HB 1571

1	A bill to be entitled
2	An act relating to consent to experimental research;
3	amending s. 381.026, F.S.; providing an exception for
4	receiving patient consent for certain treatment for
5	certain federally approved experimental research; amending
6	s. 458.331, F.S.; providing an exception to disciplinary
7	action for certain experimentation without consent for
8	certain federally approved research; amending s. 743.065,
9	F.S.; providing for an unwed pregnant minor to consent to
10	participation in certain federally approved research;
11	providing for an unwed minor mother to consent to her
12	child's participation in certain federally approved
13	research; providing an effective date.
14
15	Be It Enacted by the Legislature of the State of Florida:
16
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 provisions
24	of s. 766.103, a patient has the right to know if medical
25	treatment is for purposes of experimental research and to
26	consent prior to participation in such experimental research
27	unless such research has been approved by a federally approved
28	institutional review board in accordance with 45 C.F.R. part 46
29	or 21 C.F.R. part 56 with a waiver of informed consent as
30	permitted under such parts. For any patient, regardless of
31	ability to pay or source of payment for his or her care,
32	participation must be a voluntary matter; and a patient has the
33	right to refuse to participate. The patient's consent or refusal
34	must be documented in the patient's care record.
35	Section 2.  Paragraph (u) of subsection (1) of section
36	458.331, Florida Statutes, is amended to read:
37	458.331  Grounds for disciplinary action; action by the
38	board and department.--
39	(1)  The following acts constitute grounds for denial of a
40	license or disciplinary action, as specified in s. 456.072(2):
41	(u)  Performing any procedure or prescribing any therapy
42	which, by the prevailing standards of medical practice in the
43	community, would constitute experimentation on a human subject,
44	without first obtaining full, informed, and written consent
45	unless such research has been approved by a federally approved
46	institutional review board in accordance with 45 C.F.R. part 46
47	or 21 C.F.R. part 56 with a waiver of informed consent as
48	permitted under such parts.
49	Section 3.  Subsections (1) and (2) of section 743.065,
50	Florida Statutes, are amended to read:
51	743.065  Unwed pregnant minor or minor mother; consent to
52	medical services for minor or minor's child valid.--
53	(1)  An unwed pregnant minor may consent to the performance
54	of medical or surgical care or services relating to her
55	pregnancy by a hospital or clinic or by a physician licensed
56	under chapter 458 or chapter 459 and for her participation in
57	research approved by a federally approved institutional review
58	board in accordance with 45 C.F.R. part 46 or 21 C.F.R. part 56,
59	and such consent is valid and binding as if she had achieved her
60	majority.
61	(2)  An unwed minor mother may consent to the performance
62	of medical or surgical care or services for her child by a
63	hospital or clinic or by a physician licensed under chapter 458
64	or chapter 459 and for her child's participation in research
65	approved by a federally approved institutional review board in
66	accordance with 45 C.F.R. part 46 or 21 C.F.R. part 56, and such
67	consent is valid and binding as if she had achieved her
68	majority.
69	Section 4.  This act shall take effect upon becoming a law.

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