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.
Critical Components Setting free of coercion
The Informed Consent Process Discuss study, risk/benefits, etc. Encourage Questions Document Provide/review informed consent booklet Assess understanding and willingness Read or allow participant to read the ICF Allow time for understanding
ICF Topics ALTERNATIVES TO PARTICIPATION YOUR RIGHTS AS A RESEARCH PARTICIPANT/ VOLUNTEER BENEFITS YOUR PARTICIPATION IS VOLUNTARY STUDY GROUPS WHY YOU MAY STOP TAKING THE STUDY DRUG EARLY OR BE WITHDRAWN FROM THE STUDY WITHOUT YOUR CONSENT PREGNANCY CONFIDENTIALITY WHAT DO I HAVE TO DO IF I DECIDE TO TAKE PART IN THE ASPIRE STUDY? COSTS TO YOU CONSENT FOR STORAGE AND FUTURE TESTING OF SPECIMENS PURPOSE OF THE STUDY NEW INFORMATION RESEARCH-RELATED INJURY CONSENT FOR OFF-SITE VISITS REIMBURSEMENT STUDY PRODUCTS PROBLEMS OR QUESTIONS RISKS AND/OR 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?