Informed Consent Types of Informed Consent o Screening

Informed Consent

Types of Informed Consent o Screening

Types of Informed Consent o o Screening Enrollment q q Off-site Visits Specimen Storage

Types of Informed Consent o o Screening Enrollment q q o Off-site Visits Specimen Storage Decliner Group: screening and enrollment informed consent

Informed Consent for Screening & Enrollment in the Decliner Group o Participants can decline enrollment in HOPE at any point in the screening & enrollment period. Therefore, sites should be prepared to educate on the decliner subset throughout the process.

Informed Consent Tools o Fact Sheets

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

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

Informed Consent Tools o o Fact Sheets Ring use instructions/information sheet IC Coversheet IC Comprehension Checklist

Informed Consent Tools o o o Fact Sheets Ring use instructions/information sheet IC Coversheet IC Comprehension Checklist Decliner IC Comprehension Checklist

Informed Consent Tools o o o Fact Sheets Ring use instructions/information sheet IC Coversheet IC Comprehension Checklist Decliner IC Comprehension Checklist Visual aids: n n Pelvic model & sample ring Calendar Male & female condoms Others?

Pop Quiz o Write down which informed consent tool is on the slide, as they appear. The images will change every 5 seconds, so be quick!

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How did you do? 1. 2. 3. 4. 5. 6. 7. 8. 9. Resistance Fact Sheet HOPE Fact Sheet DECLINER Comprehension Checklist Prevention Methods Fact Sheet Anal Sex Fact Sheet Male Circumcision Fact Sheet Ring Use Instructions Informed Consent Comprehension Checklist Ring FAQ

Critical Components Setting free of coercion o Why is this especially important in HOPE? o What should be present to ensure this? o What should be absent to ensure this?

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

Documenting the IC Process • How will the session be documented at your site? • What challenges do you anticipate in documenting the process? • Documentation must cover the 8 components of IC outlined in 21 CFR • What are these components?

Ongoing Consent o When is reconsenting required?

Ongoing Consent o When is reconsenting required? n Protocol version changes –complete review

Ongoing Consent o When is reconsenting required? n n Protocol version changes –complete review When ICFs are changed and management team/IRB recommends it

Ongoing Consent o When is reconsenting required? n n n Protocol version changes –complete review When ICFs are changed and management team/IRB recommends it Minor modifications & Lo. As that effect ICFs

Ongoing Consent o When is reconsenting required? n n Protocol version changes –complete review When ICFs are changed and management team/IRB recommends it Minor modifications & Lo. As that effect ICFs Participants change their mind about participation in optional components

Ongoing Consent o When is reconsenting required? n n n Protocol version changes –complete review When ICFs are changed and management team/IRB recommends it Minor modifications & Lo. As that effect ICFs Participants change their mind about participation in optional components Resumed study participation

Ongoing Consent o Additional counseling & education should be provided throughout the study to ensure continued participant comprehension n Staff should periodically assess comprehension at study visits

Consenting Vulnerable Populations o What strategies will your site use to ensure that illiterate women can provide informed consent?

QA/QC Procedures o How will your site ensure all the correct forms are administered and completed? How many ICFs will be in use at your site? n Who is responsible for ensuring that the correct forms are administered and completed? n

Practice – After Training o Post-training practice is intended to give your team the chance to troubleshoot your informed consent process. n n Completion is not necessary for activation, but you should submit your site’s write-up to FHI 360 before beginning enrolment Instructions are provided in the following slides – please reach out to your CRM with any questions

Practice – After Training o Your team will need: n n Copies of the screening informed consent form Copies of the decliner screening and enrolment form

Practice o Break into groups of 3 as follows: n n n o 1 “study staff member” 1 “potential participant” 1 “observer” The “study staff member” should begin the informed consent process at the “what do I have to do if I decide to take part in the MTN-025 study? ”

Practice – decliner (pt 1) o The “potential participant” will go through this section with the “study staff member” and: n n Ask further questions about choosing not to use the ring Decide to decline participation in the study after discussing ring use (timing up to the “participant”)

Practice – decliner (pt 2) o The “study staff member” will then initiate the decliner population informed consent process n o Proceed through the “purpose of the decliner population” section The “observer” will then provide feedback on the process and each group should discuss what worked well and what was problematic for the process

Practice – enrollment (pt 1) o Switch roles in your group n n n o “study staff member” “observer” “participant” “study staff member” “observer” “participant” The “study staff member” will go through the screening form with the “participant”

Practice – enrollment (pt 2) o o The “study staff member” will then guide the “participant” through the enrollment informed consent form The “observer” will then provide feedback on the process and each group should discuss what worked well and what was problematic for the process

Debrief After completing the mock sessions, designate a team member to briefly answer the following questions in writing and send to FHI 360: o How did the mock sessions go? o Was your team able to accurately describe CHOICE in the consent process? How did the informed consent process change after the participant decided to decline participation? What questions or concerns do you have about facilitating the IC process? o o