“The International Committee of Medical Journal Editors (ICMJE), which is comprised of various member journals including the New England Journal of Medicine (NEJM) and The Lancet, just published its highly anticipated data sharing requirements on June 6, 2017. These new requirements are subsequent to the ICMJE’s initial clinical trial data sharing proposalpublished in January 2016, which proposed that authors share deidentified individual patient data for results presented in the article no later than six months after publication. According to ICMJE, the initial proposal was met with “many comments from individuals and groups,” as part of their request for feedback, and “many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers.”1
The newly published ICMJE data sharing requirements differ from the initial proposal. In particular, they do not include requirements for the sharing of deidentified individual patient data. ICMJE retained a requirement from the initial proposal for authors to include a plan for data sharing as a part of clinical trial registration, and added a requirement for authors to include a data sharing statement with the manuscript submission.
More specifically, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in its member journals: …”