Research involving adults lacking mental capacity

Please note that no research involving adults lacking mental capacity can be approved under the University's ethical review protocols - it must be referred for review by an NHS Research Ethics Committee.

Under the Mental Capacity Act 2005, intrusive research undertaken on adults lacking mental capacity must be approved by a designated research ethics committee to be lawful.

'Mental capacity' definition

Under the Act, 'mental capacity' refers to the ability to make a decision. Capacity is a decision relative test - a person may have the capacity to make some decisions but not others, and capacity may vary over time.

Loss of capacity may be permanent - for example, owing to traumatic head injuries - or temporary - for example, loss of consciousness in an emergency situation.  Section 2 of Mental Capacity Act 2005 provides that a person lacks capacity "if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or disturbance in, the functioning of the mind or brain".

'Intrusive research' definition

Research is 'intrusive' if it is of a kind that would be unlawful if it was carried out "on or in relation to a person who had capacity to consent to it, but without their consent" (Section 30 (2) Mental Capacity Act 2005). This extends to 'non-interventional' research such as observational research where consent is legally required.

It appears that the current definition is so broad as to encompass all research concerning adults lacking mental capacity.

Assessments of mental capacity

Under the Mental Capacity Act, the following factors have to be considered when assessing if someone has capacity to make a decision under section 3(1):

  • Whether they are able to understand the information
  • Whether they are able to retain the information related to the decision to be made
  • Whether they are able to use or weigh that information as part of the process of making the decision
  • Whether they are able to communicate that decision – by any means

Adults lacking mental capacity may include but is not limited to persons in the following categories - adults with learning disabilities, dementia, or Alzheimer’s. The Act applies to persons who are over the age of 16.

Approval of research involving adults lacking mental capacity

Research involving adults lacking mental capacity must be approved by an ethics committee designated as an appropriate body by the Secretary of State for Health. These include all NHS Research Ethics Committees in England and Wales, and the national Social Care Research Ethics Committee. (For further information please see Mental Capacity Act 2005 Code of Practice and HRA guidance on research involving adults unable to consent for themselves.) Applications under the Mental Capacity Act relating to research outside the NHS will be accepted for review by NHS Research Ethics Committees.

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