---
kind: "section"
citation: "45 C.F.R. § 46.407"
title: "45"
number: "46.407"
heading: "Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children."
url: "https://uscodex.org/cfr/45/46.407"
---

# §46.407. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.


HHS will conduct or fund research that the IRB does not believe meets the requirements of [§ 46.404](/cfr/45/46.404.md), [§ 46.405](/cfr/45/46.405.md), or [§ 46.406](/cfr/45/46.406.md) only if:

- (a) The IRB finds that the research 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 Secretary, 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, has determined either:
  - (1) That the research in fact satisfies the conditions of [§ 46.404](/cfr/45/46.404.md), [§ 46.405](/cfr/45/46.405.md), or [§ 46.406](/cfr/45/46.406.md), as applicable, or
  - (2) **The following—**
    - (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
    - (ii) The research will be conducted in accordance with sound ethical principles;
    - (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in [§ 46.408](/cfr/45/46.408.md).

## Notes

### Source

Source: 48 FR 9818, Mar. 8, 1983, unless otherwise noted.

### Authority

Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).