Patient consent form

♦ The patient consent form must include the title of the trial and should be signed and dated by the patient and, if required by the local ethics committee, by a witness.

♦ A recommended consent form is shown in Fig. 7.3. This is based on UK MREC recommendations.

♦ A recommended consent form for providing tissue or biological samples is shown in Fig. 7.4.

CONSENT FORM (Form to be on headed paper)

Name of trial: Centre:

Patient's name or other identifier:

I have read and understand the patient information sheet for the above study [version, dated] and have had the opportunity to ask questions and discuss it with my doctor.

I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reasons, without my medical care being affected.

I understand that my medical notes may be looked at by responsible individuals where it is relevant to my taking part in research. I give permission for these individuals to have access to my notes but understand that strict confidentiality will be maintained. The purpose is to check that the study is being carried out correctly.

I agree to take part in the above study.

Please initial box □

Fig. 7.3 A recommended patient consent form

CONSENT FORM FOR PROVIDING TISSUE OR BIOLOGICAL SAMPLES (Form to be on headed paper)

Name of trial: Centre:

Patient's name or other identifier:

I have read and understand the patient information sheet for the above study [version, dated] and have had the opportunity to ask questions and discuss it with my doctor.

I agree that the samples I have given and the information gathered about me can be looked after and stored on behalf of [the sponsor] for use in future projects, as described in the information sheet. I understand that some of these projects may be carried out by researchers other than [the sponsor], including researchers working for commercial companies.

I understand that I shall not benefit financially if future research leads to the development of a new treatment or medical test.

I agree to donate the samples requested.

Name of patient Date Signature

Name of person obtaining consent Date Signature

One copy should be given to the patient and one should be kept with hospital notes.

Fig. 7.4 A recommended patient consent form for providing tissue or biological samples for storage with a view to future research.

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