August 2024 SOCRA Source Journal - Journal - Page 9
to the subject (21 CFR 50.25(a)
(4)). Prospective subjects must
be informed of the appropriate
alternatives available to them,
including a description of the
care they would be likely to
receive if they choose not to
participate in the research.
This includes alternatives such
as approved therapies for the
patient’s disease or condition,
other forms of therapy (e.g.,
surgical) or diagnosis, and
when appropriate, supportive
care with no disease-directed
therapy. This disclosure must
include a description of the
current medically recognized
standard of care, particularly
in studies of medical products
intended to treat or diagnose
serious diseases or conditions.
The current medically recognized
standard of care may include
uses or treatment regimens for a
legally marketed drug or device
that are not included in the
product’s approved or cleared
uses. When describing in the
consent form an unapproved
use or treatment regimen of an
approved or cleared drug or
device that the sponsor markets,
and such use or treatment
regimen is a part of the medically
recognized standard of care,
the consent form can provide
factual information concerning
the unapproved use or treatment
regimen of the drug or device.
However, this information
should not be presented in a
promotional manner. If a sponsor
has questions related to this
issue, they may contact FDA
for feedback.29
A statement identifying
alternative therapies and
indicating that the alternatives
will be discussed by the
clinical investigator in more
detail, if appropriate, may be
used if there is more than one
alternative. FDA recommends
that treatment options lacking
evidence of therapeutic value
not be included. If additional
alternative procedures or
courses of treatment become
available during the course of
the clinical investigation, the
informed consent discussion
and documents may need to be
updated (see 21 CFR 50.25(a)(4)
and 50.25(b)(5) and Frequently
Asked Question #16).
with an appropriate healthcare
professional should be
completed prior to the subject
signing and dating the consent
form.
When disclosing appropriate
alternative procedures or
courses of treatment, FDA
recommends that a description
of any reasonably foreseeable
risks or discomforts and
potential bene昀椀ts associated
with these alternatives should
be disclosed during the
informed consent process,
although not necessarily
included in the written informed
consent document. Where such
descriptions or disclosures can
contain quanti昀椀ed comparative
estimates of the reasonably
foreseeable risks or discomforts
and potential bene昀椀ts (e.g.,
from the clinical literature)
between the alternatives, they
should do so. The Agency
does not believe that providing
such quanti昀椀ed comparative
estimates for every case would
be realistic or appropriate.30
Where such well-de昀椀ned
estimates are not possible,
the Agency believes that a
description of the risks and
bene昀椀ts should be suf昀椀cient.
While this should be more
than just a list of alternatives,
a full risk/bene昀椀t explanation
of alternatives may not be
appropriate to include in the
written document.
While an individual subject
may be eligible for more than
one clinical investigation, that
determination and the decision
as to which trial would be most
appropriate for a particular
subject would need to be
made on a case-by-case basis.
A discussion of other trials
for which the subject may be
eligible would generally be more
appropriate to address as part of
the informed consent discussion,
rather than the informed consent
document.31 The subject may
also wish to seek input from a
primary care or other healthcare
provider on this issue.
However, the person(s) obtaining the prospective subject’s
consent should be able to
discuss available alternatives
and answer the prospective
subject’s questions.
It may be appropriate to refer
the subject to their primary care
provider or another healthcare
professional who can more
fully discuss the alternatives,
for example, when alternatives
include various combinations
of treatments such as radiation,
surgery, and chemotherapy for
some cancers. Such discussions
As applicable, the informed
consent process should advise
that participation in one clinical
investigation may preclude
an individual’s eligibility to
participate in other clinical
investigations. When there are
multiple clinical investigations
for evaluating the treatment of
a particular disease for which
a subject may be eligible, the
sequence in which a subject
may participate in the clinical
investigations may be important
and should be discussed with
the prospective subject. For
example, participation in a
study of a drug for a speci昀椀c
therapeutic category may be an
exclusion criterion for another
study. The prospective subject
may wish to discuss the study
with their primary care provider,
if appropriate.
5. Con昀椀dentiality
A statement describing the
extent, if any, to which con昀椀dentiality of records identifying the
subject will be maintained and
that notes the possibility that the
Food and Drug Administration
may inspect the records. (21
CFR 50.25(a)(5))
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