Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefits should be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert commentaries, written by many of the worlds leading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.

Examines the many ethical issues related to biomedical research, including the use of animals in research, research on human subjects, clinical trials, international research ethics policies, and other related topics.

@text:Biomedical Research and Beyond investigates the ethics of biomedical and scientific inquiry, including embryonic research, animal research, genetic enhancement, and fairness in research in the developing world. Core concerns of biomedical and scientific research ethics are then shown also to be key in humanistic areas of inquiry.

The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects applying ethical standards in local circumstances and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries and the implications for multinational or transnational research in which they may be partners.

When the editors of two of the most prominent medical journals in the world—the New England Journal of Medicine and the Journal of the American Medical Association (JAMA)—were fired in the same year, under circumstances that ranged from acrimonious to politically sensational, media attention again focused on biomedical publication. The controversy highlighted yet another ethical dimension of scientific research and its publication, topics that have generated intense scrutiny in recent years. As research funding has become scarcer and competition fiercer, with links between scientific discovery and commercial applications increasingly tighter and more lucrative, allegations of misconduct have also increased. Universities and research institutions, notably the NIH, have created offices of scientific integrity and mandated educational programs to investigate such allegations and to train researchers in the highest standards of sound, ethical scientific research. Focusing on publication ethics as an essential aspect of responsible scientific conduct, Ethical Issues in Biomedical Publication examines a variety of troublesome issues, including authorship, peer review, repetitive publication, conflict of interest, and electronic publishing. The contributors include the editors of distinguished biomedical journals (among them, past or present editors of Academic Medicine, Annals of Internal Medicine, British Medical Journal, JAMA, and the Lancet), humanities scholars, scientists, lawyers, and a university administrator. Chapters address specific ethical issues and offer recommendations for preventing or solving problems associated with them. The result is a book that will serve as a standard reference for biomedical researchers, authors, editors, and teachers of research ethics. "Educators, administrators, scientists, editors, and students should all welcome this comprehensive new book. Anne Hudson Jones and Faith McLellan have gathered a veritable who's who in the field of publication ethics for biomedical research. All those with a stake in biomedical research will surely want this volume on their bookshelf."—from the Foreword by Jordan J. Cohen, M.D., President, Association of American Medical Colleges