Capacity to consent to research: The evolution and current concepts

DOI:10.1111/j.1758-5872.2012.00210.x Abstract The ethical problem of the need to conduct research on the very conditions that impair the ability to consent to such research is widely acknowledged. People with cognitive impairment and mental illness have an equitable right to research being conducted in areas relevant to their treatment and care, and should be given an equitable opportunity to participate in such research, even if they lack capacity. They also have a right to adequate safeguards to protect their interests and respect their wishes in regards to research participation. Provisions for involvement in research of those who are unable to give consent have only developed over the last 50 years. Over this period we have witnessed a proliferation of policies, regulations and laws that govern research involving subjects unable to give consent. There has been a parallel increase in our understanding of the concepts of consent and capacity, specifically as it relates to the research context, with development of standards for research consent and instruments to guide capacity evaluation. We review the evolution of research governance and the underlying ethical principles that underpin such regulations, approaches to capacity evaluation and the use of proxies and advance research directives to facilitate research participation in adults who lack capacity.