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Disclosure of potential conflicts (ISO 14155)

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  • Anon
    07/12/2020 13:54
    Hi all, ISO 14155:2020 requires to disclose potential conflicts of interest, including financial, that can interfere with the conduct of the clinical investigation or interpretation of results. This resembles a lot to FDA Form 3455 (financial disclosure form) but the latter is only applicable for studies conducted under INDs and IDEs. ISO does not provide further details on the “how” so I’m wondering in what way to comply which this ISO requirement. E.g. develop a document similar to FDA Form 3455? Any suggestions or advice? Many thanks,
  • Colin Wilsher
    07/12/2020 16:12
    No idea about ISO.》 EMA volume 10 website for clinical trial regulation has a form for conflict of interest. Might be useful.
  • Juergen Kaetzler
    07/12/2020 19:23
    I am not aware that a specific form for ISO 14155:2020 exists. But as you and Colin already wrote it would be a good idea to start with an existing form for drug studies and adapt it to medical device trials. >> For a clinical trial on medical devices in Germany a few years ago we simply took the "normal" financial disclosure form used in drug trials and removed everything that pointed/linked to the drug laws. Need to say that the form was not required by legislation and/or Ethics Committees... nevertheless, we had a statement from the investigator on possible financial interests and/or conflicts.
  • Anon
    07/12/2020 19:46
    Thanks Colin and Juergen! As always, very useful feedback. Thanks
  • Dominique Chesnais
    08/12/2020 10:35
    In the previous ISO 14155:2011, it was already stated that the principal investigator had to “disclose potential conflicts of interest, including financial, that interfere with the conduct of the clinical investigation or interpretation of results”. Furthermore, the current ISO 14155:2020 provide a direct link to the WMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (latest version October 2013), in which it is stated in its sections “22. … The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects ….”, “26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study.” and “36. … Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication.” A document similar to FDA Form 3455 could be used, but it should be extended with an additional section for listing all other potential conflicts of interest.
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