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California AB 2328 Goes to the Governor
CA UCP LEGISLATIVE UPDATE: AB 2328 PASSES ASSEMBLY - GOES TO GOVERNOR
August 26, 2002 Monday evening
LEGISLATION THAT EXPANDS WHO CAN GIVE CONSENT FOR MEDICAL
EXPERIMENTS ON PERSONS COGNITIVELY IMPAIRED PASSES ASSEMBLY 56-13 AND NOW GOES
TO GOVERNOR
AB 2328 by Assemblyman Howard Wayne (D-San Diego) which would expand the list
of persons who can give surrogate informed consent for a person who has
cognitive impairment, for medical experiments, passed the Assembly by a vote of
56-13, Monday evening (August 26). The Assembly needed to approve the the
changes (amendments) made to the bill in the Senate, and the bill, last amended
August 14, now heads to the Governor for consideration. The Senate previously
passed the bill on a partisan vote of 25-13 on August 22.
The legislation received bi-partisan support in the Assembly, with Northridge
Republican Assemblyman Keith Richman telling members on the Assembly floor that
"I raise in support of this bill - this is important bill that will allow
research to occur and I would simply remind the members in all of these research
situation there is a committee at the hospital or the medical schools that
provides oversight fir these human studies and makes sure, from an ethical
perspective, it is being done in a correct way."
Assemblywoman Dion Aroner (D-Berkeley) indicated her support, saying that
"... Mr. Wayne and I have worked very hard with the medical community, worked
with the University of California which has been involved in clinical trials -
and there have been some issues around it. We think that we have worked out most
of the kinks so that we can hopefully include more people, the idea being at
some point, how we can include more people in clinical trials."
Current law, (the Protection of Human Subjects in Medical Experimentation
Act), prohibits any person from being subjected to any medical experiment unless
the informed consent of the person is obtained.
BACKGROUND OF BILL
 | AB 2328 is sponsored by the University of California, and is intended to
facilitate research regarding diseases that impair mental functioning, such as
Alzheimer's, by making it easier to obtain informed consent from a surrogate
decision maker when the participant is incapable of giving consent. The UC
System came under some controversy earlier this year when a newspaper reported
that the UC System conducted some medical experiments without obtaining proper
okay from the surrogates that are currently authorized under state law. |
| Some researchers stress the importance to their research of being able to
include persons who have progressed into later disease stages (and thus are
incapable of giving consent) and the potential for experimental therapies to
help some of these people. |
| Several advocacy organizations, including the Older Women's League and
several Alzheimer's groups across the state, representing patients and their
families have contended that research offers hope to an individual and their
families. |
| The Alameda County Network of Mental Health Clients opposed AB 2328
contending that it is too broad, applying to all research and not just
research into Alzheimer's or other neurodegenerative diseases. They point to
cases of abuse in research studies, and state that these "demonstrate the need
for informed consent regulations to be strictly construed, particularly when
research involves those whose decision making capacity is questioned." |
| The Alliance for Human Research Protection opposed AB 2328 as being both
unnecessary and potentially harmful to vulnerable patients. The Alliance
contends that the bill will eliminate the currently required consultation with
an independent medical expert, will eliminate currently required disclosure of
researcher conflict of interest and eliminate currently required disclosure of
the experience of other participants in the study. |
| Opponents do not believe many of the surrogates will be familiar with a
patient's medical preference, and several should be eliminated. Some advocates
for people with developmental disabilities raised concerns, including
Protection and Advocacy, Inc. |
WHAT THIS BILL DOES
| Permits informed consent required for medical experimentation in a non
emergency room environment for incapacitated individuals be given by surrogate
decision makers with reasonable knowledge of the subject. |
| Restricts such surrogate decisions to medical experiments that relate to
the cognitive impairment,lack of capacity, or serious or life threatening
diseases and conditions of research participants. |
| Authorizes the following persons in descending order of priority to act as
surrogate decision makers:
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. available adult relative with the closest degree of kinship. |
| States that if two or more available surrogates in the same order of
priority disagree, consent is considered not to have been given. Provides that
refusal to consent by a higher priority surrogate cannot be superseded by a
lower priority surrogate. |
| Requires that emergency room environment obtain consent from the same
priority list as specified. |
| Provides that when there are two or more available persons, refusal to
consent by one person shall not be superseded by any other of those persons.
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| Provisions of this bill would not apply to 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. |
| Prohibits receipt of financial compensation for provision of surrogate
consent. |
| Exempts researcher/investigators who are conducting medical experiments
within institutions which have an agreement with the United States Department
of Health and Human Services pursuant to part 46, Title 45 of the Federal Code
of Regulations, from other provisions of California statute, but requires
compliance with informed consent provisions. |
| Requires research pursuant to this bill to comply with federal
regulations. |
NEXT STEPS
GOVERNOR - The bill goes to the Governor who has until September 30 to sign
or veto the bill. The Administration, as of this date, has not taken a position
on the legislation (the Administration usually doesn't give advance word on its
position on most bills)
Effective Date - If approved by the Governor, the bill would take effect
January 1. 2003.
NOTE: If you would like to get on the UCP Update distribution (and
conversely, get off of it) please send an email with that request to:
martyomoto@rcip.com. Thanks.
FOR MORE INFORMATION
Marty Omoto, Legislative Director
CA Coalition of United Cerebral Palsy Associations
1225 8th Street Suite 480 Sacramento, CA 95814
916/446-3204 FAX: 916/446-3206 email:
martyomoto@rcip.com
Coalition Chair: Michael Williams (UCP of the Golden Gate)
Immediate Past Chair: Ron Cohen (UCP LA and Ventura Counties)
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