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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, UCSD research protocols must have specific IRB 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. To assist in accomplishing this in a research setting, a UCSD task force on Decisional Capacity was appointed by the Chairman of the Department of Psychiatry at the request of the Human Research Protections Program (HRPP). The Guidelines created by the task force are now available, including examples of assessment instruments designed to document whether a subject has sufficient understanding of the elements of informed consent to participate. A new item has been added to the standard Biomedical Research Plan Application and to the Instructions for Completing the Application that addresses the elements of the protocol needed to receive IRB approval for use of Surrogate Consent. Investigators may also wish to amend currently approved protocols so that the option of using Surrogate Consent is available. Downloadable items to assist researchers in understanding and complying with California law on surrogate consent:
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