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 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

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.

Content Of The Law
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
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

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available persons described in the list of surrogate decisionmakers, refusal to consent by one person shall not be superceded by any other of those persons.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

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.

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

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.

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

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

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 subject’s 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 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
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 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

• 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
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
– Surrogate’s qualifications demonstrating reasonable knowledge of subject
(Non-ER only)

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

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

• 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