August 2024 SOCRA Source Journal - Journal - Page 8
during an MRI. For clinical
investigations involving the
comparison of an investigational
product to one or more
standards of care, it may be
acceptable to describe the more
common and signi昀椀cant risks
and discomforts of the standard
of care in the informed consent
form and provide additional risk
information, as appropriate, as
part of the consent discussion.
Any reasonably foreseeable risks
or discomforts to the subject
need to be described in the
informed consent form; however,
it is not necessary to describe
all possible risks, especially if
doing so could make the form
overwhelming for subjects to
read. Information on risks that
are more likely to occur and
those that are serious should be
described so that prospective
subjects can understand the
nature of the risk.
The discussion may include
information on whether a risk is
reversible, and the probability of
the risk based on existing data.
Information on what may be
done to mitigate serious risks,
and risks and discomforts more
likely to occur, should also be
considered for inclusion.
The description should not
understate the probability
and magnitude of the
reasonably foreseeable risks
and discomforts. If applicable,
the consent document should
include a description of the
reasonably foreseeable risks
to the subject, but also the
potential for risk to “others”
(for example, radiation therapy
where close proximity to subjects
post-procedure may create some
risk to others). In situations where
there may be a risk to others,
efforts to mitigate the potential
risk (e.g., using separate
bathrooms) may be included
in the consent document or
provided in a separate document
and given to the subject during
the consent discussion.
8
When appropriate, a
statement must be included
that a particular treatment
or procedure may involve
currently unforeseeable risks to
the subject (or to the subject’s
embryo or fetus, if the subject
is or may become pregnant)
(21 CFR 50.25(b)(1); see section
III.C.1, “Unforeseeable Risks”). If
unanticipated risks are reported
during the investigation, the
informed consent discussion
and documents may need to
be updated with the additional
risks (21 CFR 50.25(a)(2); see
Frequently Asked Question #16).
3. Bene昀椀ts
A description of any bene昀椀ts to
the subject or to others which
may reasonably be expected
from the research. (21 CFR
50.25(a)(3))
Potential bene昀椀ts should be
explained in terms of any direct
impact to the prospective
subject, in addition to the
anticipated societal bene昀椀t of
the research. The description of
potential bene昀椀ts to the subject
from the use of the test article
(and control, if appropriate)
should include appropriate
details, and should be clear,
balanced, and based on reliable
information 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 generally
describe the bene昀椀ts of the
standard of care in the informed
consent form and provide more
speci昀椀c information about the
standard of care as part of the
consent discussion rather than
in the consent document. This
element requires a description
of the potential bene昀椀ts not
only to the subject (for example,
“This product is intended to
decrease XXX; however, we
cannot guarantee that you will
receive any bene昀椀t from it or
from being in the study.”), but
also to “others” (for example,
“Your participation in this
SOCRA SOURCE © May 2024
research may not bene昀椀t you,
but information learned from this
study may bene昀椀t patients with
your disease or condition in the
future.”).
Overly optimistic representations
of the bene昀椀ts of the test article
being studied in the clinical
investigation may be misleading
and may violate FDA regulations
that prohibit promotion of
investigational drugs and devices
(21 CFR 312.7 and 21 CFR
812.7). Where the purpose of the
study is to determine the safety
and/or effectiveness of the test
article, there is usually signi昀椀cant
uncertainty regarding whether,
and to what extent, the test
article provides a bene昀椀t. If there
is no potential for direct bene昀椀t
to the prospective subject, which
may be the case, for example,
in a phase I study in healthy
volunteers, this point should
be clearly stated. An example
of a way in which to describe
in the consent document that
an investigational product
does not have direct bene昀椀ts
to participating subjects would
be to state “There are no direct
bene昀椀ts to you from taking part
in this study.”
If payments, including
reimbursement for researchrelated expenses incurred by
subjects due to participation, are
provided, the consent process
should not identify them as
bene昀椀ts.28
4. Alternative Procedures or
Treatments
A disclosure of appropriate
alternative procedures or courses
of treatment, if any, that might
be advantageous to the subject.
(21 CFR 50.25(a)(4))
To enable an informed decision
about taking part in a clinical
investigation, consent forms
must disclose appropriate
alternatives to entering the
clinical investigation, if any,
that might be advantageous