Bioethics Blogs

PRIM&R’s Response to OHRP’s Draft Guidance on Research Evaluating Standards of Care

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

Research on the comparative effectiveness of commonly used interventions is becoming increasingly common as clinicians, researchers, and healthcare funders seek to improve the efficiency and effectiveness of health care by developing a strong evidence base about medical interventions. With the growth of such efforts, questions have emerged about how oversight rules and mechanisms for the protection of human subjects should apply to such endeavors.

In October, following more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the federal regulations for the protection of human subjects apply to research evaluating alternative interventions that all meet the standard of care for preventing, diagnosing, or treating a particular condition.

In an earlier post, we provided an overview of the draft guidance, titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care,” and today, we are pleased to make available PRIM&R’s response to the draft. PRIM&R appreciates the OHRP’s efforts to foster public discussion and provide the research community with guidance on how to ensure adequate protections for human subjects in research evaluating one or more interventions that are within the standard of care. PRIM&R believes, however, that the current document does not provide the comprehensive assistance needed by investigators and IRBs, and, in our comments, urges the OHRP to rewrite the document to provide clearer guidance.

Concerns Regarding the Current Draft Guidance

In our response, PRIM&R expresses concern that the draft guidance appears to be limited to research whose purpose is to evaluate the risks of two or more “standard of care” interventions.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.