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Balanced Ethics Review: A Guide for Institutional Review Board Members

Whitney, Simon N.

Springer, (2015)
ISBN: 9783319207056 (pb)

Reviewed by Pramod Regmi and Edwin van Teijlingen, Bournemouth University

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This short book is a manual for research ethics committee members in the United States (US), the so-called IRB (Institution Review Board), however this book is also useful for investigators or early career researchers who engage in human subject research. The book aims to balance the two key moral considerations in research “the rights and welfare of research subjects and our shared interest in better treatments for disease” (p.vii). The observant reader will have immediately spotted that this manual is focused on health and medical sciences (the term ‘subjects’ is the giveaway). Historical examples and insights from several scholars are very helpful in exemplifying the basis for an IRB.

The book covers topics such as ‘Ethics and the IRB’, ‘IRB process’ and ‘Biomedical Research Topics’, all very useful topics for social scientists working in the health field. The book is quite US centric, for example “Scientists who do not realize that the IRB’s flexibility is limited by federal …regulations should become better informed” (p.24). However, Whitney covers some of the key issues relevant to medical sociologists, as well as some of the key issues generated by a formal ‘bureaucratic’ system of research ethics review.

The most interesting part for sociologists is chapter 6 ‘The Social Sciences’. Many IRBs oversee social science research with “ethical issues quite distinct from those in biomedical research” (p. 57). Whitney argues that IRBs should not review research in the humanities, and that they should not obstruct social science research. IRBs should approve social science research on politically sensitive topics or that may lead to objectionable results, or involve deception. Moreover, IRBs should refrain from making changes to research instruments / questionnaires, according to Whitney, unless “the IRB is responsible for improving social science in your institution” (p.65).

However, the book offers some useful and interesting advice. When highlighting the crucial conundrum of every IRB, sailing between ‘neglect’ because of allowing research participants to make too risky choices, and ‘paternalism’ because of limitations put on participant’s autonomy, Whitney just says get on with it: “You cannot refuse the choice; it is what you do” (p.42).

Two key topics we missed in this otherwise useful book: first, ethical approval is becoming more and more a pre-requisite for publication (Fletcher 2015). We certainly have submitted the paper work for a formal ethical review in the past just to be able to add a sentence in our paper that ‘ethical approval had been granted’. Secondly, it does not cover the issue of the review by IRBs of research proposals put forward by academics in their institutions but with fieldwork taking place abroad. Especially when the research is due to take place in low-income countries researchers must be made aware that IRB review in the US is not permit for conducting research abroad. They must be reminded that appropriate ethical approval needs to be sought in the host country (Regmi et al. 2016).

We feel that this book would be a guiding resource for researchers while developing a research protocol, particularly direction around developing consent forms (p. 52-55). Despite being very US-centric, this book is also useful for for sociologists of health and illness working elsewhere in the world.


References

REGMI, P.R., ARYAL, N., KURMI, O., PANT, P.R., VAN TEIJLINGEN, E. and WASTI, S.P. (2016) Informed consent in health research: challenges and barriers in low- and middle-income countries with specific reference to Nepal, Developing World Bioethics doi: 10.1111/dewb.12123. [Epub ahead of print]

FLETCHER, J. (2015) Ethical approval for all studies involving human participants, Canadian Medical Association Journal 187 (2): 91.