Comments on OHRP Draft Guidance

OHRP recently invited public comment on a draft guidance document entitled, “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.” This draft guidance is intended to explain how to interpret the terms “participation” and “discontinuation of participation” in research.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 the ongoing responsibilities of the investigator and IRB toward subjects whose participation in a study has terminated. The comments recommend inclusion of additional guidance on the duty to report new findings to research subjects whose participation in a study has been discontinued. In addition, PRIM&R recommends that the guidance advise researchers to include information on future risks that may exist beyond participation in research. Please review PRIM&R’s comments and let us know your thoughts by leaving a comment below.