eCFR Reference Browser

---

title: "21 CFR §50.51"

source: "https://www.ecfr.gov/current/title-21/section-50.51"

title_number: "21"

volume_number: "1"

chapter_number: "Unknown"

subchapter_code: "A"

subchapter_subject: "GENERAL"

part_code: "50"

part_subject: "PROTECTION OF HUMAN SUBJECTS"

subpart_code: "D"

subpart_subject: "Additional Safeguards for Children in Clinical Investigations"

section_number: "50.51"

section_subject: "Clinical investigations not involving greater than minimal risk."

cfr_reference: "21 CFR 50.51"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 1 to 99"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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 that:

(a)No greater than minimal risk to children is presented; and

(b)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.

§50.51 - Clinical investigations not involving greater than minimal risk.