SB2091eng 94TH GENERAL ASSEMBLY

SB2091 Engrossed LRB094 08097 RSP 38281 b

AN ACT concerning State government.

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

Section 5. The Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois is amended by adding Section 2310-280 as follows:

(20 ILCS 2310/2310-280 new)

Sec. 2310-280. Clinical trials reporting. Hospitals and universities in Illinois may not agree to conduct a clinical trial unless the results of the clinical trial will be properly reported. In this Section "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 with the United States Department of Health and Human Services' National Institutes of Health at www.clinicaltrials.gov or a successor website designated by the Department by rule. In this Section, "clinical trial" means a controlled test of a new drug or a new invasive device on human subjects that is conducted under the direction of the Federal Drug Administration before being made available for general clinical use.

The Department shall adopt rules as necessary to implement and enforce this Section pursuant to the Illinois Administrative Procedure Act. The rules may include, without limitation, requirements for the hospital or university to notify the Department and supply information concerning a clinical trial prior to its commencement.

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