[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.27]
[Page 288]
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
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]
http://a257.g.akamaitech.net/7/257/2422/26mar20071500/edocket.access.
gpo.gov/cfr_2007/aprqtr/21cfr50.27.htm