---
kind: "section"
citation: "21 C.F.R. § 50.54"
title: "21"
number: "50.54"
heading: "Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children."
url: "https://uscodex.org/cfr/21/50.54"
---

# §50.54. Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.


If an IRB does not believe that a 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 and involving children as subjects meets the requirements of [§ 50.51](/cfr/21/50.51.md), [§ 50.52](/cfr/21/50.52.md), or [§ 50.53](/cfr/21/50.53.md), the clinical investigation may proceed only if:

- (a) The IRB finds that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and
- (b) The Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, determines either:
  - (1) That the clinical investigation in fact satisfies the conditions of [§ 50.51](/cfr/21/50.51.md), [§ 50.52](/cfr/21/50.52.md), or [§ 50.53](/cfr/21/50.53.md), as applicable, or
  - (2) **That the following conditions are met—**
    - (i) The clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
    - (ii) The clinical investigation will be conducted in accordance with sound ethical principles; and
    - (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians as set forth in [§ 50.55](/cfr/21/50.55.md).

## Notes

### Amendments

[66 FR 20598, Apr. 24, 2001, as amended at 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

[66 FR 20598, Apr. 24, 2001, as amended at 78 FR 12951, Feb. 26, 2013]