Research involving vulnerable groups

Learn more about ethical issues raised by research involving vulnerable groups:

Children and young People

It is important to ensure respect for the dignity and autonomy of research participants and this principle applies equally to adult and child participants.

Research involving children and young people may give rise to particular sensitivities, and particular thought and care needs to be exercised when conducting such research. For the purposes of this document, any person under the age of 18 is deemed a child or young person. At the age of 18, individuals attain full legal maturity under UK law.

Practical guidance

Those considering undertaking research with people under this age are advised to:

  • Ensure that appropriate regard is given to ensuring the safety and well-being of the child/young person at all times
  • Consider any possible adverse impact that inclusion in the study may have upon the children at a later date
  • Check the existence and content of relevant professional guidelines concerning research with children
  • Evaluate the degree to which it is necessary to include children/young people in the research or whether it would be reasonable to conduct the research utilising information from people who are adults with decision making capacity
  • Assess the level of decision-making capacity possessed by children and young people who become participants in the research
  • Secure informed consent/assent to involvement in research
  • Ensure the disclosure of personal information deemed to be in the public interest
  • Ensure compliance with legal requirements relating to working with children within the UK and in other jurisdictions
  • Consider implications of the use of rewards/inducements for participation
  • Check the implications of the use of images of young people

More information can be found on this page of further guidance.

Adults lacking mental capacity

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.

Research involving vulnerable groups may necessitate Criminal record disclosure to ensure that their background is suitable for working with children and vulnerable adults.

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