Ethical considerations

♦ State the ethics procedures already completed and those that local investigators must follow before entering patients.

♦ The details of ethical requirements vary from country to country. For a multi-centre trial, the following statement might be appropriate.

'This trial protocol has been approved by the [appropriate ethics committee]. The patient's consent to participate in the trial must be obtained before entry and after a full explanation has been given ofthe treatment options, and the manner oftreatment allocation. The patient should be given a copy of the patient information sheet and allowed time to discuss this with other staff and with family and friends, if desired, before deciding whether to participate. A patient information sheet and patient consent form are attached. Locally relevant details, such as persons to contact and their telephone numbers, can be added to the leaflet as required. One copy of the completed and signed patient consent form should be given to the patient and another retained in the patient's casenotes.

'The right of a patient to refuse to participate without giving reasons must be respected. After the patient has entered the trial, the clinician must remain free to give alternative treatment to that specified in the protocol at any stage if he or she feels it to be in the patient's best interest, but the reasons for doing so should be recorded and the patient should remain within the trial for the purposes of follow-up and data analysis. Similarly, the patient must remain free to withdraw at any time from protocol treatment without giving reasons and without prejudicing his or her future treatment; as much information as possible relevant to the trial should continue to be collected, particularly on the primary outcome measure.'

♦ The protocol should require each patient to be given a patient information sheet describing the trial in addition to a verbal explanation from their doctor or a research nurse. It should require each patient to give 'written, informed consent' and to sign and date a consent form, unless this is inappropriate as in emergency situations or trials involving children, for example where the relevant National guidelines should be followed (see also Sections 7.8.2-7.8.4).

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