---
kind: "section"
citation: "21 C.F.R. § 312.54"
title: "21"
number: "312.54"
heading: "Emergency research under § 50.24 of this chapter."
url: "https://uscodex.org/cfr/21/312.54"
---

# §312.54. Emergency research under § 50.24 of this chapter.

- (a) The sponsor shall monitor the progress of all investigations involving an exception from informed consent under [§ 50.24](/cfr/21/50.24.md) of this chapter. When the sponsor receives from the IRB information concerning the public disclosures required by § [50.24(a)(7)(ii)](/cfr/21/50.24.md?p=a-7-ii) and [(a)(7)(iii)](/cfr/21/50.24.md?p=a-7-iii) of this chapter, the sponsor promptly shall submit to the IND file and to Docket Number 95S-0158 in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, copies of the information that was disclosed, identified by the IND number.
- (b) The sponsor also shall monitor such investigations to identify when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception in [§ 50.24(a)](/cfr/21/50.24.md?p=a) of this chapter or because of other relevant ethical concerns. The sponsor promptly shall provide this information in writing to FDA, investigators who are asked to participate in this or a substantially equivalent clinical investigation, and other IRB's that are asked to review this or a substantially equivalent investigation.

## Notes

### Amendments

[61 FR 51530, Oct. 2, 1996, as amended at 68 FR 24879, May 9, 2003; 88 FR 45065, July 14, 2023]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

### Source

Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

### Amendments

[61 FR 51530, Oct. 2, 1996, as amended at 68 FR 24879, May 9, 2003; 88 FR 45065, July 14, 2023]