How to Avoid Problems in the
Informed Consent Process
Shannon Ontiveros, MS, CIP, CIM
Institutional Review Board
Agenda
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Required elements of consent
Additional Elements
Writing the Consent Document
Reminders to Check
Amendments
Suggestions for Assent Documents
#1 POINT
Required elements of
consent
• Research
– Purpose
– Duration
– Procedures
• Risks/discomforts
• Benefits
• Alternatives
• Confidentiality
• Whom to contact
• Compensation/
treatment for
research related
injury
• Right with refuse or
withdraw
Additional Elements
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Unforeseen risks to subject (fetus)
Anticipated reasons for termination
from the study by PI
Costs
Consequences of withdrawal by
participant
New findings
Number of subjects
Writing the Consent Document
• Written in 2nd person.
• Not valid unless the consenter
understands the information that has
been provided.
• The investigator must consider subject
population, type of information, and
circumstances under which obtaining
consent.
Writing the Consent Document
• Avoid technical terms
• Simple sentences
• Translation is required when English is
not participants’ primary language
Tools for Simplifying
Language
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SMOG
Flesch Reading Ease
Flesch-Kincaid Grade Level
Medterms.com
Reminders to Check
• Remove template instructions, for
example [INSERT if applicable].
• Complete header with version date.
• Complete all sections unless not
applicable.
Reminders to Check
• If you are using a modification of the
subject injury language, submit a copy of
the contract so that the IRB can verify
language.
Problems Often Encountered
• Parent consent forms should be written
referencing “your child.”
• AGE APPROPRIATE LANGUAGE!
• Difficulty distinguishing between standard
of care and research.
• Complete alternative treatment
statement, especially when the study
involves “treatment.”
Amendments
• ALL changes to the consent document
must be submitted to the IRB for review
and approval, no matter how small!
• Update version date when submitting for
amendments.
Suggestions for Assent
Documents
• Under Age 7
– Provide very simple script to communicate to
child.
– Include dissenting procedures in the
parent/legal guardian consent form.
– Stress voluntary participation to child.
– Not typically a form requiring signature from
child.
Suggestions for Assent
Documents
• Children 7 – 12
– Very simple consent document.
– Slightly more detail with regard to study
procedures, etc.
– Sample question/answer format.
– Stress voluntary participation.
Suggestions for Assent
Documents
• Children 13 – 17
– Federal regulations allow for child to sign
form in same language as parent, however,
IRB recommends simplifying as much as
possible.
– More detail regarding study procedures.
– Would obtain signature from child.
– Discuss confidentiality issues, will parents
know outcomes?
#1 POINT
Consent is a
Process!
Review and Discussion
of Informed Consent
Document
Time for Questions
Answers
Time to
discuss with
Family and Friends
Questions?