OHRP Discusses Draft Guidance on Appropriate Disclosure of Risks in Research about Standards of Care at AER14

In October, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance “discusses whether risks are considered risks of research when one of the purposes of the research is the evaluation or comparison of risks associated with standards of care. It also discusses disclosing certain reasonably foreseeable risks to prospective subjects when seeking their informed consent to participate in such research activities.”

Following up on the release of the draft guidance, PRIM&R held a session at the 2014 Advancing Ethical Research (AER) Conference titled “Disclosing Risks Appropriately in Research About Standards of Care.” During the session, presenters from OHRP explored the issue of disclosing reasonably foreseeable risks to prospective subjects in studies about standard of care treatments and reviewed the agency’s draft guidance on this issue. Given the timely nature of this session and the importance of the draft guidance to the research community, PRIM&R is pleased to make available a recording of this session:

Comments on the draft guidance must be submitted to OHRP by Tuesday, December 23, 2014.