The Department of Health and Human Services (HHS) is seeking input on how institutional review boards (IRBs) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects as part of the informed consent process. In a June 26, 2013 notice, HHS states that it “has become aware of differing perspectives in the scientific, research, and ethics communities about these issues and how the relevant requirements of the HHS protection of human subjects regulations should apply to research studying standard of care interventions.” To inform future guidance, HHS is hosting a meeting on this topic on August 28, 2013, and the agency is seeking public comment on a variety of related questions; comments will be accepted through September 9, 2013.