Regulacje i polityka gospodarcza · 24.10.2014

Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care

The Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) is announcing the availability of a draft guidance for the research community entitled "Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care." OHRP is specifically addressing what risks to subjects are presented by research evaluating or comparing 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. OHRP is soliciting written comments from all interested parties, including, but not limited to IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, the regulated community, and the public at large. This draft guidance represents OHRP's current thinking on this topic. Certain treatments and procedures that are commonly used in health care for a given type of disease or condition have come to be known as "standards of care." Multiple "standards of care" involving widely differing treatments and risks may be available for the same diseas