A review of fraud in medical research in Britain, Europe, the USA and Australia. It includes a history of known cases of fraud since 1974 and discusses ways for detecting and dealing with fraud that have been devised by government agencies, pharmaceutical companies, academic institutions and scientific publications (especially medical journals).
Training for members of research ethics committees varies from state to state in Europe. To follow this up, the European Forum for Good Clinical Practice organised a workshop in March 2007 to explore these issues and look for solutions. This article summarises the discussion, providing ways forward to develop REC training.
Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and variable resources, difficulties of setting (...) standards for ethical debate and its outcomes and that REC members, as volunteers, may resent the imposition of standards. Other ways to set standards were discussed, including analysis of current multicentre review, collecting REC member reports for review, learning from appeals and feedback from applicants, and use of other regional and national meetings. The place of a central, national board or ethics committee was debated as was the need for collaborating with partners in other fields. (shrink)
This paper reports a European Forum for Good Clinical Practice workshop held in 2011 to consider a research ethics committee training syllabus, subsequent training needs and resources. The syllabus that was developed was divided into four competencies: committee working; scientific method; ethical analysis and the regulatory framework. Appropriate training needs for each, with possible resources, were discussed. Lack of funding for training was reported as a major problem but affordable alternatives were debated. Strengths and weaknesses of this approach were discussed (...) and the resultant proposal will be disseminated through the European Forum for Good Clinical Practice and the research ethics committees of member states. (shrink)
Make no mistake, this interesting book emphatically reflects the backgrounds of its editors, as is to be expected, which are in pharmacy and in academic ethics. There is nothing wrong with that so long as we know. The stated target audience for the book are, however, those working in the clinical research of pharmaceutical products. Also it claims to cover a neglected area of medical ethics. What a pity therefore that the book pays no regard whatsoever to the report of (...) the Faculty of Pharmaceutical Medicine on ethics in pharmaceutical medicine, first adopted and then published in 1997.1 Having said that, the editors’ preface refers to the issues which the research pharmacist may confront, as both a scientist and a member of society, and for this particular group of professionals the book will be of the greatest interest.Any collection of chapters or, as the editors prefer, articles, are likely to include those which are very good indeed and those which are more limited in their usefulness and appeal. Stimulation and thought provocation are the hallmarks of a valuable article, while irritation is the response to be most vigorously avoided. I must say that certain contributions within …. (shrink)