HCV CHIM Community Advisory Committee

The Advisory Committee met via Zoom from 10:30–12:00pm Eastern time on Friday, August 2, 2024.

Five of eight members attended. In alphabetical order: Julia Bacon, Jake Eberts, Thomas Smiley, Carolina Reid, and Jennifer van Gennip.

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

Qualitative sub-study questions

The Committee spent time thinking of potential questions for participants that Professor Biondi and her team can consider when designing interviews for a proposed qualitative study exploring the motives and experiences of HCV CHIM participants.

Possible questions compiled by the Committee, categorized:

Motives for participation

• How did you hear about this? Why did you decide to participate?
• What values that are important to you were a consideration as you decided to participate?
• What are the motivating factors that led you to join? Do you think those factors made sense? 
• How do you understand your role in this study? (Why are you being infected, and what will eventually happen because of this?)

Experience in the study

• What is a major way your experience has differed from how you expected it to go?
• Do you feel like your quality of life has been affected by joining the study? 
• How restrictive do you feel the protocol is? (How inconvenient is it to comply with the study’s requirements?) 
• What would prevent you from doing this in the future? (Would you do it again?) 
• How does this impact your daily life (e.g. socially)?
• Do you think this will impact you after the trial (job, family, lifestyle, etc.)?
• Did the informed consent document match your expectations and experience of the study?
• What is your relationship with the researchers and study team? And with other trial participants?

Communication with others

• Have you told others about your participation? 
• Would you recommend this to a friend who meets the eligibility criteria?
• How publicly do you discuss this trial with others in your life? Do you feel equipped to answer questions they have? How do you handle skepticism/disagreement?

Research team behavior

• How did researchers address questions before v. after the trial began? (Are you getting the same level of attention to your questions from the research team?) 
• Do you feel engaged/involved in the study? Do you feel like you are providing a benefit?

Transparency

Question: How should materials for the HCV CHIM (like the informed consent document) be shared? Should they be made public? Or should they only be given to participants after they’ve started screening? 

Consensus statement: While some information may not need to be made public, there should be a default assumption of transparency and the free availability of major study documents relevant to participants and prospective participants, such as informed consent documents, schedules, etc. Objections to transparency do not outweigh the interests of prospective participants, participants, and the public in having information freely available.

Notes from the discussion of this issue, which led to the eventual consensus statement (submitted via email for consideration to members not in attendance as well), are presented below, pseudonymized:

Superior: I don’t have strong opinion

Erie: I do have a strong opinion in favor of transparency. The qualifiers listed in the agenda talking about the reasons people might be nervous to be transparent are the exact reasons you should have things public in the first place. Public accountability is important. A study should be criticized if it’s not up to standards. Not every little thing necessarily — you can redact proprietary things, for example. But matters of compensation, of treatment, of scheduling etc. should absolutely be public.

Ontario: I agree with Erie. Perhaps there’s a way to make documents not completely open but you could tailor it to different groups – media, public health, participants. If there’s a surge in media interest, you could maybe track who cares and why. 

Michigan: Transparency goes hand-in-hand with accountability. It’s important that that material is available if it’s requested, but you don’t need a web page with every single little detail. But there’s also no reason to withhold information if it’s requested. Media accessing it could be a concern, but maybe not. 

Superior: If you were in a study and you knew all of these things were on a website, do you think they could be used against you? Would it be a breach of privacy? 

Michigan: Stigma would be a problem. That’s why I don’t think it’s necessarily something that should be public information 100%. Confidentiality is important.

Huron: I think it’s important to clarify that transparency measures wouldn’t involve personal information. Also, I’d note that it can be frustrating to not know the information beforehand as a participant, and that something like an informed consent document would be more likely to show others how rigorous a study is. 

Superior: Do you think people knowing compensation figures could be violating your privacy? 

Erie: No. If I make the choice to join and disclose it to people, then I can’t imagine that information would be a problem for myself personally.

Ontario: There are lots of things on the internet that are attached to my identity, so I’m not sure a compensation figure on a website would be a problem. I don’t think it would change my interest in talking about the study either. 

Michigan: I relate to what Ontario says — you can find lots of information online. So it’s a non-unique issue perhaps. 

Superior: If it’s an issue of prospective participants not knowing info beforehand, that militates in favor of having things public. Overall, it sounds like privacy concerns are not overwhelming and it sounds like it’s in the best interest of participants for information to be available. There can be some restrictions (it does not need to be all the information, all the time, always). 

Erie: Maybe issue with employers? 

Huron: Ultimately, the question of privacy is on the individual – they can always choose to withhold info related to their participation to others, so I’m not super concerned about the privacy implications. Really the only way someone could go and find their study’s informed consent document is if the participant chose to tell them about the study to begin with.

Hep C Bot — AI in the Hep C CHIM

1Day Sooner has developed an experimental AI chatbot trained on data from published, peer-reviewed literature on hepatitis C and other documents related to challenge studies and the hepatitis C CHIM.

Question: Could an AI chatbot like this be used in a study like this as part of the informed consent process or to provide background information to potential participants? If so, what conditions would need to be met?

The Committee did not feel ready to make formal recommendations on the bot, but several observations were made:

• The Bot did seem potentially useful, especially for participants or prospective participants who might not want to spend time calling or emailing study staff for what they perceive to be relatively minor issues (or are worried about taking up researchers’ time out of politeness, etc.)
• Some felt having the bot completely open to the public could open the doors for bad faith actors trying to make the study look bad, but others did not feel this was a substantial risk.
• There was not consensus on when in the screening and enrollment process a tool like the Bot might be useful, though there was hesitance towards using it during or in lieu of informed consent quizzes (that is, the informed consent quiz should require reading and re-reading the relevant documents on one’s own without access to AI).
• The committee did not find immediately concerning issues of misinformation or errors that could not be explained by inadequate underlying data (that is, information the Bot did not know but the committee knew because the committee has more recent information about the study). 
• Still, some felt that the questions asked should be logged and periodically checked by a knowledgeable study staff member as a form of audit during the study, in case erroneous responses do arise.
• Some other possible pitfalls that should be considered include: People mistaking the bot for the study team and sharing personal/medical information over an unsecured platform; and insufficiently detailed answers possibly putting off prospective participants (i.e., inability to answer concrete details about study conditions, schedules, etc.).