|
|
|
|
SB2091 Engrossed |
|
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.
|