[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.1]

[Page 277-278]
 
                        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 278]]

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]