August 2024 SOCRA Source Journal - Journal - Page 6
SELF STUDY
Informed Consent
Guidance for IRBs, Clinical Investigators, and Sponsors1
DRAFT GUIDANCE
August 2023
Good Clinical Practice
This guidance document was distributed for comment purposes only.
The document is printed here for the reader's information
and as a self study exercise.
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency)
on this topic. It does not create any rights for any person and is not binding on FDA or the public.
You can use an alternative approach if it satis昀椀es the requirements of the applicable statutes and
regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance
as listed on the title page.
SOCRA SELF STUDY
A. BASIC ELEMENTS OF
INFORMED CONSENT
As discussed in this section,
FDA regulations identify eight
basic elements of informed
consent to be provided to
the subject (21 CFR 50.25(a)).
The text of each of the eight
elements is italicized below,
followed by a discussion of
the element. As discussed in
section III.E.4.b “Short Form”,
when a short form written
consent document is used, the
document must state that the
elements of informed consent
required by 21 CFR 50.25 have
been presented orally to the
subject or the subject’s LAR (21
CFR 50.27(b)(2)).
1. Basic elements of informed
consent. In seeking informed
consent, the following
6
information shall be provided to
each subject:
1. Description of Clinical
Investigation
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 identi昀椀cation
of any procedures which are
experimental. (21 CFR 50.25(a)(1))
A clear statement that the
clinical investigation involves
research is important to make
prospective subjects aware that,
although preliminary data (bench,
animal, pilot studies, literature)
may exist, the purpose of the
subject’s participation is primarily
SOCRA SOURCE © May 2024
to contribute to research (for
example, to evaluate the safety
and effectiveness of the test
article or to evaluate a different
dose or route of administration
of an approved drug), rather
than to their own medical
treatment.
FDA recommends that when
discussing the required
elements of informed consent
with prospective subjects, there
should 昀椀rst be a discussion
of the care a patient would
likely receive if not part of the
research, if relevant, and then
the potential subject should
be provided with information
about the research. This
sequence allows prospective
subjects to understand how the
research differs from the care
they might otherwise receive.