The Department of Health and Human Services (DHHS) announced a public meeting to be held on August 28, 2013, to seek public input and comment regarding what risks should be disclosed to potential research participants in the context of research studying one or more interventions that are used as standard of care treatment in the non-research context.
This issue has been motivated by the Office of Human Research Protections (OHRP) issuance of its March 7,2013 compliance oversight determination letter regarding its investigation into “The Surfactant, Positive Pressure, and Oxygenation Randomized Trial” (SUPPORT) clinical trial, in which OHRP determined that certain risks related to the interventions being studied in the SUPPORT trial were required by the HHS protection of human subjects regulations to be disclosed to the research subjects, and the subjects were not informed of these risks. OHRP’s view of the SUPPORT trial, as described in this determination letter, triggered extensive public discussions regarding (1) what risks to subjects are presented by clinical trials studying interventions that are standard of care in the clinical treatment context, such that an IRB must evaluate those risks in relation to the anticipated benefits of the research as required by 45 CFR 46.111 (a)(2); and (2) how an IRB should assess whether those risks are reasonably foreseeable such that the risks must be described to subjects in informed consent as required by 45 CFR 46.1 16(a)(2).
Through the public reaction to this determination letter, OHRP has become aware of differing opinions on this issues and subsequently, OHRP issued another determination letter June 4, 2013 that reviewed the issues in greater detail and placed the compliance enforcement action on hold pending issuance of further OHRP guidance on the issues involved.
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