Seeking consent

Informed consent

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 consent for research is obtained in writing. If it is not, however, 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 participant’s personal information
If videoing/photography is involved in research project – must have specific clause seeking consent for this
If data from the project is being sent out of the EEA (EU + Norway, Iceland and Liechtenstein), you need a specific clause seeking consent for this. The committee will expect to see that you are ensuring that such data sent out of the EEA will be handled with the same degree of confidentiality, as it would be here.

The NRES guidelines on writing the Patient Information Sheet and Consent form 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 below)

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 a 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 by the relevant local Research Ethics Committee for use. We would strongly recommend that you use this standard form for any research project within the Trust involving patient tissue (download below).

This form conforms with guidance on the use of human tissue in research, but the Department of Health is currently reviewing policies in this area following the enforcement of the Human Tissue Act 2004.

To read more information on the Human Tissue Act and learn about the Trust's tissue bank please visit the Human Tissue Resource Centre pages.