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.