ICMJE GuidelinesYvonne Yarker, PhD

Thomson Scientific Connexions

January 11, 2006

What is the ICMJE?

International Committee of Medical Journal Editors• Group of editors representing 12 international medical

journals• Includes major biomedical journals: Ann Intern Med, BMJ,

JAMA, NEJM, LancetArose from the Vancouver Group

• Small group of medical journal editors who met in 1978• Aimed to establish guidelines for format of manuscripts

submitted to their journals• These requirements published in 1979, including reference

format (vs ‘Harvard’ format)• Expanded and evolved into the current ICMJE

Membership• By invitation only• Differs from WAME, CSE

Main Purpose

Developed ‘Uniform Requirements for Manuscripts Submitted toBiomedical Journals’

• Guidelines to help authors and journal editors create anddistribute accurate, clear, easily accessible reports ofbiomedical studies

• Standardize format for biomedical manuscriptsNow widely adopted

• >600 journals worldwide conform to ‘Uniform Requirements’• Foreign language journals (China, Saudi Arabia, Chile, India)• Organizations – US NLM, WHO journals, AMWA• Multiple biomedical topics – undersea research, military

medicineBroadened its scope to include ethical principles relating topublishing in biomedical journals

Uniform Requirements

Multiple versions and editions of these guidelines:• 1979: first published• 1997, 2003: entire document revised and reorganized• Oct 2005: current version, incorporating statements re:

clinical trials registrationContents

• Initial sections: ethical principles relating to evaluating andpublishing manuscripts in biomedical journals; relationshipsbetween editors and authors, peer reviewers, and media

• Later sections: technical aspects of preparing and submittingmanuscripts

Entire document available at www.icmje.org• May be printed, copied, and distributed without charge for

not-for-profit, educational purposes• No permission needed to reprint or translate

Current Version (Oct 2005)

I. Statement of PurposeII. Ethical Considerations in the Conduct and Reporting ofResearchIII. Publishing and Editorial Issues Related to Publication InBiomedical JournalsIV. Manuscript Preparation and SubmissionV. ReferencesVI. About the International Committee of Medical Journal EditorsVII. Authors of the Uniform RequirementsVIII. Use, Distribution, and Translation of the UniformRequirementsIX. Inquiries

II. Ethical Considerations

Authorship and Contributorship• Who qualifies as an author vs a contributor

Editorship• Journal editor’s rights and duties vs journal owners

Peer Review• Disclosure of journal’s policy

Conflicts of Interest• Author (or institution), reviewer, or editor• Financial or personal relationships that may inappropriately

influence/bias their actionsPrivacy and Confidentiality

• Patient’s right to privacy; informed consent• Author’s and reviewer’s right to confidentiality

Protection of Human Subjects and Animals in Research• Declaration of Helsinki

III. Publishing and Editorial Issues (1)

Obligation to Publish Negative Studies• Should seriously consider• Failure to submit or publish → publication bias

Corrections, Retractions and "Expressions of Concern"• Errors, corrections, fraud

Copyright• State ownership clearly; open access journals

Overlapping Publications• Duplicate submissions, redundant publications• Competing manuscripts

Correspondence• Provide a means for comments, questions, criticisms• Allow a range of opinions

III. Publishing and Editorial Issues (2)

Supplements, Theme Issues, and Special Series• Policies to avoid bias; external peer review• Editing by the funding organization should not be permitted• Journal editor to approve external suppl editor• Multisponsoring encouragedElectronic Publishing• Issues/policies unique to electronic publishing• Archiving and removal of articlesAdvertising• Policies for print and electronic advertisingMedical Journals and the General Media• Embargo system• Assisting general media with accurate reportsObligation to Register Clinical Trials• Will consider a trial for publication only if registered

before enrollment of first patient

IIII. Manuscript Preparation andSubmission

Preparing a Manuscript for Submission to a BiomedicalJournal• RCTs: CONSORT statement (Consolidated Standards of

Reporting Trials); checklist; flow diagramwww.consort-statement.org

• Other CONSORT guidelines (eg, QUORUM for systematicreviews)

• Format, style, presentation• Structure; requirements for each section• Figures, tables, referencesSubmitting a Manuscript to a Journal• Paper or online; requirements for ‘submission package’• Cover letter content• CONSORT checklist

Related Guidelines

Various other sources of guidelines relating to development andpublication of biomedical literature

• CONSORT• COPE: Committee On Publication Ethics

– Editors of peer-reviewed biomedical journals who discuss issues relating to ethics and integrity

– Membership represents ~350 journals– UK-based (BMJ Publishing Group)– 2003 Guidelines on Good Publication Practice– www.publicationethics.org.uk

• GPP: Good Publications Practice for Pharma Companies– 2003 Guidelines to increase transparency of

processes involved in publication of pharma industry-sponsored trials and to establish manuscript development standards

– www.gpp-guidelines.org

How to Use ‘UniformRequirements’

For authors, medical writers• Use in conjunction with CONSORT, GPP, COPE, and other

relevant guidelines when developing manuscripts forsubmission to biomedical journals

For journal editors• If your journal conforms to Uniform Requirements, ensure

Instructions for Authors are consistent, and that anyvariances are clearly stated

For sponsors• Use in conjunction with CONSORT, GPP, COPE, and other

relevant guidelines when providing financial support forbiomedical publications

Effects of Uniform Requirements

Standardization of minimum requirements for publishing in mostbiomedical journals worldwideWidely adopted by many journals, and by key biomedicaljournals and organizations (NEJM, JAMA, Lancet, BMJ, WHO,NLM, AMWA)Research has shown that, together with CONSORT, has led toan improvement in descriptions of methodology and overallstandard of reporting of clinical trialsLarge increase in number of clinical trials registered(>70% ↑ in 2005 on www.clinicaltrials.gov)

Variances

Some journals purporting to follow ICMJE UniformRequirements have out-of-date citation information, inconsistentInformation for Authors, etc.Individual journals have unique/specific requirements (notalways apparent from Instructions for Authors)

• JAMA: for industry-sponsored studies, independent dataanalysis by statisticians at an academic institution

• Lancet: will reject reviews if authors are pharma companyemployees or if author asked by any organization other thanLancet to write, be named on, or submit

Check individual journal ‘Instructions for Authors’ and possiblywith Editorial Office for variances from Uniform Requirements

Limitations

Does not address CME activities and requirements – seeACCME guidelines (www.accme.org)Does not have specific instructions on the reporting of animaluse in experiments (www.boyd-group.demon.co.uk)Does not cover the role of medical writing services and themedical communications industry (www.gpp-guidelines.org;www.emwa.org; www.amwa.org; www.wame.org)

What Next?

More on electronic publishing, open access journals?Expansion of guidelines for preclinical, basic research?Role of medical writing services and medical communicationscompanies?Clinical trials results reporting?

• 2005 PhRMA/EFPIA/IFPMA/JPMA Joint Statement(www.phrma.org)

• Ottawa statement (http://ottawagroup.ohri.ca)

Contact Information

Inquiries about ICMJE Uniform Requirements• Christine Laine, MD, MPH

ICMJE Secretariat OfficeAmerican College of Physicians190 N. Independence Mall WestPhiladelphia, PA 19106-1572, USAFax +1 215-351-2644E-mail claine@acponline.org

Questions about this presentation• Yvonne Yarker, PhD

Senior Director, Medical CommunicationsThomson Scientific Connexions105 Terry Drive, Suite 118Newtown, PA 18940, USATel +1 215-860-2202E-mail yvonne.yarker@thomson.com