Abstract | Keywords | Export | Availability | Bookmark

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

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