ICMJE Guidelines for Data Sharing

In an effort to improve the editorial standards and scientific quality of journal articles, the International Committee of Medical Journal Editors (ICMJE) provides a wide range of recommendations.

An editorial was published by ICMJE in 2017 detailing their initiative of clinical trial data sharing. The ICMJE considers it a moral responsibility to share data that is generated during clinical trials. It is believed that data sharing will serve to make the best use of the knowledge gained from clinical trial participants who put themselves at risk.

As a part of this initiative it is required that:

·         As of 1^st July 2018, manuscripts that report the results of clinical trials and are submitted for publication to ICMJE journals must contain a data sharing statement indicating the following:

o   whether individual deidentified participant data (including data dictionaries) will be shared

o   what data in particular will be shared

o   whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.)

o   when the data will become available and for how long

o   by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism)

ICMJE provides examples of data sharing statements that fulfil these requirements (http://icmje.org/news-and-editorials/data_sharing_june_2017.pdf ).

·         Also, clinical trials that begin enrolling participants on or after 1^st January 2019 must include a data sharing plan in the trial’s registration. If there is any deviation from this plan, it must be disclosed in the data sharing statement when the manuscript is submitted for publication.

ICMJE believes this initiative to be a step towards the process for best practices in clinical trials as described by the World Health Organization (WHO) and hopes that sharing deidentified data will becomes a standard practice in the research community.