Informed

Consent
Types of Informed Consent
 Screening
Types of Informed Consent
 Screening
 Enrollment
 Off-site Visits
 Specimen Storage
Types of Informed Consent
 Screening
 Enrollment
 Off-site Visits
 Specimen Storage

 Decliner Group: screening and enrollment

informed consent
Informed Consent for Screening &
Enrollment in the Decliner Group

 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
 Fact Sheets
Informed Consent Tools
 Fact Sheets
 Ring use instructions/information sheet
Informed Consent Tools
 Fact Sheets
 Ring use instructions/information sheet
 IC Coversheet
Informed Consent Tools
 Fact Sheets
 Ring use instructions/information sheet
 IC Coversheet
 IC Comprehension Checklist
Informed Consent Tools
 Fact Sheets
 Ring use instructions/information sheet
 IC Coversheet
 IC Comprehension Checklist
 Decliner IC Comprehension Checklist
Informed Consent Tools
 Fact Sheets
 Ring use instructions/information sheet
 IC Coversheet
 IC Comprehension Checklist
 Decliner IC Comprehension Checklist
 Visual aids:
 Pelvic model & sample ring
 Calendar
 Male & female condoms
 Others?
Pop Quiz
 Write down which informed
consent tool is on the slide, as
they appear. The images will
change every 5 seconds, so be
quick!
How did you do?
1. Resistance Fact Sheet
2. HOPE Fact Sheet
3. DECLINER Comprehension Checklist
4. Prevention Methods Fact Sheet
5. Anal Sex Fact Sheet
6. Male Circumcision Fact Sheet
7. Ring Use Instructions
8. Informed Consent Comprehension Checklist
9. Ring FAQ
Critical Components
Setting free of coercion
 Why is this especially important in HOPE?
 What should be present to ensure this?
 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
 When is reconsenting required?
 Ongoing Consent
 When is reconsenting required?
 Protocol version changes –complete review
 Ongoing Consent
 When is reconsenting required?
 Protocol version changes –complete review
 When ICFs are changed and management
team/IRB recommends it
 Ongoing Consent
 When is reconsenting required?
 Protocol version changes –complete review
 When ICFs are changed and management
team/IRB recommends it
 Minor modifications & LoAs that effect ICFs
 Ongoing Consent
 When is reconsenting required?
 Protocol version changes –complete review
 When ICFs are changed and management
team/IRB recommends it
 Minor modifications & LoAs that effect ICFs
 Participants change their mind about participation
in optional components
 Ongoing Consent
 When is reconsenting required?
 Protocol version changes –complete review
 When ICFs are changed and management
team/IRB recommends it
 Minor modifications & LoAs that effect ICFs
 Participants change their mind about participation
in optional components
 Resumed study participation
Ongoing Consent
 Additional counseling & education
should be provided throughout the
study to ensure continued participant
comprehension
 Staff should periodically assess
comprehension at study visits
Consenting Vulnerable Populations

 What strategies will your site use to

ensure that illiterate women can provide
informed consent?
QA/QC Procedures
 How will your site ensure all the correct
forms are administered and completed?
 How many ICFs will be in use at your site?
 Who is responsible for ensuring that the
correct forms are administered and
completed?
Practice – After Training
 Post-training practice is intended to give
your team the chance to troubleshoot
your informed consent process.
 Completion is not necessary for activation,
but you should submit your site’s write-up to
FHI360 before beginning enrolment
 Instructions are provided in the following
slides – please reach out to your CRM with
any questions
Practice – After Training

 Your team will need:

 Copies of the screening informed consent
form
 Copies of the decliner screening and
enrolment form
Practice

 Break into groups of 3 as follows:

 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)

 The “potential participant” will go through

this section with the “study staff member”
and:
 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)

 The “study staff member” will then initiate

the decliner population informed consent
process
 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)

 Switch roles in your group

 “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)

 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 FHI360:
 How did the mock sessions go?
 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?