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

---
identifier: "/us/cfr/t21/s50.51"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 50.51 - Clinical investigations not involving greater than minimal risk."
title_number: 21
title_name: "Food and Drugs"
section_number: "50.51"
section_name: "Clinical investigations not involving greater than minimal risk."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "50"
part_name: "PROTECTION OF HUMAN SUBJECTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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."
regulatory_source: "45 FR 36390, May 30, 1980, unless otherwise noted."
cfr_part: "50"
---


# 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 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.

[78 FR 12951, Feb. 26, 2013]