附註:Includes bibliographical references and index.
1. Introduction -- 2. A Systematic approach to human research participant protection programs -- 3. Back to basics: scientific, conflict of interest, and ethical review of research protocols -- 4. The Participant-investigator interface -- 5. Improving protection through oversight and data and safety monitoring -- 6. Improving human research participant protection program performance and clarifying roles -- 7. Improving an evolving national human research participant protection system.
摘要:Issues addressed in the book include the need to distinguish the 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 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.
