A California law effective January 1, 2003, specifies in detail who may serve as “legally authorized representative” and is therefore authorized to provide surrogate consent for an incapacitated potential research subject to participate in research. The new requirements apply only where surrogates are needed for incapacitated adults. The law restricts the use of surrogates exclusively to research that relates to the subjects’ cognitive impairment, lack of capacity, or serious or life-threatening disease. No research can use surrogates that does not relate to these topics.
UC Berkeley researchers should begin following the UCOP Guidance on Surrogate Consent for Research and using the Self-Certification of Surrogate Decision Makers for Potential Subject’s Participation in University of California Research immediately. The protocol for all studies using surrogates should reflect the UCOP guidelines. Currently approved protocols need not be modified before their renewal date unless other major changes in the protocol are proposed.
- No surrogates may be asked for consent unless CPHS 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.