Paper Retraction Puts Focus on Informed Consent Rules

摘要

Stung by a front-page newspaper expose of an alleged lapse in research ethics, officials at the University of Tokyo's Institute of Medical Science are planning to overhaul efforts to educate researchers on ethics rules and tighten internal review and compliance procedures. At the same time, scientific journals are getting stricter about documenting the fact that human studies have undergone ethics review. "What we learned is that periodic educational efforts to raise everyone's awareness of clinical research ethics guidelines were insufficient," says Motoharu Seiki, the institute's dean. The incident centers on a group led by Arinobu Tojo, who works on molecular therapies for leukemia. The group retracted a paper on acute myeloid leukemia by Sei-ichiro Kobayashi et al. that was published online on 21 May and in the 1 July issue of Haematologica. An investigation determined that a statement the authors made to the journal that the study had been approved by an institutional review board (IRB) was erroneous (Science, 18 July, p. 324).