Evaluating the Ability to Consent to Research: A Twenty-Year Track Record

Area of Science:

• Clinical Research Ethics
• Neuropsychology
• Informed Consent Process

Background:

• Standardized tools may not adequately assess research consent capacity.
• Uncertainty in participant capacity can hinder research participation.
• Ethical research requires robust methods for capacity evaluation.

Purpose of the Study:

• To evaluate an alternative, task-specific approach for assessing research consent capacity.
• To determine the effectiveness of the Ability to Consent Assessment Team's methods.
• To analyze long-term outcomes of capacity assessments in research.

Main Methods:

• Retrospective review of 944 individuals evaluated between 1999-2019.
• Utilized the National Institutes of Health's Ability to Consent Assessment Team approach.
• Assessed capacity to consent and ability to assign a surrogate.

Main Results:

• 70.1% of individuals were determined to have the capacity to consent.
• Of those lacking capacity, 86.0% could assign a surrogate.
• The task-specific approach demonstrated high success rates.

Conclusions:

• A task-specific capacity assessment facilitates ethical research participation.
• This approach safely includes individuals with initially uncertain consent abilities.
• Task-specific assessments enhance the ethical justification for research inclusion.