Abstract
Readers may wonder why this book has been picked for review in Clinical Risk, sensing that it is rare for care delivered in a research setting to trigger legal scrutiny or a claim for damages. Those concerned to minimize harm could, however, learn much by studying the way in which regulation and audit currently manages (and sometimes mismanages) risk in clinical research, and this 300-page book, now in a fourth edition after just 15 years, offers an authoritative review of this issue. Earlier editions were just a series of loosely linked essays, but the 17 contributions in the latest edition have been moulded into a much more coherent whole – outlining what the issues are, before reviewing ways to minimize misconduct, suspect its occurrence and investigate those suspicions.
Much is perverse about the current concern to minimize risk for patients in a research study while ignoring the risk they face when offered the same care in a setting where outcome cannot be properly assessed. Small babies frequently ‘burp’ and regurgitate small amounts of milk, and there is understandable concern that this may end up in their lungs. Cisapride came into use to control this and was being given to more than half the babies in many hospital ‘special care’ nurseries before it was established that the treatment was not just ineffective but could cause arrhythmia. There were no checks in place to curb its unevaluated use, but so many research regulations in place that it took 10 years for these concerns to come to light. Parental consent was not required before the babies were started on treatment in an unmonitored way, but a complex informed consent procedure had to be gone through before half could be started on treatment in a more thoughtful, carefully audited way.
Similar ethically indefensible double standards currently pervade almost all clinical research even though there can be little doubt that, in most situations, patients in a properly managed research study are at less risk than patients receiving ‘routine’ care. Sins of commission are also treated much more harshly than sins of omission. While overt data fabrication, if recognized, will quickly bring someone's career to an end, this is relatively rare and seldom harms a patient. Other forms of misconduct, such as the selective publication, or non-publication, of research are much more widespread, but they seldom trigger disciplinary action even though they can sometimes cause immense harm. That said, there is much that those concerned to minimize risk during routine care can learn from looking at some of the other issues that are more fully covered in this book, even though they will soon find that the regulatory structures in place in most countries are not, at the moment, very effective.
What receives even less attention is the effect that inter-personal relationships can have on how care gets delivered and how research gets done. Those who want to understand how these can impact on the delivery of clinical care, the conduct of research and the investigation of alleged misconduct would do well to study the way these fueled the allegations of research misconduct that swirled round Dr Olivieri and the Canadian drug company Apotex, and affected almost every aspect of their dysfunctional investigation between 1996 and 2002. Unfortunately this ‘affair’ only gets a passing mention in the book currently under review and the only authoritative study of the subject 1 is only available from booksellers in North America.
Fraud and Misconduct in Biomedical Research, 4th ednWells F, Farthing M, eds Royal Society of Medicine Press, September 2008 ISBN-13: 978-1-85315-786-8 Price: £45.00 (Paperback)