[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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

[CITE: 21CFR50.20]



[Page 281]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 50_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

              Subpart B_Informed Consent of Human Subjects

 

Sec.  50.20  General requirements for informed consent.



    Source: 46 FR 8951, Jan. 27, 1981, unless otherwise noted.





    Except as provided in Sec. Sec.  50.23 and 50.24, no investigator 

may involve a human being as a subject in research covered by these 

regulations unless the investigator has obtained the legally effective 

informed consent of the subject or the subject's legally authorized 

representative. An investigator shall seek such consent only under 

circumstances that provide the prospective subject or the representative 

sufficient opportunity to consider whether or not to participate and 

that minimize the possibility of coercion or undue influence. The 

information that is given to the subject or the representative shall be 

in language understandable to the subject or the representative. No 

informed consent, whether oral or written, may include any exculpatory 

language through which the subject or the representative is made to 

waive or appear to waive any of the subject's legal rights, or releases 

or appears to release the investigator, the sponsor, the institution, or 

its agents from liability for negligence.



[46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999]