Use Of Surrogate Consent In Research
If a prospective subject cannot consent on his/her own behalf, federal regulations permit researchers to obtain consent from a legally-authorized representative. California Health & Safety Code 24178 defines the categories of individuals who are legally authorized in California to provide surrogate consent for research. In order for researchers to obtain consent from a subject's legally-authorized representative, the IRB must approve the use of surrogate consent.
The University of California Office of the President (UCOP) has issued guidelines for following the law and designed a form for investigators to certify surrogate eligibility. UCI researchers should follow the UCOP Guidance on Surrogate Consent for Research and use the Investigator Certification of Surrogate Decision Makers for Potential Subject Participation in University of California Research Form when appropriate.
Determining Whether Use of Surrogate Consent is Appropriate
Researchers interested in using surrogate consent in their research must obtain prospective UCI IRB approval to do so. Consistent with state law, the IRB uses the following criteria when determining whether to permit the use of surrogate consent for participation in a research study:
- Surrogate consent may be permitted by the IRB only when the research involves medical experimentation relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of the research subjects.
- Surrogate consent to participate is not permitted for persons who are an inpatient on a psychiatric unit or in a mental health facility or a patient on a psychiatric hold.
- There must be a protocol-specific plan for the sequence of steps that will be employed by the researcher(s) to acquire and document surrogate consent provided by a legally authorized representative. The researcher must include a description of this plan and provide details of how the decision making capacity of subjects will be assessed and by whom.
- If the research participant lacks capacity to consent, the investigator must make a reasonable effort to describe the research to the participant in a manner consistent with the standard consent process and indicate the intent to obtain surrogate consent.
- Researchers are encouraged to use a decision-making capacity tool for assessing competency to consent. A Decision-Making Capacity Assessment Tool is available for use. This tool elicits a response from potential subjects to a series of questions that demonstrates the subject's capacity to understand the study's goals, risks/benefits, and choice to participate.
- If the research participant expresses resistance or dissent to participating in the research or to the use of the surrogate consent by word or gesture, they must be excluded from the research study.