The document summarizes a meeting held on May 2, 2018, between representatives of major scientific societies, research consultants, and senior NIH officials to discuss concerns related to NIH clinical trial policies as they apply to basic research involving human subjects. The primary focus was the scientific community’s apprehension regarding the broadening of the definition of "clinical trials" to include basic research studies that do not test medical interventions. Attendees agreed that registration and reporting of human subjects research are essential for transparency and public trust but emphasized that policies should be appropriately tailored for fundamental science rather than applying clinical trial requirements wholesale. Stakeholders expressed particular concern about the burdens introduced by new case studies and interpretations of key terms like “intervention” and “health outcome,” which have created confusion and operational challenges in the research community.
The NIH officials, acknowledging congressional pressures for greater accountability and the need for comprehensive data collection, engaged with alternative suggestions from the group, such as utilizing the Open Science Framework as a more suitable portal for registration and reporting of basic human subjects research. Stakeholders recommended separating policy issues on registration and reporting from debates over the definition of clinical trials, seeking a return to pre-2017 definitions and offering to collaborate on universal, fit-for-purpose reporting systems. The group also stressed the inadequacy of current consultation processes, advocating for broader engagement with the research community and proposing further RFIs or possibly an independent evaluation by the National Academies. In response, NIH committed to summarizing the meeting, clarifying enforcement delays on the contentious policies, considering next steps including further consultation, and regularly updating stakeholders as the policy evolves.
