July 24, 2018
NIH: Basic Science Studies Involving Human Participants
We highly recommend investigators engaged in research involving human participants review the latest NIH Notice about delayed enforcement and short-term flexibility for some requirements.
Due in large part to the advocacy of researchers, the Council on Governmental Relations (COGR), and other Institutions, the Consolidated Appropriations Act of 2018 required NIH to delay and assess their initial approach to changes announced in 2016 related to human subjects research.
As a result:
- NIH is defining “fundamental research” as equivalent to basic research.
- CT.gov registration and reporting policies for prospective basic sciences studies involving human participants is delayed through 9.24.19
- NIH still expects registration and reporting to occur
- NIH will have a period of leniency for applications submitted using an incorrect FOA. Applications will be reviewed based on criteria for which they are submitted.
- FOAs that specify clinical trials are optional; NIH will review them based on the designation specified by the applicant.
Good Clinical Practice Training continues to be an expectation for all personnel involved in the conduct, oversight, or management of prospective basic science studies involving human participants.
NIH still requires all applications for prospective basic science studies involving human participants to include FORMS-E Human Subjects and Clinical Trials Information form.
Questions about NIH FOAs? Contact firstname.lastname@example.org
Questions on IRB review related to human subjects research? Contact email@example.com
Review Good Clinical Practice Training resources from the Human Subjects Division.