Enrollment of Cognitively Impaired Persons

For all studies, the IRB suggests employing educational measures to raise the subject’s understanding to sufficient levels for them to make a meaningful choice about participating. Potential measures include orally summarizing the consent form, repetitive teaching, audiovisual presentations, and oral or written recall tests. Other measures might include follow-up questions to assess subject understanding, video- or audio-taping of consent discussions, use of waiting periods to allow more time for the potential subject to consider the information that has been presented, or involvement of a trusted family member or friend in the informed consent process.

However, when a study will enroll adult subjects who are temporarily or permanently incapable of giving informed consent additional safeguards are necessary and required. In such circumstances, the subject’s legally authorized representative (LAR) may provide permission for the subject to be enrolled in the study. Individuals with impaired decision-making capacity may include, but are not limited to, those with history of stroke, traumatic brain injury, brain tumors, intellectual disability, severe mental illness, dementia, or those with temporary impairment because of illness or psychoactive drugs. When cognitively impaired subjects take part in research, or when a subject’s cognitive state has changed and reconsent may be required, additional safeguards must be included to protect the rights and welfare of these subjects as detailed below.

Explicit IRB approval is required to enroll cognitively impaired subjects who are incapable of providing informed consent as a study population, or to enroll a single cognitively impaired subject incapable of giving informed consent. To request the enrollment of this population, please complete the applicable section in the Protocol Template or Site-Specific Appendix. Investigators must include adequate justification for inclusion of individuals with impaired decision-making capacity and explain why either the aims of the research study cannot be reasonably achieved without inclusion of this population, or the research holds out a prospect of direct benefit to the individual subject that is unavailable outside the research context.

When requesting enrollment of this population in either the Protocol or Site-Specific Appendix, investigators must also detail procedures for assessing a potential subject’s capacity to provide informed consent and, if appropriate, for re-evaluating capacity throughout study participation. Assessments of capacity to make medical decisions and/or consent for research must be documented in the research record. The following guidelines should be used when determining capacity to consent:

  • One or more individuals with relevant expertise should be identified to evaluate prospective participants’ capacity to consent and make an objective determination regarding each participant’s capacity to consent. In most instances, this will be a member of the research team. However, in some circumstances, it might be necessary to engage an independent evaluator to assess capacity.
     
  • Methods to assist with evaluators’ determinations should include at least one of the following:
    1. Conducting clinical interviews with prospective participants and asking them to describe aspects of the study (“teach-back”)
    2. Using standard psychological and neuropsychological screening tests
    3. Utilizing a formal instrument for assessing capacity to consent in clinical research. Examples of existing cognitive tests include the Mini-mental State Evaluation (MMSE) and the Montreal Cognitive Assessment (MoCa). Comprehensive capacity assessment instruments include the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC).
    4. Researchers may develop and suggest alternative procedures for evaluating the presence of decision-making capacity. Such procedures must be included in the Protocol or Site-Specific Appendix and reviewed and approved by the IRB prior to enrollment of cognitively impaired subjects in the research study
       
  • For study participants with impaired decision-making capacity who are capable of assent (affirmative agreement to participate in research, distinct from legally effective consent), assent from the individual must be obtained and methods for documenting assent must be provided in the Protocol or the Site-Specific Appendix.

Reassessment of decision-making capacity

When the study includes subjects likely to regain capacity to consent (e.g., shows improvement after a stroke or traumatic brain injury) while the research is ongoing, the Protocol or Site-Specific Appendix should include provisions to inform them of their participation and seek consent for ongoing participation.

Conversely, if subjects may lose capacity to consent while the research is ongoing, the Protocol or Site-Specific Appendix should include provisions to reassess capacity. If the subject loses capacity, then there should be a plan to either withdraw the subject from the study or to consent the LAR and obtain assent from the subject if appropriate.

For more information, please refer to the following materials available in the eIRB library:

References