The revised requirements reflect the collaborative effort of the editors of twelve peer-reviewed medical journals in eight countries.

The participating journals will publish the revised requirements in the current issue of their respective journals but they are available online now. The requirements are accompanied by an editorial, "Sponsorship, Authorship and Accountability," which was jointly authored by the participating editors.

The editors of the participating journals are available for comment directly. The editorial and revised requirements are available via the Internet on the website of each participating journal (listed alphabetically below):

Annals of Internal Medicine

BMJ

Canadian Medical Association Journal

International Committee of Medical Journal Editors

The Journal of the American Medical Association

Journal of the Danish Medical Association (no website available)

The Lancet

The Medical Journal of Australia

MEDLINE/Index Medicus

National Library of Medicine

Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine

The New England Journal of Medicine

New Zealand Medical Journal

The Norwegian Medical Association

Western Journal of Medicine

Until recently, independent clinical investigators have been key players in design, patient recruitment and data interpretation in clinical trials. The Commentary states how economic pressures are creating an environment in which the pharmaceutical industry, which often sponsors medical research, exerts control of trial design, access to raw data and the interpretation of study findings.

Concern is also expressed that research sponsors may influence decisions about how trials are published and promoted (if the results are favorable to the sponsor), or obscured (if unfavorable).

The international committee of medical journal editors has consequently strengthened its guidelines to enable editors to restrict the publication of research to studies in which the scientific objectivity of the research is not compromised.

The editorial concludes: "Authorship means both accountability and independence. A submitted manuscript is the intellectual property of its authors, not the study sponsor. We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication. We encourage investigators to use the revised ICMJE requirements on publication ethics to guide the negotiation of research contracts. Those contracts should give the researchers a substantial say in trial design, access to the raw data, responsibility for data analysis and interpretation, and the right to publish -- the hallmarks of scholarly independence and, ultimately, academic freedom. By enforcing adherence to these revised requirements, we can as editors assure our readers that the authors of an article have had a meaningful and truly independent role in the study that bears their names. The authors can then stand behind the published results, and so can we."

About the ICMJE

The International Committee of Medical Journal Editors (ICMJE) is an informal group whose participants fund work on the Universal Requirements for Manuscripts Submitted to Biomedical Journals.

Originally begun in British Columbia in 1978, when it was known as the Vancouver Group, the committee first published requirements for manuscripts and bibliographic references in 1979.

The ICMJE has since expanded and evolved to address concerns beyond manuscript preparation, such as editorial freedom, conflict of interest, confidentiality, journal advertising and the Internet. With participants from hundreds of journals worldwide, the ICMJE meets annually and is not a membership organization.

10-Sep-2001