Website of the Department of Health

Mental Capacity Act 2005: Consultation on draft research regulations

The Mental Capacity Act 2005 provides a statutory framework for people who may not be able to make their own decisions, for example because of a learning difficulties, an illness such as dementia or brain injury or mental health problems. It sets out who can take decisions, in which situations, and how they should go about this

The Act enshrines in statute current best practice and common law principles concerning people who lack mental capacity and those who take decisions on their behalf. In Section 30 to 34, the Act also provides a statutory framework for research involving people who lack capacity to consent to their participation. These provisions balance the importance of properly conducted research into the treatment or care of people who lack capacity with the need to protect their interests and respect their current and previously expressed wishes and feelings.

The Department of Health is consulting on draft research regulations under the Act, which provide detailed policy on a number of issues where broad outlines were given in the primary legislation. We are seeking views on:

The draft regulations and an explanation of the policy intention and links to some relevant publications are available below.

• Download Mental Capacity Act 2005: Research regulations consultation (PDF, 102K)
• Download Dear Colleague Letter: Mental Capacity Act 2005 - Research regulations consultation (PDF, 22K)
• Download Mental Capacity Act 2005 - Research regulations consultation accessible version with broader background about research ethics (PDF, 23K)