[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: 21CFR50.1]



[Page 278-279]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 50_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  50.1  Scope.









                      Subpart A_General Provisions



Sec.

50.1 Scope.

50.3 Definitions.



              Subpart B_Informed Consent of Human Subjects



50.20 General requirements for informed consent.

50.23 Exception from general requirements.

50.24 Exception from informed consent requirements for emergency 

          research.

50.25 Elements of informed consent.

50.27 Documentation of informed consent.



Subpart C [Reserved]



 Subpart D_Additional Safeguards for Children in Clinical Investigations



50.50 IRB duties.

50.51 Clinical investigations not involving greater than minimal risk.

50.52 Clinical investigations involving greater than minimal risk but 

          presenting the prospect of direct benefit to individual 

          subjects.

50.53 Clinical investigations involving greater than minimal risk and no 

          prospect of direct benefit to individual subjects, but likely 

          to yield generalizable knowledge about the subjects' disorder 

          or condition.

50.54 Clinical investigations not otherwise approvable that present an 

          opportunity to understand, prevent, or alleviate a serious 

          problem affecting the health or welfare of children.

50.55 Requirements for permission by parents or guardians and for assent 

          by children.

50.56 Wards.



    Authority: 21 U.S.C 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 

355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 

263b-263n.



    Source: 45 FR 36390, May 30, 1980, unless otherwise noted.







    (a) This part applies to all clinical investigations regulated by 

the Food and Drug Administration under sections 505(i) and 520(g) of the 

Federal Food, Drug, and Cosmetic 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. Additional specific obligations and commitments 

of, and standards of conduct for, persons who sponsor or monitor 

clinical investigations involving particular test articles may also be 

found in other parts (e.g., parts 312 and 812). Compliance with these 

parts is intended to protect the rights and safety of subjects involved 

in investigations filed with the Food and Drug Administration pursuant 

to sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513-516, 518-

520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and 

sections 351 and 354-360F of the Public Health Service Act.

    (b) References in this part to regulatory sections of the Code of 

Federal



[[Page 279]]



Regulations are to chapter I of title 21, unless otherwise noted.



[45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981, as amended at 63 

FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 66 FR 20597, Apr. 24, 

2001]