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Beyond Regulation. Ethics in Human Subject Research
  1. Josephine Wong
  1. Department of Psychiatry, University of Hong Kong

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    Edited by Nancy M P King, Gail E Henderson and Jane Stein, Chapel Hill, The University of North Carolina Press, 1999, 279 pages, US$ 39.95, (hc) US$18.95 (sc).

    This book challenges traditional approaches to research ethics based on moral principles and advocates a new, relationship-based paradigm for research ethics. The book begins with an explanation of the editors' reservations about the principalist approach pervading current regulations governing research. The editors' concerns are three-fold. First, they cite the continuing errors and abuse of human subjects of research in America despite federal regulations. Secondly, they argue that American regulations, grounded in the principles of autonomy, beneficence and justice, should not be applied in all cultures. Finally, the editors argue that regulation is not the answer to all ethical questions concerning human subject research. In contrast with traditional approaches, the relationships paradigm emphasises relationships, interactions, power, responsibility and contextual and historical considerations in examining moral issues.

    This book has a case-plus-commentaries approach. Six cases, from different disciplines and with different research methods, are selected to illustrate the relationships paradigm. The first case is one in which an anthropologist had to sign a contract with community representatives before he could engage in ethnographic research. The following commentaries discuss the implications of such a contract on the researcher-community relationship and whether it undermines academic freedom. The second case is about “community research” on people at risk of HIV/AIDS in order to assess and enlist cooperation for future HIV vaccine trials. But how can a community be defined? What should be the role of a community advisory board? Who should be on it? The third case is concerned with corporate sponsorship of research on infant feeding, focusing on issues of bias and potential conflicts of interest. The fourth case is about research on induced abortion in Argentina, where terminations of pregnancy are illegal except where the life of the mother is at risk or where the pregnancy has resulted from a rape. The research described in the case wishes to address whether the fear of the illegality of abortion leads to delays in obtaining treatment for the complications of abortion. Because the study focuses on illicit behaviour, it presents ethical questions concerning recruitment of participants, what information to provide regarding the research, how information should be gathered and prevention of harm to participants. The fifth case concerns research on child abuse, in which commentators discuss ethical dilemmas concerning confidentiality v duty to inform, and the universality of concepts of child abuse and different national regulations regarding disclosure of abuse. Case six is a case of emergency medicine research where the general requirements for informed consent are waived, being replaced by “consultation with representatives of the communities from which the subjects will be drawn”. Commentators on the case express numerous reservations about this approach, with particular focus on the problem of identifying valid representatives, and the power imbalance between potential participants, researcher and funders. All the case discussions include some discussion of whether and how a relationships paradigm may be useful in the consideration of ethical dilemmas raised by these examples.

    This book clearly illustrates the importance of a relationship-based perspective to research ethics as a necessary complement to the principalist paradigm. The editors go further, in saying that the relationships paradigm is normative in its own right and is independent of principalism. I am not convinced by this position. Relationships are important but they have to be considered within a framework of principles. As Ruth Macklin eloquently states in her keynote essay “Is ethics universal?”, which appears in the first half of the book, principles are not just about procedures and application of rules, for example as laid down by institutional review boards or research ethics committees. Certain moral principles are universal, transcending national boundaries, traditions and local custom. They provide an essential framework of moral analysis, even when the focus is on relationships and the context of that research.

    The case-plus-commentaries approach works well in illustrating issues and dilemmas because the cases provide concrete examples on which arguments are based. I would recommend this book to social science and biomedical science researchers and general readers with an interest in research ethics.

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