New Draft Guidance from OHRP: Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care


On October 20th, the Office for Human Research Protections’ (OHRP’s) released a new draft guidance which when finalized, will represent their current thinking on this topic. This is a timely guidance primarily as it closely relates to the FDA’s draft ICF guidance released in July of this year, which you can find here. The comment period to the OHRP’s new draft guidance is until December 23rd.
A summary about this new draft guidance:
Target Audience:

  • The general public, IRBs, investigators, research administrators and other relevant institutional officials and funding agencies that may be responsible for review or oversight of human subjects research conducted or supported by HHS.


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


  • 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.  
  • 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.  
  • Discusses disclosing certain reasonably foreseeable risks to prospective subjects when seeking their informed consent to participate in such research activities.
  • 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 The draft guidance addresses the following topics: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”?
  2. What are “risks of research” in studies evaluating risks associated with standards of care?
  3. When is evaluating a risk in a research study considered to be a “purpose” of the research study?
  4. Are the risks of research associated with the purposes of studies of standards of care “reasonably foreseeable risks” that must be disclosed to prospective subjects in the informed consent process?

 “If you have specific questions about how to apply this guidance, please contact OHRP by phone at(866) 447-4777 (toll-free within the United States) or (240) 453-6900, or by e-mail at”