Publication policy

This section contains the following:

Introduction
Things to consider when writing a protocol
Illustrative examples - Perinatal care trial
Illustrative examples - WHO pre-eclampsia trial
Additional resources
Further reading

Introduction

The policy for publication of both interim reports and final scientific papers should be clarified and documented in the trial protocol. No publications, either in writing or orally, should be made before the definitive manuscript has been agreed and accepted for publication, without the prior approval of the Trial Steering Group (see Trial Management). It is common practice to set up a sub-group of the Trial Steering Group as a ‘Writing Committee’. Both interim and final reports are then reviewed/approved by the full Trial Steering Group.

Arrangements for authorship should be agreed and documented in the protocol. Many large trials have group authorship with a list of contributors at the end of the paper, giving details of who did what in the stages of the trial, eg. the Trial Steering Group, collaborating clinicians etc. and not forgetting the participants.

A common format for reporting randomised trials has now been widely adopted. This is known as the CONSORT statement and provides a checklist consisting of 21 items that relate mainly to the methods, results and discussion of a Randomised Control Trial report and includes key pieces of information necessary to evaluate the internal and external validity of the trial.

Things to consider when writing a protocol

Describe the policies and guidelines governing the publication of scientific and technical results from the trial.
Be sure the policy is designed to promote the scientific and technical accuracy of any publications and ensure that fair credit is given to the authors and to other individuals who have contributed to the trial.
Consider all types of publications including: papers submitted to electronic archives and refereed journals; scientific or technical books or book sections; conference presentations; conference proceedings papers; and theses.

Illustrative examples - CLAP trial
Publications and Presentations The review process and authorship for publications and presentations will follow the guidelines set forth in the Policy and Procedures Manual of the Global Network for Women’s and Children’s Health Research. Any submission for publication or for presentation at professional conferences must adhere to these principles. Review Process Prior to their submission or application for presentation, all manuscripts, posters or oral presentations, or other reports of the outcomes of this research effort must be approved by a majority of the members of the Site 1 Steering Committee. This committee’s membership includes (1) the Principal Investigator, (2) the Senior Foreign Investigator, (3) the NIH Project Officer, (4) a Senior Research Officer from the Data Center, (5) the Study Coordinator, and (6) the Statistician and Data Manager. Authorship The authorship of manuscripts, poster or oral presentations, or other reports of the results of this study will be guided by the criteria for authorship formulated by the International Committee of Medical Journal Editors and published in its Uniform Requirements for Manuscripts Submitted to Biomedical Journals (updated October, 2001; available at http://www.icmje.org). According to these criteria, the authors should meet the following criteria. Each author should have participated sufficiently in the work to take public responsibility for the content. Authorship credit should be based only on substantial contributions to (a) conception and design, or analysis and interpretation of data; and to (b) drafting the article or revising it critically for important intellectual content; and on (c) final approval of the version to be published. Conditions (a), (b), and (c) must all be met. As a multicenter study, up to 12 authors, as permitted by journals such as the New England Journal of Medicine and the American Journal of Obstetrics and Gynecology, may be identified for a given manuscript, but only those authors fulfilling the criteria above are eligible. As a general, but not absolute, rule, at least one individual from the NIH, one individual from the Data Center, the U.S. Principal Investigator, and the Senior Foreign Investigator will be authors for all publications that result from this research. All publications, posters, oral presentations at scientific meetings, seminars, and any other forum in which results of this NICHD-supported research are presented will include a formal acknowledgement of NICHD support, citing the NIH grant number as identified on the award document. (CLAP Trial - go to protocol)

Illustrative examples - CLAP trial

Publications and Presentations
The review process and authorship for publications and presentations will follow the guidelines set forth in the Policy and Procedures Manual of the Global Network for Women’s and Children’s Health Research. Any submission for publication or for presentation at professional conferences must adhere to these principles.

Review Process
Prior to their submission or application for presentation, all manuscripts, posters or oral presentations, or other reports of the outcomes of this research effort must be approved by a majority of the members of the Site 1 Steering Committee. This committee’s membership includes (1) the Principal Investigator, (2) the Senior Foreign Investigator, (3) the NIH Project Officer, (4) a Senior Research Officer from the Data Center, (5) the Study Coordinator, and (6) the Statistician and Data Manager.

Authorship
The authorship of manuscripts, poster or oral presentations, or other reports of the results of this study will be guided by the criteria for authorship formulated by the International Committee of Medical Journal Editors and published in its Uniform Requirements for Manuscripts Submitted to Biomedical Journals (updated October, 2001; available at http://www.icmje.org). According to these criteria, the authors should meet the following criteria.

Each author should have participated sufficiently in the work to take public responsibility for the content. Authorship credit should be based only on substantial contributions to (a) conception and design, or analysis and interpretation of data; and to (b) drafting the article or revising it critically for important intellectual content; and on (c) final approval of the version to be published. Conditions (a), (b), and (c) must all be met.

As a multicenter study, up to 12 authors, as permitted by journals such as the New England Journal of Medicine and the American Journal of Obstetrics and Gynecology, may be identified for a given manuscript, but only those authors fulfilling the criteria above are eligible. As a general, but not absolute, rule, at least one individual from the NIH, one individual from the Data Center, the U.S. Principal Investigator, and the Senior Foreign Investigator will be authors for all publications that result from this research.

All publications, posters, oral presentations at scientific meetings, seminars, and any other forum in which results of this NICHD-supported research are presented will include a formal acknowledgement of NICHD support, citing the NIH grant number as identified on the award document. (CLAP Trial - go to protocol)

Illustrative examples - WHO pre-eclampsia trial
Authorship for publications The Steering Committee has agreed to adopt the so-called "modified conventional form" to be used for the publications of the trial. This form includes attribution to the investigators that were primarily responsible for the trial followed by the name of the corporate research group: e.g. Ann A. Meyeis, Henry C. Brown, ....., for the WHO Calcium Supplementation during Pregnancy Trial Research Group. The list of investigators primarily responsible for the study will be prepared by the Steering Committee and should include only those actively involved in the preparation, organization, implementation of the trial as well as data analysis and manuscript preparation. 23 The order of authorship in individual papers will be decided by the Group. Credit will be given to the other participants of the trial such as associated staff at participating centers and key committee membership and will be listed at the end of the manuscript. Acknowledgements will be expressed in a footnote to the title or in a section following the credits. A WHO/HRP/RHR certificate of collaboration will be given to doctors, midwives, nurses and local staff who contributed to the trial but whose names do not appear in the main papers. This strategy has been used in previous trials and is highly appreciated by collaborators. There will be a Publications Sub-Committee of the Trial Steering Committee. This Sub-Committee will be responsible for: preparing a list of tentative publications reviewing all papers sent for publication reviewing and authorization of secondary analysis proposed certifying authorship of individual papers (WHO Multicentre Randomized Trial of Calcium Supplementation for the Prevention of Pre-eclampsia - go to protocol)

Illustrative examples - WHO pre-eclampsia trial

Authorship for publications
The Steering Committee has agreed to adopt the so-called "modified conventional form" to be used for the publications of the trial. This form includes attribution to the investigators that were primarily responsible for the trial followed by the name of the corporate research group: e.g. Ann A. Meyeis, Henry C. Brown, ....., for the WHO Calcium Supplementation during Pregnancy Trial Research Group.

The list of investigators primarily responsible for the study will be prepared by the Steering Committee and should include only those actively involved in the preparation, organization, implementation of the trial as well as data analysis and manuscript preparation.
23
The order of authorship in individual papers will be decided by the Group. Credit will be given to the other participants of the trial such as associated staff at participating centers and key committee membership and will be listed at the end of the manuscript. Acknowledgements will be expressed in a footnote to the title or in a section following the credits. A WHO/HRP/RHR certificate of collaboration will be given to doctors, midwives, nurses and local staff who contributed to the trial but whose names do not appear in the main papers. This strategy has been used in previous trials and is highly appreciated by collaborators.

There will be a Publications Sub-Committee of the Trial Steering Committee. This Sub-Committee will be responsible for:

preparing a list of tentative publications
reviewing all papers sent for publication
reviewing and authorization of secondary analysis proposed
certifying authorship of individual papers

(WHO Multicentre Randomized Trial of Calcium Supplementation for the Prevention of Pre-eclampsia - go to protocol)

Additional resources

The CONSORT Statement and a CONSORT diagram template

The CONSORT statement is an important research tool that takes an evidence-based approach to improve the quality of reports of randomized trials. The statement is available in six languages and has been endorsed by prominent medical journals such as The Lancet, Annals of Internal Medicine, and the Journal of the American Medical Association. Its critical value to researchers, health care providers, peer reviewers, and journal editors, and health policy makers is the guarantee of integrity in the reported results of research.

Analysis and interpretation checklist

This checklist was developed by Dave Sackett, who prepared it for the forthcoming 3rd edition of Clinical Epidemiology; A Basic Science for Answering Questions about Health Care, to be published by Lippincott, Williams & Wilkins in 2004.

How to write a paper in scientific journal style and format

This guide has been compiled, edited, and revised by Greg Anderson and is intended to provide general content, style, and format guidelines for students learning to write papers in a standard, scientific journal style and format that can be easily adapted to specific journal requirements or disciplinary conventions