The institutional review board may approve only research or treatment that meets the standards of the federal Food and Drug Administration with respect to (i) the protection of human subjects and (ii) financial disclosure by clinical investigators. The Office of State Long Term Care Ombudsman and the State Protection and Advocacy organization shall be given an opportunity to comment on any request for approval before the board makes a decision. Those entities shall not be provided information that would allow a potential human subject to be individually identified, unless the board asks the Ombudsman for help in securing information from or about the resident. The board shall require frequent reporting of the progress of the approved research or treatment and its impact on residents, including immediate reporting of any adverse impact to the resident, the resident's representative, the Office of the State Long Term Care Ombudsman, and the State Protection and Advocacy organization. The board may not approve any retrospective study of the records of any resident about the safety or efficacy of any care or treatment if the resident was under the care of the proposed researcher or a business associate when the care or treatment was given, unless the study is under the control of a researcher without any business relationship to any person or entity who could benefit from the findings of the study.
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. No nursing home 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.
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. Nothing in 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.
The institutional review board requirements of this subsection (a) do not apply to investigational drugs, biological products, or devices used by a resident with a terminal illness as set forth in the Right to Try Act.
All physician's orders and plans of treatment shall have the authentication of the physician. For the purposes of this subsection (b), "authentication" means an original written signature or an electronic signature system that allows for the verification of a signer's credentials. A stamp signature, with or without initials, is not sufficient.
According to rules adopted by the Department, every woman resident of child-bearing age shall receive routine obstetrical and gynecological evaluations as well as necessary prenatal care.
210 ILCS 45/2-104