School of Medicine Publications and Presentations

Legally Effective but Ethically Inadequate: Institutional Review Board Policies for Consent from Legally Authorized Representatives

Document Type

Article

Publication Date

3-27-2023

Abstract

The prevailing approach to enrolling decisionally impaired adults in clinical research is to rely on permission from a default surrogate, one identified by law rather than by the prospective research participant. Reliance on a surrogate transfers the focus of ethical protection from a researcher-participant relationship to a researcher-surrogate relationship; the selection and role of the surrogate are therefore important. The Common Rule defers to state law governing default surrogate consent to research, but most states have no such law; for those states, the Common Rule defers to institutional policy. I reviewed twenty-five of the study sites with the highest National Institutes of Health funding levels to elaborate the content of institutional review board (IRB) policies and compare those to a suggested paradigm for ethically defensible policies. My findings suggest that IRB policies provide inadequate protection because they recognize surrogates who lack knowledge of the subject's current values and preferences without imposing adequate additional safeguards.

Comments

https://onlinelibrary.wiley.com/share/EMNUQUFAWXE2BGYDM5HV?target=10.1002/eahr.500158

Publication Title

Ethics and Human Research

DOI

10.1002/eahr.500158

Academic Level

faculty

Mentor/PI Department

Internal Medicine

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