Protecting Study Volunteers in Research: A Manual for Investigative SitesProtecting Study Volunteers in Research is a suggested educational resource by NIH and FDA (source: NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2002) and has become required reading in many academic institutions, IRBs, investigative sites, and for many Biopharmaceutical and CRO companies. This well-organized and concise manual teaches organizations how to successfully implement the highest standards of safe and ethical treatment of study volunteers while addressing current and emerging issues that are critical to our system of human subject protection oversight. Topics covered include: Conflicts of interest in research, Participant recruitment and retention in clinical trials, Research with secondary subjects, tissue studies, and records review, Historical perspectives on human subject research, Updated ethics and federal regulations, Roles and responsibilities of institutions and independent sites, Roles and responsibilities of investigators and the study process. --Amazon.com |
Contents
Instructions for Obtaining Continuing Education Credit | 10 |
Human Radiation Experiments | 23 |
Federal Regulations | 36 |
Copyright | |
15 other sections not shown
Other editions - View all
Common terms and phrases
accordance action activities additional adequate Administration adverse agency amended application appropriate approval associated Assurance authorization benefits biological changes chapter clinical investigation clinical trials complete concerns conducted considered contain continuing contract covered entity Department described determine device direct disclosure disease documents drug effect ensure ethical Evaluation example experience federal Food genetic human subjects identified important individual informed consent institution intended interest involving issues licensed maintain manufacturer marketing means meeting ment monitoring obtained participation patients person Phase potential practice presented Privacy Rule procedures proposed protection protocol reasonable receive records recruitment regarding regulations request research involving responsible risk safety scientific Services specific sponsor standard statement submitted Subpart testing tion tissue treatment