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Beyond Consent: Seeking Justice in Research by
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 eclipsedconcerns 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 thestage 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.
Beyond Regulations: Ethics in Human Subjects Research by
Across a broad range of disciplines--in medicine, social science, and the humanities--researchers, scholars, teachers, and administrators increasingly are looking for new ways to approach ethical issues in research with human subjects. Questions about how relationships between funders and researchers should affect research design, for example, or whether the potential benefits of research can outweigh the importance of its subjects' interests are inadequately addressed by the prevailing, regulation-based research ethics paradigm. This book constitutes a reexamination of research ethics. It combines case studies and commentaries by a multidisciplinary group of scholars and researchers to explore such topics as informed consent, conflict of interest, confidentiality, and research on illegal behavior. All human subjects research takes place within complex social, cultural, and political contexts, the contributors argue. Increased consideration of the relationships between researchers and their subjects, funders, and institutions within these contexts will facilitate research that is sensitive and responsible as well as scientifically fruitful. Beyond Regulations features a keynote essay by Ruth Macklin. Other contributors are Marcela Aracena Alvarez, Jorge Balan, B. Susan Bauer, Alan F. Benjamin, Lynn Blanchard, Allan M. Brandt, J. Pat Browder, Barbara Entwisle, Sue E. Estroff, Renee C. Fox, Lara Freidenfelds, Gail E. Henderson, Nancy M. P. King, Loretta M. Kopelman, Ernest N. Kraybill, Barry M. Popkin, Silvina Ramos, Desmond K. Runyan, Jane Stein, Ronald P. Strauss, Keith A. Wailoo, and Cynthia Waszak. Across a broad range of disciplines--in biomedicine, the social sciences, and the humanities--researchers, scholars, administrators, and teachers increasingly struggle with questions of ethics in research with human subjects. All research takes place in complex social, cultural, political, and economic contexts; yet the prevailing principle-based research ethics paradigm does not adequately account for them. This book reexamines research ethics using a new relationships paradigm. Through in-depth cases, commentaries, and essays, a multidisciplinary group of scholars and researchers addresses informed consent, conflict of interest, confidentiality, and other issues, considering questions like: What relationships should researchers have with their subjects' communities? When researchers and subjects have different views about research, who should have control? How should relationships between funders and researchers affect research design? Can research be so potentially beneficial that its importance outweighs the interests of subjects? Examining the relationships between researchers and subjects, communities, funders, and institutions--including considerations of authority and voice--can facilitate human subjects research that is morally sensitive and responsible as well as scientifically fruitful.
Case Studies in Biomedical Research Ethics by
This textbook for instruction in biomedical research ethics can also serve as a valuable reference for professionals in the field of bioethics. The 149 cases included in the book are grouped in nine chapters, each of which covers a key area of debate in the field. Some of the case studies are classics, including the famous cases of the Tuskegee Syphilis Study (in which subjects with syphilis were not given treatment) and the Willowbrook hepatitis studies (in which institutionalized subjects were intentionally exposed to hepatitis). Others focus on such current issues as human embryonic stem cell research, cloning by somatic nuclear transfer, and the design and function of institutional review boards. Each chapter begins with a brief introduction that places the issues raised in context; this is followed by a number of cases (each of which is no more than a few pages). Study questions meant to encourage further discussion follow each case. After an introductory discussion of the history and tenets of ethics in medical research, the book's chapters cover the topics of oversight and study design; informed consent; the selection of subjects; conflicts of interest; the social effects of research; embryos, fetuses, and children; genetic research; the use of animals; and authorship and publication. Following these chapters are appendixes with the texts of the Nuremburg Code and the World Declaration of Geneva, two key documents in the establishment of bioethical standards for research. Also included are a glossary, a table of cases by general category, and an alphabetical listing of cases.
Moral Science: Protecting Participants in Human Subjects Research (2011) by 
The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation by
This important new work surveys the source and ramifications of the famed Nuremburg Code -- recognized around the world as one of the cornerstones of modern bioethics.
Responsible Conduct of Research by
Recent scandals and controversies such as the fabrication of data in federally funded science, the manipulation and distortion of research sponsored by private companies, human embryonic stem cell research, cloning, and the patenting of DNA and cell lines, illustrate the importance of ethicsin scientific research. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
Responsible Research: A Systems Approach to Protecting Research Participants by
When the previous incumbent in the parish of Wodden commits suicide in mysterious circumstances, Julian Snow, a gifted young Catholic priest, is sent to take his place. Wodden is the home of a number of prominent Catholics, including a powerful Tory politician and the Trevellyans, an old Catholic family whose ancestral seat, Flamstead House, dominates the village. The ancient legend of Everard Trevellyan, the third Earl of Wodden, still haunts the village: monstrous in size, dissipated in morals, Everard is said to have preyed on the local children. As Father Snow's duties see him regularly visiting Flamstead House for Mass, a growing suspicion that something very sinister indeed is going on, and that the Trevellyan legend might be as alive as ever, begins to consume him just as he finds he has fallen in love... A compelling and atmospheric modern Gothic novel, and a moving exploration of a priest's crisis of faith, THE OGRE'S LABORATORY is an immensely impressive achievement.
Textbook of Research Ethics: Theory and Practice by
This textbook provides a brief history of human experimentation and reviews various theories of ethics from which the principles and rules that govern this research are derived. All relevant international documents and national regulations, policies and memoranda are referred to extensively to assist in addressing issues that regularly arise during the course of research involving human subjects. It includes case examples and exercises and is of interest to students and experienced researchers.
The Use of Human Beings in Research: With Special Reference to Clinical Trials by
This volume, which has developed from the Fourteenth Trans Disciplinary Symposium on Philosophy and Medicine, September 5-8, 1982, at Tel Aviv University, Israel, contains the contributions of a group of distinguished scholars who together examine the ethical issues raised by the advance of biomedical science and technology. We are, of course, still at the beginning of a revolution in our understanding of human biology; scientific medicine and clinical research are scarcely one hundred years old. Both the sciences and the technology of medicine until ten or fifteen years ago had the feeling of the 19th century about them; we sense that they belonged to an older time; that era is ending. The next twenty-five to fifty years of investigative work belong to neurobiology, genetics, and reproductive biology. The technologies of information processing and imaging will make diagnosis and treatment almost incomprehensible by my generation of physicians. Our science and technology will become so powerful that we shall require all of the art and wisdom we can muster to be sure that they remain dedicated, as Francis Bacon hoped four centuries ago, "to the uses of life." It is well that, as philosophers and physicians, we grapple with the issues now when they are relatively simple, and while the pace of change is relatively slow. We require a strategy for the future; that strategy must be worked out by scientists, philosophers, physicians, lawyers, theologians, and, I should like to add, artists and poets.
Dark Medicine: Rationalizing Unethical Medical Research by
The trial of the "German doctors" exposed atrocities of Nazi medical science and led to the Nuremberg Code governing human experimentation. In Japan, Unit 731 carried out hideous experiments on captured Chinese and downed American pilots. In the United States, stories linger of biological experimentation during the Korean War. This collection of essays looks at the dark medical research conducted during and after World War II. Contributors describe this research, how it was brought to light, and the rationalizations of those who perpetrated and benefited from it; look at the response to the revelations of this horrific research and its implications for present-day medicine and ethics; and offer lessons about human experimentation in an age of human embryo research and genetic engineering.
Ethically Impossible: STD Research in Guatemala from 1946 to 1948 by 
Examining Tuskegee: The Infamous Syphilis Study and Its Legacy by
The forty-year Tuskegee Syphilis Study, which took place in and around Tuskegee, Alabama, from the 1930s through the 1970s, has become a profound metaphor for medical racism, government malfeasance, and physician arrogance. Susan M. Reverby's Examining Tuskegee is a comprehensive analysis of the notorious study of untreated syphilis among African American men, who were told by U.S. Public Health Service doctors that they were being treated, not just watched, for their late-stage syphilis. With rigorous clarity, Reverby investigates the study and its aftermath from multiple perspectives and illuminates the reasons for its continued power and resonance in our collective memory.
The Immortal Life of Henrietta Lacks by
#1 NEW YORK TIMES BESTSELLER * "The story of modern medicine and bioethics--and, indeed, race relations--is refracted beautifully, and movingly."--Entertainment Weekly NOW A MAJOR MOTION PICTURE FROM HBO® STARRING OPRAH WINFREY AND ROSE BYRNE * ONE OF THE "MOST INFLUENTIAL" (CNN), "DEFINING" (LITHUB), AND "BEST" (THE PHILADELPHIA INQUIRER) BOOKS OF THE DECADE * ONE OF ESSENCE'S 50 MOST IMPACTFUL BLACK BOOKS OF THE PAST 50 YEARS * WINNER OF THE CHICAGO TRIBUNE HEARTLAND PRIZE FOR NONFICTION NAMED ONE OF THE BEST BOOKS OF THE YEAR BY The New York Times Book Review * Entertainment Weekly * O: The Oprah Magazine * NPR * Financial Times * New York * Independent (U.K.) * Times (U.K.) * Publishers Weekly * Library Journal * Kirkus Reviews * Booklist * Globe and Mail Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor Southern tobacco farmer who worked the same land as her slave ancestors, yet her cells--taken without her knowledge--became one of the most important tools in medicine: The first "immortal" human cells grown in culture, which are still alive today, though she has been dead for more than sixty years. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the atom bomb's effects; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks remains virtually unknown, buried in an unmarked grave. Henrietta's family did not learn of her "immortality" until more than twenty years after her death, when scientists investigating HeLa began using her husband and children in research without informed consent. And though the cells had launched a multimillion-dollar industry that sells human biological materials, her family never saw any of the profits. As Rebecca Skloot so brilliantly shows, the story of the Lacks family--past and present--is inextricably connected to the dark history of experimentation on African Americans, the birth of bioethics, and the legal battles over whether we control the stuff we are made of. Over the decade it took to uncover this story, Rebecca became enmeshed in the lives of the Lacks family--especially Henrietta's daughter Deborah. Deborah was consumed with questions: Had scientists cloned her mother? Had they killed her to harvest her cells? And if her mother was so important to medicine, why couldn't her children afford health insurance? Intimate in feeling, astonishing in scope, and impossible to put down, The Immortal Life of Henrietta Lacks captures the beauty and drama of scientific discovery, as well as its human consequences.
Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present by
From the era of slavery to the present day, the first full history of black America’s shocking mistreatment as unwilling and unwitting experimental subjects at the hands of the medical establishment. Medical Apartheidis the first and only comprehensive history of medical experimentation on African Americans. Starting with the earliest encounters between black Americans and Western medical researchers and the racist pseudoscience that resulted, it details the ways both slaves and freedmen were used in hospitals for experiments conducted without their knowledge—a tradition that continues today within some black populations. It reveals how blacks have historically been prey to grave-robbing as well as unauthorized autopsies and dissections. Moving into the twentieth century, it shows how the pseudoscience of eugenics and social Darwinism was used to justify experimental exploitation and shoddy medical treatment of blacks, and the view that they were biologically inferior, oversexed, and unfit for adult responsibilities. Shocking new details about the government’s notorious Tuskegee experiment are revealed, as are similar, less-well-known medical atrocities conducted by the government, the armed forces, prisons, and private institutions. The product of years of prodigious research into medical journals and experimental reports long undisturbed,Medical Apartheidreveals the hidden underbelly of scientific research and makes possible, for the first time, an understanding of the roots of the African American health deficit. At last, it provides the fullest possible context for comprehending the behavioral fallout that has caused black Americans to view researchers—and indeed the whole medical establishment—with such deep distrust. No one concerned with issues of public health and racial justice can afford not to readMedical Apartheid, a masterful book that will stir up both controversy and long-needed debate.
The Plutonium Files: America's Secret Medical Experiments in the Cold War by
When the vast wartime factories of the Manhattan Project began producing plutonium in quantities never before seen on earth, scientists working on the top-secret bomb-building program grew apprehensive. Fearful that plutonium might cause a cancer epidemic among workers and desperate to learn more about what it could do to the human body, the Manhattan Project's medical doctors embarked upon an experiment in which eighteen unsuspecting patients in hospital wards throughout the country were secretly injected with the cancer-causing substance. Most of these patients would go to their graves without ever knowing what had been done to them. Now, inThe Plutonium Files, Pulitzer Prize-winning reporter Eileen Welsome reveals for the first time the breadth of the extraordinary fifty-year cover-up surrounding the plutonium injections, as well as the deceitful nature of thousands of other experiments conducted on American citizens in the postwar years. Welsome's remarkable investigation spans the 1930s to the 1990s and draws upon hundreds of newly declassified documents and other primary sources to disclose this shadowy chapter in American history. She gives a voice to such innocents as Helen Hutchison, a young woman who entered a prenatal clinic in Nashville for a routine checkup and was instead given a radioactive "cocktail" to drink; Gordon Shattuck, one of several boys at a state school for the developmentally disabled in Massachusetts who was fed radioactive oatmeal for breakfast; and Maude Jacobs, a Cincinnati woman suffering from cancer and subjected to an experimental radiation treatment designed to help military planners learn how to win a nuclear war. Welsome also tells the stories of the scientists themselves, many of whom learned the ways of secrecy on the Manhattan Project. Among them are Stafford Warren, a grand figure whose bravado masked a cunning intelligence; Joseph Hamilton, who felt he was immune to the dangers of radiation only to suffer later from a fatal leukemia; and physician Louis Hempelmann, one of the most enthusiastic supporters of the plan to inject humans with potentially carcinogenic doses of plutonium. Hidden discussions of fifty years past are reconstructed here, wherein trusted government officials debated the ethical and legal implications of the experiments, demolishing forever the argument that these studies took place in a less enlightened era. Powered by her groundbreaking reportage and singular narrative gifts, Eileen Welsome has created a work of profound humanity as well as major historical significance.
The Body Hunters: Testing New Drugs on the World's Poorest Patients by
Hailed by John le Carré as "an act of courage on the part of its author" and singled out for praise by the leading medical journals in the United States and the United Kingdom, The Body Hunters uncovers the real-life story behind le Carré's acclaimed novel The Constant Gardener and the feature film based on it. "A trenchant exposé . . . meticulously researched and packed with documentary evidence" (Publishers Weekly), Sonia Shah's riveting journalistic account shines a much-needed spotlight on a disturbing new global trend. Drawing on years of original research and reporting in Africa and Asia, Shah examines how the multinational pharmaceutical industry, in its quest to develop lucrative drugs, has begun exporting its clinical research trials to the developing world, where ethical oversight is minimal and desperate patients abound. As the New England Journal of Medicine notes, "it is critical that those engaged in drug development, clinical research and its oversight, research ethics, and policy know about these stories," which tell of an impossible choice being faced by many of the world's poorest patients--be experimented upon or die for lack of medicine.
Ethical Conduct of Clinical Research Involving Children by
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. "Ethical Conduct of Clinical Research Involving Children" considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Ethical Considerations for Research Involving Prisoners by
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.
The Ethics of Pediatric Research by
Millions of children suffer from diseases and illnesses that do not have adequate treatment, and many other children are harmed by medicines intended to help them. In order to protect and help these children, society must conduct pediatric research to identify safer and more effective medicaltreatments. This research requires exposing some children to risks for the benefit of others. Yet, critics and courts have argued that it is unethical to expose children to research risks for the benefit of others, and this practice seems to violate our obligation to protect children from harm andexploitation. In this way, clinical research with children presents us with what appears to be an irresolvable dilemma: either we can protect pediatric subjects from exploitation, or we can protect pediatric patients from dangerous medicines, but not both.The Ethics of Pediatric Research is the first work to systematically evaluate this dilemma, and David Wendler offers an original justification for pediatric research based on an in-depth analysis of when it is in our interests to help others. It will be of interest primarily to scholars in pediatricethics and clinical research ethics.
Issues in Biomedical Research Involving Cognitively Impaired Subjects by Books
Animal Research and Ethical Conflict: An Analysis of the Scientific Literature, 1966-1986 by
This volume grew out of a project to conduct a survey of the scientific literature of the United States for items addressing the e. thical and humane issues of animal experimentation. The original purpose of the survey was to provide packground information for the development of a set of guide lines for the use of animals in research then in preparation by The New York Academy of Sciences' Ad Hoc Committee on Animal Research. ! We soon realized, however, that the survey constituted a valuable resource in its own right. In this book we present the results of the literature survey along with relevant information about its legislative and historical con text. We hope that this material will be helpful to biomedical researchers grappling with animal welfare problems as well as to social scientists interested in tracing the evolution of the 20th-century phase of the animal research controversy. The time span covered by the survey was selected to match the 20-year period between the passage of the first federal Animal Welfare Act in 1966 and the most recent legislation regulating animal research, which took effect during 1986. Our analysis examines this transitional period through the pages of the scientific literature. During these 2 decades, animal re search in the United States was transformed. Activist animal protection organizations catapulted troublesome ethical questions to national prom inence, throwing the scientific community2 into turmoil.
Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity by
For many years, experiments using chimpanzees have been instrumental in advancing scientific knowledge and have led to new medicines to prevent life-threatening and debilitating diseases. However, recent advances in alternate research tools have rendered chimpanzees largely unnecessary as research subjects. The Institute of Medicine, in collaboration with the National Research Council, conducted an in-depth analysis of the scientific necessity for chimpanzees in NIH-funded biomedical and behavioral research. The committee concludes that while the chimpanzee has been a valuable animal model in the past, most current biomedical research use of chimpanzees is not necessary, though noted that it is impossible to predict whether research on emerging or new diseases may necessitate chimpanzees in the future.
Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research by
Expanding on the National Research Council's Guide for the Care and Use of Laboratory Animals, this book deals specifically with mammals in neuroscience and behavioral research laboratories. It offers flexible guidelines for the care of these animals, and guidance on adapting these guidelines to various situations without hindering the research process. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research offers a more in-depth treatment of concerns specific to these disciplines than any previous guide on animal care and use. It treats on such important subjects as: The important role that the researcher and veterinarian play in developing animal protocols. Methods for assessing and ensuring an animal's well-being. General animal-care elements as they apply to neuroscience and behavioral research, and common animal welfare challenges this research can pose. The use of professional judgment and careful interpretation of regulations and guidelines to develop performance standards ensuring animal well-being and high-quality research. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research treats the development and evaluation of animal-use protocols as a decision-making process, not just a decision. To this end, it presents the most current, in-depth information about the best practices for animal care and use, as they pertain to the intricacies of neuroscience and behavioral research.
Lives in the Balance: The Ethics of Using Animals in Biomedical Research: The Report of a Working Party of the Institute of Medical Ethics by Man and Mouse: Animals in Medical Research by Online Resource
Contemporary Issues for Protecting Patients in Cancer Research: Workshop Summary by
In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. "Contemporary Issues for Protecting Patients in Cancer Research" is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges.
Ethics in Psychiatric Research: A Resource Manual for Human Subjects Protection by 
The Limits and Lies of Human Genetic Research: Dangers for Social Policy by
In The Limits and Lies of Human Genetic Research, Jonathan Kaplan weighs in on the controversial subject of the roles genes play in determining aspects of physical and behavioral human variation. Limits and Lies makes the case that neither the information we have on genes, nor on the environment, is sufficient to explain the complex variations among humans.
Access to Experimental Drugs in Terminal Illness: Ethical Issues by
Access to Experimental Drugs in Terminal Illness: Ethical Issues helps you understand the ethical dilemmas experienced by those suffering from terminal illnesses who are denied legal access to experimental, potentially life-saving drugs and who are then pressured into clinical tests designed to test and further the approval of those very same drugs. You'll get a better understanding of the urgent need for an ethical and legal re-evaluation of the current drug approval and drug testing process in most western countries. Access to Experimental Drugs in Terminal Illness assists you in gaining a better understanding of the changes to the drug testing and drug approval process political AIDS activism has achieved. In many ways, AIDS is a paradigmatic case for how people with terminal illnesses can make a difference to drug testing and drug approval. Specifically, you'll read about the importance of respecting the autonomy of terminally ill people who request to be given access to experimental drugs. The author gathers support for this view from a wide range of classical and contemporary moral philosophers. He also discusses the practical implications of his ethical analysis of the current regulations for drug approval and drug testing. Overall, you'll see that Access to Experimental Drugs in Terminal Illness is an innovative contribution to the current debate raging over the ethical justifiability of current clinical trials and their design. You'll find that your understanding of this debate will flourish and increase as you realize the need for improvement in the drug approval process worldwide.
Case Studies in Ethics and HIV Research by
This important work takes as its subject one of medicine's most pressing arenas of ethical debate. There has been a consistent interest in ethical issues arising in the context of HIV research. Ongoing international and multi-site studies and the continuing search for an HIV vaccine continue to prompt examination of how this research is conducted. Also examined are how participants are engaged in the studies and the obligations of the researchers to individual participants and their communities during the course of and following the conclusion of the research. Each chapter of this book is authored primarily by one of the editors (secondarily by the other) and is accompanied by one to two case studies.
Ethical and Scientific Issues in Studying the Safety of Approved Drugs by
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Ethics in Participatory Research for Health and Social Well-Being: Cases and Commentaries by
Participatory research is well-established as an approach involving people with a direct interest in, or experience of, the issue being studied in carrying out some aspects of the research. However, it raises unique and challenging ethical issues. Traditional concerns with respect for the rights to confidentiality, consent, privacy and protection of ¿research informants¿ do not translate easily into participatory research. Boundaries between researchers and those researched are often blurred; research trajectories may be emergent and unpredictable; and major ethical issues revolve around partnership, power, equality and respect for diverse knowledges. The book introduces the key ethical issues in participatory research, drawing on ethical theory and relevant literature before presenting seven substantive chapters, each on a different theme, such as power, ownership, confidentiality and boundaries. The chapters feature an introductory overview of the topic with reference to the literature, followed by four real-life case examples written by participatory researchers and short commentaries on each case. Drawn from around the world (from Denmark to Tanzania), the cases illustrate a range of ethical issues, outlining how they were handled and the reflections and feelings of the contributors.¿ Focusing on developing ethical awareness, confidence and courage to act in ethically challenging situations in everyday research practice, this book is an invaluable resource for all participatory researchers.
The Human Embryonic Stem Cell Debate: Science, Ethics, and Public Policy by
Human embryonic stem cells can divide indefinitely and have the potential to develop into many types of tissue. Research on these cells is essential to one of the most intriguing medical frontiers, regenerative medicine. It also raises a host of difficult ethical issues and has sparked great public interest and controversy. This book offers a foundation for thinking about the many issues involved in human embryonic stem cell research. It considers questions about the nature of human life, the limits of intervention into human cells and tissues, and the meaning of our corporeal existence. The fact that stem cells may be derived from living embryos that are destroyed in the process or from aborted fetuses ties the discussion of stem cell research to the ongoing debates on abortion. In addition to these issues, the essays in the book touch on broader questions such as who should approve controversial research and what constitutes human dignity, respect, and justice. The book contains contributions from the Ethics Advisory Board of the Geron Coroporation; excerpts from expert testimony given before the National Bioethics Advisory Commission, which helped shape recent National Institutes of Health policy; and original analytical essays on the implications of this research.
The Human Microbiome: Ethical, Legal and Social Concerns (2013) by
The human microbiome is the bacteria, viruses, and fungi that cover our skin, line our intestines, and flourish in our body cavities. Work on the human microbiome is new, but it is quickly becoming a leading area of biomedical research. What scientists are learning about humans and ourmicrobiomes could change medical practice by introducing new treatment modalities. This new knowledge redefines us as superorganisms comprised of the human body and the collection of microbes that inhabit it and reveals how much we are a part of our environment. The understanding that microbes arenot only beneficial but sometimes necessary for survival recasts our interaction with microbes from adversarial to neighborly.This volume explores some of the science that makes human microbiome research possible. It then considers ethical, legal, and social concerns raised by microbiome research. Chapters explore issues related to personal identity, property rights, and privacy. The authors reflect on how human microbiomeresearch challenges reigning views on public health and research ethics. They also address the need for thoughtful policies and procedures to guide the use of the biobanked human samples required for advancing this new domain of research. In the course of these explorations, they introduce examplesfrom the history of biomedical science and recent legal cases that shed light on the issues and inform the policy recommendations they offer at the end of each topic's discussion.This volume is the product of an NIH Human Microbiome Project grant. It represents three years of conversations focused on consensus formation by the twenty-seven members of the interdisciplinary Microbiome Working Group.
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues by
The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studies?both at the beginning and upon completion of the experiments?if they are carried out with the intent of affecting the agency's policy-making.
Jenner on Trial: An Ethical Examination of Vaccine Research in the Age of Smallpox and the Age of AIDS by
This book examines how an Ethics Review Committee using today's ethical standards as articulated in The Nuremburg Code, and the WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, might assess the scientific and ethical design of Edward Jenner's first experimental vaccine experiment. It explores the potential risks and benefits to young James, the adequacy of the preliminary evidence that Jenner used to justify performing his experiment, and how he might have complied with requirements for informed consent. In addition to its historical interest for 18th century England and for the origins of today's biomedical research ethics standards, the book is significant as a case study in the ethics of basic vaccine research. It thus raises relevant questions about today's vaccine research, particularly relating to HIV.
The National Academies' Guidelines for Human Embryonic Stem Cell Research (2008) by
In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. As it did in 2007, the Committee identified issues that warranted revision, and this book addresses those issues in a second set of amendments. Most importantly, this book addresses new scientific developments in reprogramming of somatic cells to pluripotency by adding a new section and revising other relevant sections of the Guidelines.
The Stored Tissue Issue: Biomedical Research, Ethics, and Law in the Era of Genomic Medicine by
Genetics research with stored human tissues provides many benefits and holds much promise. Yet how this critical research is conducted sometimes raises serious ethical, legal, and social concerns, and it is difficult to balance the promise of biomedical research with our time-honored commitments to individual choice in such fundamental matters as control over personal health information and the disposition of our bodily tissues.Weir and Olick provide a thorough analysis of this critical phase in the era of genomic medicine. While strongly supportive of the biomedical research enterprise, they develop a critique of many common research practices with banked tissues, DNA, and genetic data. Noting numerous examples of beneficial human tissue research, they focus on problematic research practices, controversial cases, and federal and institutional policies that limit the informed choices of patients and research participants. The authors offer a series of recommendations intended to limit the risks of inadequate informed consent to research for individuals, families, and groups, and to strengthen the bonds of trust between the research enterprise and the public upon which biomedical progress depends.This book offers a wealth of information plus well-reasoned recommendations that will be of keen interest to geneticists, other biomedical scientists, research institutions, policymakers, students and others. It will serve as a clarion call to move beyond traditional policies and practices toward a richer understanding of partnership between patients and research participants and the biomedical research enterprise - a partnership for the benefit of all.
Compensating for Research Injuries: A Report on the Ethical and Legal Implications of Programs to Redress Injuries Caused by Biomedical and Behavioral Research by Conflicts of Interest in Clinical Practice and Research by 
Ethical and Regulatory Aspects of Clinical Research by
All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested.
Ethical Issues in Biomedical Publication by
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
Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry by
For decades, medical professionals have betrayed the public's trust by accepting various benefits from the pharmaceutical industry. Both drug company representatives and doctors employ artful spin to portray this behavior positively to the public, and to themselves. In Hooked, Howard Brody argues that we can neither understand the problem, nor propose helpful solutions until we identify the many levels of activity connecting these purportedly noble industries. We can pass laws and enact regulations, but ultimately the medical profession must take responsibility for its own integrity. Hooked is a wake-up call for anyone expecting high quality, ethical medical care.
Institutional Review Board: Management and Function by
Legal/Ethics
Institutional Review Board Member Handbook by
Institutional Review Board: Member Handbook is designed to give IRB members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient. Chapters are short and to the point with the goal of presenting practical advice on what IRB members should do before and during full-committee meetings. A large portion of the book is devoted to topic-specific chapters that list the criteria IRB members should use to determine how to vote on specific kinds of studies.
Privacy Issues in Biomedical and Clinical Research: Proceedings of Forum on November 1, 1997, National Academy of Sciences, Washington, D.C. (1998) by 
When Science Offers Salvation: Patient Advocacy and Research Ethics by
Biomedical research today has a high public profile, largely because of patient advocacy. Following in the footsteps of HIV/AIDS activists, advocates representing an array of patient groups are now vocal partners in the research enterprise. Advocates want research practices and policies to bemore responsive to the people who must live with the burdens of illness. This book shows how advocates have transformed health research, often -- but not always -- for the better.Dresser is the first to examine patient advocacy through the lens of research ethics. She reveals the many ways in which a quest for cures and improved therapies shapes advocacy work. She exposes the bright and dark sides of patients' expanded opportunities to enroll in clinical trials and joinresearchers in planning and evaluating studies. She considers the virtues and drawbacks of giving patients more influence over how the government invests its research dollars. She argues that advocates should do more to promote ethical human studies and responsible media reporting about research.Patient advocates can help make research more ethical, but advocacy raises ethical issues of its own. This book clearly and vividly recounts the advocacy contribution to research and explores the thorny ethical issues facing research advocates.
Writing Clinical Research Protocols: Ethical Considerations by
This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process.