Senate Bill sb2332
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2004 SB 2332
By Senator Aronberg
27-1605-04 See HB
1 A bill to be entitled
2 An act relating to consent to experimental
3 research; amending s. 381.026, F.S.; providing
4 an exception for receiving patient consent for
5 certain treatment for certain federally
6 approved experimental research; amending s.
7 743.065, F.S.; providing for an unwed pregnant
8 minor to consent to participation in certain
9 federally approved research; amending s.
10 458.331, F.S.; providing an exception to
11 disciplinary action for certain experimentation
12 without consent for certain federally approved
13 research; providing an effective date.
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15 Be It Enacted by the Legislature of the State of Florida:
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17 Section 1. Paragraph (e) of subsection (4) of section
18 381.026, Florida Statutes, is amended to read:
19 381.026 Florida Patient's Bill of Rights and
20 Responsibilities.--
21 (4) RIGHTS OF PATIENTS.--Each health care facility or
22 provider shall observe the following standards:
23 (e) Experimental research.--In addition to the
24 provisions of s. 766.103, a patient has the right to know if
25 medical treatment is for purposes of experimental research and
26 to consent prior to participation in such experimental
27 research with a waiver of informed consent as permitted under
28 45 C.F.R. part 46 or 21 C.F.R. part 56, unless such research
29 has been approved by a federally approved institutional review
30 board in accordance with such sections. For any patient,
31 regardless of ability to pay or source of payment for his or
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CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2004 SB 2332
27-1605-04 See HB
1 her care, participation must be a voluntary matter; and a
2 patient has the right to refuse to participate. The patient's
3 consent or refusal must be documented in the patient's care
4 record.
5 Section 2. Subsection (1) of section 743.065, Florida
6 Statutes, is amended to read:
7 743.065 Unwed pregnant minor or minor mother; consent
8 to medical services for minor or minor's child valid.--
9 (1) An unwed pregnant minor may consent to the
10 performance of medical or surgical care or services relating
11 to her pregnancy by a hospital or clinic or by a physician
12 licensed under chapter 458 or chapter 459 and for her
13 participation in research approved by a federally approved
14 institutional review board in accordance with 45 C.F.R. part
15 46 or 21 C.F.R. part 56 with a waiver of informed consent as
16 permitted under such sections, and such consent is valid and
17 binding as if she had achieved her majority.
18 Section 3. Paragraph (u) of subsection (1) of section
19 458.331, Florida Statutes, is amended to read:
20 458.331 Grounds for disciplinary action; action by the
21 board and department.--
22 (1) The following acts constitute grounds for denial
23 of a license or disciplinary action, as specified in s.
24 456.072(2):
25 (u) Performing any procedure or prescribing any
26 therapy which, by the prevailing standards of medical practice
27 in the community, would constitute experimentation on a human
28 subject, without first obtaining full, informed, and written
29 consent with a waiver of informed consent as permitted under
30 45 C.F.R. part 46 or 21 C.F.R. part 56, unless such
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CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2004 SB 2332
27-1605-04 See HB
1 experimentation has been approved by a federally approved
2 institutional review board in accordance with such sections.
3 Section 4. This act shall take effect upon becoming a
4 law.
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