The document is a formal letter authored by Jackie Bendall and the Costing Policies Committee, on behalf of the Council on Governmental Relations (COGR), to Dr. Irene Stith-Coleman at the Office for Human Research Protections (OHRP), responding to the draft guidance on disclosing reasonably foreseeable risks in research involving standards of care. The Council, representing 190 major research universities and affiliated academic medical centers, expresses general support for the OHRP's intent to enhance informed consent processes by ensuring that research participants are adequately informed of the reasonably foreseeable risks, particularly in studies comparing different standards of care. The letter acknowledges the importance of transparency and of tailoring risk disclosures to the specifics of the consent process, while cautioning against excessively complex or lengthy consent forms that might overwhelm or confuse participants.
The Council specifically notes concerns about the draft guidance’s terminology and how some of its language could conflate clinical care with research, thus confusing participants. They argue that disclosures should be meaningful and comprehensible, recommending that the guidance focus strictly on foreseeable research risks that are distinct from those present in standard clinical care, and suggesting the removal of overly complicated requirements such as those inspired by the SUPPORT Trial. The letter requests revisions to ensure clearer, scaled-back guidance that both protects human subjects and maintains the efficiency and effectiveness of the consent process, ultimately supporting ethical research while facilitating scientific progress.
COGR sent a letter to the Office for Human Research Protections on draft guidance concerning disclosure of reasonably foreseeable risks in research evaluating standards of care.
