Bioethics Blogs

OHRP’s Dangerous Draft Guidance

In October, the federal Office for Human Research Protections issued a “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” It follows the controversy that erupted in 2013 over the SUPPORT study of oxygen therapy for premature babies. The draft guidance attempts to clarify federal regulations regarding the informed consent process.

We believe that the draft guidance would lead to an approach to informed consent that would predictably mislead patients rather than inform them. We propose a different and more honest, accurate, and empowering approach to informed consent, specifically tailored for research evaluating widely used medical practices that have uncertain value.

The key question in research on standard medical practices is this: Which risks should be considered to be risks of the research and which should be considered the risks of standard medical practices? As emphasized in the Belmont Report and in previous guidance, the risks that patients would incur if not participating in research should not be considered to be risks of research. Instead, the risks of research are only the incremental risks of the research itself.

The draft guidance blurs this distinction. It conveys the impression that any alteration in the care that a patient would receive if enrolled in a study, compared to what that patient would have received outside the study, will create a reasonably foreseeable risk for that patient. Virtually all therapies have identified risks. Thus, virtually any alteration in the care that a patient would receive if enrolled in a study, compared to what that patient would have received outside the study, would be considered create a reasonably foreseeable incremental risk for that patient.

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.