HB1553 94TH GENERAL ASSEMBLY

LRB094 06737 RXD 36836 b

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".

A BILL FOR

AN ACT concerning health.

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

Section 5. The Medical Patient Rights Act is amended by changing Section 3.1 and by adding Section 2.06 as follows:

(410 ILCS 50/2.06 new)

Sec. 2.06. "Clinical trial", "clinical studies", or "clinical research" means a research study using human subjects intended to answer specific health questions, including studies intended to find treatments that work in people and ways to improve health, interventional trials that determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments, and observational trials that address health issues in large groups of people or populations in natural settings.

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

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

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

(c) This Section shall not apply to any research program, clinical trial or medical experimental procedure for patients subject to a life-threatening emergency that is conducted in accordance with Part 50 of Title 21 of, and Part 46 of Title 45 of, the Code of Federal Regulations.

(d) 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, which must be provided directly to the subject or by written notice of the formal reference to the report of the results that may be accessed by the subject, including, but not limited to, internet website information available through the National Institutes of Health.

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