Consent process

A participant must give consent before being enrolled in the study. Consent must be taken by a member of the study team who has undertaken good clinical practice (GCP) training at the frequency specified by their trust and who is delegated to take consent on the trial specific delegation log.

1. Give the participant the information sheet to read 

Participants, or their personal legal representatives if they lack capacity, should be approached by their clinical team to ask if they would have an interest in participating in a research trial. They should be given at least one hour to read the information sheet.

If participants express and interest and are eligible, they will then be referred to the research team.

A member of the research team will confirm eligibility before going to speak to the patient to explain what participation in the trial involves. The patient will also be given the information sheet (PDF).

If the patient lacks capacity, their personal legal representative should be given verbal and written information about the study.

If a female patient is under 55 years old, pregnancy must be excluded. If the patient or their representative is unable to confirm she is not pregnant, verbal consent to conduct a pregnancy test should be obtained from the patient or representative and written in the medical notes.

2. Obtain consent

After having adequate time to read the information sheet, and being given the opportunity to ask questions, if the participant wishes to be involved consent must be obtained.

The participant should sign the consent form and this should be kept securely in the Investigator Site File.

If the patient lacks capacity, the personal legal representative for that patient should be asked to sign a consent form, to give permission for their friend or relative to be involved in the study. If there is no personal representative available, a professional legal representative (named on trial delegation log), can be asked to give consent on behalf of the participant.

If a participant regains capacity during their participation in the study, they must be consented to remain in the study.