November 2024 SOCRA Source Journal - Journal - Page 38
of blood draws, additional visits,
more severe risks or side effects).
This consent process continues throughout the subject’s participation and should be documen
appropriately each time an ICF is completed, meaning a separate consent process note is requ
initial and re-consent(s). Each clinical research site has a specific way of documenting the co
process, either in the electronic medical
records1or in hard copy notes added to subject binder
Diagram
Diagram 1).
This consent process continues
throughout the subject’s
participation and should be
documented appropriately
each time an ICF is completed,
meaning a separate consent
process note is required for
both initial and re-consent(s).
Each clinical research site has
a speci昀椀c way of documenting
the consent process, either in
the electronic medical records
or in hard copy notes added to
subject binders (see Diagram 1).
Best practice is for the person
obtaining informed consent
to complete the consent
process note in its entirety
contemporaneously with
consent, ensuring that the
time of consent is present
to document that FDA
regulations are met regarding
consent being obtained prior
to performance of study
activities. Per Code of Federal
Regulations (CFR) 312.62(b)
and 812.140(a)(3)(i), “The case
history for each individual
shall document that informed
consent was obtained prior to
participation in the study.”
When obtaining both initial
and re-consent, the subject or
legally authorized representative
(LAR) and the person obtaining
consent should print, sign,
and date the document for
themselves. From the author’s
perspective, if the potential
subject / LAR takes the ICF
home and signs it there, the
best practice would be to print
a blank copy and ask that the
subject / LAR sign and date the
document in the presence of the
person obtaining the consent.
FDA regulations do not require
that a clinical investigator
personally conduct the consent
interview, however, it is essential
38
that the person obtaining the
consent be trained and delegated
(i.e., present on the Delegation
of Authority Log) to perform
this task. Similarly, it is also not
required by FDA regulations that
the clinical investigator sign the
consent form.
While FDA regulations do not
require that the person obtaining
consent and performing the
consent discussion sign / date
the form or that the copy of the
form provided to the subject
is a signed / dated version,
these practices are mentioned
in the ICH (International
SOCRA SOURCE © November 2024
Council2for Harmonisation of
Technical Requirements for
Pharmaceuticals for Human
Use) E6 GCP guidelines under
Section 4 “Informed Consent
f Trial Subjects”:
• 4.8.8: “Prior to a subject’s
participation in the trial,
the written informed
consent form should be
signed and personally
dated by the subject or
by the subject’s legally
acceptable representative,
and by the person who
conducted the informed
consent discussion.”
