Protecting and empowering adults with capacity-affecting conditions to take part in health and health-related research

Health research is essential if people are to enjoy the highest attainable standard of health and healthcare. Yet, persons with capacity-affecting conditions are routinely excluded from research, as they are often judged to lack the capacity to give consent. Focusing on the Mental Capacity Act England and Wales 2005 (MCA), which regulates research involving adults judged to lack capacity, we outline the provision of the MCA and then describe the process of ethical review designed to ensure compliance with these provisions; 2) present findings from interviews with members of the committees responsible for ethical review and with researchers, who have experience of working with the MCA; 3) discuss the implications of these findings for the inclusion of adults lacking capacity in research as well as drawing conclusions about the effectiveness of the MCA.