Characteristics and Outcomes of a Capacity-to-Consent Assessment Service

Summary

Participation Requirements

Description

Objective: To characterize the process and outcomes of capacity assessments of individuals who may be unable to consent to participate in research. Study population: all individuals who came to the NIH Clinical Center for possible enrollment in research whose capacity to consent or assent was evalua...

Objective: To characterize the process and outcomes of capacity assessments of individuals who may be unable to consent to participate in research. Study population: all individuals who came to the NIH Clinical Center for possible enrollment in research whose capacity to consent or assent was evaluated by the Bioethics Consultation Service (BCS), the Human Subjects Protection Unit (HSPU), or the Ability to Consent Assessment Team (ACAT), and all surrogate decision makers of individuals who were unable to consent and were allowed by protocol to give surrogate consent. Design: Retrospective record review Outcome measures: The primary outcome measure will be whether prospective research participants were judged to be able to consent or not. Secondary measures will include: whether the consulting team considered it ethically acceptable to enroll the participant in research; how consent was obtained for doing so; and descriptive features of the consults such as the Institute that requested the consult, protocols for which consults were requested, and diseases that prompted capacity assessments, among other descriptive characteristics.

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