94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006
HB1553

 

Introduced 2/10/2005, by Rep. Karen May

 

SYNOPSIS AS INTRODUCED:
 
410 ILCS 50/2.06 new
410 ILCS 50/3.1   from Ch. 111 1/2, par. 5403.1

    Amends the Medical Patient Rights Act. Provides that any patient who is the subject of a research program, clinical trial or an experimental procedure shall be provided information regarding the results of the research, clinical trial or experimental procedure. Defines "clinical trial".


LRB094 06737 RXD 36836 b

 

 

A BILL FOR

 

HB1553 LRB094 06737 RXD 36836 b

1     AN ACT concerning health.
 
2     Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
 
4     Section 5. The Medical Patient Rights Act is amended by
5 changing Section 3.1 and by adding Section 2.06 as follows:
 
6     (410 ILCS 50/2.06 new)
7     Sec. 2.06. "Clinical trial", "clinical studies", or
8 "clinical research" means a research study using human subjects
9 intended to answer specific health questions, including
10 studies intended to find treatments that work in people and
11 ways to improve health, interventional trials that determine
12 whether experimental treatments or new ways of using known
13 therapies are safe and effective under controlled
14 environments, and observational trials that address health
15 issues in large groups of people or populations in natural
16 settings.
 
17     (410 ILCS 50/3.1)  (from Ch. 111 1/2, par. 5403.1)
18     Sec. 3.1. (a) Any patient who is the subject of a research
19 program, clinical trial or an experimental procedure, as
20 defined under the rules and regulations of the Hospital
21 Licensing Act, or as defined by the National Institutes of
22 Health, shall have, at a minimum, the right to receive an
23 explanation of the nature and possible consequences of such
24 research, clinical trial or experiment before the research or
25 experiment is conducted, and to consent to or reject it.
26     (b) No health care provider physician may conduct any
27 research program, clinical trial or experimental procedure on a
28 patient without the prior informed consent of the patient or,
29 if the patient is unable to consent, the patient's guardian,
30 spouse, parent, or authorized agent.
31     (c) This Section shall not apply to any research program,

 

 

HB1553 - 2 - LRB094 06737 RXD 36836 b

1 clinical trial or medical experimental procedure for patients
2 subject to a life-threatening emergency that is conducted in
3 accordance with Part 50 of Title 21 of, and Part 46 of Title 45
4 of, the Code of Federal Regulations.
5     (d) Any patient who is the subject of a research program,
6 clinical trial or an experimental procedure shall be provided
7 information regarding the results of the research, clinical
8 trial or experimental procedure, which must be provided
9 directly to the subject or by written notice of the formal
10 reference to the report of the results that may be accessed by
11 the subject, including, but not limited to, internet website
12 information available through the National Institutes of
13 Health.
14 (Source: P.A. 90-36, eff. 6-27-97.)