Title 21

PART 56

Part 56 - Institutional Review Boards

PART 56 - INSTITUTIONAL REVIEW BOARDS Authority:21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262. Source:46 FR 8975, Jan. 27, 1981, unless otherwise noted.

21:1.0.1.1.23.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.23.1.63.1SECTION 56.101
   56.101 Scope.
21:1.0.1.1.23.1.63.2SECTION 56.102
   56.102 Definitions.
21:1.0.1.1.23.1.63.3SECTION 56.103
   56.103 Circumstances in which IRB review is required.
21:1.0.1.1.23.1.63.4SECTION 56.104
   56.104 Exemptions from IRB requirement.
21:1.0.1.1.23.1.63.5SECTION 56.105
   56.105 Waiver of IRB requirement.
21:1.0.1.1.23.2SUBPART B
Subpart B - Organization and Personnel
21:1.0.1.1.23.2.63.1SECTION 56.106
   56.106 Registration.
21:1.0.1.1.23.2.63.2SECTION 56.107
   56.107 IRB membership.
21:1.0.1.1.23.3SUBPART C
Subpart C - IRB Functions and Operations
21:1.0.1.1.23.3.63.1SECTION 56.108
   56.108 IRB functions and operations.
21:1.0.1.1.23.3.63.2SECTION 56.109
   56.109 IRB review of research.
21:1.0.1.1.23.3.63.3SECTION 56.110
   56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
21:1.0.1.1.23.3.63.4SECTION 56.111
   56.111 Criteria for IRB approval of research.
21:1.0.1.1.23.3.63.5SECTION 56.112
   56.112 Review by institution.
21:1.0.1.1.23.3.63.6SECTION 56.113
   56.113 Suspension or termination of IRB approval of research.
21:1.0.1.1.23.3.63.7SECTION 56.114
   56.114 Cooperative research.
21:1.0.1.1.23.4SUBPART D
Subpart D - Records and Reports
21:1.0.1.1.23.4.63.1SECTION 56.115
   56.115 IRB records.
21:1.0.1.1.23.5SUBPART E
Subpart E - Administrative Actions for Noncompliance
21:1.0.1.1.23.5.63.1SECTION 56.120
   56.120 Lesser administrative actions.
21:1.0.1.1.23.5.63.2SECTION 56.121
   56.121 Disqualification of an IRB or an institution.
21:1.0.1.1.23.5.63.3SECTION 56.122
   56.122 Public disclosure of information regarding revocation.
21:1.0.1.1.23.5.63.4SECTION 56.123
   56.123 Reinstatement of an IRB or an institution.
21:1.0.1.1.23.5.63.5SECTION 56.124
   56.124 Actions alternative or additional to disqualification.