As a Principal Investigator, how do I find out who can be the Legally Authorized Representative for a research subject?
Who can serve as a legally authorized representative (LAR) is determined on a state-by-state basis. When a study requires consent to be provided by an LAR, CGIRB requests that the Principal Investigator (PI) confirm with a regulatory attorney or with the sponsor who may serve as an LAR for their particular state. The Sponsor is responsible for ensuring proper monitoring of investigators under Title 21 Part 312.50, which includes confirming that a legally effective consent process was performed. The monitor should verify that the person signing as LAR has the authority to provide consent on the subject’s behalf; otherwise the consent may not be legally effective.
Related Questions
- Can the principal investigator or PI of a Specialized Center lead a basic research project or must the P.I. direct a clinical research project?
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