Fraud and Misconduct in Biomedical Research

Description

Contributors Preface SECTION 1: SETTING THE SCENE 1. The concept of scientific dishonesty: Ethics, value systems, and research - Povl Riis 2. Ethical issues in the publication process - Richard Smith 3. What is research misconduct? - Drummond Rennie and C Kristina Gunsalus SECTION 2: THE HISTORICAL ASPECTS OF RESEARCH MISCONDUCT 4. An interpretive history of research misconduct policy in the USA and Canada - Nicholas H Steneck 5. Historical aspects of research misconduct: Europe - Frank Wells SECTION 3: THE PREVENTION OF RESEARCH MISCONDUCT 6. The promotion of good publication practice - Elizabeth Wager 7. Monitoring medical research: Better to prevent than to cure? - Helena van den Dungen 8. The role of research ethics committees - John Saunders SECTION 4: APPROACHES TO THE DETECTION OF RESEARCH MISCONDUCT 9. The role of the whistleblower - Sabine Kleinert 10. The role of the peer review process - Ana Marusic 11. Can statistical analysis reveal research misconduct? - Stephen Evans 12. The role of electronic tracking in monitoring data output in clinical trials - Erick Gaussens, Pierre-Henri Bertoye, and Jean-Marc Husson 13. The role of monitoring of research for compliance and detecting misconduct - Michael R Hamrell 14. The role of routine enhanced audit - Nicky Dodsworth SECTION 5: INVESTIGATION OF RESEARCH MISCONDUCT 15. Handling whistleblowers: Bane and boon - C Kristina Gunsalus and Drummond Rennie 16. Conduct of an inquiry into alleged misconduct - Jane Barrett SECTION 6: THE WAY FORWARD 17. The role of national advisory bodies - Michael Farthing Index.  Read more... Abstract: Contributors Preface SECTION 1: SETTING THE SCENE 1. The concept of scientific dishonesty: Ethics, value systems, and research - Povl Riis 2. Ethical issues in the publication process - Richard Smith 3. What is research misconduct? - Drummond Rennie and C Kristina Gunsalus SECTION 2: THE HISTORICAL ASPECTS OF RESEARCH MISCONDUCT 4. An interpretive history of research misconduct policy in the USA and Canada - Nicholas H Steneck 5. Historical aspects of research misconduct: Europe - Frank Wells SECTION 3: THE PREVENTION OF RESEARCH MISCONDUCT 6. The promotion of good publication practice - Elizabeth Wager 7. Monitoring medical research: Better to prevent than to cure? - Helena van den Dungen 8. The role of research ethics committees - John Saunders SECTION 4: APPROACHES TO THE DETECTION OF RESEARCH MISCONDUCT 9. The role of the whistleblower - Sabine Kleinert 10. The role of the peer review process - Ana Marusic 11. Can statistical analysis reveal research misconduct? - Stephen Evans 12. The role of electronic tracking in monitoring data output in clinical trials - Erick Gaussens, Pierre-Henri Bertoye, and Jean-Marc Husson 13. The role of monitoring of research for compliance and detecting misconduct - Michael R Hamrell 14. The role of routine enhanced audit - Nicky Dodsworth SECTION 5: INVESTIGATION OF RESEARCH MISCONDUCT 15. Handling whistleblowers: Bane and boon - C Kristina Gunsalus and Drummond Rennie 16. Conduct of an inquiry into alleged misconduct - Jane Barrett SECTION 6: THE WAY FORWARD 17. The role of national advisory bodies - Michael Farthing Index Content: FRAUD AND MISCONDUCT IN BIOMEDICAL RESEARCH -- Contents -- Contributors -- Preface -- SECTION 1 SETTING THE SCENE -- 1 The concept of scientific dishonesty: Ethics, value systems, and research -- Introduction -- Definitions -- Research -- Value systems -- Ethics -- Value universes of biomedical research -- Why do scientists transgress? -- What is the driving force for fraud? -- Scientific dishonesty in relation to its nature, prevalence, and consequences -- Good scientific practice -- New biomedical research methods -- Globalization of research ethics -- Social transfer of values -- Value conservation and the control of scientific dishonesty -- Conclusions -- References -- 2 Ethical issues in the publication process -- Introduction -- Patient consent for case reports -- Informed consent for research -- Checking approval from research ethics committees or ℗Ưinstitutional review boards -- Failure to publish and publishing too much -- Conflict of interest -- Peer review -- Authorship or contributorship? -- Developing world -- Relating to the mass media -- Acting on ethical problems -- Support and accountability for editors -- Journals and business ethics -- Conclusion -- References -- 3 What is research misconduct? -- Introduction -- Can formal definitions be avoided if good research practices are promoted? -- Why do we need a definition? -- What should our approach to a definition be? -- Jerks or crooks? -- Definition: the importance of uniformity -- Conditions and criteria necessary for any workable system -- Experience in the USA -- The scientific dialogue model -- The early 1990s: the heat increases -- The reaction -- The US government-wide regulations of December 2000 -- Lessons from the US experience -- What factors hold reform back? Professional societies -- The UK -- The Committee on Publication Ethics (COPE). The Joint Consensus Conference of 1999 Statement -- The UK Medical Research Council and the Wellcome Trust -- The UK Research Integrity Office (UKRIO) and other countries -- Conclusions -- References -- SECTION 2 THE HISTORICAL ASPECTS OF RESEARCH MISCONDUCT -- 4 An interpretive history of research misconduct policy in the USA and Canada -- Introduction -- Pre-policy period (1981-85) -- Policy development (1985-93) -- Policy definition (1993-2000) -- Recent policy developments (2000 onwards) -- Research misconduct policy in Canada -- Analysis and conclusions -- References -- 5 Historical aspects of research misconduct: Europe -- Introduction -- The Pearce case -- Classic cases of misconduct: the UK -- Misconduct in Europe -- National bodies on scientific integrity -- Recent cases: Europe -- Recent cases: the UK -- no research ethics committee approval -- Case 1 -- Case 2 -- Case 3 -- Case 4 -- Case 5 -- Registration of clinical trials -- Publication issues -- The ethical review process -- Fraud and misconduct policies -- Conclusions -- References -- SECTION 3 THE PREVENTION OF RESEARCH MISCONDUCT -- 6 The promotion of good publication practice -- Introduction -- ICMJE Uniform Requirements -- Individual journal instructions to authors/contributors -- Good Publication Practice for pharmaceutical companies -- Guidelines for medical writers -- Statements from editors' organizations -- Journal peer-review practices -- Institutional guidelines -- Preventing plagiarism -- Punishment as a deterrent -- Conclusions -- References -- 7 Monitoring medical research: Better to prevent than to cure? -- Why and how to monitor the quality and safety of medical research data -- Increase in regulation -- Quality of data -- Monitoring by the regulatory authorities -- Pharmacovigilance inspections -- Investigator site inspections -- Sponsor inspections. Inspections by ethics committees and institutional review boards -- Other inspection types -- Inspection findings -- Fraud and misconduct -- Size of the problem -- Resources -- Cure -- Prevention -- References -- 8 The role of research ethics committees -- Introduction -- Guidelines and codes of practice -- Differing roles of RECs -- Fraud and misconduct -- Scientific review -- Suitability of investigators -- Financial issues -- Registration and publication of research projects -- Recruitment of research ethics committee members -- References -- SECTION 4 APPROACHES TO THE DETECTION OF RESEARCH MISCONDUCT -- 9 The role of the whistleblower -- Introduction -- The status of whistleblowing -- The postgraduates who used the media to blow the whistle -- The technician who succeeded despite whistleblowing -- The independent whistleblower who read a published paper -- The researcher who wanted to check the data that were going to be published under his name -- Whistleblower legislation in selected countries -- US whistleblower protection laws -- UK whistleblower protection law -- Australian legislation -- A new whistleblower law in Norway -- Conclusions -- References -- 10 The role of the peer review process -- Introduction -- Preventing publication misconduct -- Guidelines for authors and reviewers -- Guidelines and codes of practice for editorial work -- Detecting publication misconduct -- Detecting repetitive and divided publication and plagiarized work -- Detecting citations of retracted articles -- Verifying accuracy of references -- Detecting manipulation of images and numerical data -- Handling allegations of publication misconduct -- Allegations of misconduct before article publication -- Allegations of misconduct after article publication -- Conclusions -- References -- 11 Can statistical analysis reveal research misconduct? -- Introduction. Characteristics of data -- Genuine data -- Altered data -- Invented data -- Misconduct that does not involve fabrication or falsification -- Deliberate selection of inappropriate analysis methods to obtain a desired result -- Misuse of subgroups -- Methods of analysis that might reveal altered or invented data -- Descriptive statistics -- univariable -- Descriptive statistics for bivariate or multivariate data -- Inferential statistics -- Baseline comparisons in randomized controlled trials -- Descriptive statistics of changes -- Exaggerated effects and random noise -- Examples -- Testing statistical methods using invented data -- Statistical methods used to detect actual misconduct -- What can editors and journals do? -- Conclusions -- References -- 12 The role of electronic tracking in monitoring data output in clinical trials -- Introduction -- Inspection duties and powers within the information technologies (IT) environment -- Electronic tracking and computerized systems in the clinical sphere: the context -- The impact of the electronic world on fraud and misconduct -- Case reports -- The various computerized systems involved in clinical trials and their functional interactions -- How to track the correctness and reliability of the data within each of these systems: 21 CFR Part 11 and validation -- Systems are interrelated and disseminated: the need for standards such as CDISC -- Some advanced approaches: how to explore databases and combinations of data and documents -- Conclusions -- Glossary -- References -- Appendix: CDISC references and links with HL7 -- 13 The role of monitoring of research for compliance and detecting misconduct -- Introduction -- Trial design considerations -- Selection of investigators -- Role of the monitor -- Detecting and dealing with non-compliance -- Research misconduct -- Detecting fraud and misconduct. Use of computers -- Preventing misconduct -- Dealing with misconduct -- Future prospects -- References -- 14 The role of routine enhanced audit -- Introduction -- Auditor qualities and skills -- Audit planning -- Audit preparation -- Audit conduct -- The audit report -- Audit follow-up -- Conclusions -- References -- SECTION 5 INVESTIGATION OF RESEARCH MISCONDUCT -- 15 Handling whistleblowers: Bane and boon -- Introduction -- What are whistleblowers and why should anyone care? -- Whistleblowers: a definition -- Challenges in discovering and responding to wrongdoing -- Practical advice for responding to whistleblowers -- Policies and people -- Provide clear guidance: policies, procedures, protections, and resources -- Devise institutional responses understanding the concerns of the whistleblower -- Make policies and help easy to find -- Provide choices for reporting -- Do not make reporting a duty -- Do not promise confidentiality to a whistleblower when you might not be able to honour the promise -- Take steps to prevent retaliation against the whistleblower -- Assign responsibilities carefully -- Devise systems for separating personalities from facts. Train those responsible for conducting and presiding over investigations -- What are the right questions to ask? -- Assess allegations consistently and even-handedly. Have a set of standards for assessing allegations -- Protect against conflicts of interest -- Seek professional support for investigations -- Carpe data -- Conclusions -- References -- 16 Conduct of an inquiry into alleged misconduct -- Introduction -- Allegations of fraud or misconduct -- Who should handle allegations? -- Pitfalls in handling allegations of research misconduct -- Best practice -- Is there a case to be answered? -- Investigations -- The role of an independent investigator -- Conclusions -- References.