---
kind: "section"
citation: "45 C.F.R. § 46.207"
title: "45"
number: "46.207"
heading: "Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates."
url: "https://uscodex.org/cfr/45/46.207"
---

# §46.207. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.


The Secretary will conduct or fund research that the IRB does not believe meets the requirements of [§ 46.204](/cfr/45/46.204.md) or [§ 46.205](/cfr/45/46.205.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 pregnant women, fetuses or neonates; and
- (b) **The Secretary, after consultation with a panel of experts in pertinent disciplines (for example—** science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, has determined either:
  - (1) That the research in fact satisfies the conditions of [§ 46.204](/cfr/45/46.204.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 pregnant women, fetuses or neonates;
    - (ii) The research will be conducted in accord with sound ethical principles; and
    - (iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.

## Notes

### Source

Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted.

### Authority

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