[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: 21CFR812.100]



[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 E_Responsibilities of Investigators

 

Sec.  812.100  General responsibilities of investigators.





    An investigator is responsible for ensuring that an investigation is 

conducted according to the signed agreement, the investigational plan 

and applicable FDA regulations, for protecting the rights, safety, and 

welfare of subjects under the investigator's care, and for the control 

of devices under investigation. An investigator also is responsible for 

ensuring that informed consent is obtained in accordance with part 50 of 

this chapter. Additional responsibilities of investigators are described 

in subpart G.



[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8957, Jan. 27, 1981]