title: The International Committee of Medical Journal Editors trial data sharing requirement and participants' consent.
abstract: The International Committee of Medical Journal Editors (ICMJE) has published a draft proposal on de-identified individual clinical trial participant data (IPD) sharing, stating that sharing trial data requires planning to ensure appropriate research ethics committee approval and participants' informed consent. This is why its implementation will be deferred for 1 year after the publication of the final version of the policy. When conducting research with anonymous data, it is not feasible to obtain the informed consent from research participants. De-identified IPD are anonymous to the investigator who is performing the secondary analysis. De-identified IPD meta-analyses have been conducted for decades. Public funders, industry and foundations have recently implemented new IPD sharing procedures; almost all trials used for secondary analyses so far were conducted without participant's consent to de-identified IPD. As stated by the ICMJE, de-identified IPD protects participant's confidentiality. It follows that publishing secondary analyses from completed trials without participant's consent is ethically acceptable. From the ethical perspective, the ICMJE requirement on de-identified IPD sharing should be implemented from the day the policy is published.
authors: Clinical Research, BUC (Biosciences UAM+CSIC) Program, International Campus of Excellence, Universidad Autónoma de Madrid, Madrid, Spain.
authors: Rafael
authors: R
authors: Dal-Ré
mesh_terms: D003219:Confidentiality / Q000941:ethics; D035081:Editorial Policies; D028744:Ethics Committees, Research; D006801:Humans; D033181:Information Dissemination / Q000941:ethics*; D007258:Informed Consent / Q000941:ethics