SURROGATE CONSENT LAW: Impact on Research

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?


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 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


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.


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


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more available persons described in the list of surrogate decisionmakers, refusal to consent by one person shall not be superceded by any other of those persons.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


Non-emergency setting: If two or more available

surrogates in the same order of priority disagree, consent is considered not to have been given.





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.





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)


• 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


• 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

Documents

SURROGATE CONSENT LAW: Impact on Research