October 30, 2018
In the last step of its five-part plan to address scientists’ concerns about the inclusion of basic science within the clinical trial case studies, NIH plans to publish Parent Funding Opportunity Announcements (FOAs) for Basic Experimental Studies with Humans. Parent FOAs are broad funding opportunity announcements that allow applicants to submit investigator-initiated applications. On October 26th, NIH issued a “Notice of Intent” to publish these FOAs in late November for applications with due dates beginning on January 25, 2019.
Parent FOAs may be helpful for investigators whose research is caught in the mix of both clinical trials and basic research, but the problem of basic science remaining in the clinical trial case studies continues to be the major challenge. Recently, FABBS sent a letter on behalf of a number of scientific societies, university associations, and academic units to NIH’s Deputy Director offering a path forward to address the needs of both NIH and the basic science community. The letter urges NIH to return to an earlier (2014) version of the clinical trial case studies that more clearly describes clinical trial case studies. There may be other paths as well, but the fact that some basic research falls simultaneously into three categories at NIH (basic research, prospective basic science studies involving human participants, and clinical trials), each associated with different policies, means that NIH needs to address this core issue as well.
The letter also reiterates that we “have been and remain committed to a registration and reporting system that is appropriately tailored to basic science.” NIH’s Request for Information (RFI) on Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants is currently open for public comment. Scientists, scientific societies, and higher education institutions are responding. In addition, FABBS is interacting with the Council on Governmental Relations on a group response to the RFI, which we anticipate will eventually lead to the approval of alternative platforms to ClinicalTrials.gov for registration and reporting of some basic science.