BILL NUMBER: AB 1174 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JANUARY 4, 2016
AMENDED IN ASSEMBLY APRIL 20, 2015
INTRODUCED BY Assembly Member Bonilla
FEBRUARY 27, 2015
An act to add Sections 100240, 100241, 100242, and 100243
to the Health and Safety Code, relating to health research.
amend Section 800 of the Business and Professions
Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
AB 1174, as amended, Bonilla. Health research: women's
health. Healing arts: licensee records.
Existing law provides for the licensure and regulation of various
professions and vocations by boards within the Department of Consumer
Affairs. Existing law requires various state licensing boards,
including the Medical Board of California and the Board of
Psychology, to create and maintain a central file of the names of
licensees to provide an individual historical record for each
licensee with information on acts of licensee misconduct and
discipline, as specified.
This bill would add the California Board of Podiatric Medicine to
the list of state licensing boards required to create and maintain
such records.
Existing law establishes the Inclusion of Women and Minorities in
Clinical Research Act, which requires 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. Existing law also requires
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. Existing law also states the legislative intent that
research include, but not be limited to, specified diseases,
disorders, and health conditions.
This bill would create the State Contingency Fund for Ancillary
Costs and the Ancillary Costs Committee. The bill would authorize the
fund to receive private donations. The bill would require the
committee to develop grant criteria once a to be determined amount is
deposited into the fund. The bill would authorize the committee to
award, on a competitive basis, grants to various organizations, to
increase patient access to cancer clinical trials.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 800 of t he
Business and Professions Code is amended to read:
800. (a) The Medical Board of California, the Board of
Psychology, the Dental Board of California, the Dental Hygiene
Committee of California, the Osteopathic Medical Board of California,
the State Board of Chiropractic Examiners, the Board of Registered
Nursing, the Board of Vocational Nursing and Psychiatric Technicians
of the State of California, the State Board of Optometry, the
Veterinary Medical Board, the Board of Behavioral Sciences, the
Physical Therapy Board of California, the California State Board of
Pharmacy, the Speech-Language Pathology and Audiology and Hearing Aid
Dispensers Board, the California Board of Occupational Therapy, the
Acupuncture Board, the California Board of Podiatric Medicine,
and the Physician Assistant Board shall each separately create
and maintain a central file of the names of all persons who hold a
license, certificate, or similar authority from that board. Each
central file shall be created and maintained to provide an individual
historical record for each licensee with respect to the following
information:
(1) Any conviction of a crime in this or any other state that
constitutes unprofessional conduct pursuant to the reporting
requirements of Section 803.
(2) Any judgment or settlement requiring the licensee or his or
her insurer to pay any amount of damages in excess of three thousand
dollars ($3,000) for any claim that injury or death was proximately
caused by the licensee's negligence, error or omission in practice,
or by rendering unauthorized professional services, pursuant to the
reporting requirements of Section 801 or 802.
(3) Any public complaints for which provision is made pursuant to
subdivision (b).
(4) Disciplinary information reported pursuant to Section 805,
including any additional exculpatory or explanatory statements
submitted by the licentiate pursuant to subdivision (f) of Section
805. If a court finds, in a final judgment, that the peer review
resulting in the 805 report was conducted in bad faith and the
licensee who is the subject of the report notifies the board of that
finding, the board shall include that finding in the central file.
For purposes of this paragraph, "peer review" has the same meaning as
defined in Section 805.
(5) Information reported pursuant to Section 805.01, including any
explanatory or exculpatory information submitted by the licensee
pursuant to subdivision (b) of that section.
(b) (1) Each board shall prescribe and promulgate forms on which
members of the public and other licensees or certificate holders may
file written complaints to the board alleging any act of misconduct
in, or connected with, the performance of professional services by
the licensee.
(2) If a board, or division thereof, a committee, or a panel has
failed to act upon a complaint or report within five years, or has
found that the complaint or report is without merit, the central file
shall be purged of information relating to the complaint or report.
(3) Notwithstanding this subdivision, the Board of Psychology, the
Board of Behavioral Sciences, and the Respiratory Care Board of
California shall maintain complaints or reports as long as each board
deems necessary.
(c) (1) The contents of any central file that are not public
records under any other provision of law shall be
confidential except that the licensee involved, or his or her counsel
or representative, shall have the right to inspect and have copies
made of his or her complete file except for the provision that may
disclose the identity of an information source. For the purposes of
this section, a board may protect an information source by providing
a copy of the material with only those deletions necessary to protect
the identity of the source or by providing a comprehensive summary
of the substance of the material. Whichever method is used, the board
shall ensure that full disclosure is made to the subject of any
personal information that could reasonably in any way reflect or
convey anything detrimental, disparaging, or threatening to a
licensee's reputation, rights, benefits, privileges, or
qualifications, or be used by a board to make a determination that
would affect a licensee's rights, benefits, privileges, or
qualifications. The information required to be disclosed pursuant to
Section 803.1 shall not be considered among the contents of a central
file for the purposes of this subdivision.
(2) The licensee may, but is not required to, submit any
additional exculpatory or explanatory statement or other information
that the board shall include in the central file.
(3) Each board may permit any law enforcement or regulatory agency
when required for an investigation of unlawful activity or for
licensing, certification, or regulatory purposes to inspect and have
copies made of that licensee's file, unless the disclosure is
otherwise prohibited by law.
(4) These disclosures shall effect no change in the confidential
status of these records.
SECTION 1. The Legislature finds and declares
the following:
(a) Almost 50 percent of clinical trial studies do not finish in
time due to low patient participation, recruitment and navigation
difficulties, and other barriers for patients. Due to economic and
socioeconomic circumstances and lack of patient knowledge, clinical
oncology trial participation and retention are both very low as they
relate to eligible participants.
(b) Overall, only 3 percent of eligible cancer patients
participate in clinical trials and of those, only 5 percent of trial
participants are from racial or ethnic minority communities.
(c) One barrier that prevents patients from participating in
federal Food and Drug Administration clinical trials is finances.
Patients can't bear the burden of the ancillary costs of
participating, such as airfare, lodging, rental cars, and fuel.
SEC. 2. Section 100240 is added to the Health
and Safety Code, to read:
100240. The Ancillary Costs Committee is hereby created to be
made up of private and public health stakeholders.
SEC. 3. Section 100241 is added to the Health
and Safety Code, to read:
100241. (a) The State Contingency Fund for Ancillary Costs is
hereby created in the State Treasury to be made up of donations from
private entities. Moneys in the State Contingency Fund for Ancillary
Costs shall, upon appropriation by the Legislature to the committee,
be allocated by the committee as provided by Section 100242.
(b) The board shall not use more than 10 percent of funds made
available for the grant program for administrative costs.
SEC. 4. Section 100242 is added to the Health
and Safety Code, to read:
100242. (a) Upon an unspecified amount of moneys being donated to
the fund, the committee shall establish a grant program to determine
grant parameters and criteria, and to make grant awards.
(b) In order to increase patient access to clinical trials, the
committee may award grants from any funds that may be made available
pursuant to Section 100241, on a competitive basis, to both of the
following:
(1) Public and private research institutions and hospitals that
conduct cancer trials approved by the federal Food and Drug
Administration approved cancer clinical trials.
(2) A nonprofit organization described in Section 501(c)(3) of the
Internal Revenue Code of 1954 which is exempt from income tax under
Section 501(a) of that code that specializes in direct patient
support for improved clinical trial enrollment and retention.
(c) The funds awarded pursuant to subdivision (b) shall be used
for activities to increase patient access to clinical trials,
including, but not limited to:
(1) Payment of ancillary costs for patients and caregivers,
including, but not limited to:
(A) Airfare during the clinical trial.
(B) Lodging during the clinical trial.
(C) Rental cars during the clinical trial.
(D) Fuel during the clinical trial
(E) Meals during the clinical trial.
(F) Child care costs during the clinical trial.
(2) Patient navigator services or programs.
(3) Education and community outreach.
(4) Patient-friendly technical tools to assist patients in
identifying available clinical trials.
SEC. 5. Section 100243 is added to the Health
and Safety Code, to read:
100243. Grant recipients shall report to the committee to ensure
the appropriate use of the funds.