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Book Review: The Ethics Police?: The Struggle to Make Human Research Safe

8 February 2016
Appeared in BioNews 838

The Ethics Police? The Struggle to Make Human Research Safe

Edited by Professor Robert Klitzman

Published by Oxford University Press

ISBN-10: 0199364605, ISBN-13: 978-0199364602

Buy this book from Amazon UK

Thousands of people enter clinical trials every month with the hope of benefiting from experimental treatments or at least advancing science. However, while this kind of research often helps those taking part, it is clear it compromises others. For example, in the Tuskegee Syphilis Experiment (one of many infamous clinical studies), syphilis-afflicted African-American men in Alabama were denied lifesaving penicillin in an attempt to further science.

In 1974, in direct response to this study, US Congress passed the National Research Act, whereby institutional review boards (IRBs) were required to be set up in hospitals and universities across the US. Since then, IRBs have been evaluating the risks and benefits of studies involving human subjects and have been responsible for halting unethical research. The history and ethics around IRBs are explored in The Ethics Police?: The Struggle to Make Human Research Safe.

Authored by Robert Klitzman, a psychiatrist and director of Columbia University’s masters program in bioethics, the book sets out to examine the inner workings of IRBs. Klitzman gathers information by interviewing IRB administrators, chairs and members. The book reveals that IRB members often 'confront heavy workloads, competing priorities, and difficulties in criticizing colleagues’ studies, and understanding complex science'.

The book finds that IRBs have a reputation among some researchers for impeding the advance of science. Klitzman himself has lost valuable time and opportunity due to IRB bureaucratic inefficiencies. Thus, their nickname: ethics police. However, he clearly states that the book is not 'an anti-IRB book' and explains that they do 'extremely valuable work' as 'committees generally struggling to do their best'. Perhaps 'Ethics Traffic Police' would be a more accurate title: keeping ethical research going while directing troubling traffic to other routes as a way of avoiding gridlock.

Klitzman identified IRBs can vary in how they regulate studies. If a study is conducted at many institutions, for example, it may have to go through multiple boards, each with different protocols. This lack of uniformity, Klitzman argues, can forestall research plans, leading to confusion and frustration. These non-standardised IRBs have given rise to private, for-profit IRBs, which review studies for a fee and promise faster services. However, one interviewee in the book stated that these IRBs 'primarily do business with drug company sponsors. So, the very people that are paying them are the ones that they are regulating'. This highlights the susceptibility these private, for-profit IRBs face to conflicts of interest.

The book succeeds in providing readers with an insight into a system that operates 'at complex intersections of science, politics, sociology, psychology, money and ethics'. Klitzman conveys how making human research safe is a difficult balancing act between the public's eagerness for treatments and the research community's propensity to respond. However, he does not offer any easy answers or solutions. Whether IRBs should be centralised or standardised is not a debate that this book attempts to resolve. Instead, it suggests that a robust regulatory system is required to help effectively step on the accelerator - or the brakes - every so often. This is increasingly important in the 21st century - as science and technology zoom forward at an astounding pace.

Buy The Ethics Police: The Struggle to Make Human Research Safe from Amazon UK.

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