---
kind: "section"
citation: "21 C.F.R. § 50.51"
title: "21"
number: "50.51"
heading: "Clinical investigations not involving greater than minimal risk."
url: "https://uscodex.org/cfr/21/50.51"
---

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


Any clinical investigation within the scope described in §§ [50.1](/cfr/21/50.1.md) and [56.101](/cfr/21/56.101.md) 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](/cfr/21/50.55.md).

## Notes

### Amendments

[78 FR 12951, Feb. 26, 2013]

### Source

Source: 66 FR 20598, Apr. 24, 2001, unless otherwise noted.

### Authority

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.

### Source

Source: 45 FR 36390, May 30, 1980, unless otherwise noted.

### Amendments

[78 FR 12951, Feb. 26, 2013]