On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (“Draft Guidance”).  The Draft Guidance addresses how researchers evaluate and characterize the risks to participants in research comparing current standards of care and how those risks are expressed in informed consent documents.

As comparative effectiveness research becomes more common, driven in part by funding under the Affordable Care Act, questions have arisen regarding whether the risks of undergoing a specific standard of care constitute research risks that must be considered by Institutional Review Boards (“IRBs”) and disclosed to study participants. The Draft Guidance follows OHRP’s 2013 compliance oversight determination letter, and subsequent controversy, regarding the informed consent process in the Surfactant, Positive Pressures, and Oxygenation Randomized Trial (“SUPPORT”).

Several prominent ethicists have argued that informed consent for comparative effectiveness research may not be required in all instances and groups like the Association of American Medical Colleges have warned that requiring informed consent in research designed to compare variations in the standard of care could chill such research.  On the other hand, in the Draft Guidance, OHRP contends that when study participants are randomized into groups, the randomization to a treatment protocol represents of a risk of research, rather than simply a risk in the underlying treatment.

The Draft Guidance seeks comment on four questions:

1. What are “standards of care”?

2. What are “risks of research” in studies evaluating risks associated with standards of care?

3. When is evaluating a risk in a research study considered to be a “purpose” of the research study?

4. 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?

Researchers, research institutions, sponsors, and other parties interested in commenting must do so by December 23, 2014.