Legally Authorized Representatives (LARs): Support for Decisionally Impaired Research Subjects

September 22nd, 2017 by Robert Romanchuk, IRB Vice Chair

A potential research subject must provide his or her informed consent before enrolling in a clinical trial. But for adult subjects with impaired decision-making capacity, hindered perhaps by a neurodegenerative condition or an emergency situation, it might not be possible to obtain truly informed consent directly from the individual. In these cases, the IRB may determine that consent can be obtained via the potential subject’s legally authorized representative, or LAR.

Defining “LAR”

OHRP and FDA regulations define LAR as “an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.” The LAR essentially “stands in the shoes” of the decisionally impaired person, making decisions on his or her behalf that are in the best interest of that person.

In the US, who can serve as an LAR depends largely on state law, and each state has its own unique requirements. This can get tricky; for example, some states define LAR requirements for clinical care but not for research. Some states permit a person’s caregiver to serve as LAR, while others forbid it. Researchers should familiarize themselves with their site’s state LAR laws to understand who can and cannot perform the duties of an LAR.

IRB Review

The IRB will evaluate each study to determine whether subjects may be consented via LAR. An LAR cannot consent on behalf of the potential subject simply because of convenience. The study protocol should include the rationale for why the research is targeting decisionally impaired subjects, and it should also include plans for assessing a potential subject’s ability to consent. NIH offers some suggestions for this assessment in its guidance Research Involving Individuals with Questionable Capacity to Consent: Points to Consider.

Subjects with impaired ability to consent are considered a vulnerable population likely to be susceptible to coercion or undue influence. The IRB will require additional protections for these subjects to ensure their rights and welfare are appropriately protected.

Ongoing Consent

Consent is an ongoing process, so it’s important that the LAR be available throughout the study to receive updated information about the research so he or she can make decisions as necessary regarding the subject’s continued participation.

Researchers must also be prepared to re-evaluate a subject’s ability to consent over time. Some conditions may cause a subject’s cognitive abilities to fluctuate or deteriorate over time; changes in medication can also impact a subject’s ability to consent for themselves.

Respect for Subjects Relying on an LAR

Even if an LAR is making all decisions on a study subject’s behalf, don’t forget that it’s the subject him or herself who is contributing to the research. Remember to respect the subject’s agency and any preferences he or she might express, and treat the subject as you would any other research participant: talk to him or her directly, and explain any study-related interventions so he or she knows what to expect. Every study subject plays an important role in helping researchers better understand and improve the health conditions of many others.

Want to learn more about protecting vulnerable subjects with diminished decision-making capacity? Read our blog post Informed Consent and Diminished Decision-Making Capacity, or review Safeguards for Vulnerable Subjects.