Fraud and Misconduct in Biomedical Research

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.