The benefits and risks of requiring researchers to share data ============================================================= * Vivian C. McAlister * Edward J. Harvey ## Summary The International Committee of Medical Journal Editors has sponsored many developments in medical research reporting that have improved the quality of research. Their proposal to require a statement by researchers regarding the availability of underlying data for sharing has the potential for a significant advance in medical knowledge. The *Canadian Journal of Surgery* supports the initiative and will develop mechanisms to support authors in meeting this new requirement. For many young authors, the steps to publication are frustrating and annoying. Their older peers can gleefully tell them that it was worse in the old days. Not too long ago, manuscripts were prepared by typewriter. If a reviewer requested changes, great ingenuity was required to avoid disrupting the citation sequence too much. If a paper was refused, submission to another journal usually required complete retyping of the manuscript to meet its different specifications. In 1978, a group of journal editors met in Vancouver, BC, to address this latter problem by developing uniform requirements for manuscripts submitted to biomedical journals. Not only did they give us the Vancouver citation style, they also continued as the International Committee of Medical Journal Editors (ICMJE) to promote quality in reporting of medical science. The *Canadian Journal of Surgery* chose then, and continues now, to follow ICMJE recommendations. The scope of ICMJE broadened from requirements for manuscript preparation to include “conduct, reporting, editing and publication of scholarly work in medical journals.” 1 While *CJS* highlighted issues, such as the minimum contribution for authorship and fraudulent reporting, ICMJE also tried to improve the definition of the roles and responsibilities of reviewers, editors, publishers and owners with respect to bias, conflict of interest and editorial freedom.2,3 In 1997, a clinical trial registry, now known as ClinicalTrials.gov, was established in the United States to give the public access to research data, particularly about pharmaceutical therapies. ICMJE exploited the existence of this registry to require preregistration of clinical trials submitted for publication to supporting journals in order to avoid the suppression of trials with negative outcomes. *CJS* adopted this requirement. Scientific reports traditionally present aggregate data. Presentation may require intense statistical manipulation, such as in certain types of survival curves, comparison between which may involve complex computer code. In January of this year, ICMJE posted a provisional policy to require reports to include a statement regarding the availability of supporting data for sharing.4 This statement should include information regarding the trial protocol (which may be available from ClinicalTrials.gov); the statistical code used and the data set. While the primary aim is to allow for the confirmation of research claims, other benefits will include better archiving of data, better meta-analysis and the possibility of secondary analysis. The strongest objections to the proposal have come from members of the cardiovascular clinical trials community, who are concerned that compliant authors will be disadvantaged by sharing data with others who have neither paid nor worked for the results. They are probably expressing in polite terms what is much more acutely felt by commercial sponsors. They counter-propose a 24-month moratorium on data sharing to permit authors the opportunity for secondary analysis.5 There are, however, other risks to data sharing. Patient identification, imagined or real, may be possible using residual identifiers despite current de-identification techniques. Hostile reviewers can use the data to discredit researchers in a forum where rebuttal is difficult or impossible. Archiving data and answering queries have costs that may extend beyond the budget and period of the research. The co-operation of patients and research ethics boards has not been established. Finally, methods to protect researchers from frivolous requests have not been considered. The current proposal applies only to data presented in aggregate form in reports of prospective trials of an intervention in humans, and it is permissible to state that data are not available. Extension of the policy is inevitable. The logic for data sharing applies to all biomedical research. Funding agencies do not currently require data sharing, but most likely will in the future. Registration of a trial on ClinicalTrials.gov now requires the disclosure of data sharing arrangements. *CJS* supports the goals of the data sharing proposal. We will make available to authors a consensus regarding adequate participant de-identification and safe storage of experimental data. We will develop a model confidentiality agreement that would allow bona-fide researchers access to data for the purpose of analyzing the published results, with a requirement that reports be submitted to the journal for publication so that the original author has an opportunity to reply. All other agreements for data sharing will be between the researcher and the applicant according to current practice. Data sharing, properly administered, represents a generational advance in the development of medical knowledge. ## Footnotes * The views expressed in this editorial are those of the author and do not necessarily reflect the position of the publisher. * **Competing interests:** E.J. Harvey is the Chief Medical Officer of Grey-box Healthcare (Montreal) and Chairman of the Board of NXT-Sens Inc. (Montreal). None declared for V.C. McAlister. ## References 1. International Committee of Medical Journal Editors Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals, Available: [www.icmje.org/recommendations](http://www.icmje.org/recommendations). accessed 2016 Nov. 2. 2. Meakins JL, Waddell JP.Authorship.Can J Surg 2002;45:84–7. 3. Meakins JL.Authorship.Can J Surg 2001;44:405–6. 4. Taichman DB, Backus J, Baethge C, et al.Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors.CMAJ 2016;188:91–2. [FREE Full Text](http://canjsurg.ca/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czo4OiIxODgvMi85MSI7czo0OiJhdG9tIjtzOjE4OiIvY2pzLzU5LzYvMzY0LmF0b20iO31zOjg6ImZyYWdtZW50IjtzOjA6IiI7fQ==) 5. Patel MR, Armstrong PW, Bhatt DL, et al.Sharing data from cardiovascular clinical trials — a proposal.N Engl J Med 2016;375:407–9. [CrossRef](http://canjsurg.ca/lookup/external-ref?access_num=10.1056/NEJMp1605260&link_type=DOI) [PubMed](http://canjsurg.ca/lookup/external-ref?access_num=27518659&link_type=MED&atom=%2Fcjs%2F59%2F6%2F364.atom)