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El. knyga: Ethics Police?: The Struggle to Make Human Research Safe

2.56/5 (18 ratings by Goodreads)
  • Formatas: 288 pages
  • Išleidimo metai: 16-Mar-2015
  • Leidėjas: Oxford University Press Inc
  • Kalba: eng
  • ISBN-13: 9780199364626
Kitos knygos pagal šią temą:
  • Formatas: 288 pages
  • Išleidimo metai: 16-Mar-2015
  • Leidėjas: Oxford University Press Inc
  • Kalba: eng
  • ISBN-13: 9780199364626
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Research on human beings saves countless lives, but has at times harmed the participants. To what degree then should government regulate science, and how? The horrors of Nazi concentration camp experiments and the egregious Tuskegee syphilis study led the US government, in 1974, to establish Research Ethics Committees, known as Institutional Review Boards (IRBs) to oversee research on humans. The US now has over 4,000 IRBs, which examine yearly tens of billions of dollars of research -- all studies on people involving diseases, from cancer to autism, and behavior. Yet ethical violations persist.

At the same time, critics have increasingly attacked these committees for delaying or blocking important studies. Partly, science is changing, and the current system has not kept up. Since the regulations were first conceived 40 years ago, research has burgeoned 30-fold. Studies often now include not a single university, but multiple institutions, and 40 separate IRBs thus need to approve a single project. One committee might approve a study quickly, while others require major changes, altering the scientific design, and making the comparison of data between sites difficult.

Crucial dilemmas thus emerge of whether the current system should be changed, and if so, how. Yet we must first understand the status quo to know how to improve it. Unfortunately, these committees operate behind closed doors, and have received relatively little in-depth investigation. Robert Klitzman thus interviewed 45 IRB leaders and members about how they make decisions. What he heard consistently surprised him.

This book reveals what Klitzman learned, providing rare glimpses into the conflicts and complexities these individuals face, defining science, assessing possible future risks and benefits of studies, and deciding how much to trust researchers -- illuminating, more broadly, how we view and interpret ethics in our lives today, and perceive and use power.

These committees reflect many of the most vital tensions of our time - concerning science and human values, individual freedom, government control, and industry greed. Ultimately, as patients, scientists, or subjects, the decisions of these men and women affect us all.

Recenzijos

The book succeeds in providing readers with an insight into a system that operates 'at complex intersections of science, politics, sociology, psychology, money and ethics'. Klitzman conveys how making human research safe is a difficult balancing act between the public's eagerness for treatments and the research community's propensity to respond. * Klaus Mitchell, Bionews.org.uk * In this intelligent, rigorous book, Robert Klitzman looks at the morality of morality-at how the bodies set up to protect research subjects can end up injuring us all. This examination of our confused notions of safety, honesty, and transparency demonstrates that none of these is simple, and that in striving toward any one, we easily betray the others. It is a book about how seeking to do the right thing can lead to justice, and about how equally often it fails to do so. * Andrew Solomon, author of The Noonday Demon and Far From The Tree * Few institutions in America are as powerful and yet as invisible to the public as scientific Institutional Review Boards (IRBs). In this important, pioneering book, Robert Klitzman details the challenges facing IRBs today and offers concrete proposals about how they might function better tomorrow. * Howard Gardner, Hobbs Professor of Cognition and Education, Harvard Graduate School of Education * In this intelligent, rigorous book, Robert Kiltzman looks at the morality of morality * at how the bodies set up to protect research subjects can end up injuring us all. This examination of our confused notions of safety, honesty, and transparency demonstrates that none of these is simple, and that in striving toward any one, we easily betray the others. It is a book about how seeking to do the right thing can lead to justice, and about how equally often it fails to do so.Daniel J. Kevles, Stanley Woodward Professor of History, Yale University * Protection of participants is an important * and inescapablepart of the contemporary world of research. In this sensitive exploration of the groups charged with that task, Robert Klitzman elucidates the complexities of human subjects protection and the reasons why it so often seems less-than-optimal. If we are ever to do better, we must begin with precisely this sort of in-depth appreciation of the challenge of balancing the advance of knowledge with the protection of our fellow human beings.Paul S. Appelbaum, MD, Elizabeth K. Dollard, Professor of Psychiatry, Medicine & Law, Columbia University * Robert Klitzman has opened wide the door on the arcane world of institutional review boards (IRBs) and interviewed their members, chairpersons and administrators. He reports on what they think about their own power and performance and their influence on the conduct of research. Based on these perspectives, Klitzman makes the case that IRBs should be shifted to a more humanistic model that recognizes the complex psychological, social and cultural forces that influence their decisions. This is an important insight into this little understood but essential institution. * Robert J. Levine, MD, Yale University *

PART I INTRODUCTION
Chapter 1 Protecting the People We Experiment On
3(32)
PART II WHO IRBs ARE
Chapter 2 "Inside the Black Box": Becoming and Being IRB Members
35(34)
PART III WHAT IRBs DO: THE CONTENTS OF IRB DECISIONS
Chapter 3 Weighing Risks and Benefits, and Undue Inducement
69(29)
Chapter 4 Defining Research and How Good It Needs to Be
98(19)
Chapter 5 What to Tell Subjects: Battles over Consent Forms
117(25)
Chapter 6 From "Nitpicky" to "User-Friendly": Inter-IRB Variations and Their Causes
142(29)
PART IV IRBs VS. INSTITUTIONS: THE CONTEXTS OF DECISIONS
Chapter 7 Federal Agencies vs. Local IRBs
171(21)
Chapter 8 The Roles of Industry
192(20)
Chapter 9 The Local Ecologies of Institutions
212(29)
PART V IRBs VS. RESEARCHERS
Chapter 10 Trusting vs. Policing Researchers
241(30)
Chapter 11 Bad Behavior: Research Integrity
271(31)
Chapter 12 Researchers Abroad: Studies in the Developing World
302(21)
PART VI THE FUTURE
Chapter 13 Changing National Policies
323(28)
Chapter 14 Conclusions: Other Changes
351(20)
APPENDICES
Appendix A Additional Methodological Information
371(3)
Appendix B Sample Semistructured Interview Questions
374(5)
Appendix C Acronyms
379(2)
Sources 381(2)
Acknowledgments 383(2)
Notes 385(30)
Index 415
Robert Klitzman, MD, is a Professor of Clinical Psychiatry in the College of Physicians and Surgeons and the Joseph Mailman School of Public Health, and the Director of the Masters of Bioethics Program at Columbia University. He has conducted research and written about a variety of bioethical issues, and has authored or co-authored over 100 articles, and seven books, including Am I My Genes?: Confronting Fate and Family Secrets in the Age of Genetic Testing; When Doctors Become Patients; Mortal Secrets: Truth and Lies in the Age of AIDS; Being Positive; A Year-long Night: Tales of a Medical Internship; The Trembling Mountain: A Personal Account of Kuru, Cannibals, and Mad Cow Disease; and In a House of Dreams and Glass: Becoming a Psychiatrist. His work has appeared in JAMA, Science, and elsewhere, and also has written for the New York Times, Newsweek, The Nation, and other publications.