Fraud and Misconduct in Biomedical Research, 4th edition

Paperback

Published: 03/10/2008

Extent: 312 pages

Illustrations: 10 line artworks

 

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Summary:

Now in its fourth edition, Fraud and Misconduct in Biomedical Research boasts an impressive list of contributors from around the globe and introduces a new focus for the book, transforming it from a series of monographs into a publication that will quickly become an essential textbook on all areas of research fraud and misconduct.

Key features include:

a comprehensive analysis of the historical aspects of research misconduct, with cases from across the world;

an extended section on the detection of research misconduct, examining the roles of the peer review process, statistical analysis, and routine enhanced audit;

a completely new section, 'The Way Forward', which looks at the role of national advisory bodies.

Fraud and Misconduct in Biomedical Research strives to uncover the issues surrounding clinical research in order to raise awareness of unethical practice, open debate and express concerns. This book is internationally relevant; from anyone who is involved with biomedical research or has an interest in fraud and misconduct, to the recipients and beneficiaries of research, who are directly affected by unreliable research.

• Unique in the way it informs us of scientific dishonesty and the lack of research integrity

• Research misconduct is a global phenomenon and, as such, this book represents a global team of Authors making the book internationally relevant

• Strives to uncover the issues, raise awareness and open debate

• This book offers answers to the 'whys and wherefores' of research misconduct and goes someway to providing solutions

• Up-to-date account of research misconduct, including recent high-profile cases from the USA, Europe and Asia

Table of Contents:
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

About the Author(s):

Frank Wells FRCP FRCPE FFPM
Retired Pharmaceutical Physician, Ipswich, UK

Michael JG Farthing DSc(Med) MD FRCP FMedSci
Vice-Chancellor and Professor of Medicine, University of Sussex, Brighton, UK

Contributors:
Jane Barrett FFPM LLM Director and Medical Advisor, MedicoLegal Investigations Ltd, Cambridge, UK Pierre-Henri Bertoy Associate Director, Inspectorate and Companies Department, Afssaps, Paris, France Nicky Dodsworth DCRR MRQA MICR Senior Director, Global Quality Assurance, Premier Research Group Ltd, Bracknell, UK Helena van den Dungen PhD Clinical Quality Assurance, Global Head Country Management, Novartis Pharma AG, Basel, Switzerland Stephen Evans MSc FRCP(Edin) Professor of Pharmacoepidemiology, London School of Hygiene and Tropical Medicine, London, UK Michael JG Farthing DSc(Med) MD FRCP FMedSci Vice-Chancellor and Professor of Medicine, University of Sussex, Brighton, UK Erick Gaussens PhD Senior Consultant, Product Life, Paris, France C Kristina Gunsalus

Readership:
Internationally relevant, from those involved in biomedical research or have an interest in fraud and misconduct, to recipients and beneficiaries of research

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