House Bill 1985

CODING: Words stricken are deletions; words underlined are additions.







    Florida House of Representatives - 1999                HB 1985

        By Representatives Fasano and Littlefield






  1                      A bill to be entitled

  2         An act relating to biomedical research;

  3         creating s. 240.5125, F.S.; establishing a

  4         biomedical research program within the

  5         Department of Health; providing goals;

  6         providing for use of funds appropriated from

  7         the Tobacco Settlement Trust Fund; creating the

  8         Biomedical Research Advisory Council; providing

  9         for membership and organization; providing for

10         staff and assistance of the department;

11         providing duties of the council; providing for

12         applications for and award of biomedical

13         research grants and fellowships; providing for

14         appointment of peer review panels; providing

15         for ethical conduct of the council and peer

16         review panels; authorizing the department to

17         contract for administration of the program;

18         providing a limitation of administrative

19         expenses; authorizing the department to adopt

20         rules; requiring an annual report; providing an

21         appropriation; providing an effective date.

22

23  Be It Enacted by the Legislature of the State of Florida:

24

25         Section 1.  Section 240.5125, Florida Statutes, is

26  created to read:

27         240.5125  Biomedical research.--

28         (1)  There is established within the Department of

29  Health a biomedical research program to support research

30  initiatives that address the health care problems of

31  Floridians in the areas of cancer, cardiovascular disease,

                                  1

CODING: Words stricken are deletions; words underlined are additions.






    Florida House of Representatives - 1999                HB 1985

    565-158-99






  1  stroke, and pulmonary disease. The long-term goals of the

  2  program shall be to:

  3         (a)  Improve the health of Florida's citizens by

  4  researching better treatments for cancer, cardiovascular

  5  disease, stroke, and pulmonary disease.

  6         (b)  Expand the foundation of biomedical knowledge

  7  relating to the diagnosis and treatment of diseases related to

  8  tobacco use, including cancer, cardiovascular disease, stroke,

  9  and pulmonary disease.

10         (c)  Improve the quality of Florida's academic health

11  centers by bringing the advances of biomedical research into

12  the training of physicians and other health care providers.

13         (d)  Increase the state's per capita funding for

14  biomedical research by undertaking new initiatives in

15  biomedical research that will attract additional funding from

16  outside the state.

17         (e)  Stimulate economic activity in the state in areas

18  related to biomedical research, such as the research and

19  production of pharmaceuticals, biotechnology, and medical

20  devices.

21         (2)  Funds appropriated from the Tobacco Settlement

22  Trust Fund to the Department of Health for the purposes of

23  this section shall be used exclusively for the award of grants

24  and fellowships, under the program established in this

25  section, for research relating to the diagnosis and treatment

26  of diseases related to tobacco use, including cancer,

27  cardiovascular disease, stroke, and pulmonary disease, and for

28  expenses incurred in the administration of this section.

29         (3)  There is created within the Department of Health

30  the Biomedical Research Advisory Council.

31

                                  2

CODING: Words stricken are deletions; words underlined are additions.






    Florida House of Representatives - 1999                HB 1985

    565-158-99






  1         (a)  The council shall consist of nine members,

  2  including: the chief executive officer of the Florida Division

  3  of the American Cancer Society, or a designee; the chief

  4  executive officer of the Florida/Puerto Rico Affiliate of the

  5  American Heart Association, or a designee; and the chief

  6  executive officer of the American Lung Association of Florida,

  7  or a designee.  The Governor shall appoint the remaining six

  8  members of the council, as follows:

  9         1.  Two members with expertise in the field of

10  biomedical research.

11         2.  One member with expertise in the field of

12  behavioral or social research.

13         3.  One member from a professional medical

14  organization.

15         4.  One member from a research university in the state.

16         5.  One member representing the general population of

17  the state.

18

19  In making his appointments, the Governor shall select

20  primarily, but not exclusively, Floridians with biomedical and

21  lay expertise in the general areas of cancer, cardiovascular

22  disease, stroke, and pulmonary disease.  The Governor's

23  appointments shall be for a 3-year term and shall reflect the

24  diversity of the state's population. A council member

25  appointed by the Governor may not serve more than two

26  consecutive terms.

27         (b)  The council shall adopt internal organizational

28  procedures as necessary for its efficient organization.

29         (c)  The department shall provide such staff,

30  information, and other assistance as is reasonably necessary

31  to assist the council in carrying out its responsibilities.

                                  3

CODING: Words stricken are deletions; words underlined are additions.






    Florida House of Representatives - 1999                HB 1985

    565-158-99






  1         (d)  Members of the council shall serve without

  2  compensation, but may receive reimbursement as provided in s.

  3  112.061 for travel and other necessary expenses incurred in

  4  the performance of their official duties.

  5         (4)  The council shall advise the Secretary of Health

  6  as to the direction and scope of the biomedical research

  7  program. The responsibilities of the council may include, but

  8  are not limited to:

  9         (a)  Providing advice on program priorities and

10  emphases.

11         (b)  Providing advice on the overall program budget.

12         (c)  Participating in periodic program evaluation.

13         (d)  Assisting in the development of guidelines to

14  ensure fairness, neutrality, and adherence to the principles

15  of merit and quality in the conduct of the program.

16         (e)  Assisting in the development of appropriate

17  linkages to nonacademic entities, such as voluntary

18  organizations, health care delivery institutions, industry,

19  government agencies, and public officials.

20         (f)  Developing criteria and standards for the award of

21  research grants.

22         (g)  Developing administrative procedures relating to

23  solicitation, review, and award of research grants and

24  fellowships, to ensure an impartial, high-quality peer review

25  system.

26         (h)  Developing and supervising research peer review

27  panels.

28         (i)  Reviewing reports of peer review panels and making

29  recommendations for research grants and fellowships.

30         (j)  Developing and providing oversight regarding

31  mechanisms for the dissemination of research results.

                                  4

CODING: Words stricken are deletions; words underlined are additions.






    Florida House of Representatives - 1999                HB 1985

    565-158-99






  1         (5)(a)  Applications for biomedical research funding

  2  under the program may be submitted from any university or

  3  established research institute in the state.  All qualified

  4  investigators in the state, regardless of institution

  5  affiliation, shall have equal access and opportunity to

  6  compete for the research funding.

  7         (b)  Grants and fellowships shall be awarded by the

  8  Secretary of Health, after consultation with the council, on

  9  the basis of scientific merit, as determined by an open

10  competitive peer review process that ensures objectivity,

11  consistency, and high quality.  The following types of

12  applications shall be considered for funding:

13         1.  Investigator-initiated research grants.

14         2.  Institutional research grants.

15         3.  Predoctoral and postdoctoral research fellowships.

16         (6)  To ensure that all proposals for research funding

17  are appropriate and are evaluated fairly on the basis of

18  scientific merit, the Secretary of Health, in consultation

19  with the council, shall appoint a peer review panel of

20  independent, scientifically qualified individuals to review

21  the scientific content of each proposal and establish its

22  scientific priority score.  The priority scores shall be

23  forwarded to the council and must be considered in determining

24  which proposals shall be recommended for funding.

25         (7)  The council and the peer review panel shall

26  establish and follow rigorous guidelines for ethical conduct

27  and adhere to a strict policy with regard to conflict of

28  interest.  No member of the council or panel shall participate

29  in any discussion or decision with respect to a research

30  proposal by any firm, entity, or agency with which the member

31  is associated as a member of the governing body or as an

                                  5

CODING: Words stricken are deletions; words underlined are additions.






    Florida House of Representatives - 1999                HB 1985

    565-158-99






  1  employee, or with which the member has entered into a

  2  contractual arrangement.  Meetings of the council and the peer

  3  review panels shall be subject to the provisions of chapter

  4  119, s. 286.011, and s. 24, Art. I of the State Constitution.

  5         (8)  The department may contract on a competitive bid

  6  basis with an appropriate entity to administer the program.

  7  Administrative expenses shall not exceed 15 percent of the

  8  total funds available to the program in any given year.

  9         (9)  The department, after consultation with the

10  council, is authorized to adopt rules as necessary to

11  implement the provisions of this section.

12         (10)  The council shall submit an annual progress

13  report on the state of biomedical research in Florida to the

14  Governor, the Secretary of Health, the President of the

15  Senate, and the Speaker of the House of Representatives by

16  February 1. The report shall include:

17         (a)  A list of research projects supported by grants or

18  fellowships awarded under the program.

19         (b)  A list of recipients of program grants or

20  fellowships.

21         (c)  A list of publications in peer reviewed journals

22  involving research supported by grants or fellowships awarded

23  under the program.

24         (d)  The total amount of biomedical research funding

25  currently flowing into the state.

26         (e)  New grants for biomedical research which were

27  funded based on research supported by grants or fellowships

28  awarded under the program.

29         (f)  Progress in the treatment of diseases related to

30  tobacco use, including cancer, cardiovascular disease, stroke,

31  and pulmonary disease.

                                  6

CODING: Words stricken are deletions; words underlined are additions.






    Florida House of Representatives - 1999                HB 1985

    565-158-99






  1         Section 2.  There is hereby appropriated from the

  2  Tobacco Settlement Trust Fund to the Department of Health for

  3  fiscal year 1999-2000 the sum of $150 million to fund the

  4  biomedical research program as provided for in s. 240.5125,

  5  Florida Statutes.

  6         Section 3.  This act shall take effect July 1, 1999.

  7

  8            *****************************************

  9                          HOUSE SUMMARY

10
      Establishes a biomedical research program under the
11    Department of Health to support research in diseases
      related to tobacco use, including cancer, cardiovascular
12    diseases, stroke, and pulmonary diseases. Provides for
      funding from the Tobacco Settlement Trust Fund. Creates a
13    Biomedical Research Advisory Council to advise and assist
      the Secretary of Health in developing and administering
14    the program and awarding research grants and fellowships.
      Provides for creation of peer review panels to provide
15    independent, scientific review of research proposals.
      Provides for appointment and duties of council and panel
16    members. Provides procedures for application for and
      award of grants and fellowships. Provides for ethical
17    conduct of the council and panels. Provides
      responsibilities of the Department of Health. Authorizes
18    the department to contract by competitive bid for
      administration of the program. Authorizes the department
19    to adopt rules. Requires the council to provide an annual
      progress report to the Governor, Secretary of Health, and
20    Legislature. Provides an appropriation.

21

22

23

24

25

26

27

28

29

30

31

                                  7