Institutional Review Board: Management and Function: Management and FunctionInstitutional Review Board (IRB) members and oversight personnel face challenges with research involving new technology, management of big data, globalization of research, and more complex federal regulations. Institutional Review Board: Management and Function, Third Edition provides everything IRBs and administrators need to know about efficiently managing and effectively operating a modern and compliant system of protecting human research subjects. This trusted reference manual has been extensively updated to reflect the 2018 revisions to the Federal Policy for the Protection of Human Subjects (Common Rule). An essential resource for both seasoned and novice IRB administrators and members, Institutional Review Board: Management and Function provides comprehensive and understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical step-by-step guidance for effectively implementing regulatory oversight. |
Contents
| 27 | |
PART 3 Organizing the IRB Committee | 89 |
PART 4 SingleCentral IRBs | 127 |
PART 5 Review of Research | 167 |
PART 6 Informed Consent | 245 |
PART 7 IRB Review of Approved Protocols | 351 |
PART 8 Administration Education and Regulatory Issues | 401 |
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Common terms and phrases
activities additional Administration allow applicable approach appropriate approval assessment associated audit authorization benefits biospecimens broad cells changes chapter clinical clinical trials collection committee Common Rule concerns conducted consider considerations context continuing criteria decision Department described determine device DHHS discussion document drug effective ensure ethical evaluation example exemption federal findings genomic guidance harm Health HRPP Human Research human subjects identifiable important individual informed consent institution involving IRB review issues laws limited meeting minimal risk obtained participation patients persons policies population potential practice present principles procedures proposed protection protocol questions reasonable References regarding regulations regulatory requirements research involving research subjects responsibility risk role Services setting social specific staff standard subpart testing tion treatment types understanding vulnerable waiver written