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Organizations Collaborate on Joint Response to NIH Registration and Reporting RFI

Twenty-three scientific societies and higher education associations, joined by an additional twenty-three higher education institutions, submitted a letter to NIH in response to the NIH Request for Information (RFI) on Registration and Reporting Standards for Prospective Basic Science Studies Involving Human Participants. The letter was directed to NIH’s Deputy Director Lawrence Tabak and NIH’s Deputy Director for Extramural Research Michael Lauer.

Led by Lisa Nichols, Director of Research and Regulatory Reform with the Council on Governmental Relations, the group’s letter focused on two objectives pushed by the scientific community for over a year:

  • Maintaining the distinction between basic science and clinical trials while increasing transparency and reporting for basic science studies involving human participants; and,
  • Fostering the development of efficient and effective processes and frameworks for the treatment and reporting of basic science research.

 

Importantly, the letter points out that the science and higher education organizations “do not accept the premise of the RFI that basic research studies involving human participants are clinical trials.” The organizations recommend that NIH “not adopt the proposed designation of ‘prospective basic science studies involving human participants,’ and simply require reporting of all NIH-funded basic science studies involving human participants in a manner that both (a) avoids subjecting these studies to clinical trial requirements and (b) is developed in consultation with stakeholders. “ The letter further recommends that NIH delay publication of the new parent funding opportunities that refer to the designation and revise the clinical trial case studies to be consistent with an earlier version that did not include basic science.

With regard to registration and reporting, the letter describes how clinical trials reporting formats are “often not compatible with how [basic] research is conducted and reported.” As a result, the regulatory requirements create an unnecessary burden on investigators and institutions, thereby diverting limited resources. The organizations suggest that NIH use existing data collections and alternatives to ClinicalTrials.gov for reporting, and specifically recommend the creation of a working group of the Advisory Committee to the Director “to establish appropriate standards and frameworks for reporting all basic science studies involving human participants.”

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