Guidelines for Research Involving Cognitively Impaired Persons

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Research involving subjects who are mentally ill or subjects with impaired decision-making capacity requires special attention. The principal concern in reviewing research involving individuals with psychiatric, cognitive or developmental disorders or involving individuals who are substance abusers is that their disorders may compromise their capacity to understand the information presented and their ability to make a reasoned decision about participation in research. In addition, research involving these populations may present greater than minimal risk; may not offer direct benefit and may include a research design that calls for washout, placebo or symptom provocation.

Protocol Components, Study Design and Selection of Subjects
Individuals with psychiatric, cognitive or developmental disorders or individuals who are substance abusers are considered a vulnerable population by the NYU SoM IRB. A detailed justification for inclusion of these subjects must be provided in the protocol. The protocol should include a description of additional protections for these subjects.

Research protocols should include the following information to ensure the IRB has reviewed all required evidence. Research involving persons with impaired decision-making capability may only be approved when the following conditions apply.

1. Only incompetent persons or persons with impaired decision making capacity are suitable as research subjects. Competent persons are not suitable for the proposed research. Compelling reasons and evidence must be provided in the protocol to justify the research design and inclusion of this population of patients. These persons should not be subjects in research simply because they are readily available.
2. The research entails no significant risks, tangible or intangible, or if the research presents some probability of harm, there must be at least a greater probability of direct benefit to the participant. Provide a thorough evaluation of the risks and potential benefits to the human subjects involved in the proposed protocol.  The evaluation of risks includes the nature, probability, and magnitude of any harms or discomforts to the subjects.  The evaluation of benefits should distinguish possible direct medical benefits to the subject from other types of benefits. If the research presents some probability of harm, there must be at least a greater probability of direct benefit to the participant. Impaired or incompetent subjects are not to be subjects in research that imposes risk of injury, unless that research is intended to benefit the subject and the probability of benefit is greater than the probability of harm. Studies that are designed to provoke symptoms, to withdraw subjects rapidly from therapies, or to use placebo controls will be subject to heightened scrutiny. Note: Research should never target persons with cognitive impairments as subjects when such research can be done with other competent populations.
3. Procedures have been devised to ensure the participant’s representatives are well informed regarding their roles and obligations to protect incompetent subjects or persons with impaired decision making capacity. Health care agents [appointed under Durable Power of Attorney for Health Care (DPHAC)] and next-of-kin, guardians, must be given descriptions of both proposed research studies and the obligations of the person’s representatives. They must be told that their obligation is to try to determine what the subject would do if competent, or if the subject’s wishes cannot be determined, what they think is in the incompetent person’s best interest.

For research protocols that present greater than minimal risk, the IRB may require that an independent, qualified professional assess the potential subject’s capacity to consent.  The protocol should describe who will conduct the assessment and the nature of the assessment.  The IRB should permit Principal Investigators to use less formal procedures to assess potential subjects’ capacity if there are good reasons for doing so.

For research protocols involving subjects who have fluctuating or limited decision-making capacity or prospective incapacity, it is the responsibility of investigators to monitor the decision-making capacity or those with decreasing capacity to give consent, a resonsenting process with surrogate consent may be necessary. It is the responsibility of investigators to monitor the decision-making-capacity of subjects enrolled in research studies and to determine if surrogate consent must be re-obtained.

Consent
No person who has the capacity for consent may be enrolled in a study without his or her legal informed consent.  Description is provided about regarding describing the requirements for the consent of legally authorized representatives and next-of-kin. A person who has been determined to lack capacity to consent to participate in a research study must be given the opportunity to assent or object to participation and any objection must be heeded.

The IRB will require investigators to conduct a competency assessment whenever there is the possibility of impaired mental status. The IRB will evaluate whether the proposed plan to assess capacity is adequate.

Persons who have been determined to lack capacity to consent should not be enrolled in research which is not likely to result in direct benefit to them, unless the research presents no more than minimal risk.

When potential subjects are capable of making informed decisions about participation, they may accept or decline participation without involvement of any third parties. Any potential or actual subject’s objection to enrollment or to continued participation in a research protocol must be heeded in all circumstances.

An investigator, acting with a level of care and sensitivity that will avoid the possibility or the appearance of coercion, may approach people who previously objected to ascertain whether they have changed their minds.

Under no circumstances may a subject be forced or coerced to participate in a research study. The IRB will evaluate whether a) the assent of subjects is required, and b) whether plan for obtaining assent is adequate.