Assessing Capacity to Consent. Individual's capacities, impairments, and needs must be taken into account, in order to develop practical and ethical approaches to enable them to participate in research. Since well-validated and practical methods to assess capacity to consent are clearly needed, the NIH is supporting and will continue to support research addressing these issues. A clear understanding of the implications of various cognitive impairments, along with a careful consideration of proposed clinical research methodology, is required. A key factor in participants' decisionmaking is their appreciation of how the risks, benefits, and alternatives to participation in the study apply to them personally.
Limited decision making capacity covers a broad spectrum.
A healthy person in shock may be temporarily decisionally impaired. Another may have been severely mentally retarded since birth, while yet a third who has schizophrenia may have fluctuating capacity. Researchers should be sensitive to the differing levels of capacity and use assessment methods tailored to the specific situation. Further, researchers should carefully consider the timing of assessment to avoid periods of heightened vulnerability when individuals may not be able to provide valid informed consent. Both IRBs and clinical investigators must keep in mind that decisionmaking capacity may fluctuate, requiring ongoing assessment during the course of the research.