[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR56.101]



[Page 292-293]

 

                        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.

56.124 Actions alternative or additional to disqualification.





[[Page 293]]





    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]