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THE COMMITTEE ON HUMAN RESEARCH

SURROGATE CONSENT (Revised: November 2006, March 2008)

Federal regulations (45 CFR 46.116 and 21 CFR 50.20) 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. In California , Health and Safety Code 24178 specifies in detail who may serve as a legally authorized representative to give consent for an incapacitated prospective research subject. The state law uses the terms “surrogate decisionmaker” or simply “surrogate” to refer to the legally authorized representative.

University of California Office of the President (UCOP) has designed a form for surrogates to self-certify their eligibility and has issued guidelines for following the new law.

UCSF researchers should follow the guidance for investigators and use the Self-Certification of Surrogate Decision Makers for Potential Subject's Participation in University of California Research. New applications and renewals and major modifications of studies using surrogates should include a completed copy of the CHR Application Appendix:Surrogate Consent, which ensures that the application will meet the criteria for approval and describe the additional safeguards for subjects required by state law. The protocol for all studies using surrogates should reflect the UCOP guidelines.

For requirements of the San Francisco Veterans Affairs Medical Center (which in most ways agree with UCOP guidance), see the Working with the VAMC and the last section of the CHR Application Supplement: Surrogate Consent.

Of special note:

	•	No surrogates may be asked for consent unless the CHR has specifically approved use of surrogates in the specific study.
	•	The protocol should include a process for formal evaluation of the prospective subject's ability to participate in the consent process.
	•	If surrogate consent will be sought for a responsive patient, the patient must be told of the investigator's plan to consult a surrogate.
	•	If a subject in any way objects to or resists study participation or the use of surrogate consent, that subject may not be included in the study.
	•	The rules for who may act as a surrogate are slightly different in emergency room and non-emergency room settings.
	•	Surrogates may not give consent for inpatients in a psychiatric ward or mental health facility or on psychiatric hold.

Please see the UCOP Guidance on Surrogate Consent for Research for the complete text.