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IRB Webinar 11/13/2014
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To recognize how to conduct
an adequate informed consent
process in adults and children
To learn how to manage the
process in special situations
To identify things to avoid
when documenting the process
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Introduction
Steps in the consent process
Informed Consent Process (ICP) in Adults, special
considerations:
o Does not speak English
o Illiterate or Visually impaired
o LAR in cases where subject cannot consent
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ICP in Children, special considerations :
o Child and parents do not speak English
o Use of short form
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Scenarios
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The are three elements involved in a successful participant
enrollment. The elements include:
o The informed consent form (ICF or ICD)
o ICP
o Consent documentation
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Interdependent Elements
o Poor documents undermine the process and vice versa
o Documenting the use of a poor form/process is GIGO
1.
2.
3.
4.
5.
Provide enough information to
weigh risks/benefits of
participation
Facilitate comprehension of the
information
Give opportunities for Q&A
Help with documentation
Continue to provide
information: Ongoing process
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Participants who do not speak
English
 Use of a translated ICF or short
form
 Oral translation of the English
language consent form is
presented
 There MUST be a translator
 There must be a witness to the
oral presentation
Participants who do not speak
English
 If using a short form, you may use
IRB approved short forms or
submit an amendment for your
own forms
 If the IRB has not approved
enrollment of non-English
speaking subjects, an amendment
will be required.
o Include this in your original
submission!
Participants who do not speak English (cont.)
 Subject (or LAR)
o Signs short form
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Investigator
o Signs ICF
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Translator
o Signs nothing (unless acting as witness)
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Witness
o Signs short form and ICF
Illiterate or Visually impaired
 Person obtaining consent
o Reads entire form aloud
o Documents subject unable to read
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Opportunity for discussing questions
and concerns is vital.
o Repeating and explaining portions of the
Informed Consent Document.
o Cover the document in stages.
Illiterate or Visually impaired
 Requires a witness to verify
o Process took place
o Subject indicates understanding
o Subject consented to participate.

“Making their mark” is sufficient.
o Names and telephone contact numbers
for the study PI and the IRB Office should
still be provided.
Legally authorized representative (LAR) considerations
 LAR = An individual authorized under law to consent on behalf
of a subject to participate in the procedure involved in the
research
 Research involving medical treatment
o If an adult, make sure person is of sound mind and body, conscious,
mentally unimpaired and physically able to read and/or hear and
understand; and has not been declared to be legally incompetent.
o If they are not, you need to use a LAR
Legally authorized representative
(LAR) considerations
 Research not involving medical
treatment
o If an adult, you may not use a LAR if
the research does not involve
medical treatment, unless there is a
legal document (e.g. power of
attorney that is specific for
research).
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Assent, not consent
Verbal or Written Assent?
If the parent of the child does not
speak English, do not use the child
as the translator. You need a
translator and the use a translated
ICF or short form.
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1 or 2 parent signatures per IRB
approval letter
If child is accompanied to the visit by
someone other than his/her parent,
consider the following:
o Medical research: Obtain legal
documentation.
o Non-medical: you may not enroll subject
unless there is legal documentation
specific to research consent.
If child is accompanied to the visit by someone other than a
parent, consider the following:
 Medical research
o If minor is accompanied by grandparent or other relative that may be
considered a LAR, ask why parent did not attend visit.
• If parents are not available, but are the legal guardians (e.g. overseas for a
long period), make every effort to contact parent and make sure they
agree with participation before adding child to study.
• If parents are not available/not able to serve as legal guardian (e.g.,
incapacitated), then family member may enroll child but should provide
legal documentation to the study team.
o In general, if using a legal guardian, obtain legal documentation.

You are doing a Phase II cancer trial study, and a non-English
speaking patients is eligible for it. The patient arrives alone to
the clinic and speaks Mandarin. You do not have an ICF or
short form approved. Which option is correct?
A.
B.
C.
You may use the IRB short form in Mandarin. You did not have that
approved before but the document is an IRB approved short form.
Have them sign the English version but get a translator from the
hospital to sign as a witness.
Submit an amendment to select the option of enrolling non-English
speaking subjects and use the IRB approved short form.

You are doing a Phase II cancer trial study, and a non-English
speaking patients is eligible for it. The patient arrives alone to
the clinic and speaks Mandarin. You do not have an ICF or
short form approved. Which option is correct?
A.
B.
C.
You may use the IRB short form in Mandarin. You did not have that
approved before but the document is an IRB approved short form.
Have them sign the English version but get a translator from the
hospital to sign as a witness.
Submit an amendment to select the option of enrolling non-English
speaking subjects and use the IRB approved short form.

You are approved to enroll non-English speaking subjects in
your pediatric, medical trial. You want to enroll a non-English
speaking, 14 year-old child into the trial. What are the
documents and procedures needed in this case (select the
right option)
A.
B.
C.
I need to translate the assent form, but not the ICF as I would be
using a translator.
I need to use the short form (already approved by IRB) and use a
translator for both the consent and assent.
I need to translate both documents (assent and ICF). I do not need
to use a translator as the documents are already translated.

You are approved to enroll non-English speaking subjects in
your pediatric, medical trial. You want to enroll a non-English
speaking, 14 year-old child into the trial. What are the
documents and procedures needed in this case (select the
right option)
A.
B.
C.
I need to translate the assent form, but not the ICF as I would be
using a translator.
I need to use the short form (already approved by IRB) and use a
translator for both the consent and assent.
I need to translate both documents (assent and ICF). I do not need
to use a translator as the documents are already translated.

You have talked to a parent about her child participating in a
non-medical trial. The day of the enrollment visit, the
grandparent accompanies the child and say that the parent is
not available.
A.
B.
C.
You may not enroll the child unless the ICP is already approved by
IRB (verbal consent).
You talked to the parent already, so the child can be enrolled by the
grandparent.
You may not enroll unless the parent agrees to come the next day
and sign the form again after child finishes with participation.

You have talked to a parent about her child participating in a
non-medical trial. The day of the enrollment visit, the
grandparent accompanies the child and say that the parent is
not available.
A.
B.
C.
You may not enroll the child unless the ICP is already approved by
IRB (verbal consent).
You talked to the parent already, so the child can be enrolled by the
grandparent.
You may not enroll unless the parent agrees to come the next day
and sign the form again after child finishes with participation.
Please call the QA and Education team
 Maria G. Davila
(404)712-0724 or maria.davila@emory.edu

Shara Karlebach
(404)712-0727 or shara.karlebach@emory.edu

Kevin Wack
(404)712-5220 or kwack@emory.edu

Sean Kiskel
(404)712-0766 or skiskel@emory.edu
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