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The objective of this use case is to demonstrate a possible scenario within a researcher-initiated longitudinal cohort study (“Study’”) in which recruitment activities target members representative of the general population, including special populations. The purpose of this scenario is to examine the unique requirements around consent and enrollment of decisionally impaired persons.

Some participants may not be able to consent for a number of reasons, including, but not limited to, mental disorders, neurological disorders, medications, substance abuse, head trauma, etc. Therefore, these participants’ capacity or competency to consent may fluctuate or change over time. The protocol should also address prospective participants that had the capacity or competency to consent at the initial enrollment phase, but may experience a change in capacity or competency for reconsent that requires the involvement of a legally authorized representative (LAR) or suspension/termination of their participation in the study.

The research team may need to include some method to make a determination on a prospective participant’s capacity to consent in the protocol if the IRB determines additional safeguards are necessary. The protocol can include any of the following methods to determine a prospective participant’s capacity to consent:

• Qualified independent party to assess the decisional capacity of the potential subject
• Independent entity to monitor the consent process
• Standardized assessment of cognition of capacity to consent. The assessment may ask the prospective participant to demonstrate that they understand the purpose of the study, procedures, potential risks and benefits, alternatives to participation, etc.
• Informational or educational techniques
• Waiting period to allow the prospective participant additional time to consider all component of the study
• Proxy consent
• Assent in addition to proxy consent

The protocol should also include a statement of rationale for administering any of the assessments described above. These might include:

• Intent to study characteristics of decisionally impaired subjects
• Intent to study general population with members who may develop impairment

The research team should also determine if a potential participant has been declared legally incapacitated or legally incompetent in their state. Participants deemed legally incapacitated or legally incompetent are not considered competent and therefore cannot legally give their consent to participate in a research study.

The team will need a process to determine who should be appointed to make data-sharing decisions on behalf of patients who cannot make this determination themselves (guidelines related to LARs[i]).