November 2024 SOCRA Source Journal - Journal - Page 7
investigator will need to obtain
IRB review and approval of the
revised consent form (21 CFR
50.27 and 56.109). In addition,
because the consent form is
being modi昀椀ed to re昀氀ect new
information that might affect the
willingness of already enrolled
and actively participating
subjects to continue in the
clinical investigation, the IRB
should determine the need to
inform the previously enrolled
subjects of the new information
and determine their willingness
to continue in the research (see
Frequently Asked Questions #16).
Any new information that is part
of the consent process must be
reviewed and approved by the
IRB as a change in approved
research before it is initiated,
except where necessary to
eliminate apparent immediate
hazards to the subject (see
21 CFR 56.108(a)(4)). In the
rare event that urgent safety
information is provided to the
subject prior to IRB approval, the
IRB should promptly be noti昀椀ed
of both the safety issue and the
noti昀椀cation of subjects.
Below are speci昀椀c areas for
consideration by the clinical
investigator:
1. Delegation of Consent
Discussion
FDA regulations require that
the investigator obtain the
legally effective informed
consent of subjects (21 CFR
50.20, 312.60 and 812.100). If
the investigator delegates this
responsibility, FDA expects
that the individual to whom the
responsibility is delegated be
quali昀椀ed by education, training,
and experience to perform
this activity. The individual
obtaining informed consent
should be knowledgeable
about the clinical investigation
and have the appropriate
training and credentials to be
able to address any questions
or concerns the subject may
have about the study and/
or alternative procedures or
courses of treatment, if any,
that might be advantageous to
the subject. The investigator
should have a detailed plan for
the supervision and training
of staff, and oversight of the
clinical investigation, including
the informed consent process.65
Even when a task is delegated
to another individual, the
investigator remains responsible
for ensuring that legally effective
informed consent is obtained for
all subjects in accordance with
21 CFR part 50.
2. Financial Relationships
and Interests
The clinical investigator should
consider whether information
related to 昀椀nancial relationships
or interests should be provided to
subjects.66 Clinical investigators
should consider the potential
effects that a 昀椀nancial relationship
might have on the clinical
investigation or on interactions
with subjects. When there are
昀椀nancial relationships or interests,
clinical investigators should
consider the following actions:
• Including information in the
informed consent form,
such as:
– The source of funding and
funding arrangements for
the conduct and review of
the clinical investigation,
or
– Information about a
昀椀nancial arrangement
or interest (e.g., stock in
the study sponsor, patent
on the investigational
product) of an institution
or an investigator and how
it is being managed.
• Using special measures to
modify the informed consent
process when a potential or
actual 昀椀nancial con昀氀ict exists,
such as:
– Having another individual
who does not have a
potential or actual con昀氀ict
of interest involved in the
consent process, especially
when a potential or
actual con昀氀ict of interest
could in昀氀uence the tone,
presentation, or type of
information presented
during the consent process.
– Using independent
monitoring of the consent
process.
Although the clinical investigator
should consider these issues
regarding 昀椀nancial relationships
and interests, IRBs have the 昀椀nal
responsibility of determining
whether subjects should be
provided with information
regarding the source of funding,
funding arrangements, or 昀椀nancial
interests of parties involved in the
clinical investigation as part of the
informed consent process (see 21
CFR 56.109 and 56.111(a)(4)-(5)).
B. THE SPONSOR
Sponsors often provide
clinical investigators with a
model consent form that may
be adapted by the clinical
investigator to meet local needs.
When the consent form for
studies that require an IND or
IDE application is submitted to
FDA for review, FDA’s comments
are generally directed to the
sponsor (see section IV.D.1,
“Investigational New Drugs
and Biologics,” and section
IV.D.2, “Investigational Medical
Devices”). The sponsor should
promptly provide the clinical
investigator with any necessary
modi昀椀cations required to satisfy
the regulations at 21 CFR 50.25
so that changes can be made to
the consent forms. A modi昀椀ed
model consent form re昀氀ecting
the changes may be used to
convey the necessary edits.
Because the clinical investigator
must receive IRB approval before
starting the clinical investigation
(see 21 CFR 312.66 and 21 CFR
812.110(a)), the sponsor should
work closely with the clinical
investigator to make certain
the modi昀椀ed consent form is
reviewed and approved by the
IRB. The clinical investigator
should provide the sponsor
with a copy of the consent form
approved by the IRB.
SOCRA SOURCE © November 2024
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