Preface to the second edition

Events have moved fast since the first edition of this book. In the United States the Office of Scientific Integrity has been replaced by the Office of Research Integrity (ORI), whose newsletters and annual reports show that the system is now dealing with many cases expeditiously and with due process - while seminars and conferences on the topic have been described as a growth industry. In particular, one fear that the courts may assume a more important role has been realised by a successful qui tam suit in May 1995 (though the decision is now under appeal). Feeling that she would get nowhere through the official channels, Pamela Berge, a former Cornell epidemiologist, filed a suit under the False Claims Act alleging that the University of Alabama, Birmingham, had made false claims in its NIH grant application and had used her work on cytomegalovirus. The jury in the Federal District Court found for Berge, stating that the false claims amounted to $550 000; by statute (the article in Science - 26 May 1995, p 1125 - states) the UAB is required to pay the government triple that amount, and Berge is entitled to 30% of what the government recovers, as well as $265 000 from the four researchers in compensatory and punitive damages. Elsewhere, several more countries have set up mechanisms to address the issues: Austria and the other Nordic countries now have central committees similar to the Danish one; France is galvanising its drug inspectorate, and Canada is requiring its universities to develop guidelines for handling allegations; and the United Kingdom, criticised in a hardhitting television programme for its inaction -and spurred on by the Pearce case (pages 19 and 252 in the second edition) - is to debate setting up a central committee. There has also been extended interest in the subject even in areas where something was already being done. In the pharmaceutical industry, for example, there has been a flurry of seminars and conferences on the handling of suspected data and there is now a collective agreement by the European industry and the profession to take action against any doctor generating fraudulent data in clinical research. There has also been a concern to extend the scope of the discussion to new topics - in particular, the argument by Iain Chalmers and his colleagues in the Cochrane collaboration that under-reporting of research is another form of misconduct, given that this can lead to seriously misleading recommendations for clinical practice and for new research. Above all, the scientific community is now doing something about the pressing issues of prevention, as shown by Science's special feature on everyday dilemmas in research (23 June 1995), the same journal's electronic discussion facility "Science Conduct On-Line", and Chalmers's further proposal that prospective registration of research projects in central registers, possibly founded on research ethics committees, would prevent a lot of non-existent trials from getting published.

To discuss such changes, we asked our contributors to update their chapters when necessary and commissioned some new ones. VandenBurg, Evans, Brock, Hodges, and Gillespie have left their chapters unaltered -whereas Howie, Hosie, Lock,Wells, Riis, Swan, Shapiro, and Maisonneuve have all altered theirs. Among the new contributions La Follette provides the much needed philosophical framework that we had hoped to include in the first edition. Horowitz reviews many of the details of the United States policies and procedures, while Stegemann-Boehl shows how some mechanism might be established in Germany, a country where commentators have claimed that this would be impossible. Finally, Husson and his colleagues extend our knowledge of the European scene, while Altounyan gives an outsider's view based on her extensive research for the BBC "Horizon" programme in March 1995.

"The next book will probably present a structured and systematic description of the disease, its detection, and its management."Would, alas, that this were possible! To be sure, we were encouraged by the largely favourable reviews of our first edition, and have now tried to address some of the constructive points raised by the other reviews, such as the one above. Several critics suggested that the chapters could be ordered more logically, and, though taken together all of the proposed changes would have cancelled one another out, we have now loosely grouped the accounts into history, prevention and management, other aspects, and experience in individual countries.

The most cogent, and consistent, criticism, however, was our failure to define our terms. This problem, however, has perplexed better minds than ours, and significantly it is high on the agenda of the new commission set up by the ORI. The dilemma hinges on a particular difficulty: is fraud solely falsification, fabrication, and plagiarism, or does it extend to "other practices that seriously deviate from those that are commonly accepted within the scientific community" - and even then would it go as far as disciplinary offences, such as sexual harassment? Perhaps what we need are terms to cover different aspects; fraud could then, say, be applied to the most egregious offences, and scientific misconduct or dishonesty (the term used in Denmark) to the entire range, details of which are best specified. For the moment, however, we have stuck to our original title, allowing authors their own choice of words, having ensured that they define these in the first place. Our critics are, of course, entitled to their views, but they should say what words they would prefer, and why.

Stephen Lock Frank Wells January 1996

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