[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: 21CFR50.27]



[Page 286-287]

 

                        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.  50.27  Documentation of informed consent.



    (a) Except as provided in Sec.  56.109(c), informed consent shall be 

documented by the use of a written consent form approved by the IRB and 

signed and dated by the subject or the subject's legally authorized 

representative at the time of consent. A copy shall be given to the 

person signing the form.

    (b) Except as provided in Sec.  56.109(c), the consent form may be 

either of the following:

    (1) A written consent document that embodies the elements of 

informed consent required by Sec.  50.25. This form may be read to the 

subject or the subject's legally authorized representative, but, in any 

event, the investigator shall give either the subject or the 

representative adequate opportunity to read it before it is signed.

    (2) A short form written consent document stating that the elements 

of informed consent required by Sec.  50.25 have been presented orally 

to the subject or the subject's legally authorized representative. When 

this method is used, there shall be a witness to the oral presentation. 

Also, the IRB shall approve a written summary of what is to be said to 

the subject or the representative. Only the short form itself is to be 

signed by the subject or the representative. However, the witness shall



[[Page 287]]



sign both the short form and a copy of the summary, and the person 

actually obtaining the consent shall sign a copy of the summary. A copy 

of the summary shall be given to the subject or the representative in 

addition to a copy of the short form.



[46 FR 8951, Jan. 27, 1981, as amended at 61 FR 57280, Nov. 5, 1996]



Subpart C [Reserved]