The author finds that these committees are predominantly influenced by members of research institutions and by the researchers themselves. Yet researchers, and their institutions, stand to gain considerable benefits from the experiments they conduct. Dr McNeill argues that committees of review, as they are presently constituted, cannot be relied on to ensure an equitable balance between the interests of researchers and the interests of the human subjects experimented on. He proposes a radically different rationale and model for committee review.
This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.
In the past few decades, scientists of human nature—including experimental and cognitive psychologists, neuroscientists, evolutionary theorists, and behavioral economists—have explored the way we arrive at moral judgments. They have called into question commonplaces about character and offered troubling explanations for various moral intuitions. Research like this may help explain what, in fact, we do and feel. But can it tell us what we ought to do or feel? In Experiments in Ethics, the philosopher Kwame Anthony Appiah explores how the new empirical moral psychology relates to the age-old project of philosophical ethics. Some moral theorists hold that the realm of morality must be autonomous of the sciences; others maintain that science undermines the authority of moral reasons. Appiah elaborates a vision of naturalism that resists both temptations. He traces an intellectual genealogy of the burgeoning discipline of "experimental philosophy," provides a balanced, lucid account of the work being done in this controversial and increasingly influential field, and offers a fresh way of thinking about ethics in the classical tradition. Appiah urges that the relation between empirical research and morality, now so often antagonistic, should be seen in terms of dialogue, not contest. And he shows how experimental philosophy, far from being something new, is actually as old as philosophy itself. Beyond illuminating debates about the connection between psychology and ethics, intuition and theory, his book helps us to rethink the very nature of the philosophical enterprise.
The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.
What does the birth of babies whose embryos had gone through genome editing mean--for science and for all of us? In November 2018, the world was shocked to learn that two babies had been born in China with DNA edited while they were embryos—as dramatic a development in genetics as the 1996 cloning of Dolly the sheep. In this book, Hank Greely, a leading authority on law and genetics, tells the fascinating story of this human experiment and its consequences. Greely explains what Chinese scientist He Jiankui did, how he did it, and how the public and other scientists learned about and reacted to this unprecedented genetic intervention. The two babies, nonidentical twin girls, were the first “CRISPR'd” people ever born (CRISPR, Clustered Regularly Interspaced Short Palindromic Repeats, is a powerful gene-editing method). Greely not only describes He's experiment and its public rollout (aided by a public relations adviser) but also considers, in a balanced and thoughtful way, the lessons to be drawn both from these CRISPR'd babies and, more broadly, from this kind of human DNA editing—“germline editing” that can be passed on from one generation to the next. Greely doesn't mince words, describing He's experiment as grossly reckless, irresponsible, immoral, and illegal. Although he sees no inherent or unmanageable barriers to human germline editing, he also sees very few good uses for it—other, less risky, technologies can achieve the same benefits. We should consider the implications carefully before we proceed.
Despite having been revised and criticised over the years, the Declaration of Helsinki remains one of the most important and internationally known ethics codes worldwide. Yet we know relatively little about its historical origins or about the prolonged revision process which accompanied this "living document". The chapters presented in this volume look at the history and theory of human experimentation, assess the role of the Helsinki Declaration in an international context, and illustrate specific issues about the history and practice of research ethics through a number of case studies in the United States, Asia and Europe. To this day, the Declaration is one of the most important landmarks in human subject research which is aimed at protecting experimental subjects in society. The current volume offers a better and historically-informed understanding of the Declaration to ensure that the existing safeguards are not only preserved but developed and improved in the future. Die 1964 veroffentlichte Deklaration zu Helsinki ist einer der wichtigsten und international bekanntesten Kodizes zur Forschungsethik, dessen Entstehungsgeschichte von steter Kritik und zahlreichen Uberarbeitungen begleitet wurde. Dennoch weiss man relativ wenig uber die historischen Wurzeln und Novellierungsprozesse dieses "gewachsenen Dokuments" der Medizingeschichte. Bis zum heutigen Tag ist die Deklaration einer der bedeutendsten Wegweiser fur die Forschung am Menschen, deren grundsatzliches Ziel es ist, Versuchspersonen in medizinischen Experimenten zu schutzen. Der Band beleuchtet Geschichte und Theorie der Experimente am Menschen, untersucht die Rolle der Deklaration im internationalen Kontext und illustriert spezifische Themen zur Geschichte und Praxis der Forschungsethik anhand von Fallstudien zu den USA, Asien und Europa. Ausserdem geben die Studien Einblick in die Entstehungsgeschichte der Deklaration - nicht nur um die bestehenden Standards zum Schutz von Versuchspersonen zu bewahren, sondern auch um diese zukunftig weiterzuentwickeln und zu verbessern. Aus dem Inhalt Ulf Schmidt / Andreas Frewer: History and Ehtics of Human Experimentation: the Twisted Road to Helsinki. An Introduction History and Theory of Medical Research Ethics Ulrich Trohler: The Long Road of Moral Concern: Doctors' Ethos and Statute Law Relating to Human Research in Europe Dietrich von Engelhardt: The Historical and Philosophical Background of Ethics in Clinical Research Ulf Schmidt: The Nuremberg Doctors' Trial and the Nuremberg Code Till Barnighausen: Communicating "Tainted Science" The Japanese Biological Warfare Experiments on Human Subjects in China The Helsinki Declaration in an International Context Susan E. Lederer: Research Without Borders: The Origins of the Declaration of Helsinki Povl Riis: Forty Years of the Declaration of Helsinki: Progress in Medical Ethics? Kati Myllymaki: Revising the Declaration of Helsinki: An Insiders' View Robert Carlson / Kenneth Boyd / David Webb: The Interpretation of Codes of Medical Ethics: Some Lessons from the Fifth Revision of the Declaration of Helsinki David Willcox: Medical Ethics and Public Perception: The Declaration of Helsinki and its Revisions in 2000 Dominique Sprumont / Sara Girardin / Trudo Lemmens: The Helsinki Declaration and the Law: An International and Comparative Analysis History and Ethics of Research - International Perspectives Andreas Frewer: History of Medicine and Ethics in Conflict: Research on National Socialism as Moral Problem Ulf Schmidt: Medical Ethics and Human Experiments at Porton Down: Informed Consent in Britain's Biological and Chemical Warfare Experiments John Williams: The Declaration of Helsinki. The Importance of Context Jonathan D. Moreno: Helsinki into the Future. An Epilogue Key Documents on the History of Research Ethics Circular of the Reich Minister of the Interior Concerning Guidelines for New Therapy and Human Experimentation (Berlin, 1931) - The Nuremberg Code (1947) - World Medical Association: Declaration of Helsinki I (1964) - World Medical Association: Declaration of Helsinki II (Tokyo, 1975) - Council of Europe: Convention on Human Rights and Biomedicine (Oviedo, 1997) - World Medical Association: Declaration of Helsinki (2004)
Studies on humans have saved countless lives, but sometimes harm participants. Research ethics committees currently monitor scientists, but have been increasingly criticized for blocking important research. How these committees work, however, is largely unknown. This book uniquely illuminates this hidden world that ultimately affects us all.
"Ethics boards have become obligatory passage points in today's medical science, and we forget how novel they really are. The use of humans in experiments is an age-old practice that records show goes back to at least the third century BC and, since the early modern period, as a practice it has become increasingly popular. Yet, in most countries around the world, hardly any formal checks and balances existed to govern the communal oversight of experiments involving human subjects until at least the 1960s. Ethics by Committee traces the rise of ethics boards for human experimentation in the second half of the twentieth century. Using the Netherlands as a case-study, Noortje Jacobs shows how the authority of physicians to make decisions about clinical research gave way in most developed nations to formal mechanisms of communal decision-making that served to regiment the behavior of individual researchers. This historically unprecedented change in scientific governance came out of a growing international wariness of medical research in the decades after World War II. Research ethics committees were originally intended not only to make human experimentation more ethical but also to raise its epistemic quality. By examining complex negotiations over the appropriate governance of human subjects research, Ethics by Committee advances our understanding not only of the history of research ethics and the randomized controlled trial but also, more broadly, of how liberal democracies in the late twentieth century have sought to resolve public concerns over charged issues in medicine and science"--
