Why would a consultee be required for participation in research?
When people are very unwell, they may lose the capacity to decide and communicate whether or not they wish to take part in a research study. In this situation, under the terms of the 2005 Mental Health Capacity Act, a ‘consultee’ must be appointed. A consultee can either be ‘personal’ or ‘nominated’.
Who can act as a consultee?
A personal consultee is someone unconnected with the research who knows the potential research participant in a personal capacity and is able to advise on the person’s wishes or feelings. This can be a friend, family member or court appointee.
A nominated consultee is someone unconnected with the research, appointed by the researcher, to advise the researcher about the person’s wishes and feeling in relation to the project. This will be one of the medical Consultants on the ward looking after the potential research participant, or their GP, but they must not have any connection with the study. At all times, the nominated consultee must comply with the duty to protect confidentiality of the patients, which applies to all NHS employees.
Before a nominated consultee is appointed, the researcher will take all reasonable steps to identify a personal consultee.
What is the role of the consultee?
The consultee advises the researcher on what the participant’s wishes and feelings would be if they were able to consent for themselves, and on whether they should take part. The consultee does not give consent, only advice. The responsibility to decide whether the participant should be entered into the research lies ultimately with the researcher. Consultees will be provided with information about the research project and will be given the opportunity to discuss it and their role as consultee. All consultees must be able to understand their role and be willing to undertake it.
How do I find out more if I am approached to be a consultee?
Further information is available in:
- the Department of Health’s 'Guidance on nominating a consultee for research involving adults who lack capacity to consent', in particular pages 5 to 7 for Personal consultees and pages 8 -11 for Nominated consultees.
- the MCIP’s ' Helping people who are unable to make some decisions for themselves – a guide for family, friends and other unpaid carers', in particular page 37.
- the MCIP’s 'Helping people who are unable to make some decisions for themselves – a guide for people who work in health and social care', in particular pages 45-46.
What documents will be used for the consultee declaration?
If the patient under consideration is at the Oxford University Hospitals NHS Foundation Trust (OUH), then the relevant paperwork is available using the links below:
If the patient under consideration is at the Buckinghamshire Healthcare NHS Trust (Bucks Healthcare), then the relevant paperwork is available using the links below: