Responsible Conduct of Research & Scholarly Activity

The Occasional Human Sacrifice is an intellectual inquiry into the moral struggle that whistleblowers face, and why it is not the kind of struggle that most people imagine. Carl Elliott is a bioethicist at the University of Minnesota who was trained in medicine as well as philosophy. For many years he fought for an external inquiry into a psychiatric research study at his own university in which an especially vulnerable patient lost his life. Elliott's efforts alienated friends and colleagues. The university stonewalled him and denied wrongdoing until a state investigation finally vindicated his claims. His experience frames the six stories in this book of medical research in which patients were deceived into participating in experimental programs they did not understand, many of which had astonishing and well-concealed mortality rates. Beginning with the public health worker who exposed the Tuskegee Syphilis Study and ending with the four physicians who in 2016 blew the whistle on lethal synthetic trachea transplants at the Karolinska Institute, Elliott tells the extraordinary stories of insiders who spoke out against such abuses, and often paid a terrible price for doing the right thing.

Research ethics and integrity are growing in importance as academics face increasing pressure to win grants and publish and universities promote themselves in an increasingly competitive market. Research Ethics in the Real World is the first book to highlight the links between research ethics and individual, social, professional, institutional, and political ethics. Drawing on both indigenous and Western research traditions, Helen Kara considers all stages of the research process, from the formulation of a research question to aftercare for participants, data and findings. She argues that knowledge of both ethical approaches is helpful for researchers working in either paradigm. Students, academics, and research ethics experts from around the world contribute real-world perspectives on navigating and managing ethics in practice. Research Ethics in the Real World provides guidance for quantitative, qualitative, and mixed-methods researchers about how to act ethically throughout the work of research.

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.

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 missedsomething 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 aboutproblems 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 theymeet 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 controlover 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 justsymbolic - partners in research.

Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated (often minutely) by federally required and supervised bureaucracies called "institutional review boards" (IRBs). Do -- can -- these IRBs do more harm than good? In The Censor's Hand, Schneider addresses this crucial but long-unasked question. Schneider answers the question by consulting a critical but ignored experience -- the law's learning about regulation -- and by amassing empirical evidence that is scattered around many literatures. He concludes that IRBs were fundamentally misconceived. Their usefulness to human subjects is doubtful, but they clearly delay, distort, and deter research that can save people's lives, soothe their suffering, and enhance their welfare. IRBs demonstrably make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging -- universities. In sum, Schneider argues that IRBs are bad regulation that inescapably do more harm than good. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.

Ethics and integrity in research are increasingly important for social scientists around the world. We are tackling more complex problems in the face of expanding and not always sympathetic regulation. This book surveys the recent developments and debates around researching ethically and with integrity and complying with ethical requirements. The new edition pushes beyond the work of the first edition through updated and extended coverage of issues relating to international, indigenous, interdisciplinary and internet research. nbsp; Through case studies and examples drawn from all continents and from across the social science disciplines, the book: demonstrates the practical value of thinking seriously and systematically about ethical conduct in social science research identifies how and why current regulatory regimes have emerged reveals those practices that have contributed to the adversarial relationships between researchers and regulators encourages all parties to develop shared solutions to ethical and regulatory problems.

Although the subject of federally mandated Institutional Review Boards (IRBs) has been extensively debated, we actually do not know much about what takes place when they convene. The story of how IRBs work today is a story about their past as well as their present, and Behind Closed Doors is the first book to meld firsthand observations of IRB meetings with the history of how rules for the treatment of human subjects were formalized in the United States in the decades after World War II.   Drawing on extensive archival sources, Laura Stark reconstructs the daily lives of scientists, lawyers, administrators, and research subjects working--and "warring"--on the campus of the National Institutes of Health, where they first wrote the rules for the treatment of human subjects. Stark argues that the model of group deliberation that gradually crystallized during this period reflected contemporary legal and medical conceptions of what it meant to be human, what political rights human subjects deserved, and which stakeholders were best suited to decide. She then explains how the historical contingencies that shaped rules for the treatment of human subjects in the postwar era guide decision making today--within hospitals, universities, health departments, and other institutions in the United States and across the globe. Meticulously researched and gracefully argued, Behind Closed Doors will be essential reading for sociologists and historians of science and medicine, as well as policy makers and IRB administrators.

Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings. This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Second Edition and the Study Guide that IRB members can access and refer to quickly and easily.

The Professional Guinea Pig documents the emergence of the professional research subject in Phase I clinical trials testing the safety of drugs in development. Until the mid-1970s Phase I trials were conducted on prisoners. After that practice was outlawed, the pharmaceutical industry needed a replacement population and began to aggressively recruit healthy, paid subjects, some of whom came to depend on the income, earning their living by continuously taking part in these trials. Drawing on ethnographic research among self-identified "professional guinea pigs" in Philadelphia, Roberto Abadie examines their experiences and views on the conduct of the trials and the risks they assume by participating. Some of the research subjects he met had taken part in more than eighty Phase I trials. While the professional guinea pigs tended to believe that most clinical trials pose only a moderate health risk, Abadie contends that the hazards presented by continuous participation, such as exposure to potentially dangerous drug interactions, are discounted or ignored by research subjects in need of money. The risks to professional guinea pigs are also disregarded by the pharmaceutical industry, which has become dependent on the routine participation of experienced research subjects. Arguing that financial incentives compromise the ethical imperative for informed consent to be freely given by clinical-trials subjects, Abadie confirms the need to reform policies regulating the participation of paid subjects in Phase I clinical trials.

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, they are still alive today, though she has been dead for more than sixty years. If you could pile all HeLa cells ever grown onto a scale, they'd weigh more than 50 million metric tons--as much as a hundred Empire State Buildings. HeLa cells were vital for developing the polio vacci≠ 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. Now Rebecca Skloot takes us on an extraordinary journey, from the "colored" ward of Johns Hopkins Hospital in the 1950s to stark white laboratories with freezers full of HeLa cells; from Henrietta's small, dying hometown of Clover, Virginia--a land of wooden slave quarters, faith healings, and voodoo--to East Baltimore today, where her children and grandchildren live and struggle with the legacy of her cells. 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, who was devastated to learn about her mother's cells. She was consumed with questions: Had scientists cloned her mother? Did it hurt her when researchers infected her cells with viruses and shot them into space? What happened to her sister, Elsie, who died in a mental institution at the age of fifteen? 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.

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.

This book is designed as an instructional manual that gives Institutional Review Board (IRB) members and administrators the information they need to run an efficient and effective system of protecting human research subjects, in compliance with federal research regulations. This reference provides a step-by-step approach to practical details of IRB administration and includes case studies, sample forms, and sample policy documents, as well as decision-making algorithms and lists of approval criteria for their resolution.

At a time of increased interest and renewed shock over the Tuskegee syphilis experiments, Acres of Skinsheds light on yet another dark episode of American medical history. In this disturbing expose, Allen M. Hornblum tells the story of Philadelphia's Holmesburg Prison.

Long before the U.S. government began conducting secret radiation and germ-warfare experiments, and long before the Tuskegee syphilis experiments, medical professionals had introduced--and hotly debated the ethics of--the use of human subjects in medical experiments. In Subjected to Science, Susan Lederer provides the first full-length history of biomedical research with human subjects in the earlier period, from 1890 to 1940. Lederer offers detailed accounts of experiments--benign and otherwise--conducted on both healthy and unhealthy men, women, and children, including the yellow fever experiments (which ultimately became the subject of a Broadway play and Hollywood film), Udo Wile's "dental drill" experiments on insane patients, and Hideyo Noguchi's syphilis experiments, which involved injecting a number of healthy children and adults with the syphilis germ, luetin.

The atrocities committed by Nazi physicians and researchers during World War II prompted the development of the Nuremberg Code to define the ethics of modern medical experimentation utilizing human subjects. Since its enunciation, the Code has been viewed as one of the cornerstones of modernbioethical thought. The sources and ramifications of this important document are thoroughly discussed in this book by a distinguished roster of contemporary professionals from the fields of history, philosophy, medicine, and law. Contributors also include the chief prosecutor of the NurembergMilitary Tribunal and a moving account by a survivor of the Mengele Twin Experiments. The book sheds light on keenly debated issues of both science and jurisprudence, including the ethics of human experimentation; the doctrine of informed consent; and the Code's impact on today's international humanrights agenda. The historical setting of the Code's creation, some modern parallels, and the current attitude of German physicians toward the crimes of the Nazi era, are discussed in early chapters. The book progresses to a powerful account of the Doctors' Trial at Nuremberg, its resulting verdict,and the Code's development. The Code's contemporary influence on both American and international law is examined in its historical context and discussed in terms of its universality: are the foundational ethics of the Code as valid today as when it was originally penned? The editors conclude with achapter on foreseeable future developments and a proposal for an international covenant on human experimentation enforced by an international court. A major work in medical law and ethics, this volume provides stimulating, provocative reading for physicians, legal professionals, bioethicists,historians, biomedical researchers, and concerned laypersons.

From 1932 to 1972, the United States Public Health Service conducted a non-therapeutic experiment involving over 400 black male sharecroppers infected with syphilis. The Tuskegee Study had nothing to do with treatment. Its purpose was to trace the spontaneous evolution of the disease in order to learn how syphilis affected black subjects. From 1932 to 1972, the United States Public Health Service conducted a non-therapeutic experiment involving over 400 black male sharecroppers infected with syphilis. The Tuskegee Study had nothing to do with treatment. Its purpose was to trace the spontaneous evolution of the disease in order to learn how syphilis affected black subjects. The men were not told they had syphilis; they were not warned about what the disease might do to them; and, with the exception of a smattering of medication during the first few months, they were not given health care. Instead of the powerful drugs they required, they were given aspirin for their aches and pains. Health officials systematically deceived the men into believing they were patients in a government study of “bad blood”, a catch-all phrase black sharecroppers used to describe a host of illnesses. At the end of this 40 year deathwatch, more than 100 men had died from syphilis or related complications. “Bad Blood” provides compelling answers to the question of how such a tragedy could have been allowed to occur. Tracing the evolution of medical ethics and the nature of decision making in bureaucracies, Jones attempted to show that the Tuskegee Study was not, in fact, an aberration, but a logical outgrowth of race relations and medical practice in the United States. Now, in this revised edition of “Bad Blood”, Jones traces the tragic consequences of the Tuskegee Study over the last decade. A new introduction explains why the Tuskegee Study has become a symbol of black oppression and a metaphor for medical neglect, inspiring a prize-winning play, a Nova special, and a motion picture. A new concluding chapter shows how the black community's wide-spread anger and distrust caused by the Tuskegee Study has hampered efforts by health officials to combat AIDS in the black community. “Bad Blood” was nominated for the Pulitzer Prize and was one of the “N.Y. Times” 12 best books of the year.

From the time of its first publication, Tearoom Trade engendered controversy. It was also accorded an unusual amount of praise for a first book on a marginal, intentionally self-effacing population by a previously unknown sociologist. The book was quickly recognized as an important, imaginative, and useful contribution to our understanding of "deviant" sexual activity. Describing impersonal, anonymous sexual encounters in public restrooms--"tearooms" in the argot--the book explored the behavior of men whose closet homosexuality was kept from their families and neighbors. By posing as an initiate, the author was able to engage in systematic observation of homosexual acts in public settings, and later to develop a more complete picture of those involved by interviewing them in their homes, again without revealing their unwitting participation in his study. This enlarged edition of Tearoom Trade includes the original text, together with a retrospect, written by Nicholas von Hoffman, Irving Louis Horowitz, Lee Rainwater, Donald P. Warwick, and Myron Glazer. The material added includes a perspective on the social scientist at work and the ethical problems to which that work may give rise, along with debate by the book's initial critics and proponents. Humphreys added a postscript and his views on the opinion expressed in the retrospect.

In the 1960s Yale University psychologist Stanley Milgram famously carried out a series of experiments that forever changed our perceptions of morality and free will. The subjects--or "teachers"--were instructed to administer electroshocks to a human "learner," with the shocks becoming progressively more powerful and painful. Controversial but now strongly vindicated by the scientific community, these experiments attempted to determine to what extent people will obey orders from authority figures regardless of consequences. "Obedience to Authority" is Milgram's fascinating and troubling chronicle of his classic study and a vivid and persuasive explanation of his conclusions.