FRAUD AND MISCONDUCT IN BIOMEDICALRESEARCH (Third Edition) Stephen Lock,Frank Wells and Michael Farthing, BMJ Publish-ing Group, London, 2001. www.bmjbooks.com.ISBN 0-7279-1508-8.

An excellent book, Fraud and Misconduct inBiomedical Research, Third Edition, 2001,

provides easy and enjoyable reading about a crit-ical topic, and is packed with information andprovocative ideas that are useful for anyoneinvolved in clinical research and concerned aboutachieving top quality data with integrity.

Loaded with case studies and anecdotes whichare reported by representatives of government,industry, medical institutions, academia andethics committees, this book goes a long way tomaking a solid case for the widespread occurrenceof fraud and the fact that fraud cannot be politelydiscounted as a rare event or only problematic incertain jurisdictions. For example, at last, thereseems to be some acknowledgement by someEuropeans that perhaps the more widely reportedincidence of fraud in the US is really a result of thefact that the US authorities are better at detectingand acting upon fraud rather than a result of sup-posedly more fraudulent activity in that part ofthe world. (This idea – that Americans were morefraudulent – was a common theme I heard duringthe 1985–1999 period when I lived in Europe!)

The book provides excellent overviews of howthe US government and medical associationsaddress fraud with details of inspections, activi-ties and sanctions for fraudulent researchers. Itwas also wonderful to read of the efforts beingundertaken in some European countries (e.g.Denmark, Finland, France, Germany, Norway,UK). Authors of those sections of the book wereremarkably candid in their acknowledgement thatthere is a long way to go towards deterring thishorrific problem. Perhaps, future editions of thebook will show that the problem is being tackledin other parts of the world as well.

Book Review

Copyright © 2002 John Wiley & Sons, Ltd. Qual Assur J 2002; 66, 125–126.DOI: 10.1002/qaj.173

The resources available in this book are ter-rific. Almost every chapter includes a detailedreference list, many with website locators. Thereare many practical suggestions for the detection offraud (e.g. statistical oversight; review of patternsand trends in data; training, alerting and sup-porting monitors; and checking data and trialmaterials) along with methods of handling con-firmed fraud. The chapter on statistical methodsfor detecting fraud was a little beyond me, butwould surely be of value to statisticians. Severalauthors wrote about motivations for fraud whichis also intriguing and important to understand.

Frequent reference to policies and proceduresto be established in research settings is appreci-ated, especially the sample standard operatingprocedure at the back of the book. There are alsomany other suggestions for setting up formal sys-tems in institutions and governments for the man-agement of fraud. Legal aspects of pursuing fraudare presented along with good descriptions ofemerging guidelines and regulations.

A wonderful chapter on the ‘whistleblower’must be read by all. The detailed personalaccount of events as experienced by a ‘whistle-blower’ were haunting. This chapter was espe-cially important to me as I believe that mostmonitors and auditors have observed fraud dur-ing their careers, but were either afraid or igno-rant about follow-up.

Some of the most provocative recurring themes inthe book were:

� There was healthy scepticism on the part ofseveral of the book’s contributors that themedical ‘establishment’ was not movingquickly enough to implement formal systemsof prevention, detection and managementof fraud. Even when fraud was detected,follow-up was weak and sanctions were rarelyapplied. In fact, sanctions were usually notofficially defined. Several authors deploredhow little things have changed (this seemed to

come through strongly by the Britishauthors) and how poor practice continues.

� At last, there was some appreciation andrecognition of the great strides made in theUS and the strengthening commitment thereto assuring integrity in research. There waseven some chastisement from some authorsabout efforts elsewhere in the world to coverup fraud. There was a suggestion that theUK is about 15 years behind the US and isperhaps trying to ‘re-invent the wheel’.

� The debate about the definition of fraudabounds. (I wonder if this is another way ofavoiding the problem.)

� Misconduct with regards to authorship,manuscript review, and grant applicationswas very interesting – I had not thoughtabout the seriousness of this problem beforereading the relevant sections in this book.

� The historical accounts of detection andmanagement of research fraud were fasci-nating. According to some of the authors, adefensive and dismissive attitude by thescientific community was (and still is) a seri-ous obstacle to combating research miscon-duct. The ‘medical establishment’ protestedthat regulations impede scientific progressand those who wrote about misconduct wereattacked. Thankfully, not everyone acceptedreassurances by the establishment that ‘allwas well’.

� Several authors in the book emphasized theimportance of education, education, andmore education. Training researchers aboutethics and integrity must start at the begin-ning and reminders must be continuallyespoused.

� Naturally, I was particularly struck by a chap-ter on the role of the editors of journals. Itsharpened my sense of review activities whenreading submitted manuscripts. (Though QAJdoes not publish a preponderance of originalresearch papers, such submissions will receivemore careful scrutiny in future!)

126 Wendy Bohaychuk

Copyright © 2002 John Wiley & Sons, Ltd. Qual Assur J 2002; 66, 125–126.

� Some authors in the book urged that weshould forget about self-regulation andpointed out how self-regulation could notovercome conflict of interests. (I agree, Iagree!)

� The many anecdotal accounts, especiallythose by MedicoLegal Investigations (UK),should make readers sit up. These storieswould make fabulous case studies for use intraining classes.

� There was a recurring theme in the bookalong the lines that we cannot declare thatthe incidence of fraud is rare because wedon’t know. In fact, what we don’t know faroutweighs what we do know. I felt mostauthors in this book were hinting that theprevalence of fraud was much greater thanwe acknowledge.

� The industry was not seen as a major culpritin research fraud. This surprised mebecause of the great financial conflict ofinterest (which of course does lead to a sig-nificant amount of fraud) but the authorsalso emphasized the fraud in the world ofacademia and publishing.

� There were strong hints that ethics commit-tees (and IRBs) should play pivotal roles infraud detection and chastisement of fraudu-lent researchers. This is already happeningin some jurisdictions and parallels the cur-rent sentiment that ethics committees mustbe more aware of research they approve.

QA personnel – you must read this book. Actually,I wish you could encourage all clinical site per-sonnel to read it as well. I have to say that I trulyfound the book exciting reading. The real confir-mation of that, for me, was the fact that the booksat by my bedside and was preferred reading evenafter a long day attending to other work-relatedissues.

WENDY BOHAYCHUKE-mail: wbohaychuk@gcrpc.com