Aanscherping van de ethische criteria voor medisch-wetenschappelijke verslaglegging en de Verklaring van Helsinki

- The ‘Bill on Medical Scientific Research with Humans’ is about to be introduced in the Netherlands. Clinicians who have scientific interests when carrying out diagnostic and therapeutic procedures and who are not solely motivated by the well-being of their patients are subject to a potential conflict of interests. The Declaration of Helsinki, of which a Dutch integral version is presented, deals with the pertinent ethical guidelines. The ‘Uniform requirements for manuscripts submitted to biomedical journals’ (so-called Vancouver rules) stipulate that research should be in accordance with the Helsinki statements. Journal editors may ask authors to produce the written approval of their research by an ethical committee. With respect to the disclosure of patient data in scientific articles, which in principle requires informed consent of the patients concerned, it is the policy of this journal to anonymize the data when the paper is edited in such a way that people other than the patients themselves are unlikely to recognize the patients. If this is not possible explicit written consent of the patients is required.