UPDATE as of July 21, 2018:After pressure from Congress and from multiple scientific societies including SRCD, NIH has agreed to delay enforcement of the definition of clinical trials as inclusive of basic research, pending further review. They have not retracted the definition but have agreed to be flexible about enforcement while evaluating the implications of the more inclusive definition of clinical trials for basic science research. There will be a Request for Information issued soon and SRCD will issue an alert and some guidance for those wishing to provide input when the opportunity to submit comments as individual researchers is issued.
UPDATE as of June 29, 2018: (From the Federation of Associations of Behavioral and Brain Sciencies- FABBS): In response to Congressional report language (see pages 34-35), and in follow up to a recent meeting among NIH and a group of stakeholders, NIH has developed a plan to “address the shared interests of involved stakeholders” and is preparing to “move forward so that [they] can widely communicate the delayed enforcement and lenient implementation described in the plan.” Within the next two weeks, NIH will issue guide notices and a Request for Information (RFI). FABBS will share information as it becomes available and plans to respond to the RFI, working collaboratively with other stakeholders. Read the full post on the FABBS website.
UPDATE as of April 5, 2018: We are disappointed to report that the instructions from Congress in the FY 2018 omnibus bill to delay the implementation of the new NIH clinical trials definition are not being interpreted by NIH in the spirit in which we believe they were intended. The Institutes have been instructed to continue to enforce the new definition of clinical trials for all new proposals for the time being. Our understanding is that NIH is choosing to interpret the language in the omnibus bill as referring only to reporting and registration guidelines (i.e., post-award procedures), not the submission process. The NIH has 30 days from the passing of the bill (which was on Mar 23) to report back to the House and Senate Appropriations Committees with a plan for consultation, so there may be further developments in the coming weeks. However, for now, NIH program staff have been advised that PIs should assume that any proposal that would be considered a clinical trial under the guidelines implemented in January should still be submitted as a clinical trial study. Please contact your NIH program officer with specific questions, and we will continue to monitor the situation and post updates as new developments occur. We are hopeful that the process will begin moving in the right direction soon, but it is obviously not yet where we need it to be.
UPDATE as of March 23, 2018: The final FY 2018 bipartisan omnibus bill in Congress delays the implementation of the new NIH clinical trials definition for projects that historically do not fall under a clinical trials definition. This is a huge victory for behavioral and social scientists which is attributable to advocacy by the research community. Read a detailed analysis from the Consortium of Social Science Associations (COSSA).
As many of our members are aware, the National Institutes of Health (NIH) recently instituted a new definition of clinical trials that directly impacts many researchers in the behavioral and brain sciences. In in the service of improving reporting and compliance for those conducting clinical trials (typically of a medical or pharmaceutical nature), Dr. Francis Collins, Director of the NIH, redefined a clinical trial to include any study that involves manipulation of a variable. Suddenly (and apparently unwittingly on the part of NIH), a large number of researchers who are not the target of Dr. Collins’ reforms and have never conducted research previously construed as clinical trials, are now required to adhere to clinical trials guidelines. SRCD is addressing this problem in two ways:
- Society leadership has partnered with other behavioral science organizations including the Consortium of Social Science Associations (COSSA) and the Federation of Associations in the Behavioral and Brain Sciences (FABBS), reaching out to both NIH leadership and sympathetic members of Congress regarding the unintended consequences of this change in definition of clinical trials. We have underscored that the change creates significant additional burden both on investigators and on the scientific review process at NIH. Although Dr. Collins has remained steadfast in his commitment to this new definition, the scientific review staff are experiencing first-hand the consequences of this decision. We are hopeful that both pressure-from-within and Congressional pressure may result in some adjustments to the definition in the coming months.
- For those members who find themselves having to navigate these new and unchartered waters, we have listed (below) available resources on how to apply for NIH funding under current guidelines. We will continue to update this resource list and will disseminate additional information as it becomes available. Assuming the guidelines are not adjusted in the near future, we are also planning webinars with NIH staff to better equip developmental scientists who are weathering this change.
- NIH’s New Definition of a Clinical Trial
- Is my study a clinical trial according to NIH? Some Case Studies
- Clinical Trials FAQ
- Guidance on completing NIH forms under the new definition
- NIH Director’s motivation for altering clinical trials definition
Petitions and Open Letters to NIH
- Letter to Congress encouraging collaboration with NIH to redefine what constitutes as a clinical trial and to put in place a registration and reporting framework to prevent unnecessary duplication (PDF)
- Open Letter to NIH Director Francis Collins, outlining concerns that the new policies will harm American science and public health (ipetitions)
- Joint letter to NIH by the Association of American Medical Colleges, Association of American Universities, Association of Public and Land-grant Universities and Council on Government (PDF)