2005 California Health and Safety Code Sections 104145 Article 1. The Breast Cancer Research Program

104145.  (a) The Legislature hereby requests the University of
California to establish and administer the Breast Cancer Research
Program, which is created by this act, as a comprehensive grant and
contract program to support research efforts into the cause, cure,
treatment, earlier detection, and prevention of breast cancer.  It is
the intent of the Legislature that this program incorporate the
principles and organizational elements specified in this act,
including, but not limited to, a research program office with a
director and other necessary staff, a Breast Cancer Research Council,
and research review panels.
   (b) For the purposes of this section:
   (1) "Breast cancer research" includes, but is not limited to,
research in the fields of biomedical science and engineering, the
social, economic and behavioral sciences, epidemiology, technology
development and translation, and public health.
   (2) "Council" means the Breast Cancer Research Council.
   (3) "Grantee" means any qualifying 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 research in California.
   (4) "Program" means the Breast Cancer Research Program.
   (5) "University" means the University of California.
   (c) It is the intent of the Legislature that this program be
administered pursuant to the following principles:
   (1) The university shall work in close collaboration with the
council and seek the consent of the council before taking an action
different from the action recommended by the council.
   (2) The council shall develop the strategic objectives and
priorities of the program, actively participate in the overall
management of the program, and make final recommendations on which
research grants should be funded based on the research priorities
established for the program and the technical merits of the proposals
as determined by peer review panels.
   (3) The program shall fund innovative and creative research, with
a special emphasis on research that complements, rather than
duplicates, the research funded by the federal government and other
entities.
   (4) The university and the council shall work in close
collaboration with the Breast Cancer Early Detection Program.
   (5) All research funds shall be awarded on the basis of the
research priorities established for the program and the scientific
merit of the proposed research, as determined by an open, competitive
peer review process that ensures objectivity, consistency, and high
quality.  All investigators, regardless of affiliation, shall have
equal access and opportunity to compete for program funds.
   (6) The peer review process for the selection of research grants
awarded under this program shall be generally modeled on that used by
the National Institutes of Health in its grantmaking process.
   (7) An awardee shall be awarded grants for the full cost, both
direct and indirect, of conducting the sponsored research consistent
with those federal guidelines governing all federal research grants
and contracts.  All intellectual property assets developed under this
program shall be treated in accordance with state and federal law.
   (8) In establishing its research priorities, the council shall
consider a broad range of cross-disciplinary breast cancer research,
as defined in paragraph (1) of subdivision (b), including, but not
limited to, research into the cause, cure, and prevention of breast
cancer; translational and technological research, including research
regarding the development and translation of technologies of earlier
detection; research regarding the cultural, economic, and legal
barriers to accessing the health care system for early detection and
treatment of breast cancer; and research examining the link between
breast cancer and environmental factors, including both natural and
industrial chemicals, estrogen imitators, and electromagnetic fields.
   (d) It is the intent of the Legislature that the university, as
lead agency, do all of the following:
   (1) Establish the Breast Cancer Research Council in accordance
with the following:
   (A) The council shall consist of at least 13 and no more than 15
members representing a range of expertise and experience, appointed
by the President of the University of California.  Individuals and
organizations may submit nominations to the council, and the
University of California shall solicit nominations from relevant
organizations and individuals.  The council shall be comprised of the
following members:
   (i) Four members from breast cancer survivor and breast
cancer-related advocacy groups, including, but not limited to, the
California Breast Cancer Organizations (CABCO).
   (ii) Four members drawn from the ranks of scientists or
clinicians, including one from an independent research university in
California.  The scientists shall have expertise covering the various
fields of scientific endeavor, including, but not limited to, the
fields of biomedical research and engineering, social, economic, and
behavioral research, epidemiology, and public health.
   (iii) Two members from nonprofit health organizations with a
commitment to breast cancer research and control.
   (iv) One member who is a practicing breast cancer medical
specialist.
   (v) Two members from private industry with a commitment to breast
cancer research and control, including, but not limited to,
entrepreneurs, or persons from the science or high technology
industry or persons from the health care sector.
   (vi) One ex officio, nonvoting member from the Breast Cancer Early
Detection Program.
   (B) If the president appoints more than 13 members, it is the
intent of the Legislature that the proportional representation remain
substantially the same as set forth in subparagraph (A).
   (C) Members shall serve without compensation, but may receive
reimbursement for travel and other necessary expenses actually
incurred in the performance of their official duties.  Any member of
the Breast Cancer Research Council shall be ineligible to apply for
or receive funding for breast cancer research from the Breast Cancer
Research Program during his or her term of service on the council,
and for one cycle immediately following his or her term of service on
the council, if the council member helped plan that subsequent
cycle.
   (D) Membership shall be staggered in such a way as to maintain a
full council while ensuring a reasonable degree of continuity of
expertise and consistency of direction.
   (2) Provide overall coordination of the program.
   (3) Provide staff assistance to the program and council.
   (4) Develop administrative procedures relative to the
solicitation, review, and awarding of grants to ensure an impartial,
high quality peer review system.
   (5) Recruit and supervise research review panels.  The membership
of these panels shall vary depending on the subject matter of the
proposals and the review requirements, and shall draw on the most
qualified individuals.  The work of the review panels shall be
administered pursuant to policies and procedures established for the
implementation of the program.  In order to avoid conflicts of
interest and to ensure access to qualified reviewers, the university
may utilize reviewers not only from California but also from outside
the state.  When serving on review panels, institutions,
corporations, or individuals who have submitted grant applications
for funding by this program shall be governed by conflict-of-interest
provisions consistent with the National Institutes of Health Manual
(Chapter 4510 (item h)), and any applicable conflict-of-interest
provisions in state law.
   (6) Provide for periodic program evaluation to ensure that
research funded is consistent with program goals.
   (7) Maintain a system of financial reporting and accountability.
   (8) Provide for the systematic dissemination of research results
to the public and the health care community, and provide for a
mechanism to disseminate the most current research findings in the
areas of cause, treatment, cure, earlier detection, and prevention of
breast cancer, in order that these findings may be applied to the
planning, implementation, and evaluation of the breast cancer-related
programs of the State Department of Health Services, including the
Breast Cancer Early Detection Program authorized by this act.
   (9) Develop policies and procedures to facilitate the translation
of research results into commercial, alternate technological, and
other applications wherever appropriate and consistent with state and
federal law.
   (10) Transmit annually on or before each December 31, a report to
the Legislature on grants made, grants in progress, program
accomplishments, and future program directions.  Each report shall
include, but not be limited to, the following information:
   (A) The number and dollar amounts of research grants, including
the amount allocated to indirect costs.
   (B) The subject of research grants.
   (C) The relationship between federal and state funding for breast
cancer research.
   (D) The relationship between each project and the overall strategy
of the research program.
   (E) A summary of research findings including discussion of
promising new areas.
   (F) The institutions and campuses receiving grant awards.
   In addition, the first annual report shall include an evaluation
and recommendations concerning the desirability and feasibility of
requiring for-profit grantees to compensate the state in the event
that a grant results in the development of a profitmaking product.
This evaluation shall include, but not be limited to, the costs and
benefits of requiring a for-profit grantee to repay the grant, to
provide the product at cost to Medi-Cal and other state programs
serving low-income breast cancer patients, and to pay the state a
percentage of the royalties derived from the product.
   (e) It is the intent of the Legislature that no more than 5
percent of the allocation to the university be used for the purposes
of administration of this program.
   (f) It is the intent of the Legislature that the responsibilities
of the council shall include, but not be limited to, the following:
   (1) Development and review of the strategic objectives and
research priorities of the program.
   (2) Delineation of resource allocation across the various
priorities established for the program.
   (3) Participation in periodic program and financial review,
including the report transmitted pursuant to paragraph (10) of
subdivision (d).
   (4) Development and review of guidelines to ensure fairness,
neutrality, and adherence to the principles of merit and quality in
the conduct of the program.
   (5) Development of appropriate linkages to nonacademic entities,
including, but not limited to, voluntary organizations, health care
delivery systems, industry, government agencies, research
entrepreneurs, and public officials.
   (6) Development and review of criteria and standards for granting
awards.
   (7) Oversight and review of the request for applications (RFA).
   (8) Review of research review panel reports and recommendations
for grant awards.
   (9) Making of final recommendations on which grants are to be
awarded.
   (10) Development and review of oversight mechanisms for the
dissemination of research results.
   (11) Development and review of policies and liaison programs to
facilitate the translation of research results into commercial,
alternate technological, or other applications wherever appropriate.
   (12) Establishment of its own internal rules of operation.
   (13) Participation in the identification and recruitment of breast
cancer advocates and survivors, clinicians, scientists, and persons
from the science, high technology, or health care sector with
relevant expertise for possible participation in a peer review panel.
  The council may propose to assign a member of the council to sit as
a nonvoting member of the peer review panels.