Stress Incontinence Paper Retracted by The Lancet
Flawed research lacked patient consent and ethics committee approval
FRIDAY, Sept. 5 (HealthDay News) -- An article on stress urinary incontinence published in The Lancet in June 2007 has been retracted by the journal due to a report by the Austrian Government's Agency for Health and Food Safety, which pinpointed many irregularities in the research.
Richard Horton, M.D., editor of The Lancet, and Sabine Kleinert, vice-chair of The Lancet's committee on publication ethics, write that the report concluded that the study did not comply with Austrian law, nor did it meet the standards of the International Conference on Harmonisation of Good Clinical Practice (GCP).
Patient consent was deficient, ethics committee approval was not obtained and inspectors were presented with document copies rather than originals, there were different versions of the same document, some were unsigned and undated, and one patient's insurance confirmation was an alleged forgery, the editorial notes. The lead author of the original study, Hannes Strasser, M.D., of the University of Innsbruck, Austria, argued that tissue engineering products are not subject to GCP requirements because they are not medicinal products.
"However, in our view, the conclusions of this official investigation pinpoint so many irregularities in the conduct of their work that, taken together, the paper should be retracted from the published record," the authors write. "In the report, the inspectors raise doubts as to whether a trial as described in The Lancet ever existed."