Decision-making capacity and informed consent to participate in research by cognitively impaired individuals

Obtaining informed consent is a fundamental part of conducting research that balances the need for participant autonomy and calls on the principal investigator to exercise beneficence. This is especially true in research involving persons with dementia and mild cognitive impairment where the ability to understand and reason may be compromised. Performing an assessment of decision-making capacity to consent to research should be the first step in helping the researcher decide who signs the consent. This article reviews the current literature available on instrumentation and procedures for capacity assessment, and in the absence of universal guidelines offers implications and suggestions for practice.