Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 995 - ILLINOIS REGENERATIVE MEDICINE INSTITUTE CODE › Section 995.90 - Research Requirements and Limitations

Current through Register Vol. 48, No. 28, July 12, 2024
All grantees shall comply with the following requirements in
				the course of performing stem cell research funded by a grant under this
				Part:
a) All research shall be
			 undertaken according to the National Academies of Science Guidelines for Human
			 Embryonic Stem Cell Research. The research shall be approved by the ESCRO
			 committee and submitted with the application. Any changes from the National
			 Academies of Science Guidelines for Human Embryonic Stem Cell Research shall be
			 submitted to the Department prior to implementation to assure compliance with
			 this Part and the grant agreement. Any use of human embryonic stem cells shall
			 be consistent with the National Academies of Science Guidelines for Human
			 Embryonic Stem Cell Research.
b)
			 All research shall at all times comply with all applicable federal laws,
			 including, but not limited to, the Occupational Health and Safety Act and
			 HIPAA, and the following federal regulations: Institutional Animal Care and Use
			 Committee (IACUC) and Attending Veterinarian and Adequate Veterinarian Care.
			 Grantees shall comply with the U.S. Department of Health and Human Services
			 regulations titled Protection of Human Subjects and the U.S. Department of
			 Agriculture regulations titled Attending Veterinarian and Adequate Veterinarian
			 Care and Institutional Animal Care and Use committee (IACUC) (see Section
			 995.15
			 ).
c) Grantees shall be responsible
			 for supervising their investigators to ensure that they conduct themselves in
			 accordance with the grant agreement and professional standards.
d) The project period shall be up to 24
			 months.
e) Grantees shall obtain
			 the informed consent of all research donors, patients and participants,
			 including a new consent from individuals who had indicated their intent to
			 donate to research any blastocysts that remain after clinical care at the time
			 of the original harvesting. Donors shall be informed that they retain the right
			 to withdraw consent until the blastocysts are actually used in cell line
			 derivation. A research project's informed consent procedures shall satisfy each
			 of the following requirements:
1) In seeking
			 informed consent, the following information shall be provided to each research
			 donor, patient or participant:
A) A statement
			 that the study involves research, an explanation of the purposes of the
			 research and the expected duration of the subject's participation, a
			 description of the procedures to be followed, and identification of any
			 procedures that are experimental;
B) A description of any reasonably
			 foreseeable risks or discomforts to the donor;
C) A description of any benefits to the donor
			 or to others that may reasonably be expected from the research;
D) A disclosure of appropriate alternative
			 options pertaining to use of the embryos;
E) A statement describing the extent, if any,
			 to which confidentiality of records identifying the donor will be
			 maintained;
F) For research
			 involving more than minimal risk, an explanation as to whether any compensation
			 and an explanation as to whether any medical treatments are available if injury
			 occurs and, if so, what they consist of, or where further information may be
			 obtained;
G) An explanation of whom
			 to contact for answers to pertinent questions about the research and research
			 donors' rights, and whom to contact in the event of a research-related injury
			 to the donor; and
H) A statement
			 that participation or donation is voluntary; that refusal to participate and/or
			 donate will involve no penalty or loss of benefits to which the donor is
			 otherwise entitled; and that the donor may discontinue participation at any
			 time without penalty or loss of benefits to which the donor is otherwise
			 entitled.