Share

Use Of Surrogate Consent In Research

Background

If a prospective subject cannot consent on his/her own behalf, federal regulations permit researchers to obtain consent from a legally-authorized representative. CA 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.

Determining Whether Use of Surrogate Consent is Appropriate

To request IRB approval to obtain consent from surrogates, researchers must indicate on the electronic IRB application or modification request that adults with Cognitive, Psychological, or Medical Impairments are a subject population of interest. Researchers are required to complete Appendix E.

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 in research studies relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of the research subjects.
  • The researcher must include a rationale for the use of surrogate consent in Appendix E of the electronic IRB Application.
  • 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 in Appendix E of the electronic IRB Application.Click here to see an example of a plan.
  • Researchers are encouraged to use a decision-making capacity tool for assessing competency to consent. A sample 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.

Important Notes:

  • When the IRB approves surrogate consent for a protocol, it is with the understanding that, whenever possible, investigators will attempt to obtain informed consent directly from the subjects. The LR understands that a re-consenting process may be necessary for those with fluctuating decision making capacity or those with decreasing capacity to give consent.
  • Surrogate consent to participate is not permitted for persons in a State of California mental health facility inpatient psychiatric ward, or persons on psychiatric hold.
  • Modification requests to add cognitively impaired or medically incapacitated populations and/or surrogate consent is considered a significant change to the protocol.

Identifying an Appropriate Surrogate in a Non-Emergency Room Environment

In a non-emergency room environment, surrogate consent may be obtained from any of the surrogate decision makers listed below in following descending order of priority:

  • The person's agent designated by an advance health care directive
  • The conservator or guardian of the person having the authority to make health care decisions for the person
  • The spouse of the person
  • The domestic partner of the person as defined in Section 297 of the Family Code
  • An adult son or daughter of the person
  • A custodial parent of the person
  • Any adult brother or sister of the person
  • Any adult grandchild of the person
  • An available adult relative with the closest degree of kinship to the person

Important Notes

  • In non-emergency room research settings, if two or more surrogates who are in different orders of priority disagree whether to consent, the decision made by the higher priority surrogate shall not be superseded by the lower priority surrogate (e.g., if the spouse of the person refuses participation, a sibling cannot consent on the person's behalf. The decision of the spouse supersedes the sibling's; the person cannot participate in the research).
  • In non-emergency room research settings, surrogate consent is not considered to be given if there is disagreement whether to consent among surrogates in the same order of priority (e.g., two children disagree or two siblings disagree).
  • When consent will be obtained from a surrogate, the IRB usually will require that the assent of the subject be obtained. Assent is defined as affirmative agreement to participate in research. Failure to object does not qualify as assent.

In non-emergency room research settings only, the researcher is responsible for ensuring that the surrogate:

  • Has reasonable knowledge of the subject;
  • Is familiar with the subject's degree of impairment;
  • Is willing to serve as the substitute decision-maker;
  • Understands the risks, potential benefits, procedures and available alternatives to research participation;
  • Makes their decisions based on the subject's known preferences, and where the subject's preferences are unknown, makes decisions based upon the surrogate's judgment of what the subject's preferences would be if different from their own.

Identifying an Appropriate Surrogate in an Emergency Room Environment

In an emergency room setting, surrogate consent may be obtained from any of the following surrogate decision-makers:

  • The person's agent designated by an advance health care directive
  • The conservator or guardian of the person having the authority to make health care decisions for the person
  • The spouse of the person
  • The domestic partner of the person as defined in Section 297 of the Family Code
  • An adult son or daughter of the person
  • A custodial parent of the person
  • Any adult brother or sister of the person

Important Note - In emergency room research settings, no surrogate consent may be utilized if there is a disagreement whether to consent among any available surrogates.

Obtaining Consent from the Surrogate

Researchers shall describe to potential surrogates the nature of ongoing decisions during the study regarding the subject's participation, decision to participate in certain procedures, changes to the study, etc., in order to ensure that the surrogate will be willing to undertake these on-going responsibilities.

The surrogate shall complete the "Self-Certification of Surrogate Decision Makers for Participation in Research" (pdf) form as an attachment to the informed consent document for the research study, and be given a copy of this form along with a copy of the consent to keep. In addition, the researcher must keep the signed form in the research records along with the signed informed consent document.

  • The "Self-Certification of Surrogate Decision Makers for Participation in Research" form verifies the willingness of the person to serve as a surrogate, details the relationship of the surrogate to the subject and the surrogate's qualifications demonstrating "reasonable knowledge" of the research subject.
  • Section 3 of the "Self-Certification of Surrogate Decision Makers for Participation in Research" form is required only for surrogate consent in non-emergency room environment settings).

Potential surrogates must be advised that if a higher-ranking surrogate is identified at any time, the investigator will defer to the higher-ranking surrogate's decision regarding the subject's participation in the research.

For non-emergency room environment research only, if the potential surrogate identifies a person of a higher degree of surrogacy, the investigator is responsible to contact such individuals to determine if they want to serve as surrogate.

Surrogates are prohibited from receiving any financial compensation for providing consent. This does not prohibit the surrogate from being reimbursed for expenses the surrogate may incur related to the surrogate's participation in the research.

Assessment of the decision-making capacity of the surrogate should be implemented only when the investigator has reason to believe that the surrogate's decision-making capacity may be impaired.

Re-Consenting of Research Subjects When a Surrogate is Used

Consenting is an ongoing process. All applicable criteria that would trigger re-consenting a subject in any study shall apply to subjects whose consent has been provided by a surrogate. In addition:

  • A subject who regains the cognitive ability to consent must be re-consented using standard consenting procedures.
  • In the event a subject has been initially consented by a surrogate, and a surrogate of higher priority subsequently notifies the investigator of that relationship to the subject, the investigator must defer to the higher priority surrogate's decision regarding whether the subject will continue to participate or to withdraw from the study.

Researchers shall describe to potential surrogates the nature of ongoing decisions during the study regarding the subject's participation, decision to participate in certain procedures, changes to the study, etc., in order to ensure that the surrogate will be willing to undertake these on-going responsibilities.

Important Note: In the event that the surrogate dies, the subject must be re-consented subsequently upon any event that would otherwise trigger re-consenting the subject.

suggestions and comments