May 23, 2018
Since mid-2017, FABBS has interacted with NIH —and later, appropriators— about our scientific community’s concerns with NIH’s inclusion of basic science involving humans in its clinical trial policies. Given the continuing concerns earlier this year, House and Senate appropriators included Congressional report language in the Fiscal Year 2018 omnibus appropriations bill. The report language directed NIH to halt implementation of the clinical trial policies as they pertain to basic science and seek input from the affected basic science community. To date, NIH has not issued any statements that it has halted implementation of the policies; instead program officers have reported to scientists that NIH is “staying the course.”
In recent weeks, however, NIH’s Deputy Director, Larry Tabak, convened a one-hour meeting with FABBS and other key stakeholders. In addition to FABBS, outside participants included the Council on Governmental Relations, American Psychological Association, Association for Psychological Science, Society for Research in Child Development, American Society for Investigative Pathology, American Society for Pharmacology and Experimental Therapeutics, the Vice Chancellor for Research at Washington University in St. Louis, and basic scientists from Harvard Medical School (FABBS Past-President Jeremy Wolfe) and Johns Hopkins University’s Kennedy Krieger Institute. The goal, as we understand it, was to hear our concerns and begin the process of charting a path forward. At this time, NIH and the outside participants are involved in collectively summarizing the meeting minutes, so that NIH’s goals and the scientific communities’ concerns are clear.
As a reminder, our requests have been to: (1) put a hold on the clinical trials policies for basic science involving humans; (2) exclude basic science from the clinical trials definition; and, (3) allow a registration and reporting system that is tailored to basic science involving humans. At this point in time, we anticipate that NIH will issue at least one Request For Information on registration and reporting for basic science. How NIH addresses the other concerns is unknown at this time, but we are cautiously optimistic, given that a meeting with interested stakeholders has occurred.
In the meantime, if you are submitting a proposal to NIH in June and you need to know whether your research is deemed a clinical trial or not, please ask your program officer, and in turn, Mike Lauer, Deputy Director for Extramural Research, whose decision is guiding for now. Unfortunately, until NIH halts the policy and announces it to the scientific community, some basic science involving humans will be caught in the broad definition of a clinical trial and included in the clinical trial policies. However, the issue is important enough to our communities that we will keep working on it until it is resolved.
