---
kind: "section"
citation: "34 C.F.R. § 97.407"
title: "34"
number: "97.407"
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/34/97.407"
---

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


ED conducts or funds research that the IRB does not believe meets the requirements of [§ 97.404](/cfr/34/97.404.md), [§ 97.405](/cfr/34/97.405.md), or [§ 97.406](/cfr/34/97.406.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 that—
  - (1) The research in fact satisfies the conditions of [§ 97.404](/cfr/34/97.404.md), [§ 97.405](/cfr/34/97.405.md), or [§ 97.406](/cfr/34/97.406.md), as applicable; or
  - (2)
    - (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; and
    - (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in [§ 97.408](/cfr/34/97.408.md).

## Notes

### Source

Source: 62 FR 63221, Nov. 26, 1997, unless otherwise noted.

### Authority

Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 42 U.S.C. 300v-1(b).

### Source

Source: 56 FR 28012, 28021, June 18, 1991, unless otherwise noted.