European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications.

BACKGROUND Many papers in biomedical journals are drafted not by the named authors, but by professional medical writers working under the direction of those authors, usually funded by pharmaceutical companies. Although this practice can improve both the quality and speed of publications, it has attracted controversy as a result of concerns about the inappropriate influence of pharmaceutical companies. OBJECTIVES To define ethical standards for professional medical writers who prepare papers for publication in medical journals. CONSENSUS METHODS Guidelines were drafted after a 4-round Delphi consultation among a group of experienced medical writers. The guidelines were then further refined by seeking comments on the draft from a range of interested parties. FINDINGS AND CONCLUSIONS The guidelines stress the importance of respecting widely recognised authorship criteria, and in particular of ensuring that those listed as named authors have full control of the content of papers. The role of medical writers must be transparent, which normally means a mention in the acknowledgements section, together with a statement about funding. Writers and authors must have access to relevant data while writing papers. Medical writers have professional responsibilities to ensure that the papers they write are scientifically valid and are written in accordance with generally accepted ethical standards.