Office of Research, UC Riverside
Office of Research Integrity

Institutional Review Board - Socio-Behavioral (IRB-SB)

Surrogate Consent Law for Persons with Impaired Decisional Capacity

Research involving human subjects is built on the principle of voluntary participation, and the idea of informed consent is that a research participant understands what they are agreeing to do, including an awareness of potential risks and benefits.  How can research be done to understand and treat conditions that involve cognitive impairment, such as dementia or psychosis, and conditions in which persons might reasonably be expected to have temporary impairment in their decision-making ability as a consequence of severe pain or anxiety or confusion, such as cancer or trauma or life-threatening illness?

Effective January 1, 2003, the State of California has become one of the few states in the nation to enact a law that specifies a variety of persons who can serve as the surrogate for the interests of a potential research participant and provide informed consent when a person does not have the capacity to decide for themselves. The law includes a number of restrictions on the types of studies and types of research participants for which surrogate consent can be used.

In order to take advantage of the new California law, UCR research protocols must have specific HRRB approval to use Surrogate Consent.  In addition, in many cases the protocol will have to employ a documented means of assessing the decision-making capacity of the potential research subject.  Guidelines for to assist in this assessment have been developed by a UCSD taskforce and are available at http://HRRB.ucsd.edu/decisional.shtml These guidelines include examples of assessment instruments designed to document whether a subject has sufficient understanding of the elements of informed consent to participate.

Downloadable items to assist researchers in understanding and complying with California law on surrogate consent: