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OHRP Guidance – Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (Draft)

Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care

Draft

This guidance, when finalized, will represent the Office for Human Research Protections’ (OHRP’s) current thinking on this topic. This guidance does not create or confer any rights for or on any person and does not operate to bind OHRP or the public.

OHRP guidance should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under the Department of Health and Human Services (HHS) regulations at 45 CFR Part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the OHRP at 240-453-6900 or 866-447-4777, or by email at ohrp@hhs.gov.

Date:

October 20, 2014

Scope:

This guidance pertains to nonexempt research involving human subjects that is designed to evaluate treatments or procedures that are medically recognized standards of care. The guidance applies to such research that is conducted or supported by the Department of Health and Human Services (HHS).

This draft guidance explains how to apply the HHS Regulations at 45 CFR Part 46 to studies that are designed to evaluate one or more standards of care. It discusses whether risks are considered risks of research when one of the purposes of the research is the evaluation or comparison of risks associated with standards of care. It also discusses disclosing certain reasonably foreseeable risks to prospective subjects when seeking their informed consent to participate in such research activities. It explains OHRP’s position that in general the reasonably foreseeable risks of research in a study include the already identified risks of the standards of care being evaluated as a purpose of the research when the risks being evaluated are different from the risks some of the subjects would be exposed to outside of the study. Reasonably foreseeable risks must be described to prospective subjects when seeking their informed consent in accordance with 45 CFR 46.116(a)(2).

The draft guidance addresses the following topics:
1. What are “standards of care”?


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