Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter A - General |
Part 56 - Institutional Review Boards |
Subpart A - General Provisions |
§ 56.101 - Scope. |
§ 56.102 - Definitions. |
§ 56.103 - Circumstances in which IRB review is required. |
§ 56.104 - Exemptions from IRB requirement. |
§ 56.105 - Waiver of IRB requirement. |
Subpart B - Organization and Personnel |
§ 56.106 - Registration. |
§ 56.107 - IRB membership. |
Subpart C - IRB Functions and Operations |
§ 56.108 - IRB functions and operations. |
§ 56.109 - IRB review of research. |
§ 56.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. |
§ 56.111 - Criteria for IRB approval of research. |
§ 56.112 - Review by institution. |
§ 56.113 - Suspension or termination of IRB approval of research. |
§ 56.114 - Cooperative research. |
Subpart D - Records and Reports |
§ 56.115 - IRB records. |
Subpart E - Administrative Actions for Noncompliance |
§ 56.120 - Lesser administrative actions. |
§ 56.121 - Disqualification of an IRB or an institution. |
§ 56.122 - Public disclosure of information regarding revocation. |
§ 56.123 - Reinstatement of an IRB or an institution. |
§ 56.124 - Actions alternative or additional to disqualification. |