Persons with Mental Disabilities or with Impaired Decision-Making Capacity

Research involving subjects who are mentally ill or subjects with impaired decision-making capacity warrants special attention. Research involving these populations may present greater than minimal risk; may not offer direct medical benefit to the subject; and may include a research design that calls for washout, placebo, or symptom provocation. In addition, these populations are considered to be vulnerable to coercion.

The requirements in this section apply to all research involving persons with mental disabilities of persons with impaired decision-making capacity regardless of funding source.

IRB Composition

The IRB membership must include at least one member who is an expert in the area of the research. Consideration may be given to adding another member who is a member of the population, a family member of such a person or a representative of an advocacy group for that population.

Approval Criteria

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. The investigator must demonstrate to the IRB that there is a compelling reason to include incompetent individuals or persons with impaired decision-making capacity as subjects. Incompetent persons or persons with impaired decision-making capacity must not be subjects in research simply because they are readily available.
2. The proposed research entails no significant risks, tangible or intangible, of if the research presents some probability of harm, there must be at least a greater probability of direct benefit to the participant. Incompetent people or persons with impaired decision-making capacity are not to be subjects of research that imposes a risk of injury, unless that research is intended to benefit that subject and the probability of benefit is greater than the probability of harm.
3. Procedures have been devised to ensure that 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 (DPAHC)) or 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.

Additional Concerns

Both investigators and IRB members must be aware that for some subjects, their decision making capacity may fluctuate. For subjects with fluctuating decision-making capacity or those with decreasing capacity to give consent, a re-consenting 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.

The IRB will require investigators to conduct a competency assessment whenever there is a possibility of either impaired mental status or decision-making capacity in prospective subjects. The IRB will evaluate whether the proposed plan to asses capacity to consent is adequate. If feasible, the investigator must explain the proposed research to the prospective research subject even when the surrogate gives consent. 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 the subjects is required and (b) the plan for obtaining assent is adequate.