Publication and Acknowledgement Policy

According to the recommendations of International Committee of Medical Journal Editors (ICMJE), http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html, authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published and 4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Authors should meet conditions 1, 2, 3 and 4.

1. It is often convenient for the main publication from a large study to be published under the author name of ‘Studyname Collaborative Group’, or a similar suitable collective name, with the full list of all those involved in the study at the end (with all of the names indexed in Pubmed by the journal).  A good example of this type of publication is:

The FOOD Trial Collaboration. Routine oral nutritional supplementation for stroke patients in hospital (FOOD): a multicentre randomised controlled trial. Lancet 2005; 365: 755–63.

For studies run through the Edinburgh Clinical Trials Unit that are published this way, we would prefer there to be a section in the author list at the end of the publication entitled ‘Edinburgh Clinical Trials Unit’.  We would prefer this list to include all Trials Unit staff members who have been involved in the design, conduct or analysis of the study (including Statisticians, Trial Managers, data entry, QC checks, admin staff, IT, nursing, health economists).  It is probably convenient for this list to be administered by the study Trial Manager. [Not all journals will publish long lists of contributors, but many of the larger journals do].

2. If the model above is not followed, then as a minimum we would prefer that:

• the list of authors includes the Statistician who ran the analyses, the Trial Manager, and the IT programmer who developed the main database, unless any of these people don’t want to help draft the article or revise it critically for important intellectual content.
• the acknowledgement section mentions Edinburgh Clinical Trial Unit, e.g. “We thank Edinburgh Clinical Trials Unit staff for their involvement.”

3. The Trial Manager, or a senior member of the Edinburgh Clinical Trials Unit staff, should be informed when a publication is accepted by a journal, and the details of this publication should be kept centrally in the Trials Unit.  We should make sure we have the publication details of the main trial publication as a minimum, but collecting other publications would also be useful.
4. Study data were collected and managed using REDCap electronic data capture tools hosted at [YOUR INSTITUTION].^1,2 REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.

¹PA Harris, R Taylor, R Thielke, J Payne, N Gonzalez, JG. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.

²PA Harris, R Taylor, BL Minor, V Elliott, M Fernandez, L O’Neal, L McLeod, G Delacqua, F Delacqua, J Kirby, SN Duda, REDCap Consortium, The REDCap consortium: Building an international community of software partners, J Biomed Inform. 2019 May 9 [doi: 10.1016/j.jbi.2019.103208]

A pdf version of the policy, with Policy Acknowledgement for Chief Investigators is available here: