affiliated with the IZA Institute for Labor Economics and the National Bureau of Economic Research, which supported this work directly and through a subcontract to Ohio State University. </span></em></p>What are research dollars actually spent on? Rather than looking at artifacts like publications and patents, a new initiative directly tracks the people and businesses that receive research funding.Bruce Weinberg, Professor of Economics, The Ohio State UniversityLicensed as Creative Commons – attribution, no derivatives.