Must treatment be provided to subjects who acquire HIV during the course of a prevention study? An analysis of ethical foundation, regulation, and recent argumentation provides no basis for the obligation. We outline an alternative approach to the problem based on moral negotiation.

In few other areas of bioethical inquiry exists as close a connection between bioethical professional advice and policy development as is the case with HIV and AIDS. Historically, the reasons for this have much to do with one of the groups initially affected most severely by HIV and AIDS, namely well-educated middle-class gay men in developed countries. This particular group of people, highly sophisticated and used to political activism in its pursuit of civil rights-related objectives, engaged the medical profession as (...) well as regulatory agencies such as the US Food and Drug Administration, and legislators (more so in the USA than in other countries) in a number of bioethically interesting policy areas. Many of the controversies of the times were framed as civil rights and/or ethical disputes. The initial areas of concern and inquiry focused on: informed consent to HIV testing and trial participation, the confidentiality of HIV test results, access to trials as a means of access to experimental drugs, the length of time it took to get an experimental drug to the market approval stage, and end-of-life decision-making. This line-up of issues explains why AIDS has become such an interesting topic for bioethicists. Bioethicists concerned about the traditional breadand- butter themes of medical ethics themes of the doctor - patient relationship (e.g., Daniels, 1991; Boyd, 1992), as well as bioethicists more concerned about policy and regulatory issues in the drug research and approval process (e.g., Edgar & Rothman, 1990; Salisbury & Schechter, 1990), found research topics worthy of vigorous pursuit. No surprise, then, that HIV/AIDS led to a probably unprecedented number of books and articles in professional journals (Manuel et al., 1990). HIV/AIDS has become a permanent fixture in all major mainstream bioethics textbooks (e.g., Kuhse & Singer, 1998; Arras & Steinbock, 1999). Reference series in medicine, ethics and law provide for dedicated volumes on AIDS.1 Even specialist bioethics textbooks, for instance those directed at dentistry students, carry chapters on HIV/AIDS (Ozar & Sokol, 2002). 128 Udo Schuklenk AIDS, designated by the medical profession a pandemic lives up to its classification. It did not stop at the borders of developed countries. As one would expect of a primarily sexually transmitted illness in the age of globalisation, it spread rapidly across the globe. Indeed, in many countries it has become one of the main causes of death, as in sub- Saharan Africa (Shisana & Simbayi, 2002). Dramatic increases in the number of AIDS cases are predicted for many Eastern European countries as well as for the two most populous nations on earth, India and China. Some of the HIV/AIDS-related bioethical and policy issues of concern to developed countries remain the same for developing countries. However, in ethically important ways they are dwarfed by concerns over drug prices, intellectual property rights, and affordable access to essential AIDS drugs for the impoverished masses of infected people in such countries. Of increasing importance have become ethical issues pertaining to the ever-growing research industry associated with clinical trials undertaken in developing countries. Indeed, major funding initiatives both in the USA and UK have brought clinical research in developing countries into focus. Some have questioned whether this attention is appropriate, considering other bioethical problems of arguably greater importance to developing countries (Chadwick & Schuklenk, 2003). Standards of clinical care in a study, and after a trial has concluded, as well as community benefits and access to the trial regime after the trial’s conclusion remain contentious issues. It is worth noting that more often than not it was an AIDS-related trial or policy decision that led to a great deal of bioethical analysis, yet the issues discussed almost always have ramifications far beyond AIDS. For instance, decisions about the question of what (if any) standards of care failures in preventive trials (of HIV vaccines or microbicides) ought to receive have important implications for non-AIDS prevention trials. (shrink)

The purpose of this dissertation is to identify some of the most pressing problems in the dominant contemporary approach to research ethics, and to devise an alternative approach that avoids these problems. I contend that the fundamental ethical values invoked in human research are often appealed to in contradictory or ambiguous ways, or in ways that do not adequately capture or do not show an adequate understanding of the specific ethical concerns of human research. One significant problem in this domain (...) is that values for ethical research are often unreflectively imported from medical therapy, producing ill-suited guidelines that cannot capture the different ethical situations that arise in the context of research. Furthermore, ethical guidelines in this area are often not developed with a sufficient understanding of the deep philosophical issues that they invoke. I suggest that we can address these problems through examining the fundamental ethical concerns of research on a philosophical level. This method will reveal severe problems with the approach to two of the ethical values underlying research; beneficence and respect for autonomy (or respect for persons). Once the nature of these problems has been revealed, and with reference to ethical problems that typically arise in the domain of research, I construct a coherent philosophical foundation for research ethics, which both avoids these deep-seated problems and better captures the ethical issues that arise in the domain of human research. I argue that we need to radically depart from the values of beneficence and autonomy/respect for persons as they are currently understood in the guidelines. We need an idea of beneficence that is clearly distinct from that which is used in the therapeutic medical context from which this notion is currently drawn. I also contend that we need to move away from autonomy as a central value in research ethics. I posit an alternative choice-based approach to informed consent which is concerned both with respecting agents’ freedom of choice, and also with their wellbeing, as providing a good means of protecting and promoting the interests of the individual research subject. Although these two imperatives are often thought to clash on a fundamental level, I will show that, in research ethics, they can be reconciled with minimal conflict. Though this represents a departure from the ethics of medical therapy, this approach is far more suited to the context of research. This theoretical basis for informed consent can help to clarify the ethical problems that are specific to this domain and provide us with relevant ethical guidance in research ethics. (shrink)

This thesis discusses implications of framing bioethical concerns in international legal discourse. It starts from the observation that legal approaches to questions of bioethical relevance have become dominant frameworks for addressing many bioethical concerns at the international level. In particular, the UN General Assembly has long attempted to regulate human cloning processes through an international Convention. Similarly, UNESCO and the Council of Europe have both addressed a variety of bioethically relevant issues, such as the processing of human genetic data, the (...) ethics of research or organ transplantation within international legal standards. It is in the context of this strong connection between international law, international legal discourse and bioethics that this thesis seeks to analyse what exactly happens when issues of bioethical relevance are discussed within such a framework, how this affects the way bioethical issues are conceptualized, conceived of and dealt with, and, ultimately, how well-suited or successful international legal discourse is in its attempt to resolve current bioethical questions. Following the methodological approach of discourse theory, this thesis bases its analysis on the assumption that where and when international legal standards, as manifestations of an international legal discourse, serve as framework for bioethical debate that also somewhat defines how bioethically relevant issues are approached, thought of and dealt with within that framework, that it somewhat determines what methods are used to resolve such issues and that it somewhat limits the range of conceivable and viable solutions to these issue. The thesis thereby does not aim to demonise or abrogate legal approaches to bioethics and it does not understand the implications discussed in this thesis to be necessarily good or bad. To the contrary, it will be shown that legal approaches to bioethics can and have contributed to the development of the field in several important ways. Yet, this thesis also shows that it is worthwhile to closely examine implications that follow from a specific legal approach to bioethical issues as these implications are not always easily perceived. Given the important, and often dominant or near exclusive role of international law and legal discourse in the area of bioethics as well as the former's strong influence on bioethical debates as a whole, the implications of addressing questions of bioethical relevance within an international legal discourse should at least be understood and acknowledged, a contribution that this thesis aims to make. Moreover, only if these implications are understood is it possible to ask whether engaging in that type of discourse is at all a valuable enterprise and whether or not international legal standards directly addressed to questions of bioethical relevance constitute a suitable means to effectively address questions in the area of bioethics. (shrink)

Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, and (...) the Bill and Melinda Gates Foundation testing the safety and efficacy of tenofovir, an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials. (shrink)

The ethical challenge is squarely focused on the question of what is owed to participants of vaccine trials who happen to become infected during the course of the trial. Not surprisingly, given the prominence of HIV/AIDS in many parts of the developing world, HIV vaccine trials have become the focal point of this debate. It is worth noting from the outset, however, that the same arguments that apply to HIV vaccines would apply to any number of microbicide trials aimed at (...) protecting women against a large variety of sexually transmitted illnesses.1 One of the controversial questions in this debate has been the issue of whether or not an infection acquired by vaccine trial participants during the course of the trial can reasonably be considered a trial related injury that ought to be subject to compensation (in the form of access to good quality AIDS treatments, including antiretrovirals). (shrink)

We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an unde.

ABSTRACT Although considerable attention has been given to ethical issues related to clinical research in developing countries, in particular related to HIV therapy, there has been limited focus on health systems research, despite its increasing importance in the light of current trends in development assistance. This paper examines ethical issues related to health systems research in ‘post’‐conflict situations, addressing both generic issues for developing countries and those issues specific to ‘post’‐conflict societies, citing examples from the author’s Cambodian experience. It argues (...) that the destruction of health infrastructure results in a loss of structures and processes that would otherwise protect prospective research subjects who are part of vulnerable populations. It identifies the growth of health systems research as part of a trend towards sectoral and programmatic development assistance, the emergence of ‘knowledge generation’ as a form of research linked to development, and the potential for conflict where multilateral and bilateral donors are both primary funders and users of health systems research. It also examines the position of the health system researcher in relation to the sponsors of this research, and the health system being analysed. (shrink)