94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006
SB2091


 
Introduced 2/25/2005, by Sen. Kimberly A. Lightford
 
SYNOPSIS AS INTRODUCED:
 		













20 ILCS 2310/2310-280 new










    Amends the Department of Public Health Powers and Duties Law. Provides that  hospitals and universities in Illinois may not agree to conduct clinical trials  unless the results of the clinical trials will be  properly reported. Provides that "properly reported" means  that  at least 30 days before the drug or device that is the subject of a clinical trial becomes available to the general public, the entity conducting the clinical trial will provide the clinical trial's results to physicians and the general public and register these results on a certain website maintained by the National Institutes of Health. Defines "clinical trial". Provides that the Department shall adopt rules as necessary to implement and enforce this Section including requirements for the hospital or university to notify the Department and supply information concerning a clinical trial prior to its commencement. Effective January 1, 2006.
















LRB094 08097 RSP 38281 b

















FISCAL NOTE ACT MAY APPLY
















 


 


A BILL FOR









 











SB2091

LRB094 08097 RSP 38281 b






1
    AN ACT concerning State government.

 
2
    Be it enacted by the People of the State of Illinois,
 
3
represented in the General Assembly:


 
4
    Section 5. The Department of Public Health Powers and 
5
Duties Law of the
Civil Administrative Code of Illinois is 
6
amended  by adding Section 2310-280 as follows:
 
7
    (20 ILCS 2310/2310-280  new)
8
    Sec. 2310-280. Clinical trials reporting. Hospitals and 
9
universities in Illinois may not agree to conduct a clinical 
10
trial  unless the results of the clinical trial will be  properly 
11
reported. In this Section "properly reported" means that  at 
12
least 30 days before the drug or device that is the subject of 
13
a clinical trial becomes available to the general public, the 
14
entity conducting the clinical trial will provide the clinical 
15
trial's results to physicians and the general public and 
16
register these results with the United States Department of 
17
Health and Human Services' National Institutes of Health at 
18
www.clinicaltrials.gov or  a successor website designated by 
19
the Department by rule. In this Section, "clinical trial" means 
20
a controlled test of a new drug or a new invasive device on 
21
human subjects that is conducted under the direction of the 
22
Federal Drug Administration before being made available for 
23
general clinical use.
24
    The Department shall adopt rules as necessary to implement 
25
and enforce this Section pursuant to the Illinois 
26
Administrative Procedure Act. The rules may include, without 
27
limitation, requirements for the hospital or university to 
28
notify the Department and supply information concerning a 
29
clinical trial prior to its commencement.
 

30
    Section 99. Effective date. This Act takes effect January 
31
1, 2006.