November 2024 SOCRA Source Journal - Journal - Page 6
SELF STUDY
Informed Consent
Guidance for IRBs, Clinical Investigators, and Sponsors
DRAFT GUIDANCE
August 2023
Good Clinical Practice
This guidance document was distributed for comment purposes only.
The document is printed here for the reader's information
and as a self study exercise.
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency)
on this topic. It does not create any rights for any person and is not binding on FDA or the public.
You can use an alternative approach if it satis昀椀es the requirements of the applicable statutes and
regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance
as listed on the title page.
SOCRA SELF STUDY
A. THE CLINICAL
INVESTIGATOR
The clinical investigator is
responsible for protecting
the rights, safety, and welfare
of subjects during a clinical
investigation, and for ensuring
that, unless an exception applies,
legally effective informed
consent is obtained from each
subject or the subject’s LAR
before that subject takes part
in the clinical investigation
(see 21 CFR 50.20(a), 312.60,
and 812.100). Legally effective
informed consent includes
meeting all applicable Federal,
State, and local laws that require
additional information in the
informed consent form beyond
what FDA regulations require.
Sponsors and investigators may
wish to seek legal guidance
regarding speci昀椀c local consent
6
requirements applicable to their
research.
The clinical investigator should
notify the IRB regarding the
consent process, including
who (e.g., the investigator or
another study team member)
will conduct the consent
discussion. Any information
that will be given to subjects
to review and discuss as part
of informed consent must be
submitted to the IRB for review
and approval (21 CFR 56.109(a)(b) and 56.111(a)(4)-(5)). An
investigator may not begin the
informed consent process with
prospective subjects until the
IRB reviews and approves the
clinical investigation, consent
form, and any other information
to be given to subjects as part
of the consent process (21 CFR
SOCRA SOURCE © November 2024
50.20, 50.27, and 56.109).
The clinical investigator’s
institution may have standard
language or a standard format
for consent forms (for example,
for those elements that deal with
con昀椀dentiality, compensation,
answers to questions, and the
voluntary nature of participation).
FDA recognizes that investigators
may also need to identify and
meet institutional requirements
and incorporate them into the
consent form for the IRB’s initial
review of the clinical investigation.
During the clinical investigation,
the investigator may need to
revise the consent form to address
new information that might arise
during the conduct of the trial,
such as a change to the protocol
or new safety information. The
