Transcript NEW CALIFORNIA LAWS: Impact on Research

SURROGATE CONSENT LAW:
Impact on Research
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?
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
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.”
Content Of The Law
Differentiation of Conditions
Non-Emergency Setting
(e.g., dementias)
Emergency Setting
(e.g., stroke, head injury, heart attack)
Hierarchy of surrogates
in place
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
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shall not be superceded by any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.
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
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.
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
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