It’s here…ICMJE Requirements on Data Sharing!

Sharing Published on June 6, 2017 (https://www.acpjournals.org/doi/10.7326/M17-1028)  

Since January 2016 when the International Committee of Medical Journal Editors (ICMJE) first announced their proposal for data sharing, there has been much discussion and debate over the proposed data sharing requirements in order for manuscripts to be considered for publication in ICMJE member journals. Now, the ICMJE’s data sharing policy is here…

Today, ICMJE released their position on data sharing through simultaneous publication in their member journals: http://annals.org/aim/article/2630766/data-sharing-statements-clinical-trials-requirement-international-committee-medical-journal.

In short, currently data sharing will not be mandated; however, authors will be required to provide a data sharing statement at the time of manuscript submission as a condition for the manuscript to be considered for publication in member journals. Specifically, the requirements are:

• Effective July 1, 2018, manuscripts reporting clinical trial results submitted to ICMJE journals must include data sharing statement, which should include the following: ̶
• Whether individual deidentified patient-level data will be shared (including “data dictionaries”);
• What specific data will be shared;
• Whether additional, related documents will be available (e.g., study protocol, analysis plan, clinical study report, etc.);
• Timing of when data will become available and duration;
• Criteria for data access (e.g., who can get access? Types of analyses? Mechanism for requesting and obtaining access?).
• As part of ICMJE’s policy for trial registration, clinical trials that initiate patient/subject enrolment on or after January 1, 2019 must include data sharing plan in the trial’s registration (e.g., ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, etc.). ClinicalTrials.gov has been adopted to allow posting of data sharing plans as part of trial registration (https://prsinfo.clinicaltrials.gov/definitions.html#shareData). Any changes to the data sharing plan after initial trial registration should be updated in the registry accordingly and reflected in the statement at the time of manuscript submission.

The ICMJE editorial provides examples of data sharing statements that fulfill the requirements; and one of the examples (example 4) is for a scenario when individual participant data would not be made available. However, of note, the ICMJE position also states that although these initial requirements do not impose a mandate,

“…investigators should be aware that editors may take into consideration data sharing statements when making editorial decisions.”

It’s unclear how journal editors will use data sharing statements in practice, when making editorial decisions to accept or reject a manuscript, which remains to be seen once the policy becomes effective next year.

Interestingly, the ICMJE editorial also shares a letter by Jerry Menikoff, MD, JD, Director of the United States Office of Human Research Protections (http://icmje.org/news-and-editorials/menikoff_icmje_questions_20170307.pdf), which indicates that separate patient informed consent may not be required for sharing of deidentified individual patient-level data from clinical trials, if appropriate conditions are met, including protection of privacy information, etc. What does this mean for study sponsors and investigators? Unavailability of patient informed consent as a general reason for not sharing data may not be considered sufficient justification. Additional reasons may need to be provided if the study sponsors and investigators opt to not provide access to patient-level data for a given trial.

In summary, based on the effective dates noted above, study sponsors and investigators need to be prepared to provide data sharing statement in manuscript submission and disclose the data sharing plan on public registry at the time of trial registration, in order to have their clinical trial-related manuscript considered for publication at ICMJE member journals. Although these ICMJE requirements will be implemented by its member journals, many other non-member journals may also follow these requirements. Some journals already have data sharing requirements as part of manuscript submission and/or acceptance. As longer-term outlook, these requirements may continue to evolve over the years as ICMJE and research community continue to work on addressing unresolved issues related to practical implementation of data sharing…as noted in the ICMJE editorial:

“Although many issues must be addressed for data sharing to become the norm, we remain committed to this goal. … moving further along in the era of transparency and access to data."

To learn more about how to optimize your scientific communication and publication planning & execution at any stage of your product lifecycle, contact us at inquiry@pubcounsel.com. We also specialize in compliance & monitoring, developing corporate policies and procedures, metrics analysis, and training. Publication Practice Counsel is your trusted partner for scientific communication and publication expertise with customized solutions to meet your needs with personalized attention to detail on every project.