PUBLICATIONS POLICY

   I. Statement of General Principles Regarding Publications
II. General Considerations
III. The Role and Responsibilities of the Publications Committee
IV. Standards of Excellence
V. Publications of Primary, and Secondary Study Aims and ACRIN-supported Ancillary Studies
VI. Abstracts and Posters
VII. Invited Presentations
VIII. Intergroup Studies
IX. Publicity, Press Releases and Interviews
X. Conflict of Interest Policy


 

   I. Statement of General Principles Regarding Publications

   Overall Goal: A goal of ACRIN, in addition to conducting clinical trials research, is to  disseminate results of the research to the scientific community. These results will include results of primary study outcomes, secondary analyses, and ancillary studies. Priorities in selecting journals and forums for publications submission will be given to peer-reviewed journals as well as presentations and publications of abstracts at national and international scientific meetings.
 
II. General Considerations
 
A.     This document represents ACRIN’s overall publications policy and provides for some flexibility. 
        By way of definition, a publication is any document submitted to a professional journal listed 
        in the Index Medicus, any popular periodical, scientific meeting, or for publication as a book 
        chapter.
B.     Publication of ACRIN data undertaken without conforming to these policies is not permitted 
        without prior written consent from the ACRIN Steering Committee.
C.     None of the rules contained herein should be allowed to contravene the principles that: all  
        individuals who have made substantial intellectual, scientific and practical contributions to 
        the trial and the manuscript should, where possible, be credited as authors; all individuals 
        credited as authors should deserve that designation. It is the responsibility of each ACRIN 
        trial principal investigator, the Publications Committee and, ultimately, the Steering Committee
        to ensure that these principles are upheld.
D.     All manuscripts resulting from ACRIN trials should be published in peer review journals.
E.     In all cases where journal policies permit, all investigators who contribute patients to the trial
        will be acknowledged.
F.     The status of manuscripts in preparation will be reviewed at each ACRIN meeting.
 
III. The Role and Responsibilities of the Publications Committee
 
A.     Promote, facilitate, and monitor the timeliness of publication of ACRIN trial results.
B.     Propose policy guidelines for authorship of publications. Update guidelines as necessary.
C.     Assure compliance with ACRIN’s publication policies.
D.     Establish standards of excellence for publications.
E.     Adjudicate authorship when necessary.
F.     Provide peer review of the science of abstracts and papers.
G.     Review, edit, and approve all publications and presentations prior to submission, enlisting the
        special assistance of ACRIN committee members whenever appropriate. Reviews will be 
        conducted pursuant to the following general editorial responsibilities:

  • Ensure that all ACRIN publications preserve the scientific integrity of the study.
  • Correct factual and conceptual inaccuracies, if necessary.
  • Safeguard the rights of volunteer participants.
  • Prepare comments to assist collaborating scientists in publishing papers of the highest quality and clarity.     
  • Avoid conflict with and/or duplication of other publications.

H.     Review, suggest necessary revisions, and approve any publications arising from approved 
        ancillary studies prior to their submission for publication. In addition to issues cited in the 
        editorial policy above, proposed publications of studies will be scrutinized to ensure that their 
        presentation or publication will not threaten the presentation/publication of results from the 
        primary study.
I.      Adjudicate disputes involving publications issues.
J.      Recommend policy and procedures for review and approval of all communications (written 
        and spoken) regarding ACRIN trials’ outcomes to outside groups.
K.     Facilitate public dissemination of the study.
L.     ACRIN headquarters will maintain an up-to-date bibliography and repository of all 
        publications and presentations pertaining to ACRIN studies. It is the responsibility of the lead 
        authors to provide ACRIN with the most up-to-date version of any publications. ACRIN 
        headquarters will be responsible for providing any related documentation to the National 
        Cancer Institute (NCI).
M.    Exceptions to the publications rules for manuscripts, abstracts, and oral presentations maY
        be recommended by the Publications Committee and approved by the Steering Committee.
 
IV. Standards of Excellence
 
A.    If, in the opinion of the Publications Committee, there is no member who has sufficient 
       scientific background to review the pertinent material, then outside expert consultants will be 
       selected by the Publications Committee and asked to critique the material.
B.    For major publications and presentations, the completeness or adequacy of reports may be
       assessed by the following criteria: 

  • Purpose of the report should be clearly stated. 
  • Rationale for selection of the population inclusion and exclusion criteria should be explicitly delineated.
  • Information should be presented on the loss of subjects during the study including reasons for loss to follow-up. 
  • Data should be presented to demonstrate comparability of the subjects who participated and who exited from each study group.
  • Statement should be made regarding the effects to achieve masking to defend against the introduction of bias.
  • The report should detail statistical tests employed.
  • The authors should provide the pertinent results as well as the estimated range of treatment effects (i.e., use of confidence intervals in reporting results).
  • There should be notation of the power to assure the reader of the strength of the conclusion, especially if a negative conclusion is reached. 
  • Significance testing should be used in conjunction with an empirical review of the data.

V. Publication of Primary, and Secondary Study Aims and ACRIN-supported Ancillary Studies
 
A. Manuscript Preparation

1.  All ACRIN manuscripts should acknowledge in the title of the paper that this is a group effort
     of the American College of Radiology Imaging Network (ACRIN).
2.  Each cover page should acknowledge the funding support of the National Cancer Institute 
     through the grants U01 CA079778 and U01 CA080098. In addition, each publication will 
     include other notices as are required by sponsors providing funding for the protocol(s) 
     discussed in the publication and any disclaimers required by the sponsor or ACRIN.
3.  Evaluation of the protocol records necessary for final analysis will begin when approximately 
     80% of the data have been collected, or if early termination of a trial is deemed appropriate.   
     The study statistician and support staff will perform this review. The study statistician will notify
     the trial PI(s) when the data are sufficiently mature to warrant generation of a publication.
4.  The trial PI(s) will work with the study statistician and other members of the protocol team to
     identify potential scientific papers related to both the study’s primary and secondary aims, 
     establish writing teams and manuscript authorship, and prioritize manuscript development. It is
     highly recommended that a list of anticipated manuscripts, lead authors and expected dates for 
     manuscript completion and journal submissions be sent to ACRIN publications shortly before the
     study data are ready for analysis at publications@acrin.org.
5.  The study statistician and lead author(s) agree on the data that are required for writing the 
     manuscript, and the statistician provides a projected date for data availability.
6.  The PI(s) will write the scientific manuscript related to the study’s primary aims as lead 
     author(s). Alternatively, the trial PI may nominate to the Publications Committee a substitute for
     consideration as lead author. The lead author will be responsible for assuring production of the 
     draft of the paper within three months of availability of the data. This time period should allow 
     for review and comment of the draft by all co-authors and input from other members of the trial 
     team. Following revisions, the trial PI(s) will submit the final manuscript to the Publications 
     Committee per section V.B.
7.  For protocols that have secondary research aims, investigators other than the trial PI may be 
     assigned lead authorship of manuscripts either by or in consultation with the PI(s). These 
     investigators frequently will be members of the protocol team who have made substantial 
     workload and intellectual contributions to the development and implementation of the protocol’s
     secondary aims.
8.  Authorship arrangements should be discussed at the time the secondary aims are established.
     Investigators who accept lead authorship of manuscripts related to secondary aims will be 
     expected to produce a manuscript of publishable quality following the same principles outlined 
     above in sections V.A.4 and V.A.5.
9.  ACRIN sites may publish study data collected by their institution after publication of the study’s 
     primary aim manuscript, provided that 1) the site’s publication does not conflict with the study’s secondary 
     aims as outlined in the protocol and 2) the site agrees to submit planned publication to ACRIN for review and 
     comment.

 
B. Manuscript Review Process

1.   Concurrent to submission to the Publications Committee, all manuscripts must be sent to the network
      chair, network statistician, and relevant scientific committee chair. The writing team works to incorporate
      recommendations, if any, into the manuscript. 
2.   The lead author gathers approval of the manuscript’s final draft from writing team members, 
      completes the Manuscript Review Form located on ACRIN’s Web site at www.acrin.org , and e-
      mails the form and the manuscript to publications@acrin.org  for review by the Publications 
      Committee.
3.   The Publications Committee chair assigns appropriate members from the committee (or, when 
      necessary, from outside the committee) to conduct the final review prior to submission for 
      publication. Within two weeks of manuscript receipt, members of the Publications Committee
      review the manuscript and return comments to the Publications Committee chair who forwards 
      results of the review to ACRIN publications at publications@acrin.org e-mail for dissemination 
      to the lead author and members of the writing team.
4.   Final manuscripts for some trials may necessitate review by a specific manufacturer, company 
      or collaborator based on prior written agreements. It will be the responsibility of the trial PI(s) 
      to be aware of such arrangements and to comply with them. ACRIN publications should be 
      notified of all necessary external reviews via e-mail at publications@acrin.org .
5.   Approval for publication or presentation of study results related to secondary aims that may 
      jeopardize the outcome of a primary ACRIN trial, or preempt the publication of the primary aim 
      results, may be withheld until such time as is deemed appropriate by the Publications 
      Committee.
6.   Consistent with the ACRIN Data Access Policy, manuscripts developed from ACRIN data requests must be
      submitted to the ACRIN Data Access Committee (DAC) one month prior to journal submission for review to
      ensure representations related to ACRIN are accurate. Feedback to investigators is non-binding; however,
      investigators publishing manuscripts that appear to misinterpret ACRIN data risk the submission of
      commentary or letter to the editor by ACRIN.  For more information on the ACRIN Data Sharing program,
      visit:  
http://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx.

C. Manuscript Submission and Follow up

1.   Within six weeks of receipt of the Publications Committee review comments, the lead author 
      submits the manuscript to a peer-reviewed journal. Prior to submitting the manuscript to a 
      journal, the lead author is responsible for: 

  • Finalizing the manuscript (with the writing team).
  • Receiving approval of the final manuscript from each member of the writing team.
  • Completing the Manuscript Submission Form located on the ACRIN Web site at www.acrin.org.
  • E-mailing the Manuscript Submission Form and final manuscript to publications@acrin.org with copy to the writing team. 

 2.   Manuscripts must be completed and submitted within a reasonable period of time following 
       the writing directive. 

  • If, after a period of three months following completion of data analysis, the draft is not substantially complete, the Steering Committee in consultation with the Publications Committee reserves the right to make other arrangements to ensure timely publication.
  • If a satisfactory manuscript is not produced within the allotted time frame, the Steering Committee or Publications Committee may reassign the manuscript. 
  • The Publications Committee may grant an extension when it is deemed necessary. 

 3.   Following submission to a journal, the lead author is responsible for: 

  • Keeping both ACRIN publications and the writing team informed regarding status of journal review. All updates should be sent via e-mail to: publications@acrin.org with copy to the writing team. 
  • Forwarding copies of the journal reviewers’ response to all members of the writing team and ACRIN publications (publications@acrin.org). 
  • Should a manuscript not be accepted, the author informs ACRIN publications and, most often, requests a teleconference call be scheduled with the writing team to determine plans for revising and/or resubmitting the manuscript. 
  • Manuscripts to be resubmitted or submitted to another journal must follow section V.C of the publications policy. 
  • Following acceptance of a manuscript, the lead author is responsible for forwarding galleys of the final manuscript to ACRIN publications at publications@acrin.org with copy to the writing team. The ACRIN Biostatistics Center member of the writing team must approve galleys before he lead author returns them to the journal.  

4.   In compliance with NCI guidelines, ACRIN publications will forward the final accepted version of 
      the manuscript to the NCI program director prior to journal publication.
5.   For all publications resulting from research funded by the National Institutes of Health (NIH), 
      lead authors will coordinate with ACRIN publications to follow the NIH requirements for making 
      the publication available through the NIH National Library of Medicine's (NLM) PubMed Central 
      (PMC) within 12 months of the manuscript publication date. Information about PMC can be 
      found at: http://publicaccess.nih.gov/ .  
6.   Copies of the reprinted article will be sent to ACRIN publications and each co-author. Requests
      for copies of manuscripts will not be considered until the manuscript is in press. 

D. Authorship

1.   Investigators will be offered the opportunity to publish as a group or with recognition of 
      individual authors. This decision should be made before the activation of a trial.
2.   Membership and authorship representation for any trial resides with the participant institution.
      a.   When an investigator leaves an institution, it is up to the site PI to assign someone to the
            authorship spot allocated for that institution.
      b.   If a site PI leaves an institution, he/she maintains his/her authorship rights with the 
            permission of the trial team, provided he/she has accrued patients to the study and 
            continues to work with the trial team.
 
In situations where papers will have individual authors, the following rules will apply:
 
3.   Members of the trial team (normally the trial PI(s) and up to three representatives from 
      organ/modalities involved in the trial) will be entitled to authorship provided they have 
      contributed patients to the trial. Principal authors of primary manuscripts of ACRIN trials will 
      also include the trial biostatistician(s).
      a.   Ordinarily, ACRIN will embrace the custom of placing the biostatistician after the lead
           author(s) of primary manuscripts.
      b.   However, the order of the author list may be adjusted as appropriate for each manuscript.
      c.   The lead author must have contributed at least 5% of the eligible cases to the study.
4.   Additional authors will be identified from institutions who have accrued "substantial" numbers 
      of patients to the study and who have met quality standards for data submission, as well as 
      other contributions.
      a.   A representative from each institution contributing the largest number of cases deemed of 
            sufficient quality to be included in the analysis will participate as co-author. 
      b.   For smaller scale (or Phase II) studies, this will be limited to 2-3 institutions, but expanded 
            to encompass 25% of the evaluable entries for larger studies. 
      c.   In general, "substantial" will be defined as at least 5% of accrual, and between 5% - 10% 
            for smaller scale studies. The exact criterion for a given trial will depend on: 

  • The total number of authors (see criterion below) .
  • The pattern of accrual by center for the trial (e.g., there may be an obvious cutoff).

      d.   Only one author per institution per paper will be allowed unless a second individual made a
            major contribution to the ACRIN study or the institution of the first author entered at least 
            25% of all analyzable cases.
      e.   Institutions contributing greater than 50% of cases that qualify for analysis will be 
            permitted a total of three authors.
      f.    A maximum of ten authors will be allowed for a small (100 patients or less study), or a 
            maximum of 15 authors for a large (>100 patients) study.
                                                                                            
5.   An institution must meet ACRIN quality standards for continuing institutional participation for 
      the investigator to qualify for authorship.
6.   The principal investigator at a qualifying institution will ordinarily be the author but may defer 
      authorship to another investigator at his/her site.
7.   If a statistician, reviewing pathologist or other scientist has made substantial contribution to a 
      study, he/she should be listed as a co-author.
8.   Additional authors may be named from the ACRIN Biostatistics Center based on specific 
      contributions.
9.   Each author is responsible for obtaining any appropriate clearances at his or her institution.
10. Every paper must include an appendix or table of all contributors to the study.
11. Disputes about authorship, which cannot be resolved by the protocol team, will be referred to 
      the Publications Committee.
12. Authorship of Correlative Projects and Secondary Studies
      a.   Authorship of manuscripts resulting from these secondary analyses of ACRIN data will be
            afforded to the investigators who are involved in the research, have the highest patient 
            accrual of analyzable cases, and have an appropriate ACRIN statistical representative (as 
            described above).
      b.   Authorship of manuscripts from secondary projects will be determined based on a variety of
            parameters, including overall workload contribution, intellectual contribution, and 
            participant accrual. Tentative arrangements regarding authorship should be discussed at 
            the time of initial approvals.
     c.    In addition to manuscripts reporting the clinical trial results, there also may be 
            methodological papers utilizing ACRIN data.

  • A charge of the Biostatistics Center is to develop methods for diagnostic test evaluation. Similarly, methodological work may be done by representatives of the ACRIN Outcomes and Economics Committee or by economists. Normally, the authors of such papers would be the methodologists who developed the particular techniques with other authors included only if they contributed intellectually to the paper. For instance, if data from a particular study are used in a methodological study, this does not automatically entitle the members of the protocol team to co-authorship. 

VI. Abstracts and Posters
 
A.  Abstracts reporting the preliminary or highlighted results of ACRIN studies will not negate the 
     necessity of preparing a full manuscript for publication.
B.  A member of the trial team may propose submission of an abstract or poster. Persons not on a
     trial team who have contributed to protocol development or implementation, or to other ACRIN
     research activities, also are invited to submit a proposal.
C.  The trial team and the Publications Committee must approve the concept and general content 
     of the abstract. Guidelines for abstracts and authorship will generally follow those established
     for manuscripts.
D.  Requests for data for the abstract should be made to the Biostatistics Center early to allow for
     delivery of the data requested—at least 60 days, unless otherwise negotiated with the 
     statistician.
E.  All ACRIN abstracts should acknowledge the American College of Radiology Imaging Network 
     (ACRIN) in the abstract title. The abstract also should acknowledge the funding support of the 
     National Cancer Institute through the grants U01 CA079778 and U01 CA080098. In addition, 
     each publication will include other notices as are required by
     sponsors providing funding for the protocol(s) discussed in the publication and any disclaimers 
     required by the sponsor or ACRIN.
F.  The author completes the Abstract Review Form located on ACRIN’s Web site at www.acrin.org, 
     and e-mails the form and the abstract or poster for review to the Publications Committee at 
     publications@acrin.org
G.  The Publications Committee must receive an abstract proposed for submission to a scientific
     meeting at least 14 days prior to the scientific society's deadline for receipt of abstracts to 
     provide time for review and possible revision, unless otherwise negotiated.
H.  Within two weeks of manuscript receipt, members of the Publications Committee review the 
     abstract and return comments to the Publications Committee chair who forwards results of the 
     review to ACRIN publications at publications@acrin.org e-mail for dissemination to the lead 
     author and members of the writing team.
I.   The author makes revisions, submits the abstract, and notifies the Publications Committee via 
     the publications@acrin.org e-mail about the abstract’s acceptance status.
J.   An abstract approved for submission is only approved for a particular meeting. If it is rejected 
     and the author wants to resubmit it to an alternative meeting, it must be treated as a new, 
     separate request.
K.  Unauthorized or premature disclosure of data is prohibited. Reproduction or reprinting of ACRIN
     data by journals without permission from ACRIN is prohibited. 
 
VII. Invited Presentations
 
A.    A presentation is the delivery of information to scientific, professional or public groups, such 
       that public dissemination might ensue through publications, press releases, and so forth.
B.    If persons who participate in ACRIN research activities are invited to present ACRIN data, or to
       represent ACRIN, the nature of the invitation must recorded on the “Abstract Review Form” 
       found at www.acrin.org and sent via e-mail to the Publications Committee at 
       publications@acrin.org.  
C.    The Publications Committee reserves the right to accept, not accept, or to suggest an 
       alternative ACRIN representative.
D.    Invited presentations requiring the submission of a manuscript or abstract involving previously
       unpublished ACRIN data cannot be accepted.
E.    ACRIN presentations must be limited to substantive information available either in the final 
       protocol or other published data, with no added interpretations or inferences. 
 
VIII. Intergroup Studies
 
A.     No universally accepted publication policy for inter-group studies currently exists. Prior to the 
        initiation of an inter-group study, members of the protocol team will negotiate in writing 
        various aspects of inter-group study conduct. One of these will be a Publications Policy. While 
        this will vary from situation to situation, the essential policy will be:
1.     Lead author(s) will be the trial PI(s). 
2.     The appropriate representative of the biostatistics center of the Cooperative Group  
        responsible for data management and analysis will be an author.
3.     Institutional authorship will be awarded to Cooperative Groups in a manner proportional to 
        case entry.
4.     While the manuscript preparation will proceed according to the policies of the responsible 
        Cooperative Group, the publications committees of each of the Cooperative Groups will 
        monitor progress and each committee prior to submission should approve the final draft.
 
IX.   Publicity, Press Releases and Interviews
 
A.    A press release is defined as a document given to radio, television, newspapers, popular 
       periodicals, or scientific journals not indexed by Index Medicus. An interview is any discussion 
       with a member of the press, a science writer, or a radio or television commentator, which in 
       turn provides information for public dissemination.
B.    Press releases and interviews should not be initiated by participating study sites or the 
       institution at which the PI resides.
C.    Any ACRIN investigator who plans to have a press release on any aspect of ACRIN research 
       activities must clear the release with ACRIN headquarters and the ACRIN Biostatistics Center.
D.    ACRIN headquarters and the ACRIN Biostatistics Center will develop press releases to be  
       distributed by ACRIN headquarters to the participating studying sites. It is suggested that 
       these prepared releases be given to the media when interviews are requested. This 
       procedure will help ensure uniformity and accuracy in the information distributed through the 
       media.
E.    Should a participating study site be solicited for information other than that detailed above, 
       the site should refer the soliciting party to ACRIN headquarters.

X.  Conflict of Interest Policy
 
ACRIN investigators must adhere to the ACRIN conflict of interest policy.  
 

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