[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.101]

[Page 321-322]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 56_INSTITUTIONAL REVIEW BOARDS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 56.101  Scope.




                      Subpart A_General Provisions

Sec.
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

56.107 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.

[[Page 322]]

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-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 
262, 263b-263n.

    Source: 46 FR 8975, Jan. 27, 1981, unless otherwise noted.



    (a) This part contains the general standards for the composition, 
operation, and responsibility of an Institutional Review Board (IRB) 
that reviews clinical investigations regulated by the Food and Drug 
Administration under sections 505(i) and 520(g) of the act, as well as 
clinical investigations that support applications for research or 
marketing permits for products regulated by the Food and Drug 
Administration, including foods, including dietary supplements, that 
bear a nutrient content claim or a health claim, infant formulas, food 
and color additives, drugs for human use, medical devices for human use, 
biological products for human use, and electronic products. Compliance 
with this part is intended to protect the rights and welfare of human 
subjects involved in such investigations.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[46 FR 8975, Jan. 27, 1981, as amended at 64 FR 399, Jan. 5, 1999; 66 FR 
20599, Apr. 24, 2001]