Patients consent

The responsibility for obtaining patients' consent to participate in a trial lies with the collaborating clinicians (see Chapter 2). The trial management group is responsible for ensuring that the trial is conducted ethically.

In a few trials, fully informed consent is not possible: for example, trials studying emergency situations. In such trials, the relevant ethics committee should be informed that immediate patient consent is not possible, and that the relevant National guidelines for this situation would be followed.

For consent to be legally valid, the patient must be competent to consent to take part in a trial. Consent must be based on adequate information. It is therefore desirable that all patients entering a trial sign a consent form confirming that the trial has been explained to them and that they have read and understand the patient information sheet. The following points should be considered in obtaining consent.

♦ Give the patient time to consider how to respond and time to discuss the matter with others.

♦ Encourage the patient to ask questions.

♦ Ask the patient to sign and date a consent form.

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