OHRP: Investigators Can’t Exempt Their Own Research Studies

November 13, 2009
Investigators should not be allowed to decide on their own that their human subject research is exempt from federal regulations enforced by the HHS Office for Human Research Protections (OHRP), according to a new question-and-answer document. Recognizing the potential conflict of interest investigators have in making such decisions, OHRP says exceptions could be made if an institution has a way to deal with such conflicts and to address an investigator’s lack of detailed knowledge of the regulations.
Clinical Trials Advisor