Objective: To report results from a national survey of coordinators and managers of clinical research studies in the US on their perceptions of and experiences with scientific misconduct.Methods: Data were collected using the Scientific Misconduct Questionnaire-Revised. Eligible responses were received from 1645 of 5302 surveys sent to members of the Association of Clinical Research Professionals and to subscribers of Research Practitioner, published by the Center for Clinical Research Practice, between February 2004 and January 2005.Findings: Overall, the perceived frequency of misconduct (...) was low. Differences were noted between workplaces with regard to perceived pressures on investigators and research coordinators, and on the effectiveness of the regulatory environment in reducing misconduct. First-hand experience with an incident of misconduct was reported by 18% of respondents. Those with first-hand knowledge of misconduct were more likely to report working in an academic medical setting, and to report that a typical research coordinator would probably do nothing if aware that a principal investigator or research staff member was involved in an incident of misconduct.Conclusion: These findings expand the knowledge on scientific misconduct by adding new information from the perspective of research coordinators. The findings provide some data supporting the influence of workplace climate on misconduct and also on the perceived effectiveness of institutional policies to reduce scientific misconduct. (shrink)

A guide for everyone involved in medical decision making to plot a clear course through complex and conflicting benefits and risks.

Darwin himself suggested the idea of generalizing the core Darwinian principles to cover the evolution of social entities. Also in the nineteenth century, influential social scientists proposed their extension to political society and economic institutions. Nevertheless, misunderstanding and misrepresentation have hindered the realization of the powerful potential in this longstanding idea. Some critics confuse generalization with analogy. Others mistakenly presume that generalizing Darwinism necessarily involves biological reductionism. This essay outlines the types of phenomena to which a generalized Darwinism applies, and (...) upholds that there is no reason to exclude social or economic entities. (shrink)

Background The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. Objectives The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. Methods An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by (...) the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. Results 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. Conclusions The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised. (shrink)

‘Banality of evil’ was a concept introduced by Hannah Arendt in order to characterize a new form of wickedness embodied in people as Adolf Eichmann and others nazis criminals. Arendt thougt that this perverseness was very awey from the one of ‘radical evil’, a notion built by Kant and employed by Arendt herself in former works. This article seeks to point out that concepts of radical evil and banality of evil are closer than Arendt recognizes.