Informed Consent Objectives: Review – Types of informed consent Informed Consent Tools Key elements of informed consent Supporting materials & documentation Define & understand IC for the decliner group Ongoing informed consent Identify potential challenges to consent and brainstorm solutions Site practice of IC

Types of Informed Consent Screening

Types of Informed Consent Screening Enrollment Off-site Visits Specimen Storage Off-site visits and specimen storage may be included in the enrollment ICF at your site, but participants must specifically agree to these activities before they can be carried out. Participants are free to decline off-site visits and/or long-term specimen storage and still participate fully in the study.

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. It is anticipated that many participants who decline participation will be identified at the point of first recruitment contact (e.g. phone contact). As such, sites should be prepared to offer education on the decliner population subset at the point of prescreening/recruitment contact (see SSP 4.3.2 for information on pre-screening/recruitment).

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? Can anyone name additional visual aids that are available or commonly used at their site?

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!

Resistance Fact Sheet 1

HOPE Overview Fact Sheet 2

DECLINER Comprehension checklist 3

Prevention Methods Fact Sheet 4

Anal Sex Factsheet 5

Male circumcision Fact Sheet 6

Ring Use Instructions 7

Informed Consent Comprehension Checklist 8

Ring FAQ 9

How did you do? 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

Setting free of coercion 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? The informed consent process must occur in a setting that is free from coercion. Why is this especially important in HOPE? The appearance of coercion at the outset of study participation (ie S&E/IC) will also have an impact on the potential participant’s later choices in the study (ie declining, non-accepting, etc). What can your site do to make sure that the setting is free from coercion? (Make sure to encourage discussion of the entire setting, ie clinic and procedure rooms, as well as phone calls) What should be present? Greeting, friendly/open manner, orderly setting if applicable What should be absent? Statements excessively linking participation to benefits, reminders of hierarchical structures

Critical Components Timing Delivery of Information Comprehension Confirmation Signature/Date Documentation Informed consent is a process by which an individual voluntarily expresses her willingness to participate in research, after having been informed of all aspects of the research that are relevant to her decision. It is not merely a form or a signature, but a process, involving information exchange, comprehension, voluntariness, and documentation. Timing When does informed consent begin? (First contact with potential ppt.) When should the formal IC session occur? (before any study procedures are conducted) Does it occur once or is it ongoing? (IC is obtained at the start of the study, but needs to be informally reassessed throughout study participation. It is a continual process. Should be repeated for new IC versions) Deliver all required information in a manner that is understandable to potential study participants. What participant factors might be important to consider here? (what language the IC should be conducted in? Is the ppt literate or not?) Confirm that the participant comprehends the information using the comprehension checklist. If the participant does not demonstrate comprehension, what are your next steps as the counselor? Sign and date the ICF. What if the participant is illiterate? How are these procedures modified? Counselor should offer the participant a copy. What is your process for this? What if the participant declines taking a copy of the IC? Document the process. Informed consent must be documented using a written form, which must be approved by the IRB/ethics committee, that is to be signed and dated by the participant or the participant’s authorized representative.

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? Will you use the IC coversheet? If yes, do you anticipate any challenges to using it? If no, do you have a site-specific tool or will you use chart notes? COMPONENTS: (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. (2) A description of any reasonably foreseeable risks or discomforts to the subject. (3) A description of any benefits to the subject or to others which may reasonably be expected from the research. (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. (8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. All of these components must happen in a setting free of coercion and undue influence. **Give tools and information about how to share this information with her partner. What tools are available at your site to help support participants if they choose to disclose to their partners?

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? Additional Discussion: Are participants predominantly literate at your site? What are the ways the site evaluates literacy?

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? How many different ICFs will your site be using for HOPE? Who does the QA/QC for the signature block?

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 How did the mock sessions go? 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?