August 2024 SOCRA Source Journal - Journal - Page 12
subject should also be informed
as to how the data that have
already been collected will be
handled.
3. Additional Costs to Subject
Any additional costs to the
subject that may result from
participation in the research.
(21 CFR 50.25(b)(3))
If subjects might incur
additional expense as a result
of taking part in the clinical
investigation, the consent
process must explain the added
costs (21 CFR 50.25(b)(3)). FDA
recommends that any additional
cost that may be charged to the
subject, the subject’s insurance,
or other reimbursement
mechanism be explained as
part of the informed consent
process. Subjects should be
made aware that insurance
or other reimbursement
mechanisms might not fund
the medical care they receive
as a result of participating in a
clinical investigation even when
the care is the standard care
they would otherwise receive
if not participating in a clinical
investigation.38
Additionally, insurance or other
forms of reimbursement might
not pay for care related to
complications or injuries arising
from participation in a clinical
investigation (see section III.B.6,
“Compensation and Medical
Treatments in Event of Injury”).
If the subject’s insurance
is charged and there are
deductibles or copayments, the
subject should be informed of
whether they will be responsible
for these costs. If funds will be
available to cover costs not
covered by insurance or other
forms of reimbursement, the
consent form should describe
how these funds will be made
available to subjects or direct
subjects on how to obtain
further information. Because
these issues may be complex,
12
it may be appropriate to refer
the subject to a knowledgeable
昀椀nancial counselor or reimbursement specialist to explain the
costs and the insurance and
reimbursement issues prior to
signing the consent form.
In some cases, the cost of an
investigational product may
be charged to the subject. In
clinical investigations involving
investigational devices, the
sponsor is permitted to
recover the costs of research,
development, manufacture,
and handling of investigational
devices (see 21 CFR 812.7(b)).
FDA may authorize sponsors in
certain clinical investigations of
drugs to recover the direct costs
of making the investigational
drug available, such as costs to
manufacture, ship, and handle
(e.g., store) the drug (see 21
CFR 312.8).39 When these costs
are passed to the subject, the
consent process must identify
these costs (21 CFR 50.25(b)(3)).
Beyond the costs directly related
to participation in the research,
it may be appropriate to identify
additional costs that may be
incurred, such as any costs
associated with participation in
the clinical investigation, e.g.,
time off from work, child or elder
care, or transportation costs. To
aid the prospective subject in
understanding these additional
costs, the consent process
should describe the protocol
requirements in suf昀椀cient detail
(e.g., number and duration of
study site visits and procedures)
to enable subjects to appreciate
how much time they may need
to take away from work, child
care, or elder care. Prospective
subjects should be made aware
of direct and indirect costs of
participation and informed as to
what extent these costs will be
covered by the sponsor versus
paid by the subject (see section
III.A.2, “Coercion and Undue
In昀氀uence”).
SOCRA SOURCE © May 2024
4. Consequences of Subject’s
Decision to Withdraw
The consequences of a subject’s
decision to withdraw from
the research and procedures
for orderly termination of
participation by the subject.
(21 CFR 50.25(b)(4))
When appropriate, the consent
process must describe the
consequences of a subject’s
decision to withdraw from
the clinical investigation and
the procedures for orderly
termination of participation by
the subject (21 CFR 50.25(b)
(4)). For example, when
withdrawal from a clinical
investigation may adversely
affect the subject, the informed
consent process must explain
the withdrawal procedures that
are recommended in order to
ensure the subject’s safety and
should speci昀椀cally state why
the withdrawal procedures
are important to the subject’s
welfare. For some clinical
investigations, an intervention
should be withdrawn gradually,
or the investigator may
recommend follow-up to ensure
the subject’s safety when an
investigational intervention is
prematurely terminated due to
a subject’s withdrawal. In these
cases, the consent process must
explicitly inform the subject of
the potential adverse effects of
premature termination of the
investigational intervention.
Prospective subjects should
be made aware of the number
of visits and approximate time
required for participation in the
study to help them determine
if they are able to make the
commitment to complete the
study. When appropriate, it
may be reasonable to counsel
prospective subjects that
they should not participate
in the trial if they do not
foresee staying in the study. If
applicable, the consent process
must explain whether a subject
who withdraws early will receive
future study payments.40 The