The AAMC Jan. 22 submitted comments to the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) regarding the draft document, “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care."
The draft guidance addresses appropriately assessing risks to human subjects involved in research that compares current “standard of care” medical practices; attempts to define standards of care; and address the idea of risk, and reasonably foreseeable risk, as it relates to the purpose of a research study as well as the informed consent process.
The letter states that while the association acknowledges the necessity of developing the guidance, it urges OHRP to clarify the scope, context, and obligations of the current document to ensure consistent and predictable application across studies and avoid unintended effects on critical research.
Additionally, the AAMC encourages OHRP to amend the draft to include additional examples of how to apply the guidance, and provide direction as to what processes are sufficient to make and document any determinations set forth in the document.
In particular, the AAMC recommends the guidance address all the information a prospective subject needs about research on standards of care, beyond disclosing risk, and recommends that OHRP consider broadening the scope of the guidance to address this issue. Additionally, the current guidance does not provide an institutional review board (IRB) or investigator direction on how to distinguish the purpose of the research from important outcome measures.
The AAMC further suggests that the draft language be revised to clarify important concepts; for example, that randomization alone is not a risk of research, and that risk and harm should not be conflated in research studies.
To maintain its commitment to improving the health of all, the AAMC cautions, “If the final guidance document is ambiguous in how to apply these standards or silent on how to demonstrate appropriate deliberation or diligence, anxiety from not understanding the implications or potential enforcement actions could cause IRBs, investigators, and institutions to decide that the safest approach is to steer clear of comparative effectiveness research altogether.”