August 2024 SOCRA Source Journal - Journal - Page 7
The description of the clinical
investigation should identify
tests or procedures required
by the protocol that would not
be part of their care outside
of the research; for example,
drawing blood samples for
a pharmacokinetic study.
Note that all experimental
procedures must be identi昀椀ed
as such (21 CFR 50.25(a)(1)).
Procedures related solely to
research must be explained
(for example, protocol-driven
versus individualized dosing,
randomized assignment to
treatment, blinding of subject
and investigator, and receipt of
placebo if the study is placebocontrolled) (21 CFR 50.25(a)
(1)). In some cases, tests or
procedures that would be
considered part of usual clinical
care will not be performed
on study participants; when
applicable, this should be
discussed as part of the
informed consent process.
The description of the clinical
investigation must describe
the test article (e.g., the
investigational product under
study) and, if used in the study,
the control (21 CFR 50.25(a)
(1)). The description should
include relevant information
on what is known about both
the test article and the control.
For example, the description
should indicate whether the test
article is approved or cleared24
for marketing and describe
the use(s) for which it has been
approved or cleared. The
description should also provide
relevant information about any
control used in the study: for
example, whether the control
is FDA approved or cleared
for marketing, considered a
medically recognized standard
of care25, or is a placebo
(including an explanation
of what a placebo is). The
information provided about the
test article and control should
include appropriate and reliable
information about the potential
bene昀椀ts and risks of each, to
the extent such information
is available. For clinical
investigations involving the
comparison of an investigational
product to one or more
standards of care, it may be
acceptable to describe the most
common risks and bene昀椀ts
of the standard(s) of care in
the consent form and provide
additional information that
may be relevant to a particular
subject as part of the consent
discussion, if appropriate.
The consent process should
outline what the subject’s
participation will involve in order
to comply with the protocol,
for example, the number of
clinic visits, maintenance of
diaries, and medical or dietary
restrictions (including the need
to avoid speci昀椀c medications or
activities, such as participation
in other clinical investigations26).
If describing every procedure
would make the consent
form too lengthy or detailed,
FDA recommends providing
the general procedures in
the consent form with an
addendum describing the
details of the study procedures
to be performed at each
visit. It may be helpful to
provide a chart outlining what
happens at each study visit
to simplify the consent form
and assist the prospective
subject in understanding
what participation in the
clinical investigation will
involve. FDA believes that
removing procedural details
from the consent form will
reduce its length, enhance
its readability, and allow the
consent document to focus on
content related to the risks and
anticipated bene昀椀ts, if any.
The informed consent process
must clearly describe the
expected duration of the
subject’s participation in the
clinical investigation (see 21
CFR 50.25(a)(1)), which includes
their active participation as
well as long-term follow-up,
if appropriate. Prospective
subjects must be informed of
the procedures that will occur
during such follow-up (21 CFR
50.25(a)(1)), which may be
provided in a chart as described
above.
2. Risks and Discomforts
A description of any reasonably
foreseeable risks or discomforts
to the subject. (21 CFR 50.25(a)
(2))
The informed consent process
must describe the reasonably
foreseeable risks or discomforts
to the subject. This includes
risks or discomforts of tests,
interventions and procedures
required by the protocol
(including protocol-speci昀椀ed
standard medical procedures,
exams, and tests), with a
particular focus on those
that carry signi昀椀cant risk of
morbidity or mortality. Possible
risks or discomforts due to
changes to a subject’s medical
care (e.g., by changing the
subject’s stable medication
regimen or by stopping the
subject’s current treatment
and randomizing them to
either the investigational drug
or placebo) should also be
addressed. Where relevant,
participants should also be
made aware of the possibility
of unintended disclosures of
private information and be
provided with an explanation
of measures to protect a
subject’s privacy and data,
and limitations to those
measures.27 The explanation
of potential risks of the test
article and control, if any, and
an assessment of the likelihood
of these risks occurring should
be based on reliable and
accurate information presented
in the protocol, investigator’s
brochure, labeling, and/or
previous research reports.
Reasonably foreseeable
discomforts to the subject must
also be described (21 CFR
50.25(a)(2)). For example, the
consent form should disclose
that the subject may be
uncomfortable having to stay
in one position or experience
claustrophobia-like symptoms
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