Research Involving Cognitively Impaired Persons

Individuals with:

• Psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders)
• Organic impairment (e.g., dementia)
• Cognitive disorder
• Developmental disorder (e.g., mental retardation)
• Substance abusers

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.

The predominant ethical concern in research involving cognitively impaired individuals is that their disorders (affecting cognitive or emotional functions) may compromise/diminish their capacity for judgment and understanding of the information presented, and their ability to make a reasoned decision about participation.

As a general rule, all adults, regardless of their diagnosis or condition, should be presumed competent to consent unless there is evidence of serious mental disability that would impair reasoning or judgment. Even those who do have a diagnosed mental disorder may be perfectly able to understand the matter of being a research volunteer, and quite capable of consenting to or refusing participation. Mental disability alone should not disqualify a person from consenting to participate in research; rather, there should be specific evidence of individuals' incapacity to understand and to make a choice before they are deemed unable to consent.

Persons formally adjudged incompetent have a court-appointed guardian who must be consulted and consent on their behalf. Officials of the institution in which incompetent patients reside (even if they are the patient's legal guardians) are not generally considered appropriate, since their supervisory duties may give rise to conflicting interests and loyalties. Family members or others financially responsible for the patient may also be subject to conflicting interests because of financial pressures, emotional distancing, or other ambivalent feelings common in such circumstances.

Witness to Consent

When obtaining Informed Consent from a mentally deficient or incompetent person, a witness must be present and must sign the consent document. The witness is verifying that the subject was fully informed and that the subject voluntarily agreed to participate.

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.) The eagerness for release may induce an institutionalized person, especially one who is involuntarily confined, to participate in research out of a desire to appear "rational" and "cooperative" to those who will make decisions about his or her release. Persons who are institutionalized, particularly if disabled, should not be chosen for studies that bear no relation to their situation just because it would be convenient for the researcher.

1. Should the patient's physician or other health care provider be consulted before any individual is invited to participate in the research? Is the research likely to interfere with ongoing therapy or regimens? Is it possible that the request to participate itself might provoke anxiety, stress, or other serious negative responses?
2. Does the research pertain to mental disabilities so that it is necessary to involve persons who are mentally disabled as subjects?
3. If the investigator proposes to involve institutionalized individuals, has he or she provided sufficient justification for using that population? Are noninstitutionalized subjects appropriate for the research and reasonably available? Does the research pertain to aspects of institutionalization?
4. Are adequate procedures proposed for evaluating the mental status of prospective subjects to determine whether they are capable of consenting? Are these procedures appropriate both to the subject population and the nature of the proposed research?
5. Is more than minimal risk involved? If so, is the risk justified by anticipated benefits to the participating subjects and the importance of the knowledge that may reasonably be expected to result?
6. Is it possible to identify persons authorized to give legally valid consent on behalf of any individuals judged incapable of consenting on their own behalf? Should assent of the prospective subjects also be required? If incapable of giving valid consent, can subjects' objection to participation be overridden? Under what circumstances?
7. Should an advocate or consent auditor be appointed to ensure that the preferences of potential subjects are elicited and respected? Should someone ensure the continuing agreement of subjects to participate, as the research progresses?
8. Does the IRB need to include a member knowledgeable about and experienced with the mentally disabled or cognitively impaired?