2d edition. Issued in looseleaf form with index dividers and a spine label. Prepared under contract by Robin Levin Penslar, at Indiana University, Poynter Center for the Study of Ethics and American Institutions. Includes sections on: institutional administration (of the Institutional Review Board, the IRB); regulations and policies; biomedical and behavioral research, an overview; special classes of subjects (such as fetuses, women, children, prisoners, comatose patients, and volunteers); bibliography; glossary; texts of international human rights documents (Nuremburg, Helsinki, and Belmont); lists of contacts; Federal regulations; and other information.
The Common Rule (45 CFR 46, Subpart A) governs research that is conducted on human beings if it is funded by one of 18 federal agencies.
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 ...
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 ...
In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.
Protecting Human Subjects in Research: Are Current Safeguards Adequate? : Hearing Before the Subcommittee on Public Health of the Committee...
2001; Albala et al. 2010). Investigators can translate technical terms into lay-language, explain complex concepts, and address subjects' questions. For these oral communications to be meaningful, subjects must trust that investigators ...
The need for quality improvement and for cost saving are driving both individual choices and health system dynamics.
The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition ...
In this respect, by providing a history and guide to interpretation and compliance, "Protection of Human Subjects" is a reference of importance and utility to the investigator entering into or working in the field of biomedical or ...
The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children.