Informed
Consent
Types of Informed Consent

Screening
Enrollment
Off-site visits
Specimen storage

In depth interviews/focus groups

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
Informed Consent Tools






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Fact Sheets
Ring use instructions/Important information
sheet
IC Booklet
Pelvic model and sample ring
IC Coversheet
IC Comprehension Checklist
Visual aids
Table top flipchart
Activity

Split into two groups.

Whichever team can identify the IC tool first gets a
point.

For an additional point, the winning team has a chance
to describe the contents/purpose of the tool and give
one example of how they might use it in the informed
consent session. If they do not get this part correct, the
other team has a chance to get the point.

Team with the most points at the end wins.
Critical Components
Timing
Setting
free of
coercion
Delivery of Information
Comprehension Confirmation
Signature/Date
Documentation
The Informed Consent Process
Discuss study,
risk/benefits, etc.
Provide/review informed
consent booklet
Document
Encourage
Questions
Assess understanding
and willingness
Read or allow participant
to read the ICF
Allow time for
understanding
ICF Topics
BENEFITS
ALTERNATIVES
TO
YOUR RIGHTS AS A
STUDY RESEARCH PARTICIPATION
GROUPSPARTICIPANT/
PREGNANCY
VOLUNTEER
YOUR
PARTICIPATION
IS VOLUNTARY
CONFIDENTIALITYWHY YOU MAY
STOP TAKING THE
STUDY DRUG
COSTS TO
WHAT DO I
EARLY OR BE
YOU
HAVE TO DO IF
WITHDRAWN FROM
CONSENT FOR
I DECIDE TO
PURPOSE
THE STUDY
TAKE PART IN STORAGE AND
OF THE
WITHOUT YOUR
THE ASPIRE FUTURE TESTING OF
STUDY
CONSENT
SPECIMENS
STUDY?
NEW
RESEARCHINFORMATION
REIMBURSEMENT
RELATED INJURY
CONSENT FOR
STUDY
OFF-SITE VISITS
RISKS AND/OR PROBLEMS OR
PRODUCTS
QUESTIONS
DISCOMFORTS
Practice

With a partner, practice conducting the
informed consent.

“A” Session counselor should start at
“Informed Consent” section.

“B” Session counselor should start at “Study
Groups” section.
Debrief


How did the mock sessions go?
What questions or concerns do you have
about facilitating the IC process?
QA/QC Procedures

How will your site ensure all the correct
forms are administered and completed?

What if ICFs go to version 2.0? What
systems are in place?