AUG

2023

INFORMED CONSENT GUIDANCE FOR IRBS,

CLINICAL INVESTIGATOR & SPONSORS

11 Key Take Aways in 10 mins from

66 page guidance document
INFORMED CONSENT GUIDANCE FOR IRBS,
CLINICAL INVESTIGATOR & SPONSORS

The IC is NOT just about obtaining signature

on the form. IC involves providing a
prospective subject, or their LAR, with
adequate information to allow for an informed
decision for participation. This might even
begin when the subject rst sees the
advertisement.

2. Lays the Requirement and Discussion

and divided it in 5 sections:
a) General Requirements
b) Basic elements in IC
c) Additional elements in IC
d) Element of IC for Applicable CT
e) Documentation of IC

3. General Requirements for IC

a) Role of IRB when IC cannot be obtained
b) Coercion and undue influence including
reimbursement to subjects
c) Simplicity of language is stressed which is
understandable to subject
d) Not using Exculpatory language
fi
INFORMED CONSENT GUIDANCE FOR IRBS,
CLINICAL INVESTIGATOR & SPONSORS

4. Eight Basic elements in IC :

a) Description of Clinical investigation - Recommends
usage of addendum IC/chart outline to explain study
procedure
b) Risk and Discomforts from tests, interventions,
procedures and IP
c) Benefits - Overly optimistic representation is violation
and must NOT include such language
d) Alternate procedure & treatment - During discussion
if subject is eligible for more than one trail —> case by
case basis —> subject to be allowed to discuss with
primary care physician
e) Confidentiality
f) Compensation and Medical Treatment in Event of
Injury
g) Contacts in the event subject wants to contact for
rights and or emergency
h) Voluntary participation
 INFORMED CONSENT GUIDANCE FOR IRBS,
CLINICAL INVESTIGATOR & SPONSORS

5. Six Additional elements in IC

a) Unforeseeable Risks
b) Involuntary termination of subject’ s participation
c) Additional Cost to subject
d) Consequences of withdrawal
e) Providing significant new findings to the subjects
f) No.of subjects - approx subjects involved in the study

6. Elements of IC for Applicable CT - Inclusion of mandatory

statement “ The statement is: “A description of this clinical trial
will be available on https://www.ClinicalTrials.gov, as required by
U.S. Law. This Web site will not include information that can
identify you. At most, the Web site will include a summary of the
results. You can search this Web site at any time”.
 INFORMED CONSENT GUIDANCE FOR IRBS,
CLINICAL INVESTIGATOR & SPONSORS

7. Documentation of IC:
a) Requirement for Written Documentation of IC
b) Alternative methods of obtaining IC - Verbal discussion, email,
facsimile, scanning, photographic image
c) Requirement for Dating Consent Form
d) Forms for Documentation of Informed Consent
• Long Form
• Short Form - Is presented orally to the subject or the
subject’s LAR (e.g visual impairment, low literacy). Witness
must be present when short IC is produced to the subject/
LAR.

8. IRB responsibilities of IC
a) Review of All Informed Consent Materials - e.g advertisement,
chart outlining study procedures
b) Review of the Consent Process
c) IRB Review of Updated Informed Consent Documents
d) Identification of Revised Consent Form
 INFORMED CONSENT GUIDANCE FOR IRBS,
CLINICAL INVESTIGATOR & SPONSORS

9. Clinical Investigator responsibilities for IC

a) Delegation of Consent Discussion - The investigator should
have a detailed plan for the supervision and training of staff,
and oversight
b) Financial Relationships and Interests - Consider whether
information related to financial relationships or interests
should be provided to subjects

10. Sponsor responsibilities for IC:

a) Considerations for Multicenter Clinical Investigations to
consider local institutional requirements.
b) Sponsor personnel (usually a field engineer) may be present
during the procedure and/or follow-up visits for some medical
device studies. This should be described in the IC
INFORMED CONSENT GUIDANCE FOR IRBS,
CLINICAL INVESTIGATOR & SPONSORS

11. FDA responsibilities for IC:

a) Investigational New Drugs and Biologics - Its not mandatory to
submit IC as per FDA. However, FDA may determines that
review of the consent form is necessary certain situations e.g -
vulnerable population, unusual therapeutic class, serious risk
to human subjects etc.
b) Investigational Medical Devices - For medical devices where
IDE is applicable. IC is mandatory to be submitted

For details and interesting FAQs read the complete guidance.

Happy Learning!!