1. Regulations
  2. title 21
  3. chapter I
  4. part 56
  5. subpart A
  6. § 56.105

View all text of Subpart A [§ 56.101 - § 56.105]

§ 56.105 - Waiver of IRB requirement.

On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements contained in these regulations, including the requirements for IRB review, for specific research activities or for classes of research activities, otherwise covered by these regulations.

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.

CITE AS: 21 CFR 56.105