[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR812.47]



[Page 111]

 

                        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]