MONICA Manual, Part I, Section 2: Organization and Management of the WHO MONICA Project
September 2004
After publication of the main results of the MONICA Project, a copy of the Basic Analysis Data Set of the MONICA Archive was distributed to the MONICA Collaborating Centres (MCC), and the Publication Rules were revisited. The Principal Investigators decided on new Publication Rules, which are given in this amendment. In May 2002 it was agreed that the MONICA Manual will no longer be revised but any changes will be included as amendments to the Manual. The old publication rules of Subsection 7 of Section 2 of Part I of the MONICA Manual, although of historical reference, will be superseded and are no longer valid after September 2004.
The MONICA publication policy is designed to encourage scientific publication of all types, while maintaining the high quality of these publications and ensuring the legitimate interests of all MONICA participants.
The policy covers:
The principles of the MONICA Publication Rules are:
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MONICA publications are coordinated by the Publication Coordinator PC (see http://www.ktl.fi/monica/public/msc.html).
No such publications can occur without the consent of each PI or his/her representative. As a general rule, consent should be received within 4 weeks; failure to reply within this time will be taken to mean consent (The 4-week rule starts from the date the document is e-mailed, faxed or posted). Presentations require only the approval of the MSC, but PIs or their representatives have to be informed of the content and location of the presentation prior to the date of the presentation.
The rules for these publications are described in detail in Section 7.2 below.
MONICA Centres are encouraged to present and publish results that are based on the data from their own centre(s), acknowledging data collection under the protocol and adherence to quality control of the WHO MONICA Project. It is advisable that proposers keep all MCCs whose data are to be used informed about the proposal and involve them as much as feasible. Publications that refer to the WHO MONICA Project in the title should be approved by the MSC before publication.
If the publications are based on MONICA data not in the public domain they have to include the statement:
"The data have been collected by the WHO MONICA investigators (for list see http://www.ktl.fi/publications/monica/investigators.htm) and have been made available for this publication by the WHO MONICA Project. Views expressed in this paper are those of the authors and may not reflect those of individual WHO MONICA Principal Investigators".
Anybody with approved access to the WHO MONICA database can propose MONICA collaborative publications (the Proposer). Before preparation of the manuscript, approval should be sought from the MSC, by submitting a proposal to the PC, including the Publication Proposal Form (Form SA) as a cover sheet, giving outline, target journal and time schedule, and whenever possible suggested authors. The list of authors must end with the term ", for the WHO MONICA Project".
The PC assesses the appropriateness of the proposal, possibly with the help of reviewers of his choice. The PC advises the MSC that decides whether the proposed paper should be accepted as a MONICA Collaborative Publication. If the MSC does not reply within 7 days, it is assumed that the proposal of the PC is accepted. The PC informs the Proposer of the decision and the KTL contact person updates the MONICA Publication Plan (see Section 7.5) as appropriate.
MCCs will be informed of the proposed manuscript through e-mail. The note to the MCCs will include the following statement:
"It is hoped that data from as many populations as possible can be included in the analysis. However, if you want to exclude your data from the analysis, please inform the PC and the Proposer within 28 days of receiving this message."
The PC will monitor the progress of the manuscript development. If no noticeable progress is made within four months, he/she will inform the Proposer that the approval for the proposal will be withdrawn and the entry in the Publication Plan will be deleted. MCCs will be informed of the deletion through e-mail.
It is the responsibility of the Proposer to assemble a group of potential authors that represent the necessary expertise and are prepared to devote the required effort for a successful and timely completion of the proposed manuscript. The group of authors will select a lead author. As much as possible, MCCs should be given an opportunity to participate in the writing groups. Authors must be significant contributors to design of the paper, data preparation, analysis and/or writing. They should be consulted by the lead author at key stages in the manuscript's development and should have seen and approved the final draft before it is submitted to the PC. In the eyes of journal editors they are responsible and answerable for the accuracy of the data and conclusions contained in the manuscript.
Such publications appear with the authorship statement as follows:
Name(s) of author(s), for the WHO MONICA Project (1),
Title:................................
Text:.................................
Whenever the publication rules of the target journal allow it, the following format should be used for footnote (1):
(1) Annex: Sites and key personnel for the WHO MONICA Project.
The Annex includes:
The list is drafted by the authors and corrected when necessary by the PIs at the same time as they approve the manuscript.
If the publication rules of the target journal preclude the use of the full Annex, an alternative format of footnote (1) is:
(1) For participants in the WHO MONICA Project see http://www.ktl.fi/monica/...
The hyperlink points to the list of MCCs and key personnel, MSC, MMC, MQS, and consultants relevant to the manuscript. The exact URL should be requested from the KTL contact person, and he should be provided with the list.
Collaborative papers should be cited as specified in Section 7.4 below.
Papers should include the following disclaimer:
"This publication was approved by the MONICA centres whose data were used. However, the views expressed in this paper are those of the authors and may not reflect the views of individual WHO MONICA investigators."
The publication has to include the following acknowledgement statement:
"The MONICA Centres were funded by regional and national governments, research councils, charities, and other local sources. Central coordination was the responsibility of the World Health Organization (WHO), assisted by the MONICA Data Centre (MDC) at the National Public Health Institute (KTL) in Helsinki. Initial funding for the MDC came from WHO, KTL, and NHLBI (USA) and later from two BIOMED grants from the European Commission. The latter supported completion of the project, along with grants from pharmaceutical companies and medical charities."
The acknowledgement paragraph may have added to it the names of internal MONICA reviewers who have made what is judged to be substantial contributions in the reviewing process. This can be agreed by the lead author and the PC prior to submission to a journal.
On completion, the manuscript is sent to the PC who sends it to three internal reviewers, at least one of them should be a statistician. The reviewers of MONICA manuscripts will be chosen among PIs and staff members as well as among scientists outside MCCs who have proven specific knowledge in the field. The PC informs the MSC about the manuscript and the reviewers. The MSC may appoint additional reviewers within 7 days.
The internal reviewers consider the appropriateness of the manuscript for publication and report back to the PC within 3 weeks. Reviewers should comment on:
On the basis of the internal reviews, the PC either returns the manuscript for revision to the authors or sends it with the reviewers' reports to the MSC.
In special cases the MSC may decide on a review process different from the one described above, if it can be expected to streamline the publication process.
The MSC considers whether the manuscript qualifies for distribution to the MCCs for approval. If the manuscript is not acceptable, the MSC decides on how to proceed further. If the MSC does not reply within 7 days, it is assumed that the proposal of the PC is accepted.
The representative of KTL distributes the manuscript to the MCCs and relevant MQCs.
The MCCs (PIs) approve the manuscript for publication on the internal MONICA website and/or send their comments to the PC or the person(s) specified in the covering letter of the manuscript. This must be forthcoming within four weeks, and if no response is obtained the publication will proceed.
Any minor modifications suggested by the MCCs should be made to the manuscript before submission. After approval, the manuscript will be submitted for publication. If a MCC refuses approval, the MSC will attempt to mediate.
The authors should agree among themselves as to who will be responsible for submitting the paper to the agreed journal, for dealing with reviewers/editorial comments, and for checking the proofs. The decision on responsibility should be communicated to the PC.
The letter to the editor on submission should include this section displayed prominently, with the accompanying statement on a separate sheet:
Please Note: WHO MONICA Project manuscripts are prepared and submitted according to collaborative project rules on authorship and citation. Journal editorial staff should be aware of, and honour these rules when considering and preparing such manuscripts for publication. Please see the accompanying statement.
Accompanying Statement.
WHO MONICA Project collaborative rules on authorship and citation
The WHO MONICA Project Principal Investigators, who own the MONICA data, have developed over many years a policy on authorship and citation in the preparation and publication of manuscripts that they ask journal editorial staff to honour. This policy is designed to give appropriate recognition both to the collaborative enterprise and constituent centres, and to those identified as primarily responsible for preparing a particular manuscript and therefore answerable for its validity. These rules comply with current international requirements on authorship for publication and citation. They have been followed in our major publications by many prestigious journals (eg Lancet, Circulation). Journals in the past that deviated had to make changes in proof, or to publish corrections with apologies. It is for this reason that we bring these rules to your attention.
Submission of this manuscript by the manuscript leader is authorized by the WHO MONICA Project on the understanding that these rules will be honoured by the journal to which it is submitted.
The publication rules cover three specific items
- The authorship line, as in the accompanying manuscript:
"A Author, B Author, C Author,(etc), for the WHO MONICA Project."- Citation of authorship of previous MONICA publications, as in the accompanying manuscript:
"Author A, Author B, Author C, (etc), for the WHO MONICA Project."- Publication of a list of MONICA sites and key personnel as an annex to the paper.
Format and print size are obviously at the discretion of the journal. Items 1 and 2 are essential to all collaborative papers, and 3 to major publications. 3 is subject to compromise for short papers or families of papers when reference to a related issue or a web-based annex may be agreed for MONICA. If a journal has a specific problem with any aspect of MONICA publication policy the manuscript leader will need to involve the MONICA Publications Coordinator and the Steering Committee. We trust that most journals agree that the above rules are reasonable and that they enhance rather than detract from the publication of our manuscripts. These rules have been admired and copied by colleagues involved in other similar large collaborative studies.
If a journal requires assignment of royalties, KTL should usually be specified. KTL will ensure that such royalties will be applied to coordination of MONICA publications and data activities without charging overhead. In such a case, the representative of KTL and the PC should be contacted for further instructions.
Anything other than minor corrections arising from the editorial-review process should be discussed with other authors and with the PC. Whoever is responsible for the proofs must inform the PC immediately on receipt of the proofs if there is any problem with the journal carrying out MONICA publication policy on authorship and citations, so that they can agree how to take the matter up with the journal editor.
If the manuscript has been accepted for publication its reference will be published on the MONICA website http://www.ktl.fi/monica by the representative of KTL.
Abstracts intended for oral/poster presentation and based on MONICA collaborative data will be sent to the PC who will distribute them to the MSC. Abstracts will be approved solely by the MSC, the only exception being when specific MCCs are mentioned in the abstract, in which case explicit permission will be sought from the MCCs concerned by the presenter and evidence of this furnished to the PC. Failure to reply within 4 weeks by the MCCs concerned will be taken as consent. The MSC makes its decision within two weeks after receiving the abstract and the PC informs the presenter. Presenters will inform the PC if an abstract has been accepted for presentation and the KTL representative will distribute the abstract to all MCCs and MQCs prior to presentation.
In addition to the above, no person invited to speak "on behalf of the WHO MONICA Project" should do so without prior approval of the MSC. If an abstract is required, the person invited should follow the rules for oral presentations. Otherwise, the MSC should be informed about the source of the invitation. If the MSC gives approval, the PC will inform the person invited who should then proceed with the presentation but must send a summary to the KTL representative for distribution to the MCCs and MQCs.
All the above rules apply, except that only PIs from MCCs participating in stroke registration have to give their consent for publications involving stroke.
see Amendment 1: Management of the MONICA Project, section 3
The MCCs have been provided with a MONICA Archive CD-ROM of the collaborative data (Version: 29 August 2003).
Terms and modality to be decided by MSC.
In order to assure accurate listing of MONICA publications in citation indices collaborative MONICA publications must be cited in the following format in both local and collaborative MONICA publications. This format should be applied both to recent and to older papers published using earlier MONICA authorship formats. All in MONICA should encourage colleagues who quote MONICA papers to cite them in the same way when they are asked to comment on or to referee papers.
Examples of citations according to MONICA publication rules:
Stewart AW, Kuulasmaa K, Beaglehole R, for the WHO MONICA Project.
Ecological analysis of the association between mortality and major risk
factors of cardiovascular disease. Int J Epidemiol 1994;23:505-16.
Stewart AW, Kuulasmaa K, Beaglehole R, for the WHO MONICA Project (1994). Ecological analysis of the association between mortality and major risk factors of cardiovascular disease. Int J Epidemiol, 23, 505-16.
If the editor tries to change this format in the proofs, the author should change it back and inform the journal that this is the WHO MONICA Project format.
The MONICA Publication Plan outlines all MONICA collaborative Agreed Publications and reports arising from checking, quality assessment, and analysis of the collaborative MONICA data. For each of the component data sets it describes the anticipated progression from compilation of data books to generation of quality assessment reports and the drafting of papers for publication in scientific journals. For each subject, there is, in general, a series of reports relating to baseline, mid-term and final results.
For each Agreed Publication and report, the Publication Plan identifies the Proposer, other suggested authors, target journal or a mention that it will be an internal report of the project, and the current status.
The representative of KTL on the MSC, in consultation with the PC, maintains the Publication Plan. The Plan is available in the internal MONICA site in the World Wide Web (http://www.ktl.fi/monica/internal/publ/pplan/).