Informed consent

It is widely, although not universally, accepted that informed consent should be obtained from all conscious patients entered into clinical trials, and the principle of freely given informed consent is emphasized in the Declaration of Helsinki ( The ethical arguments concerning consent have been discussed at length elsewhere and are not repeated in detail here. Commentaries by Doyal [14] and Tobias [15] and the subsequent debate in the British Medical Journal (vol. 316, pp. 1000-1011) provide a good overview of the subject as does the subsequent book [16].

The laws concerning consent vary internationally, but informed consent is considered essential under most circumstances by all the major organisations that manage and fund cancer trials. Obtaining such consent is therefore an important aspect of planning and conducting trials and for those run to the International Conference on Harmonisation (ICH) or other good clinical practice, there are specific and detailed guidelines for obtaining and documenting consent (see Section 7.3). Some trialists have pointed out that although rigorous informed consent is required when treating patients with a new treatment within the context of a trial, were they to give this same new treatment to all of their patients outside of a trial, then no such consent would be required [17]. However, this should not be viewed as a reason to make consent for trials any less meticulous. Rather, in an ideal world, consent to all treatment should be as informative and rigorous as the consent required for randomized trials [18].

In practice, consent has not always been as informed as it ought to be [19] and lay people and health professionals alike find it difficult to give the phrase 'informed consent' tangible meaning [20]. A review of publications relating to the ethics of randomized trials [9] found that a considerable number of doctors thought that patients included in their trials may not have fully understood that they were being included in a trial, or the information given to them. The authors suggested that for some doctors informed consent seemed little more than a ritual. Although consent is usually obtained by the medical staff caring for a patient, this does not mean that those designing and co-ordinating trials can abdicate responsibility for this important component of trial procedure. Responsible researchers should make sure that clinical staff are given as much support as possible to help ensure that consent is obtained appropriately and does not become ritualized. The importance of obtaining properly informed consent should therefore be stressed in the trial protocol and also addressed in patient information sheets and consent forms.

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