Undertaking research on people who lack decision-making capacity

The Declaration of Helsinki requires that health care research takes place with the informed consent of those who participate in the study. This approach upholds the autonomy of the participants, but restricts research to subjects who have decision-making capacity. The Mental Capacity Act 2005 introduced safeguards that enable researchers to investigate the care and treatment of people with incapacity, while protecting this vulnerable patient group. These safeguards allow people who lack decision-making capacity to benefit from research findings. In this article, Richard Griffith outlines the requirements that must be met when district nurses conduct research on subjects who lack decision-making capacity.