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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link="#0563C1" vlink="#954F72"><div class=WordSection1><div align=center><table class=MsoNormalTable border=0 cellspacing=0 cellpadding=0 width="100%" style='width:100.0%;border-collapse:collapse'><tr><td width="100%" valign=top style='width:100.0%;padding:0in 0in 0in 0in'><table class=MsoNormalTable border=0 cellspacing=0 cellpadding=0 width="100%" style='width:100.0%;border-collapse:collapse'><tr><td valign=top style='padding:7.5pt 15.0pt 7.5pt 15.0pt'><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Dear VSS Colleagues, <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>The following message is relevant for our members in the US who work with NIH funding. This concerns the implementation of a definition of clinical trials by NIH that we believe would wrongly classify the work that many of us do as clinical trials. Implementation of this new rule has many adverse consequences for NIH, for you as a researcher, and for the public and their access to actual clinical trials. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Below we summarize the issue and then invite you to take action as an individual investigator. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Here is the definition: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” (from <a href="http://r20.rs6.net/tn.jsp?f=001_hbD42GADR2PAjAazUQZy_imHEga2551rrhDRvTmYDoiDSySOM2YIPOHOAaHHQWXeVWfewI7s9cifIWbEjTXde450nW7EzTH5WQskvO54bM0RQudEWop9uF3_0vLriBH1OgYClLcck_Jd7ywqk5VlKgc0WFe4emfetCVJNXpcdn8EwMr6wsfd2opT_IZpL3wrI5s85tg3sW6E98QbLdrYA==&c=ApkhVKSwbst-lybLHqMFWBoxyh76GxksROV9pJOQ0xhrpeFb6Hef3g==&ch=x02HLuqQy4j0dwKKb6JIVUsE8Tan9veBGh-A9NhiC---4a2GbzsHQQ=="><span style='color:#09A3BA'>https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html)</span></a>. The major concern revolves around the interpretation of “intervention”, which is stated as follows, “An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.” Psychophysical studies could seem to qualify. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Here is the NIH website: <a href="http://r20.rs6.net/tn.jsp?f=001_hbD42GADR2PAjAazUQZy_imHEga2551rrhDRvTmYDoiDSySOM2YIPOHOAaHHQWXYLZFVTBV6D5G_dTYC4OfOtO106dkzXRnH30DMitU10rEMkbc07a2HT6dJBpVPbJ2dbGOZVIf65AvjOy3ZlXy8m2eik73fyITcOUW4mgo7vVqnNXof2Qh3Fnp_vim8dyJysVGWpj-UzjLshs8S2-LtL5Y-FYItm3Uh97LUUEhX6js2kmtXeha5VdrlVjhcnGuepuXm8Zz8aY=&c=ApkhVKSwbst-lybLHqMFWBoxyh76GxksROV9pJOQ0xhrpeFb6Hef3g==&ch=x02HLuqQy4j0dwKKb6JIVUsE8Tan9veBGh-A9NhiC---4a2GbzsHQQ=="><span style='color:#09A3BA'>http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials</span></a>. If you think that these new guidelines do not apply to your research, then please refer to the statement from the Office of Behavioral and Social Sciences Research <a href="http://r20.rs6.net/tn.jsp?f=001_hbD42GADR2PAjAazUQZy_imHEga2551rrhDRvTmYDoiDSySOM2YIPOHOAaHHQWXo74af9tUqmy395kWGqHZB2QaD1FzYmq2VpIRnBiFfmWWfzbOoy1r3yHdeehXlXoaZY0rsGpllni8MyRWWIUOeC-nbZQPObbgcKU5reCq9Uss71R_JIU3oKBHjox8jx35gjq58QJAeSxlOgFMqSgJuxoEwyoIZ7OoOizHIRyveP5xjVyCtWIq5NAbIbuMQGSGVT6xR3S9G2YRa4bp1PFQWQ==&c=ApkhVKSwbst-lybLHqMFWBoxyh76GxksROV9pJOQ0xhrpeFb6Hef3g==&ch=x02HLuqQy4j0dwKKb6JIVUsE8Tan9veBGh-A9NhiC---4a2GbzsHQQ=="><span style='color:#09A3BA'>https://obssr.od.nih.gov/new-nih-clinical-trials-policies-implications-for-behavioral-and-social-science-researchers/</span></a>. It certainly indicates that the definitions apply to the kind of human behavioral research that many of us do. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>The definition of clinical trials is from 2014. People did not pay much attention to it (certainly to what constitutes an "intervention" and other terms in the definition) until the new clinical trials policies came out this year, implementing the 2014 definition. Clearly this new policy has far-reaching consequences. Members of the Board know of colleagues who are already affected by this new rule. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Dr. William Riley, Director of the NIH Office of Behavioral and Social Sciences Research, is working to modify this definition by collecting information over the next few days. We urge you to send a personalized email to him (<a href="mailto:william.riley@nih.gov"><span style='color:#09A3BA'>william.riley@nih.gov</span></a>). This is urgent. Dr. Riley plans to speak to Francis Collins, the Director of NIH, in the next few days. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>We want you to know that the VSS Board of Directors will be sending a letter on behalf of the membership, and we encourage each of you who are supported by NIH funding to email a letter as well. Numbers count. Below is representative text that spells out the problems entailed by this new definition. We encourage you to revise the text with examples of how this new policy will affect your research. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Respectfully, <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Eli Brenner, David Brainard, Lynne Kiorpes, Jeff Schall, Preeti Verghese, Andrew Watson, Mike Webster, Laurie Wilcox, Jeremy Wolfe <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>PROPOSED TEXT TO CUSTOMIZE FOR INDIVIDUAL LETTERS <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>William Riley <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>NIH OBSSR <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><a href="mailto:william.riley@nih.gov"><span style='color:#09A3BA'>william.riley@nih.gov</span></a> <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Dear Dr. Riley; <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>As an NIH sponsored investigator, I would like to register my concern about the NIH Definition of Clinical Trials. My research encompasses the breadth of topics in modern vision science, from visual coding to perception, recognition and the visual control of action, as well as the recent development of new methodologies from cognitive psychology, computer vision and neuroimaging. Most of this work is basic research, using humans as experimental observers. My research provides fundamental data that can be applied to health-related issues from diagnosis and treatment of ocular and nervous system disorders to driving safety and medical image perception. These studies are not ‘clinical trials’ in the normal understanding of that term but the new NIH definition could put that label on a substantial body of my work. I believe that this would produce multiple negative effects including: <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>1) There is important clinical work in vision science. Some of this work leads to clinical trials of the sort listed on public-facing sites such as <a href="http://r20.rs6.net/tn.jsp?f=001_hbD42GADR2PAjAazUQZy_imHEga2551rrhDRvTmYDoiDSySOM2YIPOHOAaHHQWXTuJmPytjV136bFb4v03OJV7WRmevvhkBxPnKM3A_UEOW2jY1fPrkUr2G4dj_9Knm9Dsu8pv5rIrAdlLZtJ07JQ==&c=ApkhVKSwbst-lybLHqMFWBoxyh76GxksROV9pJOQ0xhrpeFb6Hef3g==&ch=x02HLuqQy4j0dwKKb6JIVUsE8Tan9veBGh-A9NhiC---4a2GbzsHQQ=="><span style='color:#09A3BA'>clinicaltrials.gov</span></a>. Classifying basic human research as clinical trials can confuse the public about the nature of the clinical trials. Note that we are not opposed to scientific openness. The public has a right to know what the NIH is funding, but defining clinical trials too broadly does not advance that goal. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>2) Diluting the clinical trials databases with studies that are not clinical trial will make it less likely that members of the public will be able to find and enroll in true clinical trials. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>3) Because the public will not appreciate the subtleties of the new definition of ‘clinical trial’, this will hold the researchers and the NIH up to public ridicule for claiming to be doing ‘clinical trials’ of matters that are clearly not clinical issues. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>4) This will dilute NIH oversight of real clinical trials that should be monitored. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>5) This will add to the bureaucratic burden for researchers and their institutions.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>6) We have a particular interest in researchers at smaller institutions that may not have administrative support to guide researchers through the increased burden. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>7) Grant review will be significantly disrupted by the requirement that “clinical trial” grants must be reviewed by study sections that review “clinical trials”. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Therefore, I urge you to seek clarification of the definition. We trust that a clarification would limit the definition of clinical trials to the appropriate and sensible subset of NIH research. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>Sincerely, <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:9.0pt;font-family:"Arial",sans-serif;color:#403F42'>VSS MEMBER NAME HERE <o:p></o:p></span></p></td></tr></table></td></tr></table></div><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><o:p> </o:p></p></div><div id="DAB4FAD8-2DD7-40BB-A1B8-4E2AA1F9FDF2"><br />
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