Adult patients whose capacity to give consent is impaired

Adult patients' capacity to give consent may be impaired by the nature or severity of their disease, or for other unrelated reasons. When an incapacitated adult is unable to give consent, the responsible clinician should fully inform the subject's legally acceptable representative of all pertinent aspects of the study, including the written information and the acceptability of the study to the relevant ethics committee.

Incapacitated patients can be entered into trials, but researchers should try to obtain consent at whatever level is possible, based on information that is understandable by the individual. When there is doubt about patients' ability to consent, independent assessors or witnesses should be asked to help assess whether consent is valid.

If the consent of such patients cannot be obtained, they should not be entered into the trial, although in some regions, consent can be obtained from legally acceptable representatives. When this is the case, representatives should be given time and opportunity to enquire about details of the study and to decide whether or not to permit participation. Before participation, the representative should sign and date the consent form and the consent procedures should be witnessed by an impartial witness who should also sign and date the consent form. By doing so, the witness attests that the information in the patient information sheet and consent form was accurately explained to and apparently understood by the subject's legally acceptable representative.

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