A two-month public consultation (15 April to 15 June 2013) on the World Medical Association’s Declaration of Helsinki on medical research involving human subjects has been launched by the World Medical Association. A revised version of the Declaration is available on the WMA website. This consultation is of particular interest in the context of the ongoing revision of the Clinical Trials legislation.
The consultation is open to the public and to the WMA’s 102 national medical association members, who are being invited to comment on the proposed changes which have been drawn up following an 18-month process of deliberation.
In its Position on Clinical Trials and also with regard to similar issues pertaining to clinical investigations of medical devices, EPHA is supporting more adherence to the important ethical principles enshrined in the Helsinki Declaration and other international reference guidelines, in particular to enable wider consideration of the needs of vulnerable groups - but also of women - e.g. to allow for stratified data analyses of trials results, which should be presented in a transparent and comprehensive manner.
The proposed changes by the WMA provide for more protection of vulnerable groups and all participants by including the issue of compensation, more precise and specific requirements for post-study arrangements and a more systematic approach to the use of placebos.
For further information:
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