Updated Guidance re: Surrogate Certification for Research

Background: What Is a Surrogate?

Federal regulations require that consent be sought from a research subject or “the subject’s legally authorized representative” and defer to “applicable law” to define who is legally authorized (45 CFR 46.116 and 21 CFR 50.20). In California, Health and Safety Code 24178 describes who may serve as a legally authorized representative to give consent for an incapacitated prospective research subject. The state law uses the terms “surrogate decision maker” or simply “surrogate” to refer to the legally authorized representative. A surrogate must be certified before they can provide surrogate consent.

Updated UCOP Guidance

Previously, surrogates would complete a self-certification form to attest to their eligibility to be a legally authorized representative. The new UCOP guidance has changed this, now requiring that the Investigators conduct the certification of surrogate decision makers. UCOP released a new form that is completed by the consenting Investigator only. The IRB website has been updated to reflect these changes, and includes links to the current UCOP-mandated forms.