NIH Clinical Trials Report Language: What’s Next?

March 30, 2018

The basic science community greeted with much enthusiasm report language attached to the omnibus spending bill that seeks to delay “NIH’ s more expansive interpretation of ‘interventions’ in relation to fundamental research projects involving humans” and to “consult with the basic research community to determine the reporting standards best suited to this kind of research.”  The language references one of several applicable policies, in particular New Review Criteria for Research Project Applications Involving Clinical Trials. How NIH will interpret the language and engage the community is an open question, but we are resolved to work on the issue until basic behavioral and brain science researchers are satisfied.

In taking a close look at the language, the first part compliments NIH on its work to improve transparency and oversight of clinical trials, and raises the concern that fundamental research is being redefined as clinical trials without consulting the basic science community, citing a host of potential unintended problems as a result.

The next part of the report language lays out the action plan for NIH: “For fiscal year 2018, the agreement directs NIH to delay enforcement of the new policy published in the Federal Register on September 21, 2017—including NIH’s more expansive interpretation of “interventions”—in relation to fundamental research projects involving humans. The new policy should go forward for research projects that would have been considered clinical trials under the prior policy.” A few points about this language:

  • The Federal Register notice on September 21, 2017, applies (as far as we can tell) to the new review criteria for research project applications involving clinical trials (see: NOT-OD-17-118), only one of many policies that NIH issued related to increased regulation of clinical trials. According to NIH staff, however, the agency is interpreting the report language as dealing with the enforcement of registration and reporting requirements, and only as it relates to basic science research.
  • The delay in enforcement—whether it is related to registration and reporting or something else—is only for fiscal year 2018, which ends on September 30, 2018. This means that we will need to continue our work into fiscal year 2019, if the issues of concern to basic scientists have not otherwise been resolved.
  • The clinical trials policies still apply to traditional clinical trials–and, of course, any basic science research that is still caught in the case study definitions. This remains the major concern of basic science investigators.
  • The language does not address how NIH should handle the basic science applications designated as clinical trials in the January 2018 round. In addition, it does not address what should happen with the June round of applications. According to program officers at NIH, Michael Lauer, Deputy Director for Extramural Research, has informed them that, “for now, nothing changes.” Bill Riley, Director of OBSSR, clarified for us that, “regardless of how basic or foundational research is handled in the future, we’ll still have a CT policy that will require CT-FOAs, registration and reporting, GCP training, etc. [It’s] just a question of [whether] the research to which these policies apply will change.” NIH is still developing a plan, and things will remain as is until any new plan is in place.

The final section of the report language gets at the heart of the matter. It states: “This delay is intended to provide NIH sufficient time to consult with the basic research community to determine the reporting standards best suited to this kind of research.” NIH’s goal (again, as we understand it) has been to get a better handle on clinical trial registration and reporting. In doing so, the agency brought basic science research involving humans under the clinical trial framework. At the same time the agency has suggested that all NIH funded research involving human participants should be registered and reported. A separate registration and reporting framework that is tailored to the needs of the basic research community is needed. With that in place, we hope that basic science studies involving humans can finally be extricated from the clinical trials policies.

As NIH develops its outreach plan to the basic science community, we hope that it will address some of the concerns we have heard: (1) getting affected stakeholders involved; (2) building trust in whatever process is developed for soliciting input; and, (3) identifying/developing a registration and reporting system that works for various stakeholders across the basic sciences.

What is clear from the report language is that Congress intends for NIH to productively engage with the basic science research community about what type of reporting standards work best for this research. NIH has until April 23 to provide House and Senate Appropriations Committees a plan for gathering input from the basic research community. By June 22, NIH must report to the committees the results of these consultations.