For consent to be legally valid, the participant must be both competent and legally entitled to consent.
Consent must be fully informed; voluntary and in writing.
It is strongly recommended that you should always have written consent for research. If you do not, this should be fully justified on the ethics form, and the verbal consent must be fully documented and witnessed.
You must ensure that on your written consent form you have specific clauses for the following:
- Consent to participate in the study
- Permission to inform GPs of their patients’ participation
- Arrangements for ensuring confidentiality of the participant’s personal information
- If videoing/photography is involved in research project, you must have specific clause seeking consent for this
- If data from the project is being sent out of the EEA (EU and Norway, Iceland and Liechtenstein), you need a specific clause seeking consent for this. The committee will expect you to ensure that any data sent out of the EEA will be handled with the same degree of confidentiality as it would be here.
The National Research Ethics Service has produced guidelines on writing the patient information sheet and consent form. They offer excellent advice and provide a template format for both documents. We recommend that you make use of these templates and adapt them to the specific contents of your research project - available to download on the right of this page.
Children and incapable adults
If your research involves minors and adults who are unable to consent for themselves, a legal representative may give their consent on behalf of the patient.
You should write separate information sheets and consent forms for the legal representative to read and sign. These should contain the same information as a normal information sheet and consent form, but should be written from the perspective of the legal representative.
Research involving tissue
If your research project involves storing tissue or clinical material from patients, then there is a standard tissue consent form that has been approved for use by the relevant local research ethics committee.
We strongly recommend that you use this standard form for any research project within the Trust involving patient tissue - available to download here:
This form meets current guidance on the use of human tissue in research, but please note that the Department of Health is currently reviewing policies in this area following the enforcement of the Human Tissue Act 2004.
To find out more on the Human Tissue Act and learn about the Trust's tissue bank, visit our Human Tissue Resource Centre pages.