TY - BOOK ID - 8432741 TI - Responsible research AU - Federman, Daniel D AU - Hanna, Kathi E AU - Rodriguez, Laura Lyman AU - Institute of Medicine (U.S.). PY - 2003 SN - 0309084881 9786610209392 1280209399 030950046X 9780309500463 6610209391 9781280209390 9780309084888 0305084881 0309169038 PB - Washington, D.C. National Academies Press DB - UniCat KW - MEDICAL KW - Research KW - Ethics KW - Human Rights KW - Epidemiologic Study Characteristics as Topic KW - Jurisprudence KW - Professional-Patient Relations KW - Investigative Techniques KW - Social Control Policies KW - Biomedical Research KW - Accident Prevention KW - Persons KW - Social Control, Formal KW - Professional Staff Committees KW - Ethics Committees KW - Therapeutics KW - Health Care Quality, Access, and Evaluation KW - Policy KW - Health Care Economics and Organizations KW - Named Groups KW - Humanities KW - Interpersonal Relations KW - Accidents KW - Sociology KW - Quality Assurance, Health Care KW - Health Care Evaluation Mechanisms KW - Analytical, Diagnostic and Therapeutic Techniques and Equipment KW - Science KW - Professional Practice KW - Quality of Health Care KW - Health Care KW - Social Sciences KW - Public Health KW - Psychology, Social KW - Natural Science Disciplines KW - Disciplines and Occupations KW - Anthropology, Education, Sociology and Social Phenomena KW - Organization and Administration KW - Environment and Public Health KW - Behavior and Behavior Mechanisms KW - Psychiatry and Psychology KW - Health Services Administration KW - Human Experimentation KW - Safety KW - Government Regulation KW - Public Policy KW - Conflict of Interest KW - Ethics Committees, Research KW - Informed Consent KW - Clinical Protocols KW - Researcher-Subject Relations KW - Ethical Review KW - Patient Rights KW - Clinical Trials Data Monitoring Committees KW - Research Subjects KW - experiment, experimenteel onderzoek (mensen) KW - ethiek (ethische aspecten) KW - geïnformeerde vrijwillige toestemming (instemming) KW - proefpersonen KW - Verenigde Staten KW - belangenconflict KW - expérimentation sur la personne humaine (chez l'humain) KW - ethique (aspects ethiques) KW - consentement libre et éclairé KW - sujets (participants) d'expérimentation KW - Etats Unis KW - conflit d'intérêt KW - Human experimentation in medicine KW - Medical ethics. KW - Medical protocols. KW - Patients KW - Moral and ethical aspects. KW - Legal status, laws, etc. KW - Patients' rights KW - Clinical algorithms KW - Clinical protocols KW - Patient care plans KW - Plans for patient care KW - Protocols in medicine KW - Biomedical ethics KW - Clinical ethics KW - Ethics, Medical KW - Health care ethics KW - Medical care KW - Medicine KW - Moral and ethical aspects KW - Clinical medicine KW - Medical records KW - Bioethics KW - Professional ethics KW - Nursing ethics KW - Social medicine KW - Medical ethics KW - Medical protocols KW - Legal status, laws, etc UR - https://www.unicat.be/uniCat?func=search&query=sysid:8432741 AB - 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. ER -