IRB: Ethics & Human Research
The Nuts and Bolts of IRBs
Two different but useful guidebooks—Working With and Within IRBs: A Practical Guide for Investigators, Sponsors, and IRB Members, by Eileen Hilton and Deirdre Hall, andInstitutional Review Board: Management and Function, 2nd ed., by Elizabeth A. Bankert and Robert J. Amdur—provide investigators, institutional review board members, and research sponsors with valuable information about how IRBs carry out their functions in reviewing research protocols and overseeing research with humans. The second book, however, is much more comprehensive than the first.
Key words/concepts: informed consent, consent document, IRB administration, ethics review, clinical trials, FDA regulations, Common Rule, Certificates of Confidentiality, Certified IRB Professions (CIP) exam