HCV CHIM Community Advisory Committee

The Advisory Committee met via Zoom from 9:30–11:00am Eastern time on Wednesday, October 18, 2023.

Six of eight members attended. In alphabetical order: Julia Bacon, Jake Eberts, Carolina Reid, Thomas Smiley, Jennifer van Gennip, Caroline Pugh-Roberts.

The Committee discussed a draft informed consent document provided by the Canadian HCV CHIM team. Overall, while we highlight some issues to address below, we felt the document was a strong draft written with necessary thoughtfulness and care.

Feedback was divided into two types: consensus statements and suggestions/notes. Consensus statements represent suggestions that the Committee believes ought to be implemented by the team in future informed consent documents. Suggestions and notes entailed other feedback, including questions and potentially useful stylistic alterations to the text. Suggestions and notes are not detailed in these meeting notes.

The draft document is not authorized for public disclosure in full, but excerpts are provided below where needed for context. The following consensus statements were made:

Appropriate Compensation

Relevant text: “You will not have to pay for any of the procedures involved with this study including hepatitis C treatment. You will receive reimbursement of any expenses incurred to attend the study visits (e.g., parking, caregiver costs) up to $100 (receipts required) and will be compensated $20 per hour spent at study visits, as well as $200 per week that you are infected with hepatitis C (up to the end of treatment…)”

Consensus statement: We have previously called for appropriately generous compensation for participants. We also note that $20 and hour falls well below the living wage in the Greater Toronto Area (see the Ontario Living Wage Network). We encourage ethicists, researchers, and other stakeholders to consider economic justice when deciding compensation and avoid keeping payment low solely for the sake of theoretically protecting volunteers.

Rewording: “Health benefits“

Relevant text: “The development of a vaccine to protect against hepatitis C could have important health benefits by preventing liver disease and liver cancer.” (Background & Purpose section)

Consensus statement: Change to “Hepatitis C is a leading cause of liver disease and liver cancer worldwide, so developing a vaccine could eventually save many lives by preventing the disease” or similar. 

Note: The phrase “health benefits” could contribute to initial confusion that the study offers potential health benefits to participants. The amended text makes clear the potential benefits, if realized, would be felt by society and not the individual participant.

Rewording: “If you become infected…”

Relevant text: In the “If you become infected with hepatitis C, samples of your blood will be taken during the first weeks of infection to use for future controlled human infection models.” (Explanation of Study section)

Consensus statement: It is our understanding that it is expected that the first dose of HCV to be used will indeed be infectious, given previous data from chimpanzees. This should reflect that expectation; possible wording could be: “We expect that will become infected with hepatitis C” or “it is very likely you will be infected with hepatitis C” or similar.

Study logistics and order: Blood donation questionnaire

Consensus statement: The questionnaire should be done before any other test mentioned here [in the Study Visits & Procedures section], or otherwise as early as possible, to make sure people who are not eligible do not have to undergo unnecessary procedures. People should be told of common reasons for deferral before being asked to come in for full screening (e.g. in a phone pre-screening).

Payment schedule

Consensus statement: This document needs to include a description or other indication of payment schedules. This should include a row in The Study Visit Schedule indicating when payments will be disbursed.

Information on stigma

Consensus statement: In the “Lifelong positive hepatitis C antibody status” paragraph of the Risks Related to Being in the Study section, add a line that notes stigmatization. For example, “Hepatitis C is often a stigmatized disease, and the presence of hepatitis C antibodies could cause some healthcare workers to make unfair assumptions about you.”

Results sharing

Relevant text: “Once the study is completed, the study team can inform you of the overall study results if you wish to receive them.”

Consensus statement: Sharing results is important. Alter this wording to “We will let you know the results through email [or other means] unless you indicate that you do not want to know this information” or similar. Perhaps include a checkbox for people to indicate if they do not want to be informed of the results. Note what medium that may take (e.g. email).

Consent for future contact

Relevant text: “You may be contacted by a member of the Principal Investigator’s research team or research staff at the site where you are participating in this study for follow-up studies or future studies done in the next 5 years.” (Consent to be Contacted for Research in the Future section)

Consensus statement: add “or related optional events or engagements” (e.g. appreciation event, seminar, other form of survey).