Cholestatic Liver Disease Consortium (CLiC) Presentations and Publications Policy

01 July 2006

Contents

1. Charge of the Presentations and Publications Committee
2. Goals
3. Scope
4. Presentations and Publications Committee membership
5. Types of publications
6. Writing groups and authorship issues
   • 6.1. Writing groups
   • 6.2. Authorship criteria
   • 6.3. Authorship format by type of report
   • 6.4. General issues for naming authors
7. Proposal of topics and review of proposed topics
8. Responsibilities of the writing group
9. Acknowledgments to be included in publications and presentations
10. Review of manuscripts
11. Publications priorities
12. Presentations, abstracts, and letters to the editor
13. Reprints and postings to the CLiC website
    

CLiC Presentations and Publications Policy

1. Charge of the Presentations and Publications Committee

The purpose of the Presentations and Publications (P&P) Committee is to oversee and provide guidance relative to reporting study data and to assure that study reports have expert input, a high standard of scientific quality, responsible conclusions, and sound interpretations and fulfill the overall objectives of the Cholestatic Liver Disease Consortium (CLiC). The charge of the P&P Committee is to:

• Develop and modify, when necessary, the policy for publications in regard to proposal of manuscripts, review and approval of manuscript proposals, assignment of tasks in analysis and writing, review of manuscripts, authorship policy, and other issues related to publications.
  
• Develop and modify, when necessary, the policy for presentations in regard to proposal of presentations, review and approval of presentation proposals, assignment of tasks in analysis and writing, review of presentations, authorship policy, and other issues related to presentations.
  
• Make recommendations to the Steering Committee about topics for publications
  
• Make recommendations to the Steering Committee about topics for presentations at national and international meetings
  
• Make recommendations concerning the priority of manuscripts and presentations
  
• Review proposals for publications and presentations and make recommendations for approval or disapproval to the Steering Committee
  
• Review manuscripts prior to journal submission and review presentations prior to presentation
  
• Mediate and settle all disputes and conflicts among study investigators over publication or presentation priorities, authorship, and any other issues related to publications or presentations. Investigators who perceive inequities in authorship or other problems relating to authorship should discuss these concerns with the P&P Committee chairperson. If the difficulty cannot be settled in this informal manner, the concerned investigator should submit a letter to the P&P Committee chairperson outlining the problem. The document will be reviewed and discussed by the P&P Committee, and a written reply will be made to the investigator. If P&P Committee deliberations fail to resolve such a dispute, the dispute will be submitted for resolution to the full Steering Committee, excepting those members of the Steering Committee with a conflict of interest.
  
• Prepare and maintain a list of concepts for publications and prepare and maintain a list of approved CLiC publications, which shows the status of each manuscript from initiation through publication

The purview of the P&P Committee includes publications and presentations arising from CLiC main studies, substudies, pilot and feasibility studies, and ancillary studies.

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2. Goals

• To promote timely, scientifically accurate, and high-quality presentation and publication of findings from CLiC studies.
  
• To support broad and equitable participation by CLiC investigators in presentations and publications.
  
• To define a set of equitable policy and procedures to determine authorship and the order in which authors are listed.
  
• To review and select topics for publications and presentations, assign authors to writing groups, set priorities for publications and presentations, and monitor progress of publications and presentations.
  
• To provide editorial support and timely review for presentations and publications.
  
• To defend the academic freedom of CLiC investigators collectively to publish results emanating from the CLiC studies, while providing limitations on publication of results from any one center that could threaten the integrity of collective data.

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3. Scope

• These policy and procedures apply to original manuscripts (including methodology, validation, laboratory approaches), abstracts, oral and poster presentations, letters to the editor, meeting proceedings, and extended abstracts that include data collected as part of CLiC. The policy and procedures also apply to review articles that include original CLiC data not previously published.
  
• These policy and procedures apply to publications and presentations arising from CLiC main studies, substudies, pilot and feasibility studies, and ancillary studies.
  
• The P&P Committee reserves the right to amend the presentation and publication policy and procedures as necessary to clarify their intent.

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4. Presentations and Publications Committee membership

• The Committee consists of a chairperson (elected by the Steering Committee) and 3 clinical center principal investigators (elected by the Steering Committee), an investigator from the Data Technology Coordinating Center, and an NIDDK representative.
  
• The chairperson and 3 clinical center principal investigators serve for 2-year terms.
  
• The members from the Data Technology Coordinating Center and NIDDK serve for the duration of the CLiC.
  
• The number of consecutive or interrupted terms that a chairperson or other elected member may serve will not be limited.
  
• Each member has one vote.
  
• If a member is an author on a presentation or manuscript or otherwise has a conflict of interest, the member will recuse himself/herself from review of the proposal, abstract, manuscript or presentation.

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5. Types of publications

• Main reports arise from main studies and address the main objectives of main studies or report primary outcome data or design and methods of main studies. Examples of main reports are those that address the outcome of CLiC patients, the results of treatment trials, and design and methods of CLiC studies.
  
• Secondary reports arise from main studies and address secondary objectives of main studies or report data or design issues or methods that are more peripheral to the main studies than those addressed in main reports.
  
• Substudy reports arise from substudies of the CLiC.
  
• Ancillary study reports arise from an ancillary study of the CLiC.
  
• Pilot and feasibility reports arise from a pilot or feasibility study of the CLiC.
  
• Abstracts, meeting proceedings, extended abstracts, oral and poster presentations.
  
• Letters to the editor.
  
• Press releases.

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6. Writing groups and authorship issues

6.1. Writing groups

• Writing groups: The writing of manuscripts will be assigned to a writing group consisting of CLiC investigators, one of whom will be designated the Chair. The P&P Committee will nominate the writing group chair and members and send the selection to the Steering Committee for final approval. Investigators proposing manuscripts may suggest writing group membership to the P&P.

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6.2. Authorship criteria

• Authors should participate in the writing of the paper according to guidelines of the International Committee of Medical Journal Editors (N Engl J Med 1997; 336:309-315). Those who participated in conception and design, analysis and interpretation of data, drafting the manuscript, critical revision of the manuscript relating to important intellectual content, and final approval of the manuscript should be included as authors. Expertise (eg, statistical, virology, or pathology) that relates directly to the conduct of the study is additional criterion for authorship. Provision of study material or patients; data collection and assembly; administrative, technical, or logistic support; and obtaining funding do not necessarily merit authorship but should be considered on a case-by-case basis, especially when other contributions are included. In general, presentations and publications from main and secondary reports will include one author from each Clinical Center, the Data Technology Coordinating Center and one NIDDK representative. Honorary authorship will not be considered.

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6.3. Authorship format by type of report

• Main reports will have authorship of one author from each Clinical Center, the DTCC and NIDDK followed by "and the CLiC Research Group." The order of authorship will be based on overall contributions to the particular study, such as conception and design, performing data analysis, writing of the manuscript, etc. An appendix listing all investigators and study coordinators in the CLiC will be included. The writing group will include one to three clinical center investigators, one investigator from the DTCC, and one investigator from the NIDDK.
• Secondary or lesser reports of main CLiC studies will have similar authorship or conventional authorship. An appendix listing all investigators and study coordinators in the CLiC will be included, journal permitting.
• Substudy reports will have modified conventional authorship (Name1, name 2, ... and the CLiC Research Group) or conventional authorship. An appendix listing all investigators and study coordinators in the CLiC will be included, journal permitting.
• Pilot and feasibility study reports will have modified conventional authorship (Name1, name 2, ...and the CLiC Research Group) or conventional authorship. An appendix listing all investigators and study coordinators in the CLiC will be included, journal permitting.
• Ancillary study reports will likely have conventional authorship. Authorship of ancillary studies is usually determined case-by-case based on the data sharing agreement between the lead investigator and CLiC.

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6.4. General issues for naming authors

The following points apply when conventional or modified conventional authorship is used for a publication or presentation.

• The writing group, plus any ad hoc contributors who fulfill criteria for authorship, will be listed as authors.
  
• Order of authorship: The Chairperson of the writing group will propose the authorship order to the P&P Committee based on the level of input into the manuscript. The P&P Committee may amend the order of authorship to recognize an exceptional contribution to the study or the manuscript by an individual. Upon P&P Committee approval, the order will be submitted to the Steering Committee for final approval. For all manuscripts, factors to be included in decisions about order of authorship are contribution to concept, design, and analysis; role in drafting the article or revising it critically for important intellectual content; completeness and integrity of the data and specimens from the investigator's site; and leadership role.
  
• For journals that limit the number of masthead authors, the following order of authorship will apply until the journal's limit is reached:
  • The writing group.
  • Other investigators identified by the writing group as having made special contributions to the concept, design, or analysis of the study.
  • Other investigators identified by the writing group as having contributed special effort to the execution of the study.
  • If the journal's limit of authors is reached before all writing group members are listed, all others in the writing group will be listed in an Acknowledgments section of the manuscript.
  • Unless he/she delegates otherwise, the Chairperson of the writing group will be the first author.

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7. Proposal of topics and review of proposed topics

• The DTCC will keep a list of topics proposed for manuscripts and will maintain a list of approved topics and their status.

• Any member of the Research Group may propose a manuscript. Non Steering Committee members should channel their requests through the Steering Committee member of their site who will forward the topic to the P&P Committee. Proposals must be submitted in writing to the P&P Committee by completion of the Publication Proposal form which is available on the CLiC members' website (http://www.rarediseasesnetwork.org/clic). This form requires:
  • a brief description of the background, hypothesis, and purpose of the topic
  • a summary of the analysis plans
  • a description of the subjects to be included
  • a list of variables of interest
  • proposed writing group membership (including statistician) and proposed chair
  • for abstracts, the date of submission and date of the meeting
  • for manuscripts, target journals or book

• The DTCC will distribute a copy of the proposals to members of the P&P with a deadline for return of comments (or will schedule a conference call). P&P members may propose additional or alternate writing group members. The P&P Committee will select the final writing group membership and appoint the writing group chair. The chair will usually be the person who proposed the project. The selection of writing groups and their Chairpersons will be submitted to the Steering Committee for final approval.

• Criteria for judging proposals:
  • scientific merit of the hypothesis or aim of the proposal
  • availability of appropriate data to address the hypothesis or aim
• If overlap in content exists between or among proposals, the P&P Committee will either eliminate overlap or consolidate the proposals.

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8. Responsibilities of the writing group

• The chair of the writing group will be responsible for assigning tasks to other members of the writing group and for overseeing the completion of these tasks on schedule.
  
• Manuscripts will be prepared at the center of the writing group Chair.
  
• All data analysis will be done through the DTCC (Main Report papers) or appropriate statistician at a CLiC site. Based upon their review of these requests, the statistician will provide an estimate of the time and resources required to be included in the final proposal.
  
• When the manuscript is judged ready for internal review, the chair will submit the completed manuscript to the P&P Committee in care of the CLiC Research Administrator.
  
• If a writing group does not complete its work or fails to meet timeline milestones, the P&P Committee may reassign the roles of chair or select new writing group members. This exigency may be exercised if no draft is produced within 3 months of the availability of a clean data set.
  
• If, during the course of work on a manuscript, the analysis is found to be too broad for a single manuscript, the writing group may suggest that the data would be more suitable for more than a single manuscript. The writing group must notify the P&P Committee that they plan to narrow the scope of the manuscript.

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9. Acknowledgments to be included in publications and presentations

• All CLiC manuscripts must include an acknowledgment of NIDDK funding, with specific grant numbers, as well as NIH funding numbers of participating General Clinical Research Centers. Acknowledgment of CRADA partners should be included as well. When appropriate, other institute or center support is to be acknowledged (e.g., National Institute of Child Health and Human Development, National Cancer Institute). Grant numbers do not have to be specified on acknowledgments for abstracts and presentations.

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10. Review of manuscripts

• The P&P Committee will serve as the editorial review committee for all manuscripts.
  
• Manuscripts that are judged ready for P&P review should be submitted to the P&P Committee in care of the CLiC Research Administrator.
  
• The CLiC Research Administrator will send all manuscripts received for P&P review to the full Steering Committee for voluntary comment directed to the corresponding author. A deadline for comments will be specified.
  
• For each report (ancillary study reports are excluded), two P&P Committee members who did not write the paper or two CLiC Research Group members with relevant expertise will be designated to provide a timely review (within four weeks) of the manuscript for editorial clarity and data integrity. The DTCC will simultaneously do their own review of the analysis and statements about the CLiC protocol. Ancillary study reports will be sent to one P&P Committee member for review for accuracy of statements about the CLiC resources used in the ancillary study and for appropriate acknowledgment of CLiC.
  
• The results of the P&P, and DTCC reviews will be collated by the CLiC Research Administrator and sent to the writing group chair.
  
• The result of the review may be that the manuscript is approved for submission to NIDDK or that the manuscript needs revision and rereview.
  
• The final step in the CLiC review process is submission to NIDDK for review. All papers arising from the CLiC, including ancillary study reports, must be reviewed by NIDDK prior to journal submission. The writing group chair will submit the manuscript to the NIDDK project officer after receiving approval from the P&P to do so.
  
• The NIDDK project officer will notify the writing group chair (with a copy to the CLiC Research Administrator) when the manuscript is approved for journal submission.
  
• If a dispute occurs between the authors and the P&P Committee, resolution of the dispute is the responsibility of the Steering Committee.
  
• Although approval by CRADA/CTA partners is not required, as a courtesy, manuscripts that relate to work carried out through the support of a CRADA/CTA will be submitted to the relevant CRADA/CTA partner at the same time as submission to the P&P. CRADA/CTA partners will not have authority to prevent or delay publication.

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11. Publications priorities

• No investigator may jeopardize the publication of CLiC study results in a peer-reviewed journal by releasing or presenting data prematurely. Local press releases are to be timed to coincide with publication of manuscripts and must respect any applicable publication embargoes.
  
• No individual site will be permitted to publish site-specific CLiC results without the approval of the Steering Committee.

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12. Presentations, abstracts, and letters to the editor

• Presentations of CLiC data at national and international meetings must be approved by CLiC. The approval process may entail review of slides and printed material by the same mechanism as that used to review abstracts. P&P Committee approval is not required for local presentations and accompanying syllabus material (eg, medical school lectures, continuing education courses, grand rounds lectures, research seminars, etc). Investigators are encouraged to consult the P&P Committee chairperson when questions about the propriety of a local presentation arise. If the chair cannot address such questions readily, the issue will be considered by the entire P&P Committee (via conference call or written communication).
  
• Presentations and abstracts will generally use modified conventional authorship (name 1, name 2, etc, and the CLiC Research Group), or alternatively the complete list of one investigator from each Clinical Center, DTCC and NIH, and will include acknowledgment of NIDDK funding.
  
• The DTCC will be responsible for data analysis and final slide preparation for CLiC corporate presentations.
  
• Investigator-initiated abstracts that require data analysis assistance from the DTCC must be proposed to the P&P Committee at least 3 months prior to the submission deadline (use the same form used to propose a manuscript). The P&P Committee will review the proposal, and if approved will prioritize the analysis requests, in consultation with the DTCC. In unusual cases, in which data analysis is not complicated or has already been accomplished to a significant degree by the DTCC, investigators may make the proposal 2 months prior to the submission deadline.
  
• Completed abstracts are to be submitted to the P&P Committee at least 10 days prior to submission to the organization sponsoring the meeting. The abstract will be circulated to the full P&P Committee with a ballot for approval as written, approval with revisions, or disapproval. A majority of the P&P Committee members responding must approve the abstract for it to be approved for submission.
  
• Letters to the editor are to be approved according to the same process as that used for abstracts.

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13. Reprints and postings to the CLiC website

• Reprints of Main Report manuscripts will be purchased by the CLiC Research Administrator, and requests for reprints may be addressed to the CLiC Research Administrator. Reprints for all other manuscripts are the responsibility of the writing group chair (who may determine that purchase of reprints is not feasible).
  
• Final versions of CLiC manuscripts will be posted on the CLiC website. Slide material prepared for presentation at national or international meetings will also be posted on the CLiC website.

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Acknowledgements:
In drafting the CLiC Presentations and Publications Policy and Procedures, we referred to the Biliary Atresia Research Consortium (BARC) Presentations and Publications Policy and Procedures.

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