REQUIREMENTS FOR INFORMED CONSENT
45
CFR 46.116 and 21
CFR 50.25
POINTS TO CONSIDER
General
Requirements for Informed Consent:
-
No investigator may involve a human being as a subject
in research unless the investigator has obtained the
legally effective informed consent of the subject or
the subject’s legally authorized representative.
-
Consent will be obtained 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 given to the subject or the representative
will 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.
THE
FOLLOWING INFORMATION ABOUT THE STUDY MUST BE PROVIDED
TO RESEARCH SUBJECTS WHEN OBTAINING INFORMED CONSENT:
Basic Elements of Informed Consent [45
CFR 46.116(a) and 21
CFR 50.25(a)]
-
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;
-
A description of any reasonably forseeable risks or
discomforts to the subject;
-
A description of any benefits to the subject or to
others which may reasonably be expected from the research;
-
A disclosure of appropriate alternative procedures
or courses of treatment, if any, that might be advantageous
to the subject;
-
A statement describing the extent, if any, to which
confidentiality of records identifying the subject
will be maintained [a general statement is
included in the standard language];
-
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
[a general statement is included in the standard language];
-
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; [a general statement
is included in the standard language] and
-
A statement that participation is voluntary, refusal
to participate will involve no penalty or loss of
benefits to which the subject is otherwise entitled,
and the subject may discontinue participation at any
time without penalty or loss of benefits to which
the subject is otherwise entitled [a general
statement is included in the standard language].
Additional
elements of informed consent [45
CFR 46.116(b) and 21
CFR 50.25(b)]
When appropriate, the following information must be provided
to each subject:
-
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 unforseeable;
-
Anticipated circumstances under which the subject’s
participation may be terminated by the investigator
without regard to the subject’s consent;
-
Any additional costs to the subject that may result
from participation in the research;
-
The consequences of a subject’s decision to withdraw
from the research and procedures for orderly termination
of participation by the subject;
-
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 [a general
statement is included in the standard language];
and
-
The approximate number of subjects involved in the
study.
DOCUMENTATION
OF INFORMED CONSENT [COMMON RULE 45
CFR 46.117]
(a)
Informed consent shall be documented by use of a written
consent form approved by the IRB and signed by the subject
or the subject’s legally authorized representative. A
copy shall be given to the person signing the form.
(b) Except as provided in paragraph (c) of this section,
the consent form may be either of the following:
-
A written consent document that embodies the elements
of informed consent required by 46.116
and 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; or
-
A short form written consent document stating that
the elements of informed consent required by 46.116
and 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.
A copy of the summary shall be given to the subject
or the representative, in addition to a copy of the
short form.
(c)
An IRB may waive the requirement for the investigator
to obtain a signed consent form for some or all subject
if it finds either:
-
That the only record linking the subject and the research
would be the consent document and the principal risk
would be potential harm resulting from a breach of
confidentiality. Each subject will be asked whether
the subject wants documentation linking the subject
with the research, and the subject’s wishes will govern;
or
-
That the research presents no more than minimal risk
of harm to subjects and involves no procedures for
which written consent is normally required outside
of the research context. In cases in which the document
requirement is waived, the IRB may require the investigator
to provide subjects with a written statement regarding
the research.
In
cases where the documentation requirement is waived under
paragraph (c)(1) of this section, the IRB may require
the investigator to provide subjects with a written statement
regarding the research.
DOCUMENTATION
OF INFORMED CONSENT [FDA REGULATIONS 21
CFR 56.109 & 21
CFR 50.27]
(c) An IRB shall require written documentation in accordance
with 50.27
of this chapter, except as follows:
-
The IRB may, for some or all subjects, waive the requirement
that the subject, or the subject’s legally authorized
representative, sign a written consent form if it
finds that the research presents no more than minimal
risk of harm to subjects and involves no procedures
for which written consent is normally required outside
the research context; or
-
The IRB may, for some or all subjects, find that the
requirements in 50.24
of this chapter for an exception from informed consent
for emergency research are met.
(d)
In cases where the documentation requirement is waived
under paragraph (c)(1) of this section, the IRB may require
the investigator to provide subjects with a written statement
regarding the research.
WAIVER
OR ALTERATION OF SOME OR ALL OF THE ELEMENTS OF INFORMED
CONSENT [45
CFR 46.116(c)(d)] Note: These regulations
do not apply to FDA regulated research.
An IRB may approve a consent procedure which does not
include, or which alters, some or all of the elements
of informed consent set forth above, or waive the requirement
to obtain informed consent provided the IRB finds and
documents that:
(c)(1)
The research or demonstration project is to be conducted
by or subject to the approval of state or local government
officials and is designed to study, evaluate, or otherwise
examine: (i) Public benefit of service programs; (ii)
procedures for obtaining benefits or services under those
programs; (iii) possible changes in or alternatives to
those programs or procedures; or (iv) possible changes
in methods or levels of payment for benefits or services
under those programs; and
(2)
The research could not practicably be carried out without
the waiver or alteration.
(d)(1)
The research involves no more than minimal risk to the
subjects;
(2)
The waiver or alteration will not adversely affect the
rights and welfare of the subjects;
(3) The research could not practicably be carried out
without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided
with additional pertinent information after participation.
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