August 2024 SOCRA Source Journal - Journal - Page 11
then the new contact information
must be provided to the subject
(21 CFR 50.25(a)(7)). This may be
done through a variety of ways,
for example, a card providing the
relevant contact information for
the clinical investigation may be
given to the subject during a visit
or mailed to the subject in an
envelope to protect the subject’s
privacy.
8. Voluntary Participation
A statement that participation
is voluntary, that refusal to
participate will involve no penalty
or loss of bene昀椀ts to which the
subject is otherwise entitled, and
that the subject may discontinue
participation at any time without
penalty or loss of bene昀椀ts to
which the subject is otherwise
entitled. (21 CFR 50.25(a)(8))
This element requires that
subjects be informed that
they may decline to take part
in the clinical investigation or
may stop participation at any
time without penalty or loss
of bene昀椀ts to which subjects
are entitled (21 CFR 50.25(a)
(8)). Language that limits the
subject’s right to decline to
participate or withdraw from the
clinical investigation must not
be used. If special procedures
should be followed for the
subject to withdraw from the
clinical investigation, the consent
process must outline and
explain the procedures (21 CFR
50.25(b)(4); see section III.C.4,
“Consequences of Subject’s
Decision to Withdraw”). Written
withdrawal from the study by
the subject is not a requirement.
When possible, the site staff
should document the withdrawal
and the date it occurred. Note,
when a subject withdraws
from a study conducted
under an investigational new
drug application (IND) or
investigational device exemption
(IDE), the data collected on
the subject to the point of
withdrawal remains part of the
study database and may not
be removed.36
B. ADDITIONAL ELEMENTS
OF INFORMED CONSENT
FDA regulations identify six
additional elements of informed
consent to be provided to each
subject, when appropriate. (21
CFR 50.25(b))
2. Additional elements of
informed consent. When
appropriate, one or more
of the following elements
of information shall also be
provided to each subject:
The following elements are
appropriate to provide to
prospective subjects when the
IRB determines the information
is material to prospective
subjects’ decisions to
participate:
1. Unforeseeable Risks
A statement that the particular
treatment or procedure may
involve risks to the subject
(or to the embryo or fetus, if
the subject is or may become
pregnant) which are currently
unforeseeable. (21 CFR 50.25(b)
(1))
When appropriate, the
consent process must contain
a statement that the particular
test article or procedure may
involve risks to subjects (or
to the embryo or fetus, if the
subject is or may become
pregnant) that are currently
unforeseeable (21 CFR 50.25(b)
(1)). If long-term safety studies
(such as bench and animal
testing37) are not completed,
the informed consent process
should explain that researchers
have not completed studies that
may identify potential risks (e.g.,
carcinogenicity or teratogenicity
studies), and that there may
be potential risks to subjects
(or to the embryo or fetus, if
the subject is or may become
pregnant) that are currently
unforeseeable (21 CFR 50.25(b)
(1)). Sponsors may want to
consider whether appropriate
birth control measures and
notifying the investigator of
pregnancy should be included
in the protocol and addressed
in the informed consent
document.
2. Involuntary Termination of
Subject’s Participation
Anticipated circumstances
under which the subject’s
participation may be terminated
by the investigator without
regard to the subject’s consent.
(21 CFR 50.25(b)(2))
When appropriate, the
consent process must inform
the subject of anticipated
circumstances under which
the investigator may end the
subject’s participation without
the subject’s consent (21 CFR
50.25(b)(2)). Such circumstances
may arise if, for example, the
subject is unable to comply
with procedures required by
the clinical investigation, if the
subject meets discontinuation
criteria for continuing in the
study, or if the site withdraws
from the study. A simple
statement that the investigator
or sponsor may withdraw the
subject from participation at
any time is inadequate and
does not inform the subject of
anticipated circumstances that
may trigger their withdrawal
from the clinical investigation.
For example, the consent
process may inform the
subject that the investigator
may withdraw the subject’s
participation in the clinical
investigation if the subject does
not follow the instructions given
to them by the investigator,
such as repeatedly failing to
return for protocol-required
clinic visits or repeatedly failing
to follow dosing or device
instructions. If a subject is
withdrawn from the study, the
clinical investigator should
explain to the subject the
reasons for withdrawal, discuss
other available treatment
or research options, and, if
appropriate, discuss plans
to follow the subject after
withdrawal for side effects. The
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