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

Science Center, Bent Corridor

In order for research to be conducted with human participants, adequate consent must be obtained. It is preferable, and often required, that the research participant be able to give informed consent for herself. Although, in some cases surrogates are allowed to give consent on behalf of the research participant. At the NIH Clinical Center, there are times when investigators need to conduct research with individuals whose ability to consent is in doubt. In these cases, an evaluation of the research participant’s capacity to consent and determination of whether and how it may nonetheless be ethical to include these individuals in research is required. The Bioethics Department at the Clinical Center, began performing and keeping records of capacity-toconsent assessments in 1999. The Bioethics Department’s records constitute, to our knowledge, one of the largest and most comprehensive databases of capacity assessments in a research setting and provide a unique opportunity to retrospectively examine the practice of performing these capacity-to-consent assessments in a systematic way.