HCV CHIM Community Advisory Committee

The Advisory Committee met via Zoom from 12:00–1:30pm Eastern time on Monday, November 27, 2023.

Six of nine members attended. In alphabetical order: Julia Bacon, Jake Eberts, Carrielynn Lund, Carolina Reid, Thomas Smiley, Pam Young.

Comments below are presented with pseudonyms to encourage frank discussion and per the Committee’s guidelines.

Introduction

Jake begins with a 10-minute review of the design of the CHIM and where the process is now. Notes that submission to Health Canada anticipated to happen soon as will screening for chronic donors. Review of the committee’s previous work — feedback compensation, informed consent, and other questions.

Compensation

Jake introduces the compensation statement. Notes that it is a draft and should be criticized and there are probably things that need changing.

Comments anonymized to preserve ability for members to speak candidly.

• Robin: I liked the part about a compensation cap → more lower-income participants in general as opposed to a more diverse participant body. 
• Sparrow: (more context) This document also would be something sent to researchers and made publicly available.
• Robin: Re: concern of why people would want to be in study, maybe consent document/process could ask why someone participates.
• Jay: Would that have weight in terms of people being recruited? Should reason concern who we define or choose? It may not be egalitarian or just to exclude people motivated by money. We are paying you for your time, contribution, ability to complete the tasks asked of you. Doing it for ‘noble’ or ‘right’ reasons seems concerning. 
• Pheasant: The “why” someone joins gets a bit hard to define. 
• Robin: And I agree, I was not sure if the ethical parameters required you to figure out motives, since I’m unfamiliar with this type of trial. 
• Cardinal: My personal experience in trials here is relevant. My reasons to enter a trial are my reasons and mine alone, no need for researchers to psychoanalyze me! Most of my reasons were to hope to benefit to self and for cure for the world. Process I’d support would be making sure it’s extremely clear that you’re convinced this person understands what’s being signed up for. Being able to repeat it back to you in plain language. We shouldn’t have to justify someone’s reasoning. People work in mines or other dangerous occupations for the good of their family, we don’t ask for their reasoning. Concern for the low-income can entail unnecessary scrutiny that is based on unjustified assumptions about people. 
• Sparrow: I agree — the solution to things like mining being dangerous are to make sure we enforce occupational safety law, and making sure people are paid a minimum wage, not a maximum one. Overall, I think the problem with asking about motives as well is that people can lie.

Consensus statement on motive: Participants’ reasons for participation in a study can be deeply personal. Be they financial, altruistic, or otherwise, as long as the informed consent process is sufficient and robust, someone’s reasons for participation do not make them more or less able to reason and provide consent. 

• Cardinal: I’ve seen many presumptions by researchers in medical studies about low-income people, often inaccurate, and they subtract from a person’s dignity. 
• Robin: You see this among addiction community as well — significant stigma. 
• Sparrow: OHRP workshop touched on this, too. There’s this concerning idea that people who are low-income etc. necessarily must have more scrutiny and control imposed on them.
• Cardinal: Yes, and again, a lot of the assumptions made are disrespectful — about what people addicted to drugs can or can’t do, etc.

Add to consensus statement: Preoccupation with participation for the “right” reasons might lead to unfair scrutinization of low-income people.

• Cardinal: In my own personal experience, so much comes down to engagement and relationships with the researchers. There needs to be personal rapport to establish trusting relationship, which enables trust. That will make reasons for participation clear anyways.
• Dove: You’re inevitably going to run into folks who want to do the study for financial, for personal reasons, or for humanitarian reasons. It’s a variety of motives. Key will always be the informed consent, digging in to personal reasons for participation isn’t needed.
• Sparrow: We’ve reached a rough consensus that reasoning itself (as long as it is not flawed/erroneous) does not matter — consent does.
• Jay: The $20,000 figure does warrant personalized approach and followup to make sure people’s reasoning is sound (regardless of motive). Rapport with researchers would enable this to more easily. 
• Cardinal: How would you screen down from larger numbers of applicants, so people don’t bring unconscious bias into the process, and ensure the screening process doesn’t exclude certain types of people?

Occupational exclusions

Occupational exclusions — Question presented previously to cochairs by Professor Biondi: What are professions that might need to be excluded from a health/safety standpoint (e.g. healthcare workers, sex workers, nursery caretakers)? Do we think that occupational exclusions make sense, and what might they look like?

• Sparrow: Notes another example of Shigella studies excluding food service workers on public health/safety grounds.
• Robin: Excluding sex workers seems difficult given the stigma involved.
• Sparrow: I agree — it’s probably easy to lie about. Also, sexual transmission still seems very rare based on published medical literature — so we should just make people aware and ask them to use protection. That seems adequate.
• Cardinal: I don’t think there should be occupational exclusions. Healthcare workers should be following standard practice, which would keep them from exposing others anyways. Someone in healthcare could be exposed anyways, too. Something like a pedicure might be more risky, but we couldn’t keep people from getting pedicures. I’m hesitant to start IDing restricted occupations. You wouldn’t exclude a promiscuous person, even if they have more sexual partners than sex worker!
• Robin: Also want to be clear how it’s transmitted so people are aware — that should be sufficient.
• Sparrow: Compared to e.g. Shigella, the risk profile to exposing others is still much lower. Perhaps pedicure risk is worth noting, add to informed consent about behaviors rather than occupations. Something like “You should consider not getting a tattoo or going to nail salons given the low but non-zero risk” maybe.
• Cardinal: Along with note about protection during sex too. 
• Jay: I’m not opposed to occupational exclusion, but the threshold is high — occupations that represent substantial risk of transmission. If there’s a profession with a logical, high likelihood, then it’d be fine to exclude them
• Cardinal: It can be extremely hard to clear fiberglass materials used in nail salons with hepatitis C. So people should be warned against it. 

Consensus: Ask researchers about actual risk profiles (what sort of professions might be excluded, and what would the transmission risk be), and note that the threshold is high. A general healthcare worker exclusion seems overbroad. Pedicure and manicures and tattoos though should be avoided, however — note this to participants and maybe prohibit it/make it exclusion factor.

• Pheasant: Does this tie in to questions about PWIDs?
  • Sparrow: I think the difference is PWIDs would a) be very hard to not notice (and be deceptive about, compared to e.g. someone not telling researchers that they’re a sex worker) in screening and b) would present a clear and present infection risk to many others.
• Jay: We’re paying for fair service — your joining a study, it requires you to do X, and it’s fair to include “don’t get a tattoo” or “don’t get a manicure” under that umbrella.

Community engagement

Engagement question, from Professor Biondi: We don’t know how much engagement is “enough” engagement for stakeholders, community, etc. For example the session [a panel at The Liver Meeting in Boston], how often should that happen? How should we engage in general? Does the CAB reach out to their networks? I know it will be difficult to ever say we had “representative engagement” - but how can we strive to do the best possible job? 

• Sparrow: Suggestions for things like happy hours or other event in casual setting for casual engagement setting for prospective participants, but politics of it might be difficult, REB might be a problem since it’s out of a clinical setting and might require more spontaneous responses.
  • Pheasant: My initial reaction is that that seems great — but there’s politics to it definitely. What if someone shows up and says it’s unregulated/unapproved?
  • Jay: I like the casual/informal idea. But what if people learn the wrong things from other participants, especially if alcohol is involved.
  • Sparrow: Good point, though I think alcohol involvement could be limited even in a “happy hour” setting.
  • Cardinal: I wouldn’t want to do something like this in a public setting because of stigma. Open house approach could be helpful but want to be cognizant of the personal nature of the questions involved. 
  • Sparrow: Devil would definitely be in the details, but I think that a more public info session orientation would be doable (not as something to replace informed consent or be a venue for you to talk about personal medical concerns). 
• Sparrow: Potential engagement of previous volunteers for future vaccine esp. among PWIDs. Could former participants in an HCV CHIM be brought in to talk to PWIDs?
• Jay: Open forum process feels very appealing to me, curious as to Cardinal & Robin’s thoughts and what you would have liked to see done.
  • Robin: I’ve always been an open book, so that process makes sense for me as someone with experience in public speaking. Would need to make people in a forum like this comfortable to ask uncomfortable questions.
  • Cardinal: “Safe, ethical place” environment is key
  • Jay: Maybe an anonymous public question forum
• Sparrow: Researchers did ask about us reaching out to our networks as well — curious as to what that would look like, e.g., townhalls, presentations? Would that be useful in PWID advocacy space?
  • Dove: I have lived experience with hep C, substance use — thru our networks, peer groups/led conversations tend to be very helpful, because people are often very willing to share information. Having peers AND specialists (doctor/nurses presenting) would be great to help establish trust, and make sure they are co-involved. This would enable much more information to be shared.
  • Cardinal: Focus group participation among PWIDs can be really low due to stigma, so there’d need to be flexibility 

12-week infection arm

In remaining 10 minutes, Jake discusses 12-week intermediate arm in the CHIM design and argues it may represent aggregate increase in risk. Two members express that it seems reasonable, but for lack of time, no consensus is reached. Further discussion may be necessary.