Protecting Study Volunteers in Research: A Manual for Investigative SitesRecommended by the National Institutes of Health, the Office of Health and Human Services and the FDA, Protecting Study Volunteers in Research is a 250-page manual designed to assist clinical research professionals in providing the highest standards of safety and ethical treatment for their study volunteers. This convenient and portable manual has become required reading in academic institutions, IRBs and independent investigative sites. Many sponsor and CRO companies have also made this manual mandatory reading for their staff and service providers. Developed in accordance with the essentials and standards of the ACCME, readers can apply for CME credits or Nursing Credit Hours. An exam is provided with each manual. pics include... Historical perspectives on human subject research; Ethics and federal regulations; Roles and responsibilities of institutions and independent sites; Roles and responsibilities of investigators and study staff. |
Contents
The Study of Untreated Syphilis In The Negro Male | 8 |
Introduction | 15 |
The Roles and Responsibilities of Institutions in Human Subject Research | 33 |
Copyright | |
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accordance activity additional adequate adverse Agency amended animals application appropriate approval assurance authorized benefits biological Board Center changes chapter clinical investigation complete concerns conducted considered contain continuing copy covered Department described determine device document drug Drug Administration effect established ethical Evaluation experience Federal Food and Drug Health human subjects immediate individual informed consent initial institution intended investigational drug involving issues legally licensed maintain manufacturer marketing means meeting monitoring obtained Office otherwise paragraph participation patients period person Phase potential presented principles procedures proposed protection protocol reasonable receive records regarding regulations reports representative request respect responsible risk safety scientific signed specific sponsor standards statement submission submitted subpart terminate tion treatment trial unless written