Date post: | 13-Dec-2015 |
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Types of Informed Consent
Screening Enrollment Off-site visits Specimen storage In depth interviews/focus groups
Informed Consent Tools 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.
The Informed Consent ProcessDiscuss study,
risk/benefits, etc.
Read or allow participant to read the ICF
Assess understanding and willingness
Allow time for understanding
Allow time for understanding
Document Provide/review informed consent booklet
Encourage Questions
ICF Topics
YOUR PARTICIPATION IS VOLUNTARY
PURPOSE OF THE STUDY
STUDY PRODUCTS
STUDY GROUPS
WHAT DO I HAVE TO DO IF
I DECIDE TO TAKE PART IN THE ASPIRE
STUDY?
RISKS AND/OR DISCOMFORTS
BENEFITS
PREGNANCY
NEW INFORMATION
WHY YOU MAY STOP TAKING THE
STUDY DRUG EARLY OR BE
WITHDRAWN FROM THE STUDY
WITHOUT YOUR CONSENT
ALTERNATIVES TO
PARTICIPATION
COSTS TO YOU
REIMBURSEMENT
CONFIDENTIALITY
RESEARCH-RELATED INJURY
YOUR RIGHTS AS A RESEARCH
PARTICIPANT/ VOLUNTEER
PROBLEMS OR QUESTIONS
CONSENT FOR STORAGE AND
FUTURE TESTING OF SPECIMENS
CONSENT FOR OFF-SITE VISITS
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?