August 2024 SOCRA Source Journal - Journal - Page 13
subject should also be informed
as to how the data that have
already been collected will be
handled (see also section III.B.8,
“Voluntary Participation”).
5. Providing Signi昀椀cant New
Findings to Subjects
A statement that signi昀椀cant new
昀椀ndings developed during the
course of the research which may
relate to the subject’s willingness
to continue participation will be
provided to the subject. (21 CFR
50.25(b)(5))
The consent process must,
when appropriate, include a
statement that signi昀椀cant new
昀椀ndings that may relate to the
subject’s willingness to continue
participation, such as new risk
information, will be provided
to the subject (21 CFR 50.25(b)
(5)). Signi昀椀cant new 昀椀ndings
may include an unexpected
adverse event, an adverse event
occurring at greater frequency
or severity than previously
stated in the consent process,
results from interim analyses
(in some cases), additional
alternative procedures or courses
of treatment that become
available during the course of
the clinical investigation, and
information from other clinical
trials about the effectiveness of
the investigational product, the
comparator, or other products
for the same indication. FDA
encourages the inclusion of
this statement in the consent
form for clinical investigations
where knowledge of risk is
limited, for example, clinical
investigations involving the 昀椀rst
use of an investigational product
in humans, novel therapies,
and new molecular entities, or
complex clinical investigations
that involve signi昀椀cant risk.
Where there are signi昀椀cant new
昀椀ndings, the IRB should consider
whether enrolled subjects should
be contacted to determine if
this information impacts their
decision to continue participation
in the clinical investigation (see
Frequently Asked Question
#16).
6. Number of Subjects
The approximate number of
subjects involved in the study.
(21 CFR 50.25(b)(6))
When appropriate, the informed
consent process must state
the approximate number of
subjects involved in the clinical
investigation (21 CFR 50.25(b)
(6)). For example, a subject’s
decision whether or not to
participate in the study may be
in昀氀uenced by knowledge that
the clinical investigation is a
small initial trial of the product
(such as a phase 1 or 2 drug
clinical investigation or a device
feasibility clinical investigation
where only a small number of
subjects participate).
All informed consent forms
for “applicable clinical trials”
initiated on or after March 7,
2012, must contain the above
quoted statement, which
cannot be modi昀椀ed (21 CFR
50.25(c)).43 However, additional
explanation may be provided, if
appropriate. For example, with
respect to clinical trials involving
investigational devices, an
additional statement could be
added that information about
device trials might not be made
publicly available until after a
product is cleared or approved
by FDA.
C. ELEMENT OF INFORMED
CONSENT FOR “APPLICABLE
CLINICAL TRIALS”
When seeking informed consent
for applicable clinical trials, as
de昀椀ned in 42 U.S.C. 282(j)(1)(A),
the following statement shall be
provided to each clinical trial
subject in informed consent
documents and processes.
This will notify the clinical
trial subject that clinical trial
information has been or will be
submitted for inclusion in the
clinical trial registry databank
under paragraph (j) of section
402 of the Public Health Service
Act. The statement is: “A
description of this clinical trial
will be available on https://www.
ClinicalTrials.gov, as required
by U.S. Law. This website will
not include information that
can identify you. At most, the
website will include a summary
of the results. You can search
this website at any time.” (21
CFR 50.25(c))
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