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".  
















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A BILL FOR









 











HB1553

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    AN ACT concerning health.

 
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    Be it enacted by the People of the State of Illinois,
 
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represented in the General Assembly:


 
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    Section 5. The Medical Patient Rights Act is amended  by 
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changing Section 3.1 and  by adding Section 2.06 as follows:
 
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    (410 ILCS 50/2.06  new)
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    Sec. 2.06. "Clinical trial", "clinical studies", or 
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"clinical research" means a research study using human subjects 
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intended to answer specific health questions, including 
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studies intended to find treatments that work in people and 
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ways to improve health, interventional trials that determine 
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whether experimental treatments or new ways of using known 
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therapies are safe and effective under controlled 
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environments, and observational trials that address health 
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issues in large groups of people or populations in natural 
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settings.
 



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    (410 ILCS 50/3.1)  (from Ch. 111 1/2, par. 5403.1)



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    Sec. 3.1. (a) Any patient who is the subject of a research 
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program, clinical trial or
an experimental procedure, as 
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defined under the rules and regulations of
the Hospital 
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Licensing Act, or as defined by the National Institutes of 
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Health, shall have, at a minimum, the right to receive
an 
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explanation of the nature and possible consequences of such 
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research, clinical trial or
experiment before the research or 
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experiment is conducted, and to consent
to or reject it.

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    (b) No health care provider
physician may conduct any 
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research program, clinical trial or experimental
procedure on a 
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patient without the prior informed consent of the patient
or, 
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if the patient is unable to consent, the patient's guardian, 
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spouse,
parent, or authorized agent.

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    (c) This Section shall not apply to any research program, 
 


 






HB1553
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clinical trial or medical
experimental procedure for patients 
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subject to a life-threatening emergency
that is conducted in 
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accordance with Part 50 of Title 21 of, and Part 46 of
Title 45 
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of, the Code of Federal Regulations.

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    (d) Any patient who is the subject of a research program, 
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clinical trial or an experimental procedure shall be provided 
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information regarding the results of the research, clinical 
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trial or experimental procedure, which must be provided 
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directly to the subject or by written notice of the formal 
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reference to the report of the results that may be accessed by 
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the subject, including, but not limited to, internet website 
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information available through the National Institutes of 
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Health.

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(Source: P.A. 90-36, eff. 6-27-97.)