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SURROGATE CONSENT LAW: Impact on Research. AB 2328: Surrogate Consent for Research Question: Prior to January 1, 2003, within the state of California,

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Presentation on theme: "SURROGATE CONSENT LAW: Impact on Research. AB 2328: Surrogate Consent for Research Question: Prior to January 1, 2003, within the state of California,"— Presentation transcript:

1 SURROGATE CONSENT LAW: Impact on Research

2 AB 2328: Surrogate Consent for Research 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?

3 AB 2328: Surrogate Consent for Research 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

4 AB 2328: Surrogate Consent for Research 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.

5 Content Of The Law Differentiation of Conditions Non-Emergency Setting (e.g., dementias) Hierarchy of surrogates in place Emergency Setting (e.g., stroke, head injury, heart attack) Hierarchy of surrogates is not imposed

6 Content 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.

7 Content Of The Law Section (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:

8 Surrogate DecisionMakers for Emergency Situations (ASA, AHA) a. Agents identified by an advance health care directive b. Conservator or guardian c. Spouse d. Individual as defined in Section 297 of the Family code: the declared domestic partner e. Adult son or daughter f. Custodial parent g. Adult brother or sister

9 Content Of The Law 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.

10 Content Of The Law Section (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:

11 Content Of The Law Non-emergency Setting: a. agents identified by an advance health directive b. the conservator or legal guardian; c. the spouse d. the domestic partner e. an adult son or daughter f. a custodial parent g. any adult sibling h. any adult grandchild i. the closest adult relative available

12 Content Of The Law Non-emergency setting: If two or more available surrogates in the same order of priority disagree, consent is considered not to have been given.

13 Content Of The Law Non-emergency Setting: a. agents identified by an advance health directive b. the conservator or legal guardian; c. the spouse d. the domestic partner e. an adult son or daughter f. a custodial parent g. any adult sibling h. any adult grandchild i. the closest adult relative available

14 Content 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.

15 Content Of The Law Non-emergency Setting: a. agents identified by an advance health directive b. the conservator or legal guardian; c. the spouse d. the domestic partner e. an adult son or daughter f. a custodial parent g. any adult sibling h. any adult grandchild i. the closest adult relative available

16 Content Of The Law 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

17 Content of the Law Non-emergency setting Investigator is responsible to ensure that the surrogate: 1.Has reasonable knowledge of the subject 2.Is familiar with the subjects degree of impairment 3.Is willing to serve as the substitute decision-maker 4.Understands the risks, potential benefits, procedures and available alternatives to research participation 5.Makes their decisions based on the subjects known preferences, and where the subjects preferences are unknown, makes decisions based upon the surrogates judgment of what the subjects preferences would be if different from their own.

18 How Is The New Law Implemented In Our Research Environment? IRB submission and approval is required –IRB guide: –New box to on IRB application for surrogate use (new application form or modification form) –Approval is protocol-specific –Approval requires full committee review

19 What To Include In 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

20 What About Surrogate Consent 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.

21 Obtaining Consent From Surrogate 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 –Surrogates qualifications demonstrating reasonable knowledge of subject (Non-ER only)

22 Obtaining Consent From Surrogate 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

23 Obtaining Consent From Surrogate 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

24 What About Re-Consenting of 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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