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.

• 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.

21:1.0.1.1.23.1	SUBPART A	Subpart A - General Provisions
21:1.0.1.1.23.1.63.1	SECTION 56.101	56.101 Scope.
21:1.0.1.1.23.1.63.2	SECTION 56.102	56.102 Definitions.
21:1.0.1.1.23.1.63.3	SECTION 56.103	56.103 Circumstances in which IRB review is required.
21:1.0.1.1.23.1.63.4	SECTION 56.104	56.104 Exemptions from IRB requirement.
21:1.0.1.1.23.1.63.5	SECTION 56.105	56.105 Waiver of IRB requirement.
21:1.0.1.1.23.2	SUBPART B	Subpart B - Organization and Personnel
21:1.0.1.1.23.2.63.1	SECTION 56.106	56.106 Registration.
21:1.0.1.1.23.2.63.2	SECTION 56.107	56.107 IRB membership.
21:1.0.1.1.23.3	SUBPART C	Subpart C - IRB Functions and Operations
21:1.0.1.1.23.3.63.1	SECTION 56.108	56.108 IRB functions and operations.
21:1.0.1.1.23.3.63.2	SECTION 56.109	56.109 IRB review of research.
21:1.0.1.1.23.3.63.3	SECTION 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.
21:1.0.1.1.23.3.63.4	SECTION 56.111	56.111 Criteria for IRB approval of research.
21:1.0.1.1.23.3.63.5	SECTION 56.112	56.112 Review by institution.
21:1.0.1.1.23.3.63.6	SECTION 56.113	56.113 Suspension or termination of IRB approval of research.
21:1.0.1.1.23.3.63.7	SECTION 56.114	56.114 Cooperative research.
21:1.0.1.1.23.4	SUBPART D	Subpart D - Records and Reports
21:1.0.1.1.23.4.63.1	SECTION 56.115	56.115 IRB records.
21:1.0.1.1.23.5	SUBPART E	Subpart E - Administrative Actions for Noncompliance
21:1.0.1.1.23.5.63.1	SECTION 56.120	56.120 Lesser administrative actions.
21:1.0.1.1.23.5.63.2	SECTION 56.121	56.121 Disqualification of an IRB or an institution.
21:1.0.1.1.23.5.63.3	SECTION 56.122	56.122 Public disclosure of information regarding revocation.
21:1.0.1.1.23.5.63.4	SECTION 56.123	56.123 Reinstatement of an IRB or an institution.
21:1.0.1.1.23.5.63.5	SECTION 56.124	56.124 Actions alternative or additional to disqualification.

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