California has enacted a new law that addresses surrogate decision making in research. It was effective as of January 1, 2003. Federal human subjects regulations require that consent for research be obtained from the subject's "legally authorized representative" if the subject lacks the capacity to consent. The new state law specifies who the legally authorized representative can be in most (but not all) research situations.
(1) an individual is "unable to consent and does not express dissent or resistance to participation;" AND
(2) the individual is not an inpatient on a psychiatric unit or in a mental health facility or a patient on a psychiatric hold; AND
(3) the research involves "medical experimentation," as defined by CA law (e.g., investigational use of a drug or device; withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject [e.g., double blind/placebo testing]); AND
(4) the medical experiments "relate to the cognitive impairment, lack of capacity, or serious or life threatening diseases and conditions of research participants."
If these conditions are met, surrogate decision makers, such as a spouse, a domestic partner, an adult brother or sister, or others, may give informed consent for the individual to participate in the research.