Developing World Bioethics
April 2015 Volume 15, Issue 1 Pages ii–iii, 1–57
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2015.15.issue-1/issuetoc

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EDITORIAL
Empirical Research and Bioethics
Debora Diniz
Article first published online: 3 MAR 2015
DOI: 10.1111/dewb.12078
Extract
What counts as empirical evidence in bioethics? Differently from epidemiology or social sciences, bioethics is more argumentative than demonstrative, more normative than explanatory. Saying that, I am suggesting some parameters for the field: we need strong concepts, yet pieces of data. My provocative argument is that we should not import the epistemic criteria of what counts as data from epidemiology or social sciences to evaluate a contribution as relevant to bioethics. An ethical argument is more important than a long deep description of data…

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ARTICLE
Cultural Conundrums: The Ethics of Epidemiology and the Problems of Population in Implementing Pre-Exposure Prophylaxis
Kirk Fiereck*
Article first published online: 23 DEC 2013
DOI: 10.1111/dewb.12034
Abstract
The impending implementation of pre-exposure prophylaxis (PrEP) has prompted complicated bioethical and public health ethics concerns regarding the moral distribution of antiretroviral medications (ARVs) to ostensibly healthy populations as a form of HIV prevention when millions of HIV-positive people still lack access to ARVs globally. This manuscript argues that these questions are, in part, concerns over the ethics of the knowledge production practices of epidemiology. Questions of distribution, and their attendant cost-benefit calculations, will rely on a number of presupposed, and therefore, normatively cultural assumptions within the science of epidemiology specifically regarding the ability of epidemiologic surveillance to produce accurate maps of HIV throughout national populations. Specifically, ethical questions around PrEP will focus on who should receive ARVs given the fact that global demand will far exceed supply. Given that sexual transmission is one of the main modes of HIV transmission, these questions of ‘who’ are inextricably linked to knowledge about sexual personhood. As a result, the ethics of epidemiology, and how the epidemiology of HIV in particular conceives, classifies and constructs sexual populations will become a critical point of reflection and contestation for bioethicists, health activists, physicians, nurses, and researchers in the multi-disciplinary field of global health. This paper examines how cultural conundrums within the fields of bioethics and public health ethics are directly implicated within the ethics of PrEP, by analyzing the problems of population inaugurated by the construction of the men who have sex with men (MSM) epidemiologic category in the specific national context of South Africa.

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ARTICLE
Not Fit for Purpose: The Ethical Guidelines of the Indian Council of Medical Research
Priya Satalkar* and David Shaw
Article first published online: 8 NOV 2013
DOI: 10.1111/dewb.12036
Abstract
In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India.