Suchergebnisse

Intro -- HUMAN SUBJECTS RESEARCH: PROTECTING PARTICIPANTS -- Library of Congress Cataloging-in-Publication Data -- CONTENTS -- PREFACE -- Chapter 1: MORAL SCIENCE: PROTECTING PARTICIPANTS IN HUMAN SUBJECTS RESEARCH -- ABOUT THE PRESIDENTIAL COMMISSION FOR THE STUDY OF BIOETHICAL ISSUES -- PRESIDENTIAL COMMISSION FOR THE STUDY OF BIOETHICAL ISSUES -- EXECUTIVE SUMMARY -- SECTION 1. INTRODUCTION -- SECTION 2: ASSESSING THE CURRENT SYSTEM -- SECTION 3. FURTHER ANALYSIS AND RECOMMENDATIONS -- COMMISSION RECOMMENDATIONS -- APPENDIX I. HUMAN SUBJECTS RESEARCH LANDSCAPE PROJECT:SCOPE AND VOLUME OF FEDERALLY SUPPORTED HUMAN SUBJECTSRESEARCH -- APPENDIX II. HUMAN SUBJECTS RESEARCH LANDSCAPEPROJECT METHODS -- APPENDIX III: US TREATMENT/COMPENSATIONFOR TREATMENT METHODS -- APPENDIX IV. INTERNATIONAL AND TRANSNATIONALREQUIREMENTS FOR TREATMENT AND COMPENSATION FORRESEARCH INJURIES -- APPENDIX V. INTERNATIONAL RESEARCH -- APPENDIX VI. GUEST SPEAKERS -- Chapter 2: CHALLENGES TO FDA'S ABILITY TO MONITOR AND INSPECT FOREIGN CLINICAL TRIALS -- EXECUTIVE SUMMARY -- AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL RESPONSE -- INTRODUCTION -- METHODOLOGY -- FINDINGS -- AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL RESPONSE -- APPENDIX A -- APPENDIX B -- APPENDIX C -- APPENDIX D -- INDEX.

"An engaging, compelling and disturbing confrontation with evil …a book that will be transformative in its call for individual and collective moral responsibility." - Michael A. Grodin, M.D., Professor and Director, Project on Medicine and the Holocaust, Elie Wiesel Center for Judaic Studies, Boston University Human Subjects Research after the Holocaust challenges you to confront the misguided medical ethics of the Third Reich personally, and to apply the lessons learned to contemporary human subjects research. While it is comforting to believe that Nazi physicians, nurses, and bioscientists were either incompetent, mad, or few in number, they were, in fact, the best in the world at the time, and the vast majority participated in the government program of "applied biology." They were not coerced to behave as they did-they enthusiastically exploited widely accepted eugenic theories to design horrendous medical experiments, gas chambers and euthanasia programs, which ultimately led to mass murder in the concentration camps. Americans provided financial support for their research, modeled their medical education and research after the Germans, and continued to perform unethical human subjects research even after the Nuremberg Doctors' Trial. The German Medical Association apologized in 2012 for the behavior of its physicians during the Third Reich. By examining the medical crimes of human subjects researchers during the Third Reich, you will naturally examine your own behavior and that of your colleagues, and perhaps ask yourself "If the best physicians and bioscientists of the early 20th century could do evil while believing they were doing good, can I be certain that I will never do the same?" · Presents relatively unknown aspects of human subjects research during the Third Reich · Reveals surprising relationships between German and American human subjects research · Dispels myths about Nazi human subjects research · Compels introspection and self-examination by today's medical and research practitioners · Addresses contemporary bioethical issues affecting vulnerable populations · Brings together experts in the history of medicine during the Third Reich and thoughtful new voices

Composed of scientific and technical experts and lay members, thousands of research ethics committees—Institutional Review Boards (IRBs) in the United States—must identify and assess the potential risks to human research subjects, and balance those risks against the potential benefits of the research. IRBs handle risk and its uncertainty by adopting a version of the precautionary principle. To assess scientific merit, IRBs use a tacit ``sanguinity principle,'' which treats uncertainty as inevitable, even desirable, in scientific progress. In balancing human subjects risks and scientific benefits, IRBs use uncertainty as a boundary-ordering device that allows the mediation of the science and ethics aspects of their decisions. One effect is the entangling of methodological and ethical review. Some have suggested these should be more clearly separated, but decisions by research ethics committees depend in part on the negotiating space created by incommensurable approaches to uncertainty.

This book is the 43rd in a series entitled 'Basic bioethics', and is intended to make work in bioethics accessible to a broad audience. This volume looks at the regulations safeguarding research involving human participants, and explores the legislative framework governing research in the US, in particular the 'Common Rule for the Protection of Human Subjects'. The reason for this focus is that there have been a number of proposed changes (described within the Advanced Notice for Proposed Rulemaking, or ANPRM) which aim to take a risk-based approach to targeting regulatory oversight, as well as modifying regulations to keep pace with research, particularly regarding multi-site trials and the challenges facing research involving use of biological specimens. One of the points made in the introduction is that at the time of writing (late 2013) little progress had been made in terms of this legislative review. Indeed, at the time of writing this review, the process is far from complete. The aim of the book, therefore, is to stimulate dialogue around the proposed changes.

Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated by federally required and supervised bureaucracies called 'institutional review boards' expected to apply bioethical principles in making decisions. Do - can - these administrative agencies do more harm than good? This book answers this fundamental but long-unasked question by consulting a critical experience - the law's learning about regulation - and by amassing the empirical evidence scattered around many literatures.