In the United States, it is common practice that individuals who lack the capacity to make informed decisions on their own rely on support from others who are intimately familiar with their lives, best interests, preferences, beliefs, and values. Such individuals serve as surrogates and/or proxies who are legally authorized to assist in medical, health care, and financial decision-making.Reference Buchanan and Brock ¹ In parallel to medical practice, the research enterprise also relies on a similar delegation defined in US federal regulations as a Legally Authorized Representative (LAR). The necessity of this role is the same regardless of the context: an LAR is a legally recognized individual advocate capable of making a values-based decision on behalf of another individual who cannot do so for themselves.

Institutional Review Boards (IRBs) are federally mandated to protect the rights and welfare of individuals participating in biomedical and social-behavioral research. IRB oversight is conducted in accordance with federal regulations, state laws, and institutional policies, as well as ethical standards and responsible research practices. IRBs must draw from each of these frameworks to balance protectionism and paternalism; respecting participant autonomy while also safeguarding them from exploitation, undue influence, and/or harm. The role of the LAR (i.e. an individual able to protect the prospective participant from harm) is also a counterbalance to mitigate research participation risks.

Dr. Morreim’s paper, So You Think You Know Who’s the “Legally Authorized Representative”: Clinical Research Hits a Snag, conceptually compares and contrasts the medical and research models of LARs, seeking to explore two core questions: (1) how an LAR is identified and (2) how appropriate decision-making capacity assessments are determined.Reference Morreim ² In the paper, Morreim relies on health care proxy decision-making frameworks to judge existing research practices and to inform ambiguous or nonexistent research regulations and standards. However, in Morreim’s critique, several arguments and practical realities are overlooked, including real-world IRB operational practices. In this commentary, I hope to bring attention to these omissions and extend the argument by adding a practitioner’s perspective.

Morreim highlights flaws within the evolving LAR regulations but does not explore their strengths. For example, the paper mentions the revised definition of LAR, which took effect as part of the 2019 Revised Common Rule regulations ³ (additions appear in bold; non-bold text remains unchanged from the original 1991 version):

Morreim’s criticism of this definition supposes that the lack of “applicable [state] law” is a detriment, whereas an IRB would see this as an opportunity. Morreim documents the few state laws that describe how to obtain consent for research participants unable to provide it themselves. Absent a specific “applicable law,” the regulations point to institutional policy to define an LAR. Research institutions, such as universities and laboratories, are unlikely to reinvent the wheel. Adopting the medical/health care definition of LARs provides a more precise road map while informing research-specific LAR policy with “the laws of the jurisdiction in which the research is conducted (e.g., local or state law).” ⁵ Morreim’s interpretation holds that many non-research LAR definitions are limited to Durable Power of Attorney (DPoA) and end-of-life scenarios and thus are inadequate for guiding research consent practices. According to Morreim, more often than not, this process of elimination leaves IRBs “empty-handed in states that offer no guidance at all.” Instead of seeing the revised definition as an asset, Morreim instead is quick to conclude that: “In these states, research involving incapacitated participants appears to be restricted to people who have [a DPoA or court-appointed conservator].”

The main limitation of this critique is that it leads the reader to believe that, without explicit state laws, there is a finite dead end when it comes to enrolling participants without the decisional capacity to consent. This is an incomplete assessment. Morreim insists that “the reality is that many states’ governance for capacity and surrogacy are either absent or do not work well for clinical research.” However, in my experience, the opposite is true. State laws can provide more sensitive guardrails for populations of interest than federal regulations, and IRBs complement those protections by identifying study-specific risks and corresponding safeguards.

Morreim’s analysis appears to lack direct experience negotiating the definition of an LAR with an IRB and/or as an IRB member reviewing research necessitating an LAR. Consider the following real-world example:

I am a researcher and conduct my work in Massachusetts, where there are no state laws that specify how to obtain consent for prospective research participants who may lack the ability to do so themselves. Without explicit state laws, I seek guidance from the IRB and follow their written policies/standard operating procedures (SOPs). The SOP directs me to follow the applicable components of the Commonwealth of Massachusetts General Laws (MGL) 190 and 201D, ⁶ which define health care proxies and guardianships. Upon review of the MGL, there are bright legal distinctions that address consent for minors and incapacitated individuals, for example, delineating the assignment of an LAR based on the developmental maturity of the individual versus an individual with a degenerative condition. In addition, the law draws helpful distinctions about who can serve as a guardian and when, including factors like age, court appointments, limitations on power, emergency orders, immunities, religious freedom, estate management, protective orders, and more.

This is a key component of IRB operations overlooked by Morreim. Written IRB policies are required by federal regulations ⁷ and the Association for the Accreditation of Human Research Protection Programs. ⁸ These details are not trivial; they are, in fact, what hold IRBs accountable. Well-written IRB SOPs can provide research-specific translation of the law, largely avoiding the ambiguity and dead ends Morreim suggests are inevitable.

Turning now to Morreim’s debate about who may be an appropriate assessor of decision-making capacity, the paper immediately disqualifies a researcher who is also the participant’s primary physician. Morreim describes such a person as carrying “inevitable conflicts of interest” because a researcher’s “first priority is to the science, not to the research participants.” This is mistaken; a physician’s first priority is to Do No Harm. The perception that medical professionals have a “hierarchy of interests” that motivates their behavior towards patients has been challenged in recent scholarship.Reference Wiersma, Kerridge and Lipworth ⁹ Additional support can be found in the literature on learning health care systems, which are purpose-built to integrate research and medical practice on the basis of continuously improving the broader system and diffusing perceptions of hierarchical priorities.Reference Faden ¹⁰

In an attempt to provide a solution to the conflicted physician, Morreim suggests “the IRB could assemble a cadre of professionals who are willing and statutorily qualified to assess [participant decision-making] capacity.” However, this is not a novel suggestion; federal research regulations have already anticipated such needs and allow an IRB to “invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB.” ¹¹ IRBs presently use this provision to address tensions between the current pace of innovation and meaningful protection of research participants. Recent research on IRB expertiseReference Serpico ¹² demonstrates that, while many IRBs engage outside experts for this purpose, external consultation is relatively infrequent, typically just a few times each year, because IRBs are sufficiently composed to review the research conducted at their institutions.

As an IRB professional for over 15 years, I have found that researchers do not attempt to interpret regulations and laws in a vacuum; they seek expert guidance from their IRB, research administrators, and general counsel offices. Early in the article, Morreim entrenches negative IRB stereotypes by raising timeworn criticisms about turnaround time, member expertise, and lack of training, suggesting a lack of engagement with current literature on these themes. The Common Rule (at 45 C.F.R. § 46.107 (2017)) and FDA regulations (at 21 C.F.R. § 56.107 (1981)) require that IRBs are composed of “sufficiently qualified” members who provide “complete and adequate review of research activities commonly conducted by the institution.” To suggest otherwise alleges that IRBs operate deficiently and out of compliance, which does not align with my experience as a practitioner.

Morreim clearly has the same end goal as the IRB: to ensure protectionism and paternalism are adequately balanced for participants without the decisional capacity to consent. However, the practical realities of LAR implementation include much greater IRB involvement and researcher mindfulness than given credit for in this paper.