Applicable Regulation or Guidance

The FDA and the DHHS have regulations that contain provisions for the equitable selection of research subjects. These regulations require the institution’s IRB to only approve research protocols that contain adequate provisions to ensure that subject selection is equitable. In making this assessment the IRB is to take into account the purposes of the research and the setting in which the research will be conducted. In addition, IRBs are to be particularly cognizant of the inclusion of vulnerable populations in research, and when included, ensure that appropriate safeguards are incorporated.

The following links provide access to the specific Federal regulations:

The following links provide additional interpretive guidance from the FDA and DHHS, including guidance on subject selection and recruitment: