Copyright, Open Access and data sharing

Copyright, Open Access

JLE journals make clear their copyright policy and, if retained, their position on the transfer of copyright for all types of content, including audio or video files, protocols, and data sets.

Articles are published under an exclusive license or a non-exclusive license when JLE has agreed that a license applies.

Open access articles may be reused under the terms of the Creative Commons license applied to facilitate reuse of content.

The author may wish to publish his article in an institutional or thematic repository, or on a scientific social sharing network. What he can do, without obtaining permission, depends on the license he has chosen and the version of his article.

Sharing of clinical trial data

Sharing the full datasets underlying the results of a research article brings many benefits. It enables reuse, reduces research waste, and promotes collaboration. Greater transparency increases confidence in research results by allowing results to be independently verified. These benefits lead to a more reliable evidence base.

Manuscripts submitted to journals published by JLE that report clinical trial results must contain the data sharing statement described below.

According to ICMJE recommendations, clinical trials that begin enrolling participants on or after Jan. 1^er, 2019, must have a data-sharing plan outlined at the time of trial registration. ICMJE's policy on trial registration is explained at www.icmje.org/recommendations/browse/publishing-an d-editorial-issues/clinical-trial-registration.html. If the data sharing plan has changed after registration, this should be stated in the statement submitted and published with the article, and in the trial registry.

Authors of secondary analyses using shared data must state that the use of the data was made under the agreed-upon conditions (if any) when they were received. They should also cite the source of the data using the unique, permanent identifiers to give credit to those who generated the data and enabled the research. Authors of secondary analyses must clearly explain the differences between their analyses and those originally conducted. In addition, those who generate and then share clinical trial data deserve substantial credit for their efforts. Those who use data collected by other researchers should seek collaboration with those who generated the data. Since collaboration is not always possible, practical or even desired, the efforts of those who generated the data should be recognized.

Details of ICMJE's policy on clinical trial registration are provided in a series of editorials (see "Updates and Editorials" [www.icmje.org/news-and-editorials/] and "Frequently Asked Questions" [www.icmje.org/about-icmje/faqs/]).

JLE requires that a study be registered in a public clinical trials registry no later than the enrollment of the first patient in order to consider publication of a report on the research.

A clinical trial is defined as a research project that prospectively assigns individuals or groups of individuals to a medical intervention, with or without comparison or control groups, to study the relationship between a medical intervention and an outcome. Medical interventions are means used to change a biomedical or health-related outcome; examples include drug treatments, surgical procedures, medical devices, behavioral therapies, training programs, dietary interventions, quality improvement strategies, and process of care changes. Outcome evaluation is based on biomedical or health-related criteria measured in patients or participants, including pharmacokinetic parameters and adverse events. The ICMJE does not provide a definition for when the first participant is enrolled, but good practice dictates that enrollment should occur prior to obtaining consent from the first participant.

The purposes of clinical trial registration are diverse: to prevent selectivity in publication and reporting of research results, to avoid unnecessary duplication of research efforts, to allow patients and the public to obtain information about planned or ongoing studies in which they may wish to participate, and to provide ethics committees seeking approval for new studies with an overview of similar work and data relevant to the research in question. Retrospective registration, for example at the time of manuscript submission, does not fulfill any of these purposes. These goals also apply to research that uses other types of methods, such as observational studies. For this reason, the ICMJE encourages the recording of non-experimental protocols, but this is not a requirement since the exposure or intervention is not dictated by the investigators in this type of observational research.

Secondary analyses of data from an original clinical trial should not be registered separately but should use the registration number of the original trial as a reference.

Journals will publish the registration number of the trial at the end of the abstract. When the registration number is available, authors are also advised to include this number the first time they use an acronym to refer to the clinical trial they are submitting or other trials mentioned in the manuscript.

Editors should consider whether a failure to properly register a clinical trial is likely to have been intentional or to have resulted in biased reporting. Because of the importance of prospective trial registration, if an exception to this policy is made, trials should be registered and the authors should indicate in the publication when registration was achieved and why it was delayed. Editors will issue a statement indicating why an exception was allowed. These exceptions should be rare: if authors have not prospectively registered a trial, they risk non-receipt of the publication in our journals.

How to access the data available on request:

Data requesters should proceed as follows:

–  send an e-mail to the corresponding author of the article to request the relevant data;

–  if one month goes by without a response from the authors, send an e-mail to the editor of the journal concerned;

–  The journal will evaluate the request and, if appropriate, encourage authors or their institutions to share the data, although the JLE is not in a position to compel publication of the data or to negotiate agreements.