The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

Modernizing Human Subjects Research Protections: Legally Authorized Representatives and Consent Capacity

This is the last installment in a series of blog posts about recent proposed changes to the Common Rule, and how they relate to the work of the Bioethics Commission. The Common Rule currently requires permission from a legally authorized representative (LAR) to enroll participants who lack consent capacity in research. LARs consider and evaluate the merits of research participation on behalf of others—often loved ones—who lack consent capacity.

In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2) the Bioethics Commission noted that the Common Rule does not specify who can serve as an LAR, what kinds of decisions an LAR can make, and what processes and procedures are required to establish an LAR. Rather, it indicates that these decisions be made according to “applicable law,” including state law. However, while some states have laws that outline LARs for clinical care, few states have laws that specifically address LARs for research, leaving researchers and IRBs with uncertainty. In Gray Matters, Vol. 2, the Bioethics Commission recommended that “federal regulatory bodies should establish clear requirements to identify who can serve as legally authorized representatives for individuals with impaired consent capacity to support their responsible inclusion in research.”

The recent notice of proposed rulemaking (NRPM), which proposes revisions to the Common Rule, recognizes this regulatory gap that was highlighted by the Bioethics Commission. It notes that a possible ramification of this gap is that in states without clear laws, enrolling participants with impaired consent capacity could be difficult or impossible. The NPRM proposes a revision to the Common Rule that would permit LAR requirements to meet an accepted common practice standard, such as an established state or local hierarchy. This proposed revision mirrors the Bioethics Commission’s recommendation and its suggestion that federal regulatory bodies could recognize previous efforts on this front, such as the priority list of potential LARs developed in 2009 by the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP).

If the NPRM proposed revisions are implemented, new research regulations will reflect the Bioethics Commission’s recommendation for clarity in LAR requirements. Clear requirements for LARs facilitate the responsible inclusion of participants with impaired consent capacity in research, which is necessary to fulfill the promise of research that might one day ameliorate neurological disorders and psychiatric conditions.

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About blog.Bioethics.gov

This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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