Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations

e-CFR Data is current as of November 20, 2009

Title 21: Food and Drugs
PART 50—PROTECTION OF HUMAN SUBJECTS
Subpart D—Additional Safeguards for Children in Clinical Investigations

Browse Previous | Browse Next

§ 50.51   Clinical investigations not involving greater than minimal risk.

Any clinical investigation within the scope described in §§50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds and documents that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians as set forth in §50.55.

For questions or comments regarding e-CFR editorial content, features, or design, email ecfr@nara.gov.

For questions concerning e-CFR programming and delivery issues, email webteam@gpo.gov.

Section 508 / Accessibility