ETHICS IN BIOMEDICAL RESEARCH potx

[...]...This page intentionally left blank FOREWORD WHY BOTHER WITH ETHICS IN BIOMEDICAL RESEARCH? Biomedical research from pioneering investigations of molecular and cellular functions to Phase III clinical trials of new medicines—is inherently interesting, fascinating at a scientific level It is of immense importance to human life and well-being These are reasons enough to explain why scholars, policymakers... infectious diseases, especially HIV/AIDS, as a signs of global instability and global threats; (3) HIV/AIDS as influential in changing ethical attitudes towards research on vulnerable subjects; (4) Some persisting controversies in international clinical research; (5) The standard of care for participants in international research ethics; and the (6) Potential for new perspectives on the ethics of international... where the research is being undertaken.21 Informed consent is one of the major underlying principles of research If we believe all that we say and claim about informed consent, we would ensure that researchers of the same culture and language group as the research subjects obtain the consent In reality, having highly trained people obtaining informed consent is rare A multi-page translation of an informed... the use of placebos in trials of treatments to prevent mother-to-child transmission of HIV excited an intense, ongoing, and often acrimonious debate In reviewing persisting controversies in international research ethics, Ruth Macklin has described general agreement on the following points: (1) Research should be responsive to the needs of people in the community we study (2) We need research on diseases... overseas investigators (developing country partners) increased by 444 percent between 1992 and 1998 This growth in clinical research and in collaboration with colleagues in the developing world results from several factors First, investigators have a greater dependence on the pharmaceutical industry for funding, and most universities in the developed and developing world receive inadequate funding to... For anyone interested in understanding the most important contemporary ethical issues in biomedical research, this volume is essential reading Alexander Morgan Capron, Director Department of Ethics, Trade, Human Rights and Health Law World Health Organization Genève, Switzerland August 2005 PREFACE On 21–23 August 2003, an international symposium was held in Helsinki on Ethics in Biomedical Research. .. Macklin, “After Helsinki: Unresolved Issues in International Research, ” Kennedy Institute of Ethics Journal, 11:1 (2001), pp 17–36 17 Ibid 18 Alex J London, “The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Arguments in International Research, ” Journal of Medicine and Philosophy, 25:4 (2000), pp 379–397; and Alex J London, “Equipoise and International HumanSubjects Research, ” Bioethics,... that researchers were not treating subjects in the developing world with the same respect and dignity as subjects in wealthier countries They contended that this represented a double standard in the ethics of research Under critical scrutiny, the validity of this argument was found to be too simplistic.18 Critics have also argued that a real interest in applying the same standard of care in developing... stimulated intense debate on ethical issues—from the micro level of interpersonal relations to the ethics of national relations with transnational pharmaceutical companies, and the ethics of international relations that affect population health—is not surprising 5 Persisting Controversies in International Clinical Research Much of the recent controversy on research ethics has arisen from research on... Even in these cases, though, considerations of autonomy should prevent us from blaming people if they fail to act in ways we view as moral In chapter thirteen, Elma Lourdes Campos Pavone Zoboli creates an analytical framework for assessing vulnerability in biomedical research Her starting point is in a historical model originally produced to evaluate the different policies of protecting and empowering . WITH ETHICS IN BIOMEDICAL RESEARCH? Biomedical research from pioneering investigations of molecular and cellu- lar functions to Phase III clinical trials of new medicines—is inherently inter- esting,. having in mind the needs of these countries. In chapter four, Leo Pessini and Leonard M. Martin provide an optimistic view of the development of research ethics in one so-called developing. framework for assessing vulnerability in biomedical research. Her start- ing point is in a historical model originally produced to evaluate the different policies of protecting and empowering persons