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1.  Licensing the future: report on BioMed Central’s public consultation on open data in peer-reviewed journals 
BMC Research Notes  2013;6:318.
We report the outcomes of BioMed Central’s public consultation on implementing open data-compliant licensing in peer-reviewed open access journals. Respondents (42) to the 2012 consultation were six to one in favor (29 in support; 5 against; 8 abstentions) of changing our authors’ default open access copyright license agreement, to introduce the Creative Commons CC0 public domain waiver for data published in BioMed Central’s journals. We summarize the different questions we received in response to the consultation and our responses to them – matters such as citation, plagiarism, patient privacy, and commercial use were raised. In light of the support for open data in our journals we outline our plans to implement, in September 2013, a combined Creative Commons Attribution license for published articles (papers) and Creative Commons CC0 waiver for published data.
doi:10.1186/1756-0500-6-318
PMCID: PMC3751723  PMID: 23962139
2.  Open by default: a proposed copyright license and waiver agreement for open access research and data in peer-reviewed journals 
BMC Research Notes  2012;5:494.
Copyright and licensing of scientific data, internationally, are complex and present legal barriers to data sharing, integration and reuse, and therefore restrict the most efficient transfer and discovery of scientific knowledge. Much data are included within scientific journal articles, their published tables, additional files (supplementary material) and reference lists. However, these data are usually published under licenses which are not appropriate for data. Creative Commons CC0 is an appropriate and increasingly accepted method for dedicating data to the public domain, to enable data reuse with the minimum of restrictions. BioMed Central is committed to working towards implementation of open data-compliant licensing in its publications. Here we detail a protocol for implementing a combined Creative Commons Attribution license (for copyrightable material) and Creative Commons CC0 waiver (for data) agreement for content published in peer-reviewed open access journals. We explain the differences between legal requirements for attribution in copyright, and cultural requirements in scholarship for giving individuals credit for their work through citation. We argue that publishing data in scientific journals under CC0 will have numerous benefits for individuals and society, and yet will have minimal implications for authors and minimal impact on current publishing and research workflows. We provide practical examples and definitions of data types, such as XML and tabular data, and specific secondary use cases for published data, including text mining, reproducible research, and open bibliography. We believe this proposed change to the current copyright and licensing structure in science publishing will help clarify what users – people and machines – of the published literature can do, legally, with journal articles and make research using the published literature more efficient. We further believe this model could be adopted across multiple publishers, and invite comment on this article from all stakeholders in scientific research.
doi:10.1186/1756-0500-5-494
PMCID: PMC3465200  PMID: 22958225
3.  Five years of Trials 
Trials  2011;12:248.
This editorial marks the launch of a special collection of articles highlighting 'Five years of Trials' (http://www.trialsjournal.com/series/5years). The journal's achievements on its objectives since 2006 are described and some of the challenges still ahead are outlined - in particular further innovating in the reporting of trials and the publication of negative results. The other articles in this series are examples of where Trials has demonstrated progress on its objectives. These include the publication of raw data, extended versions of previously published trial-related articles, descriptions of 'lessons learned', negative results, and educational articles regarding ethics and reporting bias.
doi:10.1186/1745-6215-12-248
PMCID: PMC3254076  PMID: 22112799
5.  A call for BMC Research Notes contributions promoting best practice in data standardization, sharing and publication 
BMC Research Notes  2010;3:235.
BMC Research Notes aims to ensure that data files underlying published articles are made available in standard, reusable formats, and the journal is calling for contributions from the scientific community to achieve this goal. Educational Data Notes included in this special series should describe a domain-specific data standard and provide an example data set with the article, or a link to data that are permanently hosted elsewhere. The contributions should also provide some evidence of the data standard's application and preparation guidance that could be used by others wishing to conduct similar experiments. The journal is also keen to receive contributions on broader aspects of scientific data sharing, archiving, and open data.
doi:10.1186/1756-0500-3-235
PMCID: PMC2940773  PMID: 20813027
7.  Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers 
Trials  2010;11:9.
In recognition of the benefits of transparent reporting, many peer-reviewed journals require that their authors be prepared to share their raw, unprocessed data with other scientists and/or state the availability of raw data in published articles. But little information on how data should be prepared for publication - or sharing - has emerged. In clinical research patient privacy and consent for use of personal health information are key considerations, but agreed-upon definitions of what constitutes anonymised patient information do not appear to have been established. We aim to address this issue by providing practical guidance for those involved in the publication process, by proposing a minimum standard for de-identifying datasets for the purposes of publication in a peer-reviewed biomedical journal, or sharing with other researchers. Basic advice on file preparation is provided along with procedural guidance on prospective and retrospective publication of raw data, with an emphasis on randomised controlled trials.
In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal web sites.
doi:10.1186/1745-6215-11-9
PMCID: PMC2825513  PMID: 20113465
8.  Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers 
Many peer reviewed journals now require authors to be prepared to share their raw, unprocessed data with other scientists or state the availability of raw data in published articles, but little information on how such data should be prepared for sharing has emerged. Iain Hrynaszkiewicz and colleagues propose a minimum standard for de-identifying datasets to ensure patient privacy when sharing clinical research data
doi:10.1136/bmj.c181
PMCID: PMC2813427  PMID: 20110312
9.  Towards agreement on best practice for publishing raw clinical trial data 
Trials  2009;10:17.
Many research-funding agencies now require open access to the results of research they have funded, and some also require that researchers make available the raw data generated from that research. Similarly, the journal Trials aims to address inadequate reporting in randomised controlled trials, and in order to fulfil this objective, the journal is working with the scientific and publishing communities to try to establish best practice for publishing raw data from clinical trials in peer-reviewed biomedical journals. Common issues encountered when considering raw data for publication include patient privacy – unless explicit consent for publication is obtained – and ownership, but agreed-upon policies for tackling these concerns do not appear to be addressed in the guidance or mandates currently established. Potential next steps for journal editors and publishers, ethics committees, research-funding agencies, and researchers are proposed, and alternatives to journal publication, such as restricted access repositories, are outlined.
doi:10.1186/1745-6215-10-17
PMCID: PMC2662833  PMID: 19296844
11.  The ISRCTN Register: achievements and challenges 8 years on 
The ISRCTN register has been operational for the past 8 years and is approaching 10,000 trial records. It complies with international guidelines and pools its data in the International Trial Search Portal initiated by the World Health Organisation. Through its ongoing collaboration with the Department of Health in England, the register has been able to participate in a national initiative aiming to bring clinical trials to the attention of a wider public with the objective of maximising participation. As part of BioMed Central, the register provides the first step in the concept of threaded publications, enabling the tracking of clinical research studies from inception and the linking of all resulting publications including the raw data where this is available.
doi:10.1111/j.1756-5391.2011.01138.x
PMCID: PMC3206222  PMID: 21894613
12.  Sharing of clinical trial data among trialists: a cross sectional survey 
Objective To investigate clinical trialists’ opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team.
Design and setting Cross sectional, web based survey.
Participants Clinical trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factor in 2011.
Main outcome measures Support for and prevalence of data sharing through data repositories and in response to individual requests, concerns with data sharing through repositories, and reasons for granting or denying requests.
Results Of 683 potential respondents, 317 completed the survey (response rate 46%). In principle, 236 (74%) thought that sharing de-identified data through data repositories should be required, and 229 (72%) thought that investigators should be required to share de-identified data in response to individual requests. In practice, only 56 (18%) indicated that they were required by the trial funder to deposit the trial data in a repository; of these 32 (57%) had done so. In all, 149 respondents (47%) had received an individual request to share their clinical trial data; of these, 115 (77%) had granted and 56 (38%) had denied at least one request. Respondents’ most common concerns about data sharing were related to appropriate data use, investigator or funder interests, and protection of research subjects.
Conclusions We found strong support for sharing clinical trial data among corresponding authors of recently published trials in high impact general medical journals who responded to our survey, including a willingness to share data, although several practical concerns were identified.
doi:10.1136/bmj.e7570
PMCID: PMC3502744  PMID: 23169870

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