Declaration of Helsinki: what are the challenges for research and clinical trials 50 years on?

Publié le : 12 June 2014

Following the involvement of doctors in human experiments during the Second World War, physicians came together to draft the Declaration of Helsinki, outlining the recommendations and ethical principles underpinning research involving human beings. Is this reference document still relevant today?

 

A seminar was organised last week at the Ministry of Health where professionals could discuss current issues regarding research and clinical trials. Delegates referred to the basic principles of informing and obtaining the consent of patients participating in clinical trials. Catherine Ollivet, President of France Alzheimer 93, pointed out that any person suffering from a serious disorder experiences “contradictory feelings” and it is therefore difficult to assess whether informed consent has been given voluntarily. Jean-Claude Ameisen, President of the Comité consultatif national d’éthique (CCNE) (National Consultative Ethics Committee) is calling for greater dialogue and more ethical considerations, warning against the forms and procedures replacing dialogue between doctors and their patients.

 

The new challenges brought by the “big data” tools are currently swamping rights and entitlements. As pointed out by Marie-France Mamzer, Deputy Director of the Laboratoire d’éthique et de médecine légale (Ethics and Forensic Laboratory) in Paris-Descartes and President of the Comité de Protection des Personnes d’Ile-de-France (Paris Ethics Committee), “although in 2008 it [the Declaration of Helsinki] included the question of research focusing on identifiable data, these additions appear to be somewhat of a quick fix”.  The issue as to whether personal and confidential data should be disclosed in “non-interventional” research programmes questions the legal boundaries that should be implemented. In France, the Huriet-Sérusclat Act (20/12/1988) relating to the protection of persons involved in biomedical research, which defines the role of Ethics Committees, is currently being replaced by the next round of legislation incorporating this “non-interventional research” in conjunction with the CNIL. On a European scale, a new directive is in the pipeline.  It should provide information on the logic behind decisions to disclose (or not disclose) data, as explained by Jacques Lucas, Vice-President of the Conseil national de l’ordre des médecins (French Medical Association). 

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