OPEN LETTER TO NIH DIRECTOR FRANCIS COLLINS Francis Collins, MD, PhD Director National Institutes of Health Bethesda, MD 20892 Dear Dr. Collins: We are writing to request that NIH delay implementation of its policy that sweeps basic science into a clinical trials framework until adequate feedback about its impact is obtained from the affected scientific community. We wholeheartedly agree with NIH’s goals of increasing scientific transparency and rigor, but we ask that you consider alternative mechanisms to accomplish those goals that would have fewer adverse effects on basic research. The mission of National Institutes of Health is to fund a wide range of health-related research. Some of this research consists of clinical trials: testing the effects of interventions that could be developed into treatments for improving health. Clinical trials are the key method for establishing the efficacy, and safety, of potential new treatments. The NIH also funds, as part of its mandate, basic discovery science on health-related topics. Basic discovery science tests hypotheses about how human minds and bodies work. History shows that basic science is necessary: the discoveries made by the basic science of today provide the foundation for the clinical trials of tomorrow. New treatments can only be invented on the basis of new knowledge about how the mind and body work. The NIH’s interpretation of its definition of “clinical trials” is so broad that many experiments designed to test hypotheses about how the mind and body work will be inappropriately classified as clinical trials. The negative impact of the new policy is substantial: Basic scientists whose research is now deemed a “clinical trial” may only submit applications for funding through a funding opportunity announcement designated specifically for clinical trials, even though other funding vehicles are more appropriate; The basic research studies now classified as “clinical trials” will be reviewed by study sections constituted for clinical trial review and would need to be significantly reconstituted to handle discovery science; Training grants cannot be used to fund “clinical trials,” so basic research involving humans will be ineligible for T-awards; Exploratory research, which is the lifeblood of discovery, would be hampered. If exploratory research could be registered at all, such registration is likely to slow the pace of research, impeding innovation and discovery; The new policies unnecessarily increase the administrative burden on investigators, and this burden will fall disproportionately on researchers at less well-funded universities and colleges, which have fewer administrative resources to help; and, Members of the public who seek information in clinicaltrials.gov will find a potentially confusing array of basic science experiments that are not in the clinical trial stage. We understand that a motivation for this change is to increase transparency and replicability in NIH funded research. We strongly applaud this motivation. Indeed, many of the undersigned are actively involved in scientist-led efforts to increase replicability and transparency. Examples include the Open Science Framework (OSF), and OpenfMRI. And other efforts to increase transparency are underway, both inside and outside government. NIH has also helped to increase data sharing in the NIMH data archive. And scientists are currently developing mechanisms for more sharing of code as well. We encourage (and applaud the NIH for encouraging) pre-registration, data sharing, protocol sharing, and code sharing. We support the goals of transparency and replicability. Unfortunately, the current effort to improve transparency and replicability in basic science does so by mislabeling basic research as a clinical trial. In our view, NIH could easily transform a policy that is harmful to basic science researchers into one that will do no harm and yet increase the transparency and accountability for all of the research it funds, but in parallel tracks. We respectfully request that you: Affirm that health-related discovery science is an important part of the NIH research portfolio that enables us to build a foundation of fundamental knowledge that will be needed, in time, to design clinical trials. Take this opportunity to invite to NIH representatives from affected basic research communities, listen to the concerns raised, and work with us to shape a policy for this important segment of NIH grantees; and, Specifically develop a protocol for promoting transparency and replicability based on input from the basic science community. A new protocol could be based on existing efforts such as OSF and OpenfMRI. Sincerely, 1 Jeremy Wolfe Brigham and Women's Hospital / Harvard Med 2 Nancy Kanwisher MIT 3 David Badre Brown University 4 Ken Norman Princeton University 5 Rebecca Saxe MIT 6 Adina Roskies Dartmouth College 7 Daniel Schacter Harvard University 8 Marlene Behrmann Carnegie Mellon University 9 Richard Aslin Haskins Laboratories 10 David Plaut Professor, Carnegie Mellon University 11 Kody Manke Professor 12 Dwight Kravitz The George Washington University 13 Jack Gallant University of California at Berkeley 14 Russell Poldrack Stanford University 15 Benjamin Backus Graduate Center for Vision Research, SUNY College of Optometry 16 Kasey Creswell Carnegie Mellon University 17 Samuel Norman-Haignere Massachusetts Institute of Technology 18 Luke Hyde University of Michigan 19 Brock Kirwan Brigham Young University 20 Sarah Shomstein George Washington University 21 Edward Vogel University of Chicago 22 Jennifer Beer University of Texas at Austin 23 Molly Crockett Yale University 24 Jay Van Bavel New York University 25 Aidan Wright University of Pittsburgh 26 Breana Carter George Washington University 27 Tyler Davis Texas Tech University 28 Frank Keil Yale University 29 Eran Dayan UNC-CH 30 Allyson Mackey University of Pennsylvania 31 Scott Huettel Duke University 32 Samuel Gershman Harvard University 33 Edward Awh University of Chicago 34 Samuel Mehr Harvard University 35 Wm Wren Stine University of New Hampshire 36 Mike Angstadt University of Michigan 37 Simon W Davis Duke University 38 adele diamond Univ. of British Columbia (UBC) 39 Brian Wandell Stanford University 40 Claire Morrison University of Michigan 41 Robert Desimone MIT 42 Elizabeth Phelps New York University 43 Jordan Grafman Northwestern University 44 Robert Sekuler Brandeis University 45 Elika Bergelson Duke University 46 Chunyue Teng The George Washington University 47 Evelina Fedorenko MIT; HMS/MGH 48 Stephen Adamo Postdoctoral Researcher 49 Jochen Weber Columbia University 50 Bradley R Postle University of Wisconsin-Madison 51 Deborah Hannula University of Wisconsin, Milwaukee 52 Kevin LaBar Duke University 53 Rosie Cowell University of Massachusetts Amherst 54 Leigh Goetschius University of Michigan 55 Edward Ester Florida Atlantic University 56 Charan Ranganath University of California at Davis 57 Amitai Shenhav Brown University 58 Daniel Willingham University of Virginia 59 Alex Shackman University of Maryland 60 Alison Preston The University of Texas at Austin 61 Hailey Dotterer University of Michigan 62 Ennio Mingolla Northeastern University 63 Diana Tamir Princeton University 64 John Wixted UC San Diego 65 Scott Lilienfeld Emory University 66 Vishnu P Murty University of Pittsburgh 67 Melissa Kline MIT 68 Michael Frank Stanford University 69 Matthew Walker UC Berkeley 70 Taylor Stephan University of Michigan 71 Michael Rugg UT Dallas 72 Ben Deen Rockefeller University 73 Rachel Diana Virginia Tech 74 Preston Thakral Harvard University 75 Hilary Richardson MIT 76 Anna Schapiro Harvard Medical School 77 Ione Fine University of Washington 78 Jonathan Victor Weill Medical College 79 Mingbo Cai Princeton University 80 Eric Schumacher Georgia Institute of Technology 81 Bharath Chandrasekaran Associate Professor 82 Jessica Church-Lang The University of Texas at Austin 83 Howard Egeth Johns Hopkins University 84 Megan deBettencourt University of Chicago 85 David Schnyer University of Texas 86 Shuo Wang WVU 87 Jonathan Phillips Harvard University 88 Emily Garnett University of Michigan 89 Mina Cikara Harvard University 90 Kristen Stauffer University of Michigan 91 Alfonso Caramazza Harvard University 92 Alejandro Lleras University of Illinois at Urbana-Champaign 93 Brian Allen University of Washington biomedical researcher 94 Cary Savage Banner University Health 95 William Heindel Brown University 96 Ryan Ly Princeton University 97 Alexander Dufford University of Denver 98 Lauretta Reeves University of Texas at Austin 99 Eric Donny University of Pittsburgh 100 Steven Pinker Harvard University 101 Lindsey Powell MIT 102 Sara Weisenbach University of Utah 103 Robert Siegler Carnegie Mellon University 104 Timothy Rogers University of Wisconsin Madison 105 Stephen Engel University of Minnesota 106 Shreesh Mysore Johns Hopkins University 107 Regan Bernhard Harvard University 108 Justin Hulbert Bard College 109 Andrew Oxenham University of Minnesota 110 Stefano Anzellotti MIT 111 Arne D Ekstrom UC Davis 112 Paul Bloom Yale 113 Josh McDermott MIT 114 Robert C Welsh University of Utah, Department of Psychiatry 115 Dima Amso Brown University 116 Emily Falk University of Pennsylvania 117 Michael Kalish Syracuse university 118 Julia Leonard MIT 119 Jasper Hajonides van der Meulen Princeton university 120 Kyle Dillon Harvard University 121 Maureen Ritchey Boston College 122 James Antony Princeton University 123 Sean Dae Houlihan MIT 124 Jeffrey Lees Harvard