77 Ill. Adm. Code 380.580
Research
Section 380.580Â Research
a)
No consumer shall be subjected to research or treatment
without first obtaining his or her informed, written consent. The conduct of
any experimental research or treatment shall be authorized and monitored by an institutional
review board appointed by the executive director. No person who has received
compensation in the prior 3 years from an entity that manufactures, distributes
or sells pharmaceuticals, biologics, or medical devices may serve on the
institutional review board
.
1)
The membership of the institutional review board shall
include, at a minimum:
A)Â Â Â Â Â Â Â Director of the Department of Public Health or designee;
B)Â Â Â Â Â Â Â Director of DHS-DMH or designee;
C)Â Â Â Â Â Â Â An academic faculty member of a college or university who is in
a mental health field;
D)Â Â Â Â Â Â Â The DHS-DMH bureau chief of Evaluation and Services Research or
designee;
E)Â Â Â Â Â Â Â Two additional persons with a background in ethics, policy
development and research who may be from outside DHS-DMH or the Department; and
F)Â Â Â Â Â Â Â Â A representative from the Department's or DHS-DMH's legal
services staff as a non-voting member.
2)
The operating procedures for the institutional review board
shall be
jointly developed by the Department and by DHS-DMH and shall be
made available to the public upon request. The operating procedures shall
address:
A)Â Â Â Â Â Â Â The appointment protocol and tenure of the membership;
B)Â Â Â Â Â Â Â Conflict-of-interest policies;
C)Â Â Â Â Â Â Â The meeting schedule;
D)Â Â Â Â Â Â Â The application process, including university-initiated
applications;
E)Â Â Â Â Â Â Â Informed consent requirements, which shall reference 45 CFR 46 (Protection
of Human Subjects), Subparts B, C and D, and the Mental Health and
Developmental Disabilities Confidentiality Act;
F)Â Â Â Â Â Â Â Â Requirements for progress reports; and
G)Â Â Â Â Â Â Â The review process and expedited review process.
3)
The
review criteria for the institutional review board shall be
developed
jointly by the Department and by DHS-DMH and shall include:
A)Â Â Â Â Â Â Â Voting procedures;
B)Â Â Â Â Â Â Â A categorization of risks inherent in the conduct of the
research; and
C)Â Â Â Â Â Â Â A description of the categorical ratings that result from the
review.
b)
No facility shall permit research or treatment to be
conducted on a consumer, or give access to any person or person's records for a
retrospective study without the prior written approval of the institutional
review board. No executive director, or person licensed by the State to
provide medical care or treatment to any person, may assist or participate in
any experimental research on or treatment of a consumer, including a
retrospective study that does not have the prior written approval of the
board.
This
conduct shall be grounds for professional discipline by the
Department of Financial and Professional Regulation
.
c)Â Â Â Â Â Â Â Â Following a formal review,
the institutional review board
may exempt from ongoing review research or treatment initiated on a consumer
before the individual's admission to a facility and for which the board
determines there is adequate ongoing oversight by another institutional review
board. Nothing in this Section
or the Act
shall prevent a facility, any
facility employee, or any other person from assisting or participating in any
experimental research on or treatment of a consumer, if the research or treatment
began before the person's admission to a facility, until the board has reviewed
the research or treatment and decided to grant or deny approval or to exempt
the research or treatment from ongoing review.
(Section 3-116 of the Act)