Informed Consent Types of Informed Consent o Screening

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 Informed Consent

Informed Consent

Types of Informed Consent o Screening Enrollment Off-site visits Specimen storage o In depth

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

Informed Consent Tools o o o o Fact Sheets Ring use instructions/Important information sheet

Informed Consent Tools o o o o 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 o Split into two groups. o Whichever team can identify the IC tool

Activity o Split into two groups. o Whichever team can identify the IC tool first gets a point. o 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. o Team with the most points at the end wins.

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

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

The Informed Consent Process Discuss study, risk/benefits, etc. Document Encourage Questions Assess understanding and

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

ICF Topics BENEFITS ALTERNATIVES TO YOUR RIGHTS AS A YOUR STUDY RESEARCH PARTICIPATION PARTICIPATIO

ICF Topics BENEFITS ALTERNATIVES TO YOUR RIGHTS AS A YOUR STUDY RESEARCH PARTICIPATION PARTICIPATIO GROUPSPARTICIPANT/ N IS PREGNANCY VOLUNTEER VOLUNTARY WHY YOU MAY CONFIDENTIALITY STOP TAKING THE STUDY DRUG COSTS TO WHAT DO I EARLY OR BE YOU HAVE TO DO IF WITHDRAWN FROM CONSENT FOR I DECIDE TO PURPOSE OF THE STUDY TAKE PART IN STORAGE AND THE STUDY WITHOUT YOUR THE ASPIRE FUTURE TESTING OF CONSENT SPECIMENS STUDY? NEW RESEARCHINFORMATION REIMBURSEMENT RELATED INJURY CONSENT FOR STUDY OFF-SITE VISITS RISKS AND/OR PROBLEMS OR PRODUCTS QUESTIONS DISCOMFORTS

Practice o With a partner, practice conducting the informed consent. n “A” Session counselor

Practice o With a partner, practice conducting the informed consent. n “A” Session counselor should start at “Informed Consent” section. n “B” Session counselor should start at “Study Groups” section.

Debrief o o How did the mock sessions go? What questions or concerns do

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

QA/QC Procedures o How will your site ensure all the correct forms are administered

QA/QC Procedures o How will your site ensure all the correct forms are administered and completed? o What if ICFs go to version 2. 0? What systems are in place?