A Legally Authorized Representative (LAR) provides, or maintains, informed consent on behalf of a research participant. An LAR may help researchers recruit participants who lack decision making capacity, or retain those at risk of losing it.
The US Office of Human Research Protections (OHRP) has offered guidance that anyone who can serve as a proxy or surrogate decision maker for healthcare decisions could serve as an LAR for research participation decisions:
“When the laws of the jurisdiction in which the research is being conducted provide a reasonable basis for authorizing an individual to consent on behalf of a prospective subject to their participation in the research procedure(s), OHRP would consider such an individual to be an LAR as defined by HHS regulations at 45 CFR 46.102(c)”
In this section, we provide you with guidance on how to help participants appoint an LAR and how to navigate this complex issue. Specifically, we provide guidance on:
We additionally provide:
A tool to help educate participants regarding an LAR and to help with having the LAR discussion, which can be sensitive.
A note to file template document that can be used to document participant’s wishes regarding an LAR.
Sample language and references you could incorporate into an IRB application to explain why you have adopted this practice.
Note: This is not legal advice. We present educated opinions only. We encourage you to consult with your IRB or legal counsel to ensure that the guidance offered by ConsentTools.org complies with laws in your jurisdiction.
We thank Sarah Fowler Dixon, PhD, and Jesse Goldner, JD, MA, for their expertise on developing the guidance regarding Legally Authorized Representatives that is provided here.