The US Code of Federal Regulations governing human participants research requires that investigators disclose reasonably foreseeable risks of a research study to prospective participants during the informed consent process. Although this mandate appears straightforward, controversy surrounds how investigators should define and describe risks of comparative effectiveness randomized clinical trials (CE-RCTs) that compare treatments within accepted standards of care. The Office for Human Research Protections (OHRP) has published draft guidance prompted by the controversy of the Surfactant, Positive Pressure, and Pulse Oximetry (SUPPORT) trial of oxygenation targets in premature infants to address this question. The draft guidance concludes that “if a research study examining standards of care includes as a purpose evaluating identified risks associated with those standards of care, the identified risks associated with the standards of care being evaluated that are different from the risks of standards of care at least some of the subjects would be exposed to outside of the research study are generally considered…to be reasonably foreseeable risks of research.”1
Weiss EM, Joffe S. Promoting Informed Decision Making for Comparative Effectiveness Randomized Trials. JAMA Pediatr. 2015;169(9):803–804. doi:10.1001/jamapediatrics.2015.0906
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