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.