On October 24, 2014, the HHS Office for Human Research Protections published a notice announcing that it is seeking comments on draft guidance for the research community entitled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The guidance addresses risks to subjects that are presented by research evaluating risks associated with standards of care, and which of these risks are reasonably foreseeable and should be disclosed to prospective research subjects as part of their informed consent. Comments on the guidance will be accepted until December 23, 2014.
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