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New ICMJE Requirements and the PLOS Data Policy

PLOS Medicine Chief Editor Larry Peiperl discusses the PLOS data policy in relation to new ICMJE requirements around sharing data from clinical trials

In January 2016, member journals of the International Committee of Medical Journal Editors (ICMJE), including PLOS Medicine, published an editorial proposing that journals require researchers to share de-identified data underlying published clinical trials. ICMJE member journals have now published new requirements around data sharing that differ from the earlier proposal.

ICMJE will require prospective, public registration of a data sharing plan (as part of mandatory clinical trials registration) for trials that begin enrollment on or after January 1, 2019, and will require authors to include a data sharing statement with all clinical trials submitted for publication as of July 1, 2018.  However, ICMJE is not requiring authors to share the data itself in any particular way or on any particular timeframe.

This change comes after ICMJE and individual editors received hundreds of comments in a variety of venues expressing marked polarization within the research community.  The new ICMJE requirements reflect concern that “the requisite mechanisms are not in place to mandate universal data sharing at this time” and that “many issues must be addressed for data sharing to become the norm.” Nonetheless, ICMJE expresses its continued commitment to advancing data sharing and has worked with major clinical trials registries to accommodate inclusion of the required data sharing plan. ICMJE has also sought policy clarification on whether sharing de-identified data requires separate participant consent, a frequent concern among researchers asked to share data. In response to a query from ICMJE, the United States Office for Human Research Protections has indicated that the sharing of de-identified individual participant data from clinical trials, provided that appropriate conditions are met by those who receive the data, does not require separate consent from trial participants. These represent important practical steps, if not the great strides we at PLOS might have preferred to see.

The PLOS data sharing policy remains unaffected. While not yet requiring “universal” data sharing, the ICMJE editors see the new rules as “minimum requirements…intended to move the research enterprise closer to fulfilling our ethical obligation to participants.”  The editorial notes specifically that “Some ICMJE member journals already maintain, or may choose to adopt, more stringent requirements for data sharing.”  In other words, it is consistent with the ICMJE policy that PLOS journals require authors to share the de-identified data underlying a study, provided it is both legal and ethical to do so, at the time of publication.

We share the ICMJE’s vision of “a global research community in which sharing de-identified data becomes the norm.” While disappointed that universal data sharing has not advanced more quickly, editors of PLOS journals accept the challenges that come with recognizing research data as a public good. (Some of these are described in a recent discussion by PLOS ONE editors.)  We continue to work within scientific and publishing communities to advance data availability as a key aspect of transparent, reproducible and re-analyzable research—not only in clinical trials, but in studies of all designs.

 

Larry Peiperl receives salary and benefits from PLOS in his employment as Chief Editor, PLOS MedicinePLOS Medicine is a member journal of ICMJE.

 

Featured Image: Jake Rustenhoven (gotcredit.com), Flickr

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