Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 186
AAHRPP Elements # I.1.G., II.4.A., II.4.B., III.1.C., III.1.F
- It is the policy of the UIC IRB to review, approve, and provide guidance as to ethical considerations to afford additional protections when cognitively and decisionally impaired subjects are involved in human subjects research to uphold their rights and welfare and to prevent coercion or undue influence.
- Conducting research involving participants with cognitive disorders, substance abuse or physical traumas is essential to further the understanding of these conditions and to develop new treatment approaches. Thus, it is critical to both acknowledge the ethical harm that may result by including or excluding people who might lack the capacity to consent to participate in research and to recognize that these groups require special research protections. The presence of a cognitive impairment, however, should not lead to a presumption that a person is not capable of making a decision to participate in research.
- A UIC investigator applying to conduct a research activity involving decisionally impaired or cognitively impaired subjects in another jurisdiction (i.e., state) must become familiar and provide evidence of compliance to the IRB with all applicable legal, professional, and ethical requirements for the conduct of research involving subjects with impaired decision-making capacity for each jurisdiction where the research will be conducted.
- Studies that involve children or other vulnerable populations, are greater than minimal risk and are not conducted in Illinois must be reviewed and approved by an IRB in the appropriate jurisdiction (i.e., state) as well as the UIC IRB.
- COGNITIVELY IMPAIRED: Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests. (Penslar RL, Porter JP. Institutional Review Board Guidebook, Chapter 6: Special Classes of Subjects, OHRP, 1993).
- COMPETENCE: Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. (See terms Incompetence, Incapacity below) Competence may fluctuate as a function of the natural course of a mental illness, response to treatment, effects of medication, general physical health, and other factors. Therefore, mental status should be re-evaluated periodically. As a designation of legal status, competence or incompetence pertains to an adjudication in court proceedings that a person's abilities are so diminished that his or her decisions or actions (e.g., writing a will) should have no legal effect. Such adjudications are often determined by inability to manage business or monetary affairs and do not necessarily reflect a person's ability to function in other situations. (Penslar RL, Porter JP. Institutional Review Board Guidebook, Chapter 6: Special Classes of Subjects, OHRP, 1993).
- CLOSE FRIEND: In Illinois, “Any person 18 years of age or older who has exhibited special care and concern for the patient and who presents an affidavit to the attending physician stating that he or she (i) is a close friend of the patient, (ii) is willing and able to become involved in the patient's health care, and (iii) has maintained such regular contact with the patient as to be familiar with the patient's activities, health, and religious and moral beliefs. The affidavit must also state facts and circumstances that demonstrate that familiarity.” (755 ILCS 40/10).
- DECISIONAL CAPACITY: In Illinois, “the ability to understand and appreciate the nature and consequences of a decision regarding medical treatment or forgoing life-sustaining treatment and the ability to reach and communicate an informed decision in the matter as determined by the attending physician.” (755 ILCS 40/10).
- GUARDIAN: DHHS and the FDA define a guardian as an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. In Illinois, the term Guardian “means a court appointed guardian of the person who serves as a representative of a minor or as a representative of a person under legal disability.” In Illinois, a variety of guardianship appointments exist and the investigator should take care to document that the guardian’s representation of the ward is within the scope of their authority: limited guardianship, plenary guardianship, guardian of the person, guardian of the estate, and temporary guardianship. (Health Care Surrogate Act, 755 ILCS 40).
- INCAPACITY: Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence. (Penslar RL, Porter JP. Institutional Review Board Guidebook, Chapter 6: Special Classes of Subjects, OHRP, 1993)
- INCOMPETENT: A legal term meaning inability to manage one's own affairs. Often used as a synonym for incapacity.
- LEGALLY AUTHORIZED REPRESENTATIVE (LAR): DHHS and the FDA define a legally authorized representative as “an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.” (46.102(c); 21 CFR 50.3).
- UIC policy is guided by OHRP’s Institutional Review Board Guidebook (Chapter 6 Section D), i.e., “the predominant ethical concern in research involving individuals with psychiatric, cognitive, or developmental disorders [including temporary or sporadic decisional impairment resulting from substance abuse or trauma] is that their disorders may compromise their capacity to understand the information presented and their ability to make a reasoned decision about participation. Many individuals with disabilities affecting their reasoning powers may be residents of institutions responsible for their total care and treatment. The impact of institutionalization may further compromise their ability to exercise free choice (voluntariness). (These concerns apply both to voluntary patients and those committed involuntarily.).”
- This policy and procedure is based on the following Illinois state laws: the Illinois Health Care Surrogate Act (755 ILCS 40/1 et seq.), the Mental Health Treatment Preference Declaration Act (755 ILCS 43/10), and the Medical Practice Act (410 ILCS 50/3.1). These statutes, other than the Medical Practice Act, relate to medical treatment decisions; however, the UIC HSPP has extended application of the concepts of these statutes to research. OPRS staff or IRB members consult with the Office of University Counsel when needed. PIs should contact OPRS with any questions concerning Illinois state law or this policy.
21 CFR 50.3
45 CFR 46.102(c)
Illinois Living Will Act
Illinois Health Care Surrogate Act (755 ILCS 40/1 et seq.)
Medical Practice Act (410 ILCS 50/3.1)
Mental Health Treatment Preferences Declaration Act (755 ILCS 43/10)
21 CFR 50.3
Version (#, date)
Replaces (#, date)
Summary of changes
Specified the responsibilities of the investigator when research is being conducted in another state.
Updated for revised VHA Handbook 1200.05, date 10/15/2010. Changed approval to the Human Protections Administrator.
Updated sections on fluctuating ability to consent, process to assess ability to provide consent, and definition of indirect benefit.