State of Illinois Policies Applicable to Human Subjects Research
The following is a limited selection of Illinois policies relevant to human subjects research:
Illinois Mandated Reporters
While any person may make a report if they have reasonable cause to believe that a child or elder was abused or neglected, Illinois law mandates that certain persons who suspect child or elder abuse or neglect report this to the Illinois Department of Children and Family Services (DCFS) or the Illinois Department on Aging, as appropriate.
Read the complete Illinois Manual for Mandated Reporters in English or Spanish.
What should prospective research subjects (or their parents or guardians) be told before consent to research participation is obtained?
UIUC policy requires the solicitation of informed consent from all adult research subjects and assent from children involved as research subjects, in addition to the consent of their parents. In situations where conditions of abuse or neglect might be revealed, mandated reporters should make themselves known as such to parents of children under age 18, to subjects who are children, and to subjects who are potential victims of elder abuse or neglect.
Who is a mandated reporter of suspected child abuse or neglect?
The Abused and Neglected Child Reporting Act (P.A. 79-65, cite 325 ILCS 5/1 et seq.), approved June, 1975 states (emphasis added):
"Sec. 4. Any physician, resident, intern, hospital, hospital administrator and personnel engaged in examination, care and treatment of persons, surgeon, dentist, dentist hygienist, osteopath, chiropractor, podiatrist, physician assistant, substance abuse treatment personnel, Christian Science practitioner, funeral home director or employee, coroner, medical examiner, emergency medical technician, acupuncturist, crisis line or hotline personnel, school personnel, educational advocate assigned to a child pursuant to the School Code, truant officers, social worker, social services administrator, domestic violence program personnel, registered nurse, licensed practical nurse, advanced practice nurse, home health aide, respiratory care practitioner, director or staff assistant of a nursery school or a child day care center, recreational program or facility personnel, law enforcement officer, registered psychologist and assistants working under the direct supervision of a psychologist, psychiatrist, or field personnel of the Illinois Department of Public Aid, Public Health, Human Services (acting as successor to the Department of Mental Health and Developmental Disabilities, Rehabilitation Services, or Public Aid), Corrections, Human Rights, or Children and Family Services, supervisor and administrator of general assistance under the Illinois Public Aid Code, probation officer, or any other foster parent, homemaker or child care worker having reasonable cause to believe a child known to them in their professional or official capacity may be an abused child or a neglected child shall immediately report or cause a report to be made to the Department."
DCFS requires the following on its "Acknowledgment of Mandated Reporter Status" form (emphasis added):
"...I am required to report or cause a report to be made to the child abuse Hotline number (1-800-25A-BUSE) whenever I have reasonable cause to believe that a child known to me in my professional or official capacity may be abused or neglected."
"I also understand that if I am subject to licensing under the Illinois Nursing Act of 1987, the Medical Practice Act of 1987, the Illinois Dental Practice Act, the School Code, the Acupuncture Practice Act, the Illinois Optometric Practice Act of 1987, the Illinois Physical Therapy Act, the Physician Assistants Practice Act of 1987, the Podiatric Medical Practice Act of 1987, the Clinical Psychologist Licensing Act, the Clinical Social Work and Social Work Practice Act, the Illinois Athletic Trainers Practice Act, the Dietetic and Nutrition Services Practice Act, the Marriage and Family Therapy Act, the Naprapathic Practice Act, the Respiratory Care Practice Act, the Professional Counselor and Clinical Professional Counselor Licensing Act, the Illinois Speech-Language Pathology and Audiology Practice Act, I may be subject to license suspension or revocation if I willfully fail to report suspected child abuse or neglect."
Who is a mandated reporter of suspected elder abuse or neglect?
The Elder Abuse and Neglect Act (P.A. 85-1184, cite 320 ILCS 20/) effective January 1, 1999, states (emphasis added):
""Mandated reporter" means any of the following persons while engaged in carrying out their professional duties: (1) a professional or professional's delegate while engaged in: (i) social services, (ii) law enforcement, (iii) education, (iv) the care of an eligible adult or eligible adults, or (v) any of the occupations required to be licensed under the Clinical Psychologist Licensing Act, the Clinical Social Work and Social Work Practice Act, the Illinois Dental Practice Act, the Dietetic and Nutrition Services Practice Act, the Marriage and Family Therapy Licensing Act, the Medical Practice Act of 1987, the Naprapathic Practice Act, the Nursing and Advanced Practice Nursing Act, the Nursing Home Administrators Licensing and Disciplinary Act, the Illinois Occupational Therapy Practice Act, the Illinois Optometric Practice Act of 1987, the Pharmacy Practice Act of 1987, the Illinois Physical Therapy Act, the Physician Assistant Practice Act of 1987, the Podiatric Medical Practice Act of 1987, the Respiratory Care Practice Act, the Professional Counselor and Clinical Professional Counselor Licensing Act, the Illinois Speech-Language Pathology and Audiology Practice Act, the Veterinary Medicine and Surgery Practice Act of 1994, and the Illinois Public Accounting Act, (2) an employee of a vocational rehabilitation facility prescribed or supervised by the Department of Human Services; (3) an administrator, employee, or person providing services in or through an unlicensed community based facility; (4) a Christian Science Practitioner; (5) field personnel of the Department of Public Aid, Department of Public Health, and Department of Human Services, and any county or municipal health department; (6) personnel of the Department of Human Services, the Guardianship and Advocacy Commission, the State Fire Marshal, local fire departments, the Department on Aging and its subsidiary Area Agencies on Aging and provider agencies, and the Office of State Long Term Care Ombudsman; (7) any employee of the State of Illinois not otherwise specified herein who is involved in providing services to eligible adults, including professionals providing medical or rehabilitation services and all other persons having direct contact with eligible adults; or (9) a person who performs the duties of a coroner or medical examiner."
TopGenetic Information Privacy
A new Illinois law [enacted July 20, 1998, revised March 4, 2001] creates the Genetic Information Privacy Act. The act provides that information derived from genetic testing is confidential. It limits the use of genetic information by insurers and employers and provides an exception to the confidentiality of genetic information with respect to criminal proceedings. It provides that the Act does not limit the use of DNA or other tests under the Illinois Parentage Act of 1984 and Article X of the Illinois Public Aid Code.
The act excludes chemical, blood, and urine analyses, drug testing and HIV testing from the scope of the bill. It provides that samples obtained by peace officers may be used for identification purposes and it authorizes expungement of court records only. It requires employers to treat genetic information in a manner consistent with federal law. It provides that compliance by insurers with the requirements of the Insurance Information and Privacy Article of the Illinois Insurance Code shall be deemed compliance with the disclosure limitations of this Act, and it limits remedies against insurers that violate the Act. The details of the act follow:
Public Act 90-0025—an act concerning genetic information. Be it enacted by the People of the State of Illinois, represented in the General Assembly:
Section 1. Short title.
This Act may be cited as the Genetic Information Privacy Act.
Section 5. Legislative findings; intent.
The General Assembly finds that:
(1) The use of genetic testing can be valuable to an individual.
(2) Despite existing laws, regulations, and professional standards, which require or promote voluntary and confidential use of genetic testing information, many members of the public are deterred from seeking genetic testing because of fear that test results will be disclosed without consent or be used in a discriminatory manner.
(3) The public health will be served by facilitating voluntary and confidential nondiscriminatory use of genetic testing information.
Section 10. Definitions. As used in this Act:
"Genetic testing" means a test of a person's genes, gene products, or chromosomes for abnormalities or deficiencies, including carrier status, that
(i) are linked to physical or mental disorders or impairments,
(ii) indicate a susceptibility to illness, disease, impairment, or other disorders, whether physical or mental, or
(iii) demonstrate genetic or chromosomal damage due to environmental factors.
Genetic testing does not include routine physical measurements; chemical, blood, and urine analyses that are widely accepted and in use in clinical practice; tests for use of drugs; and tests for the presence of the human immunodeficiency virus.
"Insurer" means (i) an entity that transacts an insurance business and (ii) a managed care plan.
"Managed care plan" means a plan that establishes, operates, or maintains a network of health care.
Illinois Medical School Experiments
Public Act 91-0861
SB1329 Enrolled LRB9109590NTksB
AN ACT concerning higher education.
Effective date. June 22, 2000
Be it enacted by the People of the State of Illinois, represented in the General Assembly:
Section 5. The University of Illinois Act is amended by adding Section 20 as follows:
(110 ILCS 305/20 new)
Sec. 20. Medical school research experiments; informed consent.
If a person is to participate as a subject in a research experiment conducted at the College of Medicine but does not understand the English language, then the informed consent document for the research experiment must be written in a language that the person does understand. If the person cannot read or has difficulty reading, the document must be read to the person in that same language.
Section 10. The Southern Illinois University Management Act is amended by adding Section 10 as follows:
(110 ILCS 520/10 new)
Sec. 10. Medical school research experiments; informed consent. If a person is to participate as a subject in a research experiment conducted at the School of Medicine but does not understand the English language, then the informed consent document for the research experiment must be written in a language that the person does understand. If the person cannot read or has difficulty reading, the document must be read to the person in that same language.