The Florida Senate

381.85  Biomedical and social research.--

(1)  SHORT TITLE; PURPOSE AND INTENT.--

(a)  This section may be cited as the "Florida Biomedical and Social Research Act."

(b)  The purpose of this section is to provide a procedure by which proposed research on children or adults will be supported with funds appropriated to the department, and can be efficiently and expeditiously assessed for compliance with the substantive and procedural requirements established by the Review Council for Biomedical and Social Research in rules adopted by the department.

(c)  It is the intent of the Legislature that:

1.  Research involving human beings be conducted by the department, or with funds appropriated to the department, only when necessary and appropriate, and only after review and approval pursuant to the provisions of this section and related rules.

2.  The department and the Review Council for Biomedical and Social Research jointly develop rules under which proposed research on human beings shall be promptly and appropriately submitted for review and approval pursuant to this section.

3.  The rules to be adopted by the department and the procedures and criteria to be adopted by the Review Council for Biomedical and Social Research be guided by the ethical standards for human research set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

(2)  DEFINITIONS.--When used in this section:

(a)  "Department" means the Department of Health.

(b)  "Research" means a systematic investigation designed to develop or contribute to knowledge that can be generalized.

(c)  "Intervention" means physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

(d)  "Interaction" means communication or interpersonal contact between investigator and subject.

(e)  "Private information" means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.

(3)  REVIEW COUNCIL FOR BIOMEDICAL AND SOCIAL RESEARCH.--

(a)  There is created the Review Council for Biomedical and Social Research to consist of nine members. The Governor, the President of the Senate, and the Speaker of the House of Representatives shall each appoint, no later than January 1, 1991, three members, as follows: one individual knowledgeable in biomedical research, one individual knowledgeable in behavioral research, and one individual from the client advocacy community. The chairperson shall be elected by majority vote of the members.

(b)  Members of the Review Council for Biomedical and Social Research shall be appointed to serve terms of 3 years. A member may not serve more than two consecutive terms.

(c)  The council shall adopt internal organizational procedures or bylaws necessary for efficient operation of the council.

(d)  The council shall have a budget and shall be financed through an annual appropriation made for this purpose in the General Appropriations Act. Each member shall be entitled to receive per diem and expenses for travel, as provided in s. 112.061, while carrying out official business of the council. For administrative purposes only, the council shall be assigned to the Department of Legal Affairs.

(e)  The council shall be staffed by an executive director and a secretary who shall be appointed by the council and who shall be exempt from the provisions of part II of chapter 110 relating to the Career Service System.

(f)  The council shall meet and conduct business at least quarterly, or more often at the call of the chairperson.

(g)  The council shall consult outside experts, target populations, and others to assist in decisionmaking during the review process.

(h)  Meetings of the council shall be subject to the provisions of chapter 119 and s. 286.011

(4)  RESEARCH SUBJECT TO REVIEW.--Any research on human beings conducted under the authority of the department shall be subject to review and approval by the Review Council for Biomedical and Social Research. In order to effectuate the review and approval process, the council shall adopt criteria to be used in its review of proposed research, procedures by which proposals for research on human beings by the department are to be submitted to the council, and other procedures necessary to assist in providing an efficient and effective decisionmaking process.

(5)  RULES.--The department, in consultation with the Review Council for Biomedical and Social Research, shall adopt rules necessary to carry out the provisions of this section. Such rules shall include, but not be limited to, defining the type of research to which such rules shall apply and prescribing internal departmental procedures for review and approval of research on human beings prior to submission to the council.

History.--ss. 75, 76, ch. 90-306; s. 5, ch. 91-429; s. 77, ch. 95-143; s. 805, ch. 95-148; s. 47, ch. 97-237.

Note.--Former s. 402.105.