U.S. Department of Health & Human Services
Email Updates 
Font Size
Print
Download Reader
Who can be a legally authorized representative (LAR) for the purpose of providing consent on behalf of a prospective subject?
Legally authorized representative (LAR) means 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 (45 CFR 46.102(c)). The regulations state that “no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative” (45 CFR 46.116). The issue as to who can be an LAR is determined by the laws of the jurisdiction in which the research is conducted (e.g., local or state law). Some states have statutes, regulations, or common law that specifically address consent by someone other than the subject for participation in research. Most states have no law specifically addressing the issue of consent in the research context. In these states, law that addresses who is authorized to give consent on behalf of another person to specific medical procedures or generally to medical treatment may be relevant if the research involves those medical procedures or medical treatment.
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). IRBs may wish to consult with legal counsel when deciding who can serve as an LAR for subjects of proposed research.
Last Reviewed: 01/20/2011
Related Questions:
- When may a legally authorized representative provide consent on behalf of an adult with diminished decision-making capacity?
- What should be considered in seeking informed consent from individuals with diminished decision-making capacity?
- What are the requirements for assent and parental permission in research with children?
- May the requirement for obtaining informed consent or parental permission be altered or waived?
- What is the definition of guardian in the context of obtaining consent for research involving children?
