[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.47]

[Page 110]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
                 Subpart C_Responsibilities of Sponsors
 
Sec. 812.47  Emergency research under Sec. 50.24 of this chapter.

    (a) The sponsor shall monitor the progress of all investigations 
involving an exception from informed consent under Sec. 50.24 of this 
chapter. When the sponsor receives from the IRB information concerning 
the public disclosures under Sec. 50.24(a)(7)(ii) and (a)(7)(iii) of 
this chapter, the sponsor shall promptly submit to the IDE file and to 
Docket Number 95S-0158 in the Division of Dockets Management (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 Sec. 50.24(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.

[61 FR 51531, Oct. 2, 1996, as amended at 64 FR 10943, Mar. 8, 1999]