Comments on OHRP’s Draft Guidance for Disclosing Risks in Research Evaluating Standards of Care and the SUPPORT Trial

View the Comments and Enclosures as a PDF.

Public Citizen generally supports the positions expressed by the Office for Human Research Protections (OHRP) in the draft guidance regarding the disclosure of reasonably foreseeable risks in research evaluating “standard of care” or usual care interventions. However, the draft guidance is too narrowly constrained in its scope and fundamental position statement and lacks clarity with respect to several important points.