Paula Skedsvold and Jeremy Wolfe*
In the summer of 2017, researchers in the mind, brain, and behavioral science communities became engaged in a dialogue of sorts with the National Institutes of Health about their plan to reclassify a great deal of basic science research as “clinical trials” and, as a result, subject that research to a number of policies specific to clinical trials. Our conversation with NIH has progressed, but it is not finished.
To be sure, there has been progress. Through interactions with NIH staff, the case studies that define whether a research project is or is not a clinical trial have been revised on multiple occasions, resulting in an apparent narrowing of the reach of the clinical trial definition to include less basic behavioral and brain science. The latest revision of the case studies can be found here.
Case 18 (in its many parts) has been central to the definition of clinical trials from the vantage point of basic behavioral and brain science. That case is revised in the newest list and it seems that much of our basic science (behavioral and fMRI) has been removed from the clinical trials framework. Cases 24 and 26 have also been of concern to our science community. In the latest revision, these case studies have been removed. It is unclear at this time whether the case studies are undergoing revision and will be posted later.
Beyond the case studies, there is other progress to report. Basic scientists have been concerned about a variety of issues including the implications of the new policies for grant application and review and for training from undergraduate to postdoctoral levels. To get a better understanding about progress made in these areas, FABBS immediate Past-President Jeremy Wolfe posed a series of questions to NIH’s Deputy Director for Extramural Research, Michael Lauer. These questions and NIH’s answers were just published in Nature Human Behavior.
In addition, NIH is signaling that the agency is prepared to troubleshoot new issues related to implementation of the clinical trials policies as they arise. We are interacting with the agency about the best ways to collect and convey this information.
Getting to the Core Issue(s)
As we understand it, NIH’s goals in taking these actions were to address problems identified by the Government Accountability Office in collecting information about the clinical trials it funded. In addition, there were concerns that the results of clinical trials were not being published in a timely manner.
As FABBS and other organizations have conveyed to NIH, there are alternative vehicles for registering studies and reporting findings that are better tailored for basic science. For those basic science studies that are still deemed to be clinical trials, other systems such as the Open Science Framework may be a user-friendly alternative. Since last summer, there has been movement in this direction as well. NIH is currently in discussions with Open Science Framework Director Brian Nosek about the possibility that basic scientists might register and report through OSF rather than clinicaltrials.gov, if they so choose. Doing so would reduce the number of irrelevant fields for basic scientists and, hopefully, make the process easier. According to Nosek, OSF and NIH are working through technical and implementation details so that, if an investigator used OSF, it would be as efficient and effective a process as possible. Since NIH needs a public database to house the information, data elements from OSF would be pulled into clinicaltrials.gov.
A Path Forward
Most basic scientists would like to maintain the historical distinction between basic science and clinical trials. The community is not opposed to the goals of openness and accountability. However, the path to those goals does not require a fundamental change in the meaning of the term “clinical trial.” Although there is progress with NIH, it is unclear where this will land, but we will continue to interact with agency staff to get this right. As long as the policies affect basic brain and behavioral science, we will be at the table trying to make them work for our scientists. We will also continue to share information with organizations such as the Council on Governmental Relations, which has taken a leadership role on this issue for higher education organizations.
FABBS is also engaged in conversations with key staff on Capitol Hill about the continued concerns of the community, and Congressional staff are in communication with NIH. These conversations will also continue. While it is not an easy process for anyone involved, we are hopeful that we will continue to make progress one way or another.
*Paula Skedsvold, JD PhD, is Executive Director of the Federation of Associations in Behavioral and Brain Sciences (FABBS).
*Jeremy Wolfe, PhD, is immediate Past-President of FABBS and Professor at Brigham & Women’s Hospital and Harvard Medical School.