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An overview of the key debates in biomedical research ethics, presented through a wide-ranging selection of 149 case studies. 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 Declaration of Helsinki, two key documents in the establishment of bioethical standards for research.

Professional ethics. Deontology --- Human medicine --- Bioethics --- Medical ethics --- Research --- experiment, experimenteel onderzoek (mensen) --- bio-ethiek (medische, biomedische ethiek, bio-ethische aspecten) --- casuïstiek (gevallenstudie, gevalstudie) --- geïnformeerde vrijwillige toestemming (instemming) --- proefpersonen --- belangenconflict --- genetica (genen) --- experiment, experimenteel onderzoek (dieren, dierproeven) --- expérimentation sur la personne humaine (chez l'humain) --- bioéthique (éthique médicale, biomédicale, aspects bioéthiques) --- casuistique --- consentement libre et éclairé --- sujets (participants) d'expérimentation --- conflit d'intérêt --- génétique (gènes) --- expérimentation sur l'animal --- Biomedical ethics --- Clinical ethics --- Ethics, Medical --- Health care ethics --- Medical care --- Medicine --- Biology --- Life sciences --- Life sciences ethics --- Moral and ethical aspects --- Professional ethics --- Nursing ethics --- Social medicine --- Science

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Ces réflexions portent sur l'éthique de la recherche biomédicale, en particulier lorsque celle-ci s'applique aux personnes vulnérables: malades mentaux, prisonniers et soldats, personnes des pays en voie de développement, enfants, personnes en fin de vie.

Ethics, Medical --- Informed Consent --- Biomedical Research --- Vulnerable Populations --- ethics --- BPB0703 --- proefpersonen --- experiment, experimenteel onderzoek (mensen) --- biomedisch, medisch-wetenschappelijk onderzoek --- kwetsbaarheid (kwetsbaarheidsbeginsel) --- geesteszieken --- gevangenen (gedetineerden, gevangenis) --- ontwikkelingsland (derdewereld) --- kinderen --- bejaarden (ouderen) --- 174 --- 614.253.8 --- 612-089 --- sujets (participants) d'expérimentation --- expérimentation sur la personne humaine (chez l'humain) --- recherche biomédicale --- vulnérabilité (principe de vulnérabilité) --- malades mentaux --- prisonniers (détenus, prison) --- pays en développement (tiersmonde) --- enfants --- personnes agées --- Beroepsethiek. Beroepsmoraal. Deontologie van het beroep --- Rechten en plichten van patienten. Relatie van patient tot arts--(vanuit standpunt patient) --- Biomedical methods. Surgical techniques. Dissection --- 612-089 Biomedical methods. Surgical techniques. Dissection --- 174 Beroepsethiek. Beroepsmoraal. Deontologie van het beroep --- Biomedical Research - ethics

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Outlines an approach to ensure the protection of participants through the establishment of effective Human Research Participant Protection Programs (HRPPP). Topics covered in this book include improved research review processes, recognition and integration of research participants contributions to the system, and vigilant maintenance of HRPPP performance. When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants safety and their capacity to safeguard the well-being of those who volunteer for research studies. "Responsible Research" outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: improved research review processes; recognition and integration of research participants contributions to the system, and vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. "Responsible Research" will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsors but also including volunteers who may agree to serve as research participants.

MEDICAL --- Research --- Ethics --- Human Rights --- Epidemiologic Study Characteristics as Topic --- Jurisprudence --- Professional-Patient Relations --- Investigative Techniques --- Social Control Policies --- Biomedical Research --- Accident Prevention --- Persons --- Social Control, Formal --- Professional Staff Committees --- Ethics Committees --- Therapeutics --- Health Care Quality, Access, and Evaluation --- Policy --- Health Care Economics and Organizations --- Named Groups --- Humanities --- Interpersonal Relations --- Accidents --- Sociology --- Quality Assurance, Health Care --- Health Care Evaluation Mechanisms --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Science --- Professional Practice --- Quality of Health Care --- Health Care --- Social Sciences --- Public Health --- Psychology, Social --- Natural Science Disciplines --- Disciplines and Occupations --- Anthropology, Education, Sociology and Social Phenomena --- Organization and Administration --- Environment and Public Health --- Behavior and Behavior Mechanisms --- Psychiatry and Psychology --- Health Services Administration --- Human Experimentation --- Safety --- Government Regulation --- Public Policy --- Conflict of Interest --- Ethics Committees, Research --- Informed Consent --- Clinical Protocols --- Researcher-Subject Relations --- Ethical Review --- Patient Rights --- Clinical Trials Data Monitoring Committees --- Research Subjects --- experiment, experimenteel onderzoek (mensen) --- ethiek (ethische aspecten) --- geïnformeerde vrijwillige toestemming (instemming) --- proefpersonen --- Verenigde Staten --- belangenconflict --- expérimentation sur la personne humaine (chez l'humain) --- ethique (aspects ethiques) --- consentement libre et éclairé --- sujets (participants) d'expérimentation --- Etats Unis --- conflit d'intérêt --- Human experimentation in medicine --- Medical ethics. --- Medical protocols. --- Patients --- Moral and ethical aspects. --- Legal status, laws, etc. --- Patients' rights --- Clinical algorithms --- Clinical protocols --- Patient care plans --- Plans for patient care --- Protocols in medicine --- Biomedical ethics --- Clinical ethics --- Ethics, Medical --- Health care ethics --- Medical care --- Medicine --- Moral and ethical aspects --- Clinical medicine --- Medical records --- Bioethics --- Professional ethics --- Nursing ethics --- Social medicine --- Medical ethics --- Medical protocols --- Legal status, laws, etc