ICMJE Recommendations

ICMJE Recommendations
Name	ICMJE Recommendations
Formation	1978

ICMJE Recommendations. The ICMJE Recommendations are a set of standardized guidance for manuscript preparation and publication practice developed to harmonize editorial policy across medical journals and to improve transparency in biomedical reporting. They influence submission, peer review, authorship, disclosure, data reporting, and publication ethics across many leading journals and professional organizations.

History

The Recommendations originated in 1978 when editors from journals including The New England Journal of Medicine, JAMA, The Lancet, Annals of Internal Medicine, BMJ, Canadian Medical Association Journal, Australian Medical Journal, and New Zealand Medical Journal met in Vancouver, producing the initial "Vancouver guidelines". Subsequent meetings involved representatives from organizations such as World Health Organization, United States National Institutes of Health, European Medicines Agency, Food and Drug Administration (United States), and publishers including Elsevier, Springer Nature, Wiley-Blackwell, Oxford University Press, and Taylor & Francis. Notable participants over time have included editors associated with Richard Horton of The Lancet, Howard Bauchner of JAMA, and figures connected to Harvard Medical School and Johns Hopkins University. Revisions were influenced by events like the rise of clinical trial registries prompted by decisions at International Committee of Medical Journal Editors meetings and by controversies such as the Vioxx litigation and reporting debates involving institutions like Merck & Co.. International policy shifts reflected interactions with bodies including Council for International Organizations of Medical Sciences, Committee on Publication Ethics, World Association of Medical Editors, and national regulators such as Medicines and Healthcare products Regulatory Agency.

Purpose and Scope

The Recommendations aim to standardize manuscript elements for journals such as The BMJ, Nature Medicine, Cell Press journals, PLOS Medicine, and specialty titles from societies like American Heart Association, American College of Physicians, European Society of Cardiology, and American Diabetes Association. Scope extends to clinical trials registered in databases like ClinicalTrials.gov, ISRCTN registry, WHO International Clinical Trials Registry Platform, and influences reporting checklists like the CONSORT statement, PRISMA guidelines, STROBE statement, and CARE guidelines. They guide interactions among authors affiliated with institutions such as Mayo Clinic, Cleveland Clinic, Massachusetts General Hospital, University of Oxford, and Karolinska Institutet and funding agencies including National Institutes of Health, Wellcome Trust, and European Research Council.

Key Recommendations

Key recommendations cover manuscript structure, data sharing, trial registration, reporting transparency, and citation practices. They endorse prospective registration of trials in registries like ClinicalTrials.gov, mandatory disclosure of funding from bodies such as Bill & Melinda Gates Foundation and Wellcome Trust, and support data-sharing policies aligned with principles from Open Science Framework and initiatives involving European Commission research programs. They align with reporting standards championed by groups like Equator Network and address preprint use as seen in platforms such as medRxiv and bioRxiv.

Authorship and Contributorship

The Recommendations define authorship criteria to credit contributors from institutions such as Stanford University School of Medicine, Yale School of Medicine, University of Cambridge School of Clinical Medicine, and Imperial College London. They require substantial contributions comparable to roles within teams at Dana-Farber Cancer Institute or Fred Hutchinson Cancer Research Center and call for identification of guarantors akin to practices at Mount Sinai Hospital and Toronto General Hospital. Contributorship statements echo models used in projects like Human Genome Project and collaborations between centers such as Cold Spring Harbor Laboratory and Sanger Institute.

Ethical Standards and Conflicts of Interest

Ethical guidance intersects with policies from Declaration of Helsinki, Belmont Report, Nuremberg Code, and oversight by institutional review boards at universities like Columbia University and University of California, San Francisco. Conflict of interest disclosure requirements target relationships with commercial entities including Pfizer, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, and Novartis. Policies influence corrective actions when misconduct involves institutions such as Retraction Watch-reported cases or regulatory inquiries by Office of Research Integrity and national agencies like Health Canada.

Implementation and Impact

Adoption by major publishers including Elsevier, Springer Nature, Wiley-Blackwell, and society journals from American Medical Association and European Society of Cardiology has shaped editorial policies at outlets like The New England Journal of Medicine, JAMA, and The Lancet. Implementation has encouraged trial registration at ClinicalTrials.gov and data sharing in repositories such as Dryad, Figshare, and Zenodo. The Recommendations influenced meta-research from groups at Stanford University, University of Oxford, University of Toronto, and fostered education in organizations like Association of American Medical Colleges and European Association of Science Editors.

Criticisms and Revisions

Critiques have come from stakeholders including editors at BMJ, researchers at Harvard School of Public Health, ethicists at Georgetown University, and investigative journalists associated with The New York Times and ProPublica. Criticisms address enforcement gaps noted in cases involving pharmaceutical companies like Merck & Co. and GlaxoSmithKline, inconsistencies highlighted by systematic reviewers at Cochrane Collaboration, and challenges raised by advocates at Global Health Council. Revisions have responded through consultations with entities such as Committee on Publication Ethics, World Health Organization, and legal considerations involving agencies like European Court of Human Rights.

Category:Medical publishing