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

Occasionally, the ability of prospective research participants to consent may be uncertain. Yet standardized capacity-assessment tools may not suffice to determine the ability to consent to a particular research protocol. This study consisted of a retrospective review of the outcomes of an alternative approach used by the Ability to Consent Assessment Team at the National Institutes of Health. Of 944 individuals evaluated over 20 years (1999-2019), 70.1% were determined to have capacity to consent to participate in research. Of those who lacked capacity to consent and were subsequently evaluated for their ability to assign a surrogate, 86.0% had the ability to do so. The findings demonstrate that establishing a task-specific approach for assessing the capacity of potential participants to consent to a variety of research protocols can facilitate safe and ethically justifiable inclusion of individuals whose ability to consent is initially uncertain.

Improving recruitment in clinical trials: why eligible participants decline.

There is a need to explore why protocol-eligible subjects refuse participation in clinical trials. Without a clear understanding, participation by representative populations will be an ongoing obstacle to recruitment. This descriptive research study analyzes frequency data regarding a sample of 965 individuals who, despite being eligible for studies with the National Institute of Mental Health intramural program, declined research participation. Overall, responses regarding reasons for declining fell into the following five categories: a result of specific protocol issues; inconvenience; for other reasons not mentioned; financial reasons; and, lastly, decided to participate elsewhere. The results of this study identify common factors which suggest there are steps that investigators can take to better accommodate the needs of the public and, consequently, improve research participation.