1. Informed Consent

2. Types of Informed Consent  Screening  Enrollment  Off-site visits  Specimen storage  In depth interviews/focus groups

3. 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

4. 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.

15. Critical Components Timing Delivery of Information Comprehension Confirmation Signature/Date Documentation Setting free of coercion

16. The Informed Consent Process Discuss study, risk/benefits, etc. Read or allow participant to read the ICF Assess understanding and willingness Allow time for understanding Document Provide/review informed consent booklet Encourage Questions

17. 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 RISKS AND/OR DISCOMFORTS BENEFITS PREGNANCY NEW INFORMATION WHY YOU MAY STOP TAKING THE STUDY DRUG EARLY OR BE WITHDRAWN FROM THE STUDY WITHOUT YOUR CONSENT ALTERNATIVES TO PARTICIPATION COSTS TO YOU REIMBURSEMENT CONFIDENTIALITY RESEARCH- RELATED INJURY YOUR RIGHTS AS A RESEARCH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

18. 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.

19. Debrief  How did the mock sessions go?  What questions or concerns do you have about facilitating the IC process?

20. 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?