Farthing M., Wells F. (eds.) Fraud and Misconduct in Biomedical Research

Boca Raton: CRC Press, 2008. — 311 p.Setting the SceneThe concept of scientific dishonesty: Ethics, value systems, and researchDefinitions
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
ConclusionsEthical issues in the publication processPatient 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 ethicsWhat is research misconduct?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
ConclusionsThe Historical Aspects of Research MisconductAn interpretive history of research misconduct policy in the USA and CanadaPre-policy period (1981-85)
Policy development (1985-93)
Policy definition (1993-2000)
Recent policy developments (2000 onwards)
Research misconduct policy in Canada
Analysis and conclusionsHistorical aspects of research misconduct: EuropeThe 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
ConclusionsThe Prevention of Research MisconductThe promotion of good publication practiceICMJE 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
ConclusionsMonitoring 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
PreventionThe role of research ethics committeesGuidelines 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 membersApproaches to the Detection of Research MisconductThe role of the whistleblowerThe 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
ConclusionsThe role of the peer review processPreventing 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
ConclusionsCan 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?
ConclusionsThe role of electronic tracking in monitoring data output in clinical trialsInspection 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
ConclusionsAppendix: CDISC references and links with HL7
The role of monitoring of research for compliance and detecting misconductTrial 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 prospects14 The role of routine enhanced auditAuditor qualities and skills
Audit planning
Audit preparation
Audit conduct
The audit report
Audit follow-up
ConclusionsInvestigation of Research MisconductHandling whistleblowers: Bane and boonWhat 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
ConclusionsConduct of an inquiry into alleged misconductAllegations 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