SURROGATE CONSENT LAW:SURROGATE CONSENT LAW:
Impact on ResearchImpact on Research
AB 2328: Surrogate Consent for AB 2328: Surrogate Consent for ResearchResearch
Question: Prior to January 1, 2003, within the state of California, who was allowed to provide consent for an adult to be involved in a research study?
AB 2328: Surrogate Consent for AB 2328: Surrogate Consent for ResearchResearch
Answer:– The adult person who was being asked to
be a subject in the research project, or– A Legally Authorized Representative
• A court-appointed conservator• A legal guardian
AB 2328: Surrogate Consent for AB 2328: Surrogate Consent for ResearchResearch
AB 2328 expands the definition of
Legally Authorized Representative (LAR)
Modifies CA Health & Safety Code Section 24178:– Authorizing specific individuals to give surrogate
informed consent for the enrollment of adult subjects who lack capacity to consent for medical experiments that “relate to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of participants.”
Content Of The LawContent Of The Law
Differentiation of Conditions
Non-Emergency Setting(e.g., dementias)
Emergency Setting(e.g., stroke, head injury, heart attack)
Hierarchy of surrogatesin place
Hierarchy of surrogates isnot imposed
Content Of The LawContent Of The Law
Exempts from this section individuals who have been involuntarily committed pursuant to the Lanterman-Petris-Short Act and persons voluntarily committed or committed by a conservator to mental hospitals or institutions.
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Section 24178 (F) For medical experiments in an “emergency” room environment, if a person is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from a surrogate decisionmaker who is any of the following persons:
Surrogate DecisionMakers for Surrogate DecisionMakers for Emergency Situations (ASA, AHA)Emergency Situations (ASA, AHA)
a. Agents identified by an advance health care directive
b. Conservator or guardian c. Spoused. Individual as defined in Section 297 of the
Family code: the declared domestic partnere. Adult son or daughterf. Custodial parentg. Adult brother or sister
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Emergency Situations:
When there are two or more available persons described in the list of surrogate decisionmakers, refusal to consent by one person shall not be superceded by any other of those persons.
Content Of The LawContent Of The LawSection 24178 (C)
For medical experiments in a “nonemergency” room environment, if a person is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from a surrogate decisionmaker with reasonable knowledge of the subject, who shall include any of the following persons, in the following descending order of priority:
Content Of The LawContent Of The LawNon-emergency Setting:
a. agents identified by an advance health
directiveb. the conservator or legal guardian; c. the spoused. the domestic partnere. an adult son or daughterf. a custodial parentg. any adult siblingh. any adult grandchildi. the closest adult relative available
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Non-emergency setting: If two or more available
surrogates in the same order of priority disagree, consent is considered not to have been given.
Content Of The LawContent Of The LawNon-emergency Setting:
a. agents identified by an advance health
directiveb. the conservator or legal guardian; c. the spoused. the domestic partnere. an adult son or daughterf. a custodial parentg. any adult siblingh. any adult grandchildi. the closest adult relative available
Content Of The LawContent Of The Law
Non-emergency setting:
States that if two or more available persons who are in different orders of priority disagree, the higher priority person shall not be superceded by the lower priority person.
Content Of The LawContent Of The LawNon-emergency Setting:
a. agents identified by an advance health
directiveb. the conservator or legal guardian; c. the spoused. the domestic partnere. an adult son or daughterf. a custodial parentg. any adult siblingh. any adult grandchildi. the closest adult relative available
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Surrogates should not receive compensation for giving permission
Any person who provides surrogate consent pursuant to subdivisions (c) and (f) may not receive financial compensation for providing the consent
Content of the LawContent of the LawNon-emergency setting
Investigator is responsible to ensure that the surrogate:1. Has reasonable knowledge of the subject2. Is familiar with the subject’s degree of impairment3. Is willing to serve as the substitute decision-maker4. Understands the risks, potential benefits,
procedures and available alternatives to research participation
5. 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.
How Is The New Law Implemented In How Is The New Law Implemented In Our Research Environment?Our Research Environment?
IRB submission and approval is required– IRB guide:
http://www.rgs.uci.edu/hs/proxy.htm
– New box to on IRB application for surrogate use (new application form or modification form)
– Approval is protocol-specific – Approval requires full committee review
What To Include InWhat To Include InIRB Protocol?IRB Protocol?
• Acknowledge that informed consent from subject will always be obtained if possible
• If decision-making capacity (DMC) is questionable, the investigator should:– Describe research to subject and perform a DMC
assessment relevant to this study-specific information
• If DMC is lacking:– Inform the subject of intent to seek surrogate consent– Resistance or dissent to participation or use of
surrogate mandates exclusion from the study– Otherwise, proceed with documentation of DMC
assessment and initiate identification of surrogate
What About Surrogate Consent What About Surrogate Consent in Longitudinal Research?in Longitudinal Research?
• If appropriate, identify and include surrogate as early as possible, even for those subjects who have DMC at the beginning of the study that may likely change during the course of the study.
• Reaffirm stability of surrogate choice at each longitudinal visit.
Obtaining Consent From Obtaining Consent From SurrogateSurrogate
• Describe detailed research plan to the surrogate, including present and future decisions to be made
• Surrogate completes the Self-Certification form (this form stays with consent)– Verifies willingness of surrogate to serve– Details relationship of surrogate to subject– Surrogate’s qualifications demonstrating
reasonable knowledge of subject (Non-ER only)
Obtaining Consent From Obtaining Consent From SurrogateSurrogate
• Self-certification form– If a person exists of a higher order in the
hierarchy, the investigator is responsible to contact such individuals to determine if they want to serve as surrogate
• If surrogate of higher priority is later identified, investigator must defer to person who is higher in the hierarchy – re-consent is required
Obtaining Consent From Obtaining Consent From SurrogateSurrogate
• Surrogates cannot receive any financial compensation for providing consent (does not prohibit the surrogate from being reimbursed for expenses incurred related to research participation)
• DMC assessment of the surrogate should occur only when the investigator has reason to believe that impairment may exist
What About Re-Consenting of What About Re-Consenting of Subjects?Subjects?
• Consenting is an ongoing process
• Known triggers for re-consenting still apply– New information becomes available– Significant protocol changes have been made and approved by
the IRB– New surrogate is identified– Investigator has the option to re-consent for longitudinal data
collection timepoints
• If subject regains cognitive ability, they must consent to continue
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