77 Ill. Adm. Code 390.190
Experimental Program Conflicting With Requirements
Section 390
Section 390.190Â Experimental
Program Conflicting With Requirements
a)Â Â Â Â Â Â Â Â Any facility desiring to conduct an experimental program or do
research that is in conflict with this Part shall submit a written request to
the Department and secure prior approval. The Department will not approve
experimental programs that would violate residents' rights under the Act, this
Section, and Section 390.3220(e). Additionally, experimental programs in
facilities shall comply with the following:
1)
No
facility shall permit experimental research or treatment to be conducted on a
resident or give access to any person or person's records for a retrospective
study about the safety or efficacy of any care or treatment without the prior
written approval of the institutional review board
;
2)
No
administrator, 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 resident, including a retrospective study, that does not
have the prior written approval of the institutional review board. Such conduct
shall be grounds for professional discipline by the Department of Financial and
Professional Regulation
; and
3)
The
institutional review board may exempt from ongoing review research or treatment
initiated on a resident before the individual's admission to a facility and for
which the board determines there is adequate ongoing oversight by another
institutional review board.
b)
Nothing
in
the Act or
this Section shall prevent a facility, any facility
employee, or any other person from assisting or participating in any
experimental research on or treatment of a resident 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 2-104(a)
of the Act)