October 25, 2014
On October 24, 2014, the Office for Human Research Protections (OHRP), in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), announced in the Federal Register the availability of a draft guidance document entitled, "Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care," and are inviting public comments on that document. The draft guidance pertains to nonexempt research involving human subjects designed to evaluate treatments or procedures that are medically recognized standards of care. The guidance applies to such research that is conducted or supported by HHS.
The draft guidance explains how to apply the HHS Regulations at 45 CFR Part 46 to studies that are designed to evaluate one or more standards of care. It 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. It explains OHRP’s position that in general the reasonably foreseeable risks of research in a study include the already identified risks of the standards of care being evaluated as a purpose of the research when the risks being evaluated are different from the risks some of the subjects would be exposed to outside of the study. Reasonably foreseeable risks must be described to prospective subjects when seeking their informed consent in accordance with 45 CFR 46.116(a)(2).
The draft guidance addresses the following topics:
- What are “standards of care”?
- What are “risks of research” in studies evaluating risks associated with standards of care?
- When is evaluating a risk in a research study considered to be a “purpose” of the research study?
- Are the risks of research associated with the purposes of studies of standards of care “reasonably foreseeable risks” that must be disclosed to prospective subjects in the informed consent process?
The draft guidance, when finalized, will provide OHRP’s first formal guidance on this topic.
The Federal Register notice of availability, the draft guidance document, and instructions for how to submit comments can be accessed from the OHRP website's Requests for Comments page.
