Research Integrity
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: