August 2024 SOCRA Source Journal - Journal - Page 10
The consent process must
describe the extent to which
con昀椀dentiality of records
identifying subjects will be
maintained (21 CFR 50.25(a)
(5)) and should identify all
entities, for example, the study
sponsor, the research team,
regulatory agencies, and/or
ethics committee members,
who may gain access to
the records relating to the
clinical investigation. The
consent process must also
note the possibility that FDA
may inspect records (21 CFR
50.25(a)(5)) and should not
state or imply that FDA needs
permission from the subject
for access to the records.
Under the Health Insurance
Portability and Accountability
Act (HIPAA) Privacy Rule, FDA
does not need permission to
inspect records containing
protected health information
(45 CFR 164.512). FDA may
inspect study records to assess
investigator compliance with
the study protocol and the
validity of the data reported by
the sponsor.
FDA may inspect and copy
records relating to a clinical
investigation (see, e.g.,
sections 704(a) and 704(e)
of the FD&C Act, 21 CFR
56.115(b), 312.58(a), 312.68,
and 812.145(b)). FDA generally
will not copy records that
include the subject’s name
unless it is necessary to do so
for the reasons described in
21 CFR 312.68 and 812.145,
such as when there is reason to
question whether the records
represent the actual cases
studied or results obtained.
When FDA requires subject
names or other information
that could connect the
individual subject with the
personal health information
contained in the record,
FDA will generally treat such
information as con昀椀dential, but
on rare occasions, FDA may
be required to disclose this
information to third parties, for
example, if required by a court
of law (see 5 U.S.C. 552(b)
10
(6); see also 21 CFR 20.63(a)
and 20.83(a)-(b)). Therefore,
the consent process should
not promise or imply absolute
con昀椀dentiality with regard to
records that may be inspected
by FDA.32
6. Compensation and Medical
Treatment in Event of Injury
For research involving more than
minimal risk, an explanation as to
whether any compensation and
an explanation as to whether any
medical treatments are available
if injury occurs and, if so, what
they consist of, or where further
information may be obtained.
(21 CFR 50.25(a)(6))
For clinical investigations
involving more than minimal risk,
the informed consent process
must describe any compensation
and medical treatments available
to subjects if injury occurs33
(21 CFR 50.25(a)(6)). Because
available compensation and
medical treatments may vary
depending on the medical
circumstances of the individual
subject or the policies of the
institution, the consent process
should include an explanation
to subjects of where they may
obtain further information.
An example of an adequate
statement is:
“The sponsor has made plans
to pay for medical costs related
to research-related injuries”
followed by an explanation
of how to obtain further
information.
If no compensation is available,
the consent process should
include a statement such as:34
“Because of hospital policy,
the hospital is not able to pay
for your medical care if you are
injured as a result of being in
this study. If you are injured as
a result of being in this study,
you or your insurance will be
responsible for paying your
medical expenses. However,
SOCRA SOURCE © May 2024
you do not give up any of your
legal rights by being in this
study, and you may choose to
pursue legal action if you are
injured by being in the study.”
See section III.A.4, “Exculpatory
Language”, for additional
information.
7. Contacts
An explanation of whom to
contact for answers to pertinent
questions about the research
and research subjects’ rights,
and whom to contact in the
event of a research-related
injury to the subject. (21 CFR
50.25(a)(7))
The consent document (or
oral presentation, if a short
form is used) must provide
information on how to contact
an appropriate individual for
questions about the clinical
investigation and the subjects’
rights, and whom to contact
in the event that a researchrelated injury to the subject
occurs (21 CFR 50.25(a)(7)).
This information should include
contact names (or of昀椀ces), email
addresses, and their telephone
numbers. FDA recommends that
the individual or of昀椀ce named
for questions about subjects’
rights not be part of the
investigational team, because
subjects may be hesitant to
report speci昀椀c concerns or
identify possible problems to
someone who is part of the
investigational team. Therefore,
an appropriate contact for
subjects’ rights questions may
be the IRB Of昀椀ce, the facility’s
Patient Advocate Of昀椀ce,
or other staff with training
regarding the rights of clinical
trials subjects. In addition, the
consent process should include
information on whom to contact
and what to do in the event
of an emergency, including
24-hour contact information, if
appropriate.35
If contact information changes
during the clinical investigation,