November 2024 SOCRA Source Journal - Journal - Page 8
Below are speci昀椀c areas for
consideration by the sponsor:
1. Considerations for
Multicenter Clinical
Investigations
For multicenter clinical
investigations, changes may
need to be made to the
consent form to address local
and institutional requirements.
For multicenter clinical
investigations reviewed by more
than one IRB, when local IRB
review results in substantive
modi昀椀cations to the consent
form, i.e., changes that affect
the rights, safety, or welfare of
the subjects, FDA expects the
sponsor to share the revisions
with all investigators and their
IRBs. In this situation it may
be more ef昀椀cient to share the
changes with the sites using
a modi昀椀ed model consent
form, when appropriate.
If the multicenter clinical
investigation has a central IRB
cooperating with local IRBs
or human research protection
of昀椀ces, the revisions should be
forwarded to the central IRB.67
Alternatively, local issues may
be addressed by the central
IRB depending on the review
agreement between the local
IRB(s) and central IRB. Note that
for medical device studies that
require submission of an IDE
application, such changes must
be submitted to FDA.68, 69
2. Sponsor Personnel
Sponsor personnel (usually a
昀椀eld engineer) may be present
during the procedure and/
or follow-up visits for some
medical device studies. These
individuals may provide
technical support and/or record
study- related information
for the test article. If sponsor
personnel will be present during
the procedure or follow-up, or
if the activities of the sponsor
personnel directly affect the
subject, those activities should
also be described in the
informed consent form.70
8
C. THE FDA
FDA’s regulations for drug
(including biologic) and
device investigations have
different requirements for
the submission of informed
consent materials (see sections
IV.D.1, “Investigational New
Drugs and Biologics,” and
IV.D.2, “Investigational Medical
Devices,” for additional
information). Sponsors are not
required to submit informed
consent materials to FDA for
all clinical investigations (see,
for example, 21 CFR 312.2(b)
and 21 CFR 812.2(b) and (c));
however, FDA may require that
they be submitted in some
cases as discussed below.
Below are speci昀椀c areas FDA
considers in its review of the
consent form:
Generally, when informed
consent materials are
submitted, FDA reviewers
assess the adequacy of the
consent form by considering its
communication of reasonably
foreseeable risks or discomforts
to the subject and other
elements required by 21 CFR
50.25. In some situations,
FDA may 昀椀nd a consent form
to be misleading, inaccurate,
or incomplete in a way that
would make informed consent
inadequate and noncompliant
with 21 CFR part 50. In these
cases, FDA may require that
speci昀椀c revisions be made to
address the concern(s) before
the clinical investigation can
proceed (21 CFR 312.42 and
812.30).
As a general matter, FDA will
review the informed consent
form for treatment INDs and
treatment protocols (21 CFR
part 312, subpart I) and INDs
for studies conducted under
the Exception From Informed
Consent Requirements for
Emergency Research (21 CFR
50.24) for consistency with 21
CFR 50.25 (see 21 CFR 50.24(a)
(6)).
FDA’s review of the consent
form as part of an IND or IDE
application submission does not
substitute for the responsibility
or authority of the IRB to review
and approve the consent
form and consent process
as a condition for the clinical
investigation to begin (21 CFR
56.103(a)). IRBs are responsible
for ensuring the adequacy
of the information in the
consent form and may require
modi昀椀cation as appropriate
(21 CFR 56.109(a)-(b)).
SOCRA SOURCE © November 2024
1. Investigational New Drugs
and Biologics 71
The IND regulations (21 CFR
part 312) do not speci昀椀cally
require submission to FDA of
the consent form with the IND.
However, if FDA determines
that review of the consent
form is necessary to make
the determination of whether
the clinical investigation may
safely proceed, the Agency will
request that the sponsor submit
the consent form for review
under 21 CFR 312.23(a)(11).
For other clinical investigations
of drugs, FDA often considers
the following factors in
determining whether to require
submission and review of the
consent form:
• Nonclinical studies
submitted in support of the
昀椀rst administration of a drug
in humans have identi昀椀ed an
unusual toxicity.
• Unusual known toxicity
is associated with the
investigational drug, the
drug class to which the drug
belongs, or with a different
drug with characteristics
similar to those of the
study drug.
• The study subject population
is particularly vulnerable.
• The study design is unusual
for the therapeutic class.
• The clinical investigation is a
postmarketing safety clinical
trial, required under section
