Ethics And Law In Biological Research

Scientific research on biotechnologies has become the protagonist of discoveries that exert a formidable impact on public opinion. Every day popular opinion is challenged by the media, so that it becomes not only a witness of these developments, but is also, to a certain extent, forced to become a judge of those cases where human and animal genetics have been investigated over the last decades. The man-in-the-street is thus confronted by moral positions ranging from cautious approval, to wait-and-see attitudes, to unconditional condemnation. On the other hand, scientists are involved in the ethical evaluation of the results of their own research. However, the results of scientific pursuits are capable of producing immediate effects on the daily life of every human being. Consequently, alongside the scientists, people feel strongly about their need and their right to contribute to an accurate assessment of the effects of science on society. This is a collection of essays reflecting a considerable range of different cultural experiences and different ethical underpinnings. The main subject is cloning. Cloning is the most accessible and most readily perceived point of convergence from which ethical judgments on the current developments of scientific investigations can be proposed. Cloning is also the 'paradox' on which the confrontation between scientific research and popular imagination is focused.

#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.

The National Institutes of Health and the National Science Foundation together fund more than $40 billon of research annually in the United States and around the globe. These large public expenditures come with strings, including a complex set of laws and guidelines that regulate how scientists may use NIH and NSF funds, how federally funded research may be conducted, and who may have access to or own the product of the research. Until now, researchers have had little instruction on the nature of these laws and how they work. But now, with Robert P. Charrow’s Law in the Laboratory, they have a readable and entertaining introduction to the major ethical and legal considerations pertaining to research under the aegis of federal science funding. For any academic whose position is grant funded, or for any faculty involved in securing grants, this book will be an essential reference manual. And for those who want to learn how federal legislation and regulations affect laboratory research, Charrow’s primer will shed light on the often obscured intersection of government and science.

Improvement of man's genetic endowment by direct ac tions aimed at striving for the positive propagation of those with a superior genetic profile (an element of which is commonly recognized as a high intelligence quotient) or-conversely-delimitation of those with negative genetic inheritance has always remained a pri mary concern of the geneticist and the social engineer. Genetic integrity, eugenic advancement, and a strong genetic pool designed to eliminate illness and suffering have been the benchmarks of the "Genetic Movement" and the challenge of Orwell's Nineteen Eighty-Four. If the quality of life can in some way be either im proved or advanced by use of the law, then this policy must be developed and pursued. No longer does the Dostoyevskian quest to give life meaning through suf fering become an inescapable given. By and through the development and application of new scientific advances in the field of genetics (and especially genetic engi neering), the real potential exists to prevent, to a very vii Preface viii real extent, most human suffering before it ever mani fests itself in or through life. Freedom to undertake re search in the exciting and fertile frontiers of the "New Biology" and to master the Genetic Code must be nur tured and maintained. The search for the truth inevi tably prevents intellectual, social, and economic stag nation, as well as-ideally-frees all from anxiety and fright. Yet, there is a very real potential for this quest to confuse and confound.

Although law and science have interacted for centuries, today their interactions pose enormous challenges. These challenges are reflected in issues ranging from reproductive technology and resource conservation, to genetic technology and biological warfare. The emerging dialogue is complex and requires an ongoing re-thinking of general principles, such as expert biological evidence, which features in a wide range of legal contexts, and including medical law, torts, crime and intellectual property. Studying the many ways in which law and biology come together in many areas of contemporary life, The Nexus of Law and Biology: New Ethical Challenges explores the juridical uses of biological sciences to illuminate key issues and contemporary intersections, arguing that each of several disciplines must communicate with one another, recognizing a common ground in ethics. Featuring an impressive list of contributors, this book is an invaluable reference for legal scholars, students, practising lawyers and scientists engaged with the legal system.

This book represents my experience teaching graduate students in Biomedical Science at Hood College. Being science majors, the students have a limited background in philosophy and ethics. Most of the graduate students are employed at area research laboratories while also pursuing a Master of Science degree. Their practical day-to-day experience in scientific research is helpful in discussions of responsible conduct of research cases. Being aware of increased cases of misconduct the United States established the Office of Research Integrity (ORI). Their publication, Introduction to the Responsible Conduct of Research, defines misconduct as fabrication, falsification, and plagiarism. Concern for the breach of public trust with repercussions in scientific funding has led to mandates for courses in ethics for students pursuing a scientific career. In addition, the Human Genome Project megaproject funded Ethical, Legal, and Social Implications Research (www.genome.gov/ELSI/) recognizing that the genetic information produced by the project would come with applied ethical dilemmas. Teaching can be understood as conveying knowledge from generation to generation. Likewise systems of morality are collective acquisitions built up over millennia with social norms and values that aim to maintain social order. Research does not support the premise that knowing the rules of conduct will prevent misconduct. Indeed, compliance with rules can give a false sense of security, especially if the ethical reasoning grounding the rules is not understood. Therefore, I try to sketch a path through the potential phases and avenues of a scientific career, imagining that a person may do basic research, serve on ethics committees, and engage the public in ethical use of new advances in genetics. As a result the content of this text is divided into three parts. The first part deals with foundational material on science and ethics and cases that highlight proper scientific professional conduct. The second part deals with clinical research through which a research discovery is moved to the bedside of patients and the ethical parameters of the transition. The third part sketches the ethical dilemmas evolving from progress in genetic information to clinical applications. Helping students find a moral compass, a grounding of why one ought to behave in ethical ways in their profession and more generally in life is challenging. Doing so increases their awareness and mine of potential dilemmas and how to deal with them ethically.

The rapid advances made in genetic research and technology over the last few decades have led to a host of important discoveries that have allowed for the detection (and hopefully soon the treatment) of a number of genetic conditions and diseases. Not surprisingly, these advances have also raised numerous ethical concerns about how result ing technologies will be implemented, and the impact they will have on different com munities. One particular concern is the enormous costs involved in conducting genetic research and the fact that the private sector has become heavily involved; the desire to commercialize the results and technology derived from genetic research is considered problematic. In September 1998, the Second International Conference on DNA Sampling, titled "The Commercialization of Genetic Research: Ethical, Legal and Policy Issues," was held of the conference, and of this book, was to in Edmonton, Alberta, Canada. The goal facilitate an interdisciplinary discussion of the legal, ethical, and policy implications arising from the commercialization of genetic research. We solicited contributions for the book from authors in fields as diverse as ethics, law, medicine, health policy, and the social sciences. The papers included, while based on presentations given at the conference, have been substantially expanded and enhanced by the commentary received and discussions held at the conference.

In the past few years, an increasing number of colleges and universities have added courses in biomedical ethics to their curricula. To some extent, these additions serve to satisfy student demands for "relevance. " But it is also true that such changes reflect a deepening desire on the part of the academic community to deal effectively with a host of problems which must be solved if we are to have a health-care delivery system which is efficient, humane, and just. To a large degree, these problems are the unique result of both rapidly changing moral values and dramatic advances in biomedical technology. The past decade has witnessed sudden and conspicuous controversy over the morality and legality of new practices relating to abortion, therapy for the mentally ill, experimentation using human subjects, forms of genetic interven tion, and euthanasia. Malpractice suits abound, and astronomical fees for malpractice insurance threaten the very possibility of medical and health-care practice. Without the backing of a clear moral consensus, the law is frequently forced into resolving these conflicts only to see the moral issues involved still hotly debated and the validity of the existing law further questioned. Take abortion, for example. Rather than settling the legal issue, the Supreme Court's original abortion decision in Roe v. Wade (1973), seems only to have spurred further legal debate. And of course, whether or not abortion is a mo rally ac ceptable procedure is still the subject of heated dispute.

"Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss.EU project ('Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union--an Evidence-Based Impact Analysis') to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project's results"--Publisher's description