[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: 21CFR50.20]
[Page 282]
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]
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