BILL NUMBER: AB 2038	CHAPTERED  08/28/00

	CHAPTER   250
	FILED WITH SECRETARY OF STATE   AUGUST 28, 2000
	APPROVED BY GOVERNOR   AUGUST 25, 2000
	PASSED THE SENATE   AUGUST 10, 2000
	PASSED THE ASSEMBLY   MAY 4, 2000
	AMENDED IN ASSEMBLY   MAY 2, 2000

INTRODUCED BY   Assembly Member Alquist
   (Coauthors: Assembly Members Honda, Kuehl, Longville, Mazzoni,
Migden, Romero, and Shelley)
   (Coauthor: Senator Escutia)

                        FEBRUARY 18, 2000

   An act to add Article 1.5 (commencing with Section 100237) to
Chapter 2 of Part 1 of Division 101 of the Health and Safety Code,
relating to health research.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 2038, Alquist.  Health research:  women's health.
   Under existing law, the State Department of Health Services
administers various public health programs.
   This bill would enact the Inclusion of Women and Minorities in
Clinical Research Act, which would require a grantee, as defined, in
conducting or supporting a project of clinical research, as defined,
to ensure that women of all ages, and members of minority groups, as
defined, are included as subjects in the clinical research projects,
except under prescribed circumstances.  The bill would also require
state agencies to, and would declare legislative intent that the
University of California include in specified progress reports, data
on the extent to which state funds administered by state agencies and
the University of California are used by grantees for research on
diseases, disorders, and health conditions, that includes women and
minorities in the research trials, and that studies diseases,
disorders, and health conditions of particular concern to women and
minorities.  This bill would state legislative intent that research
include, but not be limited to, specified diseases, disorders, and
health conditions.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  Article 1.5 (commencing with Section 100237) is added
to Chapter 2 of Part 1 of Division 101 of the Health and Safety Code,
to read:

      Article 1.5.  Inclusion of Women and Minorities in Clinical
Research Act.

   100237.  (a) This article shall be known, and may be cited as, the
"Inclusion of Women and Minorities in Clinical Research Act."
   (b) For purposes of this article, the following definitions and
descriptions shall apply:
   (1) "Grantee" means any qualified public, private, or nonprofit
agency or individual, including, but not limited to, colleges,
universities, hospitals, laboratories, research institutions, local
health departments, voluntary health agencies, health maintenance
organizations, corporations, students, fellows, entrepreneurs, and
individuals conducting clinical research using state funds.  A
grantee may also be a corporation that is headquartered in California
and that conducts research using state funds.
   (2) "Minority group" shall be defined pursuant to the definition
in the 1993 National Institutes of Health guidelines.
   (3) "Project of clinical research" includes a clinical trial.
   100238.  (a) In conducting or supporting a project of clinical
research, a grantee shall, except as provided in subdivision (b) or
(e), do all of the following:
   (1) Ensure that women, including, but not limited to, women over
the age of 40 years, are included as subjects in each research
project.
   (2) Ensure that minority groups are included as subjects in each
research project.
   (3) Conduct or support outreach programs for the recruitment of
women and members of minority groups as subjects in projects of
clinical research.
   (b) The requirement established in subdivisions (a) and (d)
regarding women and members of minority groups shall not apply to a
project of clinical research if the inclusion, as subjects in the
project, of women and minority groups is inappropriate for either of
the following reasons:
   (1) With respect to the health and safety of the subjects.
   (2) With respect to the purpose of the research.
   (c) In the case of any clinical trial in which women or members of
minority groups will, under subdivision (a), be included as
subjects, a grantee shall ensure that the trial is designed and
carried out in a manner sufficient to provide for a valid analysis of
whether the variables being studied in the trial affect women or
members of minority groups, as the case may be, differently than
other subjects in the trial.
   (d) In any grant, or in any contract by a grantee under a grant,
the grantee or contracting party shall acknowledge, agree to, and be
bound by, the terms of this section.
   (e) If a grantee is in compliance with the 1993 National
Institutes of Health guidelines, the grantee shall be deemed to be in
compliance with this section.
   100239.  (a) Pursuant to Section 439.904, state agencies shall,
and it is the intent of the Legislature that the University of
California, include, in appropriate periodic progress reports
required under existing law, data on the extent to which state funds
administered by those agencies and the University of California, or
both, are used by grantees to support research on diseases,
disorders, and health conditions that includes women and minorities
in the research trials, and that studies diseases, disorders, and
health conditions of particular concern to women and minorities.
   (b) It is the intent of the Legislature that research shall
include, but not be limited to, cardiovascular diseases, cancer,
Alzheimer's disease, HIV and AIDS, sickle-cell anemia, obesity,
mental illness, arthritis, and osteoporosis.