---
kind: "section"
citation: "21 C.F.R. § 812.47"
title: "21"
number: "812.47"
heading: "Emergency research under § 50.24 of this chapter."
url: "https://uscodex.org/cfr/21/812.47"
---

# §812.47. 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 under § [50.24(a)(7)(ii)](/cfr/21/50.24.md?p=a-7-ii) and [(iii)](/cfr/21/50.24.md?p=a-7-iii) of this chapter, the sponsor shall promptly submit to the IDE file and to Docket Number FDA-1995-S-0036 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 IDE number.
- (b) The sponsor also shall monitor such investigations to determine 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 51531, Oct. 2, 1996, as amended at 64 FR 10943, Mar. 8, 1999; 88 FR 16880, Mar. 21, 2023]

### Authority

Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262.

### Source

Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

### Amendments

[61 FR 51531, Oct. 2, 1996, as amended at 64 FR 10943, Mar. 8, 1999; 88 FR 16880, Mar. 21, 2023]