CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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.

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.