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This volume captures the recent changes and evolution in ethics in research involving humans and provides future directions to achieve alternative drug development strategies for equitable global health. It presents ethical considerations in current day clinical trials and new trends of ethics in research. It also describes the historical context, illustrates the process in alternative paradigms to achieve democracy after World War II, how the framework of ethics in research was established in different regions, and policies implemented to protect research participants from the exploitation of new drug development. The book is organized into three themed parts: relevant constructions from Brazil, South Africa, Taiwan, South Korea, and Japan; historical and international perspectives of principles of ethics in research; and alternative frameworks of clinical development and innovation. Ethical Innovation for Global Health: Pandemic, Democracy and Ethics in Research is an informative resource for academic researchers, the global pharmaceutical industry, regulators, civil society and other role players involved in global health. It is contributed to by leaders in global policy development in research ethics, and experts in drug development activities with its trajectory being global health. The COVID-19 pandemic, as a global disaster, necessitated not only socio-economic but also cultural transformation. While effective vaccines were developed under a successful new methodology, there remains inequity of distribution of these vaccines globally. The book re-engages with the notion of the primacy of distributing results of scientific innovation to those who most require the benefits.

The untold history of America's mid-twentieth-century program of hepatitis infection research, its scientists'aspirations, and the damage the project caused human subjects From 1942 through 1972, American biomedical researchers deliberately infected people with hepatitis. Government-sponsored researchers were attempting to discover the basic features of the disease and the viruses causing it, and to develop interventions that would quell recurring outbreaks. Drawing from extensive archival research and in-person interviews, Sydney Halpern traces the hepatitis program from its origins in World War II through its expansion during the initial Cold War years, to its demise in the early 1970s amid an outcry over research abuse. The subjects in hepatitis studies were members of stigmatized groups—conscientious objectors, prison inmates, the mentally ill, and developmentally disabled adults and children. The book reveals how researchers invoked military and scientific imperatives and the rhetoric of a common good to win support for the experiments and access to recruits. Halpern examines the participants'long-term health consequences and raises troubling questions about hazardous human experiments aimed at controlling today's epidemic diseases.

At the heart of research with human beings is the moral notion that the experimental subject is altruistic, and is primarily concerned for the welfare of others. Beneath the surface, however, lies a very different ethical picture. Individuals participating in potentially life-saving research sometimes take on considerable risks to their own well-being. Efforts to safeguard human participants in clinical trials have intensified ever since the first version of the World Medical Association's Declaration of Helsinki (1964) and are now codified in many national and international laws and regulations. However, a comprehensive understanding of how this cornerstone document originated, changed, and functions today does not yet exist in the sphere of human research. Ethical Research brings together the work of leading experts from the fields of bioethics, health and medical law, the medical humanities, biomedicine, the medical sciences, philosophy, and history. Together, they focus on the centrality of the Declaration of Helsinki to the protection of human subjects involved in experimentation in an increasingly complex industry and in the government-funded global research environment. The volume's historical and contemporary perspectives on human research address a series of fundamental questions: Is our current human protection regime adequately equipped to deal with new ethical challenges resulting from advances in high-tech biomedical science? How important has the Declaration been in non-Western regions, for example in Eastern Europe, Africa, China, and South America? Why has the bureaucratization of regulation led to calls to pay greater attention to professional responsibility? Ethical Research offers insight into the way in which philosophy, politics, economics, law, science, culture, and society have shaped, and continue to shape, the ideas and practices of human research.

This book reprints Human Guinea Pigs, by Kenneth Mellanby, a seminal work in the history of medical ethics and human subject research that has been nearly unavailable for over 40 years. Detailing the use of World War II conscientious objectors who volunteered for experimentation on scabies transmission, Mellanby's book offers insight into one approach to human subject experimentation before the development of ethical oversight regulations. His work was initially published prior to the articulation of the Nuremberg Code, which makes his subsequent position as a reporter for the British Medical Journal at the Nuremberg Trials very interesting, particularly given his sometimes controversial opinions on Nazi medical experimentation. This book reprints the second edition together with commentary essays that situate Mellanby's ethical approach in historical context and relative to contemporary approaches. This volume is of particular interest to scholars of the historyof human subject research.

Helping human research protection program professionals create, implement, and evaluate quality assurance/quality improvement programs.Quality Assurance and Quality Improvement Handbook for Human Research is the first comprehensively designed instructional manual aimed at teaching human research protection program (HRPP) professionals how to create, implement, evaluate, and improve QA/QI programs. Geared toward institutions and individuals responsible for establishing new QA/QI programs or functions, the book offers several organizational models for consideration. It also provides practical information for improving and strengthening established programs, both big and small.Written in a conversational style, the book's step-by-step instructions make it easily accessible to those who may not be well versed in QA/QI concepts and fundamentals. Developed by the QA/QI Subcommittee of the Harvard Catalyst Regulatory Foundations, Ethics, and Law Program, which is committed to designing and strengthening QA/QI programs and functions, this volume• includes contributions by fifteen experts with diverse professional experiences from varied organizations • is enhanced with flow charts, examples, sample forms, and templates• incorporates model slide presentations and instructional materials• discusses the respective benefits and challenges of different organizational models• is applicable across many organizational types with a variety of reporting structures and available resources, including academic and medical institutionsPerfect for both seasoned personnel and newcomers to the field, Quality Assurance and Quality Improvement Handbook for Human Research is a needed resource for ensuring investigative accountability.Contributors: Hila Bernstein, MS, MPH, Barbara E. Bierer, MD, Elizabeth Bowie, JD, MPH, MSc, Susan Corl, MSW, MPH, CIP, CCRP, Jacquelyn-My Do, MPH, Lisa Gabel, CIP, Alyssa Gateman, MPH, CCRP, Jennifer A. Graf, Nareg D. Grigorian, Leslie M. Howes, MPH, CIP, Jennifer Hutchinson, CIP, CPIA, Cynthia Monahan, MBA, CIP, Eunice Newbert, MPH, Sarah A. White, MPH, CIP, Elizabeth Witte, MFA

A clássica biografia sobre o médico mais infame que a humanidade já conheceu. Chefe do serviço médico do campo de concentração de Auschwitz entre 1943 e 1945, Mengele usou prisioneiros como cobaias humanas em experimentos pseudocientíficos, com os quais buscava comprovar suas teses sobre a superioridade da raça ariana. O grande diferencial dessa obra sobre o'Anjo da Morte de Auschwitz'é que o único filho do médico nazista deu aos autores acesso irrestrito a mais de 5 mil páginas de diários, cartas e anotações particulares de seu pai, de 1945 até sua morte, em 1979, em Bertioga, no litoral paulista. Além disso, um dos autores – Gerald Posner – já havia reunido, no início dos anos 80, o maior arquivo particular de documentos e entrevistas sobre o Mengele. Escrito de forma ágil, tal como uma obra de jornalismo investigativo com um toque de novela policial, o livro traz uma narrativa arrebatadora sobre a vida de um dos fugitivos mais procurados da Segunda Guerra Mundial.

When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research results—such as results with unknown validity—and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholders—investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participants—and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

The aim of this book is to describe the methodology of conducting the THEDRE research'Traceable Human Experiment Design Research'. It applies to Research in Human Centered Informatics (RICH). These are areas of computer research that integrate users to build scientific knowledge and supporting tools for this research. As an example, we can mention the relevant fields such as Information Systems (IS), Human Machine Interfaces (HMI) Engineering, and Human Information Systems (HIA). The construction of this language and method is based on experiments conducted since 2008 in the field of RICH.

Patients with cancer and AIDS now clamor for access to clinical trials. Federal policies governing research that once emphasized protecting subjects from dangerous research now promote access to clinical research. Have claims about justice and access to the benefits of research eclipsed concerns about consent and protection from risks? How can we make good and fair decisions about the selection of subjects and other questions of justice in research? Beyond Consent examines the concept of justice and its application to human subject research through the different lenses of important research populations: children, the vulnerable sick, captive and convenient populations, women, people of color, and subjects in international settings. To set the stage for this examination, and introductory chapter addresses the evolution of research policies. After a look at specific subject populations, the authors discuss the concept of justice for research with human subjects in the future and analyze justice throughout the research enterprise.

Between 1942 and 1975, the U.S. Army conducted tests on human subjects to study the effects of a variety of agents, including chemical warfare agents, biological agents, medications, vaccines, and other substances. The tests investigated the immediate or short-term health effects from acute exposure to understand vulnerabilities to attack. Whether the exposures could have resulted in long-term health consequences to the test subjects has been assessed periodically, and the Army is required to notify subjects of information relating to potential health effects associated with exposure to the test agents. Most recently, a 2016 court injunction directed the Army to provide test subjects with new information about potential long-term health effects associated with their exposures, and to provide medical care if an injury or illness could be attributed to their participation in an Army chemical or biological testing program. In support of the first requirement, the Army contracted a report, Assessment of Potential Long-Term Health Effects on Army Human Test Subjects of Relevant Biological and Chemical Agents, Drugs, Medications and Substances: Literature Review and Analysis (the Report), to determine whether new information published since 2006 should be provided to the veterans. At the request of the Army, the National Academies of Sciences, Engineering, and Medicine formed an ad hoc committee that was tasked with conducting an independent review of the Report. The committee assessed whether the Report appropriately identified potential long-term health effects that could have resulted from test exposures using an adequate weight-of-evidence approach. The general approach for evaluating agent- and outcome-specific associations as outlined in the Army Memorandum was also reviewed. An interim report of its overarching findings and their supporting evidence was prepared in February 2018. This final report provides additional detail about the basis of the committee's findings and recommendations. No new findings or recommendations have been added to this report.

Between 1942 and 1975, the U.S. Army conducted tests with human subjects to study the effects of a variety of agents, including chemical warfare and biological agents. The potential long-term health effects on the test subjects from their exposures have been evaluated periodically, most recently in a report titled Assessment of Potential Long-Term Health Effects on Army Human Test Subjects of Relevant Biological and Chemical Agents, Drugs, Medications and Substances: Literature Review and Analysis (the Report), which was prepared by a contractor to assist the Army with making determinations about providing medical care to former test subjects. In response to a request by the Army, the National Academies of Sciences, Engineering, and Medicine formed a committee that was tasked with examining whether the Report appropriately identified potential long-term health effects from exposure to the test agents and whether an adequate weight-of-evidence approach was used to characterize the strength of the associations between the agents and their potential health effects. The committee was made aware at its first meeting on November 30, 2017, that the Army had already begun to receive applications for medical care and that some determinations may need to be made before the committee's evaluation of the Report was completed. Because of this urgency, the Army developed a process by which applications for medical care will be reviewed, and as a result, the committee was given the additional task of reviewing the Army's Memorandum that describes the approach that will be used by the Army to evaluate agent- and outcome-specific associations. This interim report was prepared to facilitate the Army's deliberations. A review of the Report is presented first, followed by a review of the Memorandum.

Two well-known Princeton alumni at last reveal the true inside story of how they got caught up in and nearly done in by the CIA's LSD-laced deep hypnosis research while they were Princeton students in the late 1960's. Reminiscent in some respects of A Beautiful Mind, the Princeton setting and the artificial, hypnotically induced schizophrenic states for experimental psychological research are the basis for exploring the actual psychiatrists and psychologists involved as well as their student'guinea pigs.'Princeton and the now-defunct New Jersey Neuro-Psychiatric Institute (NJNPI) were just two of 86 American institutions (incuding universities and hospitals) engaged in almost 150 top secret mind-control research projects funded by the CIA. The authors worked at NJNPI in deep hypnosis research while attending the waning days of Princeton as an all-male university before Princeton went coed. This is also an intense love story reawakening the rebellious wild spirit of those early days of the Psychedelic Revolution. The true story, which vivifies the beginning of the'psychedelic era,'unfolds as to how the authors'naive and well-intentioned participation warped their intimate lives at a formative stage of their development and nearly cost them their personal identities.

An important contribution in the burgeoning literature relating to the delivery of medical care, and to the broader question of responsible decision-making in those social areas where tragic choices have to be made. The effort is an excellent example of research into, and therapy for, an important social process.

The 2014–2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014–2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014–2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014–2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

So much to read, so little time? This brief overview of Stiff tells you what you need to know—before or after you read Mary Roach's book. Crafted and edited with care, Worth Books set the standard for quality and give you the tools you need to be a well-informed reader. This short summary and analysis of Stiff: The Curious Lives of Human Cadavers by Mary Roach includes: Historical contextChapter-by-chapter summariesProfiles of the characters and placesImportant quotesFascinating triviaGlossary of termsSupporting material to enhance your understanding of the original work About Stiff: The Curious Lives of Human Cadavers by Mary Roach: Acclaimed journalist Mary Roach's bestselling book Stiff offers an inside look through the through the weird world of human cadavers. This globe-spanning story is deeply informative, surprisingly funny, and occasionally disgusting. These “superheroes,” as Roach refers to them, brave high-speed car crashes, gunshots, decomposition in the sun, and other indignities all in the name of advancing science and making life better for the living. The summary and analysis in this ebook are intended to complement your reading experience and bring you closer to a great work of nonfiction.

When is a human study ethical? For years, science and society have struggled with this question. Experts have put great effort into developing ethical principles and rules that adequately protect and respect volunteers in studies aimed at improving human health. But experts have missed something important. They have created a research ethics system without the help of people who know what it is like to be a research subject. This is a serious omission. Experienced research subjects can make valuable contributions to research ethics. People who have been in studies have information about the experience that other people can overlook. Their experience as subjects gives them special insights into ethics, too. Experienced subjects also know about problems that can lead people to refuse to join studies, or drop out before studies are complete. Scientists and ethicists often speak of subjects as partners in research, but the reality is quite different. Experienced subjects are rarely appointed to the advisory groups that create guidelines for ethical research, or to the committees that review individual studies to determine whether they meet ethical and regulatory standards. A large body of work describes the perceptions and viewpoints of people who have participated in research. But experts rarely use this material to guide improvements in human subject protection. Although subjects have the power to decide whether to participate in a study, they have little control over anything else that goes on in research. Silent Partners moves research subjects to the forefront. It examines what research participation is like for healthy volunteers and patients. It explains why subjects'voices should influence research ethics. Silent Partners shows how experienced research subjects can become real-not just symbolic-partners in research.

Designing and conducting experiments involving human participants requires a skillset different from that needed for statistically analyzing the resulting data. The Design and Conduct of Meaningful Experiments Involving Human Participants combines an introduction to scientific culture and ethical mores with specific experimental design and procedural content. Author R. Barker Bausell assumes no statistical background on the part of the reader, resulting in a highly accessible text. Clear instructions are provided on topics ranging from the selection of a societally important outcome variable to potentially efficacious interventions to the conduct of the experiment itself. Early chapters introduce the concept of experimental design in an intuitive manner involving both hypothetical and real-life examples of how people make causal inferences. The fundamentals of formal experimentation, randomization, and the use of control groups are introduced in the same manner, followed by the presentation and explanation of common (and later, more advanced) designs. Replete with synopses of examples from the journal literature and supplemented by 25 experimental principles, this book is designed to serve as an interdisciplinary supplementary text for research-methods courses in the educational, psychological, behavioral, social, and health sciences. It also serves as an excellent primary text for methods seminar courses.

While the coerced human experiments are notorious among all the atrocities under National Socialism, they have been marginalised by mainstream historians. This book seeks to remedy the marginalisation, and to place the experiments in the context of the broad history of National Socialism and the Holocaust. Paul Weindling bases this study on the reconstruction of a victim group through individual victims'life histories, and by weaving the victims'experiences collectively together in terms of different groupings, especially gender, ethnicity and religion, age, and nationality. The timing of the experiments, where they occurred, how many victims there were, and who they were, is analysed, as are hitherto under-researched aspects such as Nazi anatomy and executions. The experiments are also linked, more broadly, to major elements in the dynamic and fluid Nazi power structure and the implementation of racial policies. The approach is informed by social history from below, exploring both the rationales and motives of perpetrators, but assessing these critically in the light of victim narratives.

From the early 1990s, allegations that servicemen had been duped into taking part in trials with toxic agents at top-secret Allied research facilities throughout the twentieth century featured with ever greater frequency in the media. In Britain, a whole army of over 21,000 soldiers had participated in secret experiments between 1939 and 1989. Some remembered their stay as harmless, but there were many for whom the experience had been all but pleasant, sometimes harmful, and in isolated cases deadly. Secret Science traces, for the first time, the history of chemical and biological weapons research by the former Allied powers, particularly in Britain, the United States, and Canada. It charts the ethical trajectory and culture of military science, from its initial development in response to Germany's first use of chemical weapons in the First World War to the ongoing attempts by the international community to ban these types of weapons once and for all. It asks whether Allied and especially British warfare trials were ethical, safe, and justified within the prevailing conditions and values of the time. By doing so, it helps to explain the complex dynamics in top-secret Allied research establishments: the desire and ability of the chemical and biological warfare corps, largely comprised of military officials, scientists, and expert civil servants, to construct and identify a never-ending stream of national security threats which served as flexible justification strategies for the allocation of enormous resources to conducting experimental research with some of the most deadly agents known to man. Secret Science offers a nuanced, non-judgemental analysis of the contributions made by servicemen, scientists, and civil servants to military research in Britain and elsewhere, not as passive, helpless victims'without voices', or as laboratory and desk perpetrators'without a conscience', but as history's actors and agents of their own destiny. As such it also makes an important contribution to the burgeoning literature on the history and culture of memory.

La Seconde guerre mondiale n'a pas dérogé à l'apparition d'innovations, notamment sur le plan médical, au prix parfois de vies humaines perdues au cours d'expérimentations très discutables. L'infiniment petit semble avoir joué un rôle inattendu dans le déroulement des évènements. Amphétamines, expérimentations médicales douteuses, projet de guerre bactériologique sans parler de l'atome et de ses conséquences dévastatrices sur le Japon, les nazis ont-ils été les seuls criminels de cette guerre?

The Experiment Must Continue is a beautifully articulated ethnographic history of medical experimentation in East Africa from 1940 through 2014. In it, Melissa Graboyes combines her training in public health and in history to treat her subject with the dual sensitivities of a medical ethicist and a fine historian. She breathes life into the fascinating histories of research on human subjects, elucidating the hopes of the interventionists and the experiences of the putative beneficiaries. Historical case studies highlight failed attempts to eliminate tropical diseases, while modern examples delve into ongoing malaria and HIV/AIDS research. Collectively, these show how East Africans have perceived research differently than researchers do and that the active participation of subjects led to the creation of a hybrid ethical form. By writing an ethnography of the past and a history of the present, Graboyes casts medical experimentation in a new light, and makes the resounding case that we must readjust our dominant ideas of consent, participation, and exploitation. With global implications, this lively book is as relevant for scholars as it is for anyone invested in the place of medicine in society.

This widely adopted textbook provides the essential content and skill-building tools for teaching the responsible conduct of scientific research. Scientific Integrity covers the breadth of concerns faced by scientists: protection of animal and human experimental subjects, scientific publication, intellectual property, conflict of interest, collaboration, record keeping, mentoring, and the social and ethical responsibilities of scientists. Learning activities and resources designed to elucidate the principles of Scientific Integrity include Dozens of highly relevant, interactive case studies for discussion in class or online Numerous print and online resources covering the newest research guidelines, regulations, mandates and policies Discussion questions, role-playing exercises, and survey tools to promote critical thought Documents including published rules of conduct, sample experimentation protocols, and patent applications The new edition of Scientific Integrity responds to significant recent changes—new mandates, policies, laws, and other developments—in the field of responsible conduct of research. Dr. Macrina plants the seeds of awareness of existing, changing, and emerging standards in scientific conduct and provides the tools to promote critical thinking in the use of that information. Scientific Integrity is the original turnkey text to guide the next generations of scientists as well as practicing researchers in the essential skills and approaches for the responsible conduct of science.

This book provides a history and discussion of the use of human tissues as an alternative to animal-based testing for assessing the efficacy and safety of new medicines. Beginning by providing a historical background to animal-based testing, this text then describes in detail the issues relating to access to human cells and tissue and the rules and regulations governing their use. The book illustrates what is currently possible in humanising medicines research and development, and suggests more rational and reliable means of developing safe and effective drugs for the future than those on which we currently rely. Early chapters establish the need to generate more data in human-derived test systems, and the need for resources such as tissue banks and standardised processes whilst highlighting the barriers that have prevented such developments so far. Subsequent chapters explore the alternatives to current animal toxicology studies, including stem cells and computational models, with balanced views of the technical challenges and opportunities these offer. In addition, useful information on computational methods and pharmacokinetics are included. This book is an essential read for anyone engaged in translational drug discovery who wishes to consolidate their understanding and broaden their awareness of the key issues involved in accessing primary human tissue and the advantages of doing so.

“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 UniversityHuman 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?'

On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary focuses on six broad topic areas: 1. Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions. 2. The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm, because the ANPRM asks for input on calibration of levels of review to levels of risk. 3. The consent process and special populations, because new rules have been proposed to improve informed consent (e.g., standard consent form, consent for future uses of biospecimens, and re-consenting for further use of existing research data). 4. Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data. 5. Multidisciplinary and multisite studies, because the ANPRM proposed a revision to the regulations that would allow multisite studies to be covered by a single IRB. 6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight.

This book brings together a range of academic, industry and practitioner perspectives on translational medicine (TM). It enhances conceptual and practical understanding of the emergence and progress of the field and its potential impact on basic research, therapeutic development, and institutional infrastructure. In recognition of the various impli

Medical research involving human subjects has contributed to considerable advancements in our knowledge, and to medical benefits. At the same time the development of new technologies as well as further globalisation of medical research raises questions that require the attention of researchers from a range of disciplines. This book gathers the contributions of researchers from nine different countries, who analyse recent developments in medical research from ethical, historical, legal and socio-cultural perspectives. In addition to reflections on innovations in science such as genetic databases and the concept of “targeted therapy” the book also includes analyses regarding the ethico-legal regulation of new technologies such as human tissue banking or the handling of genetic information potentially relevant for participants in medical research. Country and culture-specific aspects that are relevant to human medical research from a global perspective also play a part. The value of multi- and interdisciplinary analysis that includes the perspectives of scholars from normative and empirical disciplines is a shared premise of each contribution.

Clinical research requires that some people be used and possibly harmed for the benefit of others. What justifies such use of people? This book provides an in-depth philosophical analysis of several crucial issues raised by that question. Much writing on the ethics of research with human subjects assumes that participation in research is a distinctive activity that requires distinctive moral principles. In most contexts, we allow people to choose the activities in which they engage. By contrast, people are permitted to participate in research only after Institutional Review Boards determine that it is appropriate for them to do so. Although we assume that consent to participate in research must be preceded by an elaborate disclosure of information, we make no such assumption in many other areas of life. Although it is thought to be morally problematic to provide financial inducements to prospective subjects, we make no such assumptions when we hire people as loggers, fishermen, and fire fighters. Although we readily accept the'off-shoring'of manufacturing, many regard the off-shoring of medical research with great skepticism. This book seeks to widen the lens through which we consider such issues. When we do so, we will find that many standard principles of research ethics are difficult to defend. The book first argues that because respect for'autonomy'has been a central tenet of research ethics, many have failed to recognize that the structure of the regulation of research is deeply paternalistic and have therefore failed to justify such paternalism. The book then rejects'the autonomous authorization'model that characterizes most writing in bioethics and argues for a'fair transaction'model. Although many worry that the use of financial payment to recruit research subjects is coercive or constitutes an undue inducement, the book argues that most of those worries are misplaced. Shifting its attention to research in developing societies, the book considers the claim that international researchers exploit research abroad often exploits its subjects. Finally, the book considers the claim that because researchers benefit from their use of research subjects, they acquire special obligations to them or their communities.

Asserting that the U.S. government is carrying out microwave experimentation on its citizens, this discussion of various governmental chemical and biological testing sets forth unnerving accusations that are not for the faint of heart. This book is for those who wonder if national and global tragedies are not mere accidents, but rather planned events that are executed by the U.S. military-industrial-oil-bank complex for nefarious purposes. A variety of taboo topics not discussed in the mainstream media are addressed. Allegations such as electro-bolts to the brain, driverless cars swerving through traffic, and preparation for urban warfare are discussed in this book full of hard-hitting allegations.

When the Nazis invaded Hungary in 1944, they sent virtually the entire Jewish population to Auschwitz. A Jew and a medical doctor, Dr. Miklos Nyiszli was spared from death for a grimmer fate: to perform “scientific research” on his fellow inmates under the supervision of the infamous “Angel of Death”: Dr. Josef Mengele. Nyiszli was named Mengele's personal research pathologist. Miraculously, he survived to give this terrifying and sobering account.

Researchers conduct observational human exposure studies to understand how and the extent to which people come into contact with chemicals and environmental stressors in their everyday lives, through the air they breathe, the food and liquids they consume, and the things they touch. This book looks at the U.S. Environmental Protection Agency's (EPA's) National Exposure Research Laboratory (NERL) which has conducted observational human exposure studies for several decades and uses the information and data from these studies to improve the Agency's understanding of human exposures to chemicals and other stressors and ultimately to support efforts to improve public health. This book consists of public documents which have been located, gathered, combined, reformatted, and enhanced with a subject index, selectively edited and bound to provide easy access.

Tom L. Beauchamp of Georgetown is one of the founding fathers of contemporary bioethics, and is particularly influential as one of the co-authors (with James Childress) of PRINCIPLES OF BIOMEDICAL ETHICS, first published by OUP over 25 years ago and a true cornerstone of contemporary bioethics. This volume is both an introductory textbook as well as a definitive expression of what is known as the dominant'principlist'approach which views bioethical reasoning developing out of four key principles: respect for autonomy, nonmaleficence, beneficence, and justice. This view has been highly influential over the last two decades and has set the agenda for the field. This volume will collect Tom Beauchamp's 15 most important published articles in bioethics, most of which were published over the last 25 years, and most of which have a strong connection to the principlist approach. Most of the essays included here augment, develop, or defend various themes, positions and arguments in that earlier book, both adding depth as well as taking off in new directions. Among the topic discussed are the historical origins of modern research ethics, to moral principles and methodological concerns. Beauchamp will include a new introduction to explain the history of the essays and their relationship to the principlist theory.

‘I liked The Unit very much... I know you will be riveted, as I was.'Margaret Atwood ‘Echoing work by Marge Piercy and Margaret Atwood, The Unit is as thought-provoking as it is compulsively readable.'Jessica Crispin, NPR.org Ninni Holmqvist's eerie dystopian novel envisions a society in the not-so-distant future where men and women deemed economically worthless are sent to a retirement community called the Unit. With lavish apartments set amongst beautiful gardens and state-of-the-art facilities, elaborate gourmet meals, and wonderful music and art, they are free of financial worries and want for nothing. It's an idyllic place, but there's a catch: the residents – known as dispensables – must donate their organs, one by one, until the final donation. When Dorrit Weger arrives at the Unit, she resigns herself to this fate, seeking only peace in her final days. But she soon falls in love, and this unexpected, improbable happiness throws the future into doubt. Clinical and haunting, The Unit is a modern-day classic and a spine-chilling cautionary tale about the value of human life.

The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.

Understanding the history of psychiatry requires an accurate view of its function and purpose. In this provocative new study, Szasz challenges conventional beliefs about psychiatry. He asserts that, in fact, psychiatrists are not concerned with the diagnosis and treatment of bona fide illnesses. Psychiatric tradition, social expectation, and the law make it clear that coercion is the profession's determining characteristic.Psychiatrists may'diagnose'or'treat'people without their consent or even against their clearly expressed wishes, and these involuntary psychiatric interventions are as different as are sexual relations between consenting adults and the sexual violence we call'rape.'But the point is not merely the difference between coerced and consensual psychiatry, but to contrast them. The term'psychiatry'ought to be applied to one or the other, but not both. As long as psychiatrists and society refuse to recognize this, there can be no real psychiatric historiography.The coercive character of psychiatry was more apparent in the past than it is now. Then, insanity was synonymous with unfitness for liberty. Toward the end of the nineteenth century, a new type of psychiatric relationship developed, when people experiencing so-called'nervous symptoms,'sought help. This led to a distinction between two kinds of mental diseases: neuroses and psychoses. Persons who complained about their own behavior were classified as neurotic, whereas persons about whose behavior others complained were classified as psychotic. The legal, medical, psychiatric, and social denial of this simple distinction and its far-reaching implications undergirds the house of cards that is modern psychiatry. Coercion as Cure is the most important book by Szasz since his landmark The Myth of Mental Illness.

Die Arbeit behandelt die rechtlichen Grundlagen der medizinischen Forschung mit Kindern und Jugendlichen. Dargestellt werden die faktischen und rechtlichen Rahmenbedingungen der medizinischen Forschung mit Minderjährigen. Das Buch liefert zudem eine aktuelle Übersicht über die auf die Humanforschung anwendbaren Normen des schweizerischen, deutschen, europäischen und internationalen Rechts. Der Schwerpunkt liegt dabei in der Untersuchung und Darstellung der Persönlichkeitsrechte Minderjähriger im medizinischen Kontext im Allgemeinen und in der medizinischen Forschung im Besonderen.

From 1951 until 1974, Holmesburg Prison in Philadelphia was the site of thousands of experiments on prisoners conducted by researchers under the direction of University of Pennsylvania dermatologist Albert M. Kligman. While most of the experiments were testing cosmetics, detergents, and deodorants, the trials also included scores of Phase I drug trials, inoculations of radioactive isotopes, and applications of dioxin in addition to mind-control experiments for the Army and CIA. These experiments often left the subject-prisoners, mostly African Americans, in excruciating pain and had long-term debilitating effects on their health. This is one among many episodes of the sordid history of medical experimentation on the black population of the United States.The story of the Holmesburg trials was documented by Allen Hornblum in his 1998 book Acres of Skin. The more general history of African Americans as human guinea pigs has most recently been told by Harriet Washington in her 2007 book Medical Apartheid. The subject is currently a topic of heated public debate in the wake of a 2006 report from an influential panel of medical experts recommending that the federal government loosen the regulations in place since the 1970s that have limited the testing of pharmaceuticals on prison inmates.Sentenced to Science retells the story of the Holmesburg experiments more dramatically through the eyes of one black man, Edward “Butch” Anthony, who suffered greatly from the experiments for which he “volunteered” during multiple terms at the prison. This is not only one black man's highly personal account of what it was like to be an imprisoned test subject, but also a sobering reminder that there were many African Americans caught in the viselike grip of a scientific research community willing to bend any code of ethics in order to accomplish its goals and a criminal justice system that sold prisoners to the highest bidder.

In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations&#8212racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis&#8212are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services'Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: &#8226 expand the definition of'prisoner'; &#8226 ensure universally and consistently applied standards of protection; &#8226 shift from a category-based to a risk-benefit approach to research review; &#8226 update the ethical framework to include collaborative responsibility; and &#8226 enhance systematic oversight of research involving prisoners.