[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: 21CFR50.25]
[Page 287-288]
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. 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent,
the following information shall be provided to each subject:
(1) A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the subject's
participation, a description of the procedures to be followed, and
identification of any procedures which are experimental.
(2) A description of any reasonably foreseeable risks or discomforts
to the subject.
(3) A description of any benefits to the subject or to others which
may reasonably be expected from the research.
(4) A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject.
(5) A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be maintained
and that notes the possibility that the Food and Drug Administration may
inspect the records.
(6) For research involving more than minimal risk, an explanation as
to whether any compensation and an explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist
of, or where further information may be obtained.
(7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects' rights, and whom to
contact in the event of a research-related injury to the subject.
(8) A statement that participation is voluntary, that refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and that the subject may discontinue
participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled.
(b) Additional elements of informed consent. When appropriate, one
or more of the following elements of information shall also be provided
to each subject:
(1) A statement that the particular treatment or procedure may
involve risks to the subject (or to the embryo or fetus, if the subject
is or may become pregnant) which are currently unforeseeable.
(2) Anticipated circumstances under which the subject's
participation may be terminated by the investigator without regard to
the subject's consent.
[[Page 288]]
(3) Any additional costs to the subject that may result from
participation in the research.
(4) The consequences of a subject's decision to withdraw from the
research and procedures for orderly termination of participation by the
subject.
(5) A statement that significant new findings developed during the
course of the research which may relate to the subject's willingness to
continue participation will be provided to the subject.
(6) The approximate number of subjects involved in the study.
(c) The informed consent requirements in these regulations are not
intended to preempt any applicable Federal, State, or local laws which
require additional information to be disclosed for informed consent to
be legally effective.
(d) Nothing in these regulations is intended to limit the authority
of a physician to provide emergency medical care to the extent the
physician is permitted to do so under applicable Federal, State, or
local law.
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