Section 350.190  Experimental Program Conflicting with Requirements

a)         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 or this Part. 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 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)

(Source:  Amended at 46 Ill. Reg. 10519, effective June 2, 2022)