Decisionally impaired persons are those who have a diminished capacity for rationally and autonomously providing informed consent due to a psychiatric, organic, developmental or other disorder that affects cognitive or emotional functions. The diminution of capacity may be a temporary impairment such as from physical trauma or emotional-stress; or it may be chronic impairment such as from neurologic, psychiatric or substance abuse problems.
A distinction should be made between the legal meaning of the term "incompetent" and the broader term "decisionally impaired". Many decisionally impaired individuals have been declared "incompetent" by a court of law with the appointment of a legally authorized representative for the individual judged incompetent by the court; but this declaration is not necessarily the case for all decisionally impaired persons and the lack of its occurrence should not be the only indicator of decisional impairment.
The IRB shall recognize that important research questions may only be answered by studies involving subjects with impaired decision-making capacity and that precluding such research would deprive such subjects from potential study benefits including potential therapies of many disorders. As is true for almost all clinical research, it is also possible that such studies may not directly benefit the individual participant but may offer future benefits to others who have or will develop the condition or disorder. For example, genetic studies, biochemical measures, or other non-therapeutic approaches may benefit subsequent generations. While limited decision-making capacity should not prevent participation in research, the IRB shall provide additional scrutiny for research involving this population.
Informed consent for prospective research subjects who are not competent must be obtained from a legally authorized representative or health care surrogate who is specifically appointed. A signature line for the representative or health care surrogate must be added to the consent form in these cases.
Criteria for IRB approval of studies involving cognitively impaired subjects shall be defined in IRB deliberations and included in the meeting minutes. Such criteria include:
1) Cognitively impaired individuals are the only suitable research subjects or are required subjects for the study. There must be a compelling reason to include cognitively impaired subjects and such individuals must not be subjects in research simply because they are readily available
2) Whether, if the study is of more than a minor increase over minimal risk, the study holds out the prospect of direct benefit to the individual in a risk- benefit ratio at least as favorable to the subjects as that presented by available alternate approaches
3) Whether the research is intended to benefit the subjects and the probability of benefit is greater than the probability of harm
4) The Principal Investigator shall attempt to obtain assent from the potential subjects and under no circumstances shall subjects being forced or coerced to participate
5) The subjects' representatives are well informed on the proposed research and regarding their roles and obligations to protect the cognitively impaired subjects and representatives must be told that their obligation is to try to determine what the subjects would do if competent or what they think is in the subjects' best interest.
6) Whether the informed consent process can be structured to be appropriate and effective within the limits of the potential subjects' decisional capacity
The IRB shall consider the guidance of the National Institutes of Health it is review of research involving subjects who are or may be decisionally-impaired. This guidance includes:
1) The consent process and documents should clearly differentiate between individualized treatment and research and between clinician and clinical investigator. This is because cognitively impaired subjects may find it difficult to differentiate between research and treatment
2) At least one voting member of the IRB shall have the appropriate professional background or knowledge and experience working with cognitively impaired persons [45 CFR 46.107; 21 CFR 56.107]
3) The IRB shall be sensitive to the fact that decision-making capacity may fluctuate, requiring ongoing assessment during the course of the study. The consent process should be ongoing
4) The IRB shall ensure that if impairment increases, additional safeguards are in place prior to involving impaired subjects in research that poses greater than minimal risk