The Office for Human Research Protections (OHRP), has issued a Federal Register notice requesting information and comments from the public about whether the office should pursue a notice of proposed rulemaking to enable OHRP to hold IRBs and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements of 45 CFR part 46. OHRP is contemplating this regulatory change to encourage institutions to rely on IRBs that are operated by another institution or organization, when appropriate. OHRP believes that such a regulatory change in its enforcement authority may address one of the main disincentives institutions have cited as inhibiting them from exercising the regulatory flexibility that currently permits institutions to implement a variety of cooperative review [...] Read more


OHRP recently invited public comment on a draft guidance document entitled, "Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.'' This draft guidance is intended to explain how to interpret the terms “participation” and “discontinuation of participation” in research. The guidance would also clarify that investigators may continue to analyze already collected individually identifiable private information about a subject even when the subject's participation has been discontinued, and that research may continue to involve human subjects even when the participation of all subjects has been completed or discontinued.PRIM&R's Public Policy Committee developed comments that request further clarification about [...] Read more