Compensation to participants in human challenge studies should not incentivise risk-taking Premium

Authors of an Aug 2023 paper argue $20K for 6-month Hep C CHIS study in US is "reasonable". ICMR's Bioethics Unit says payment should take into account loss of wages & time spent. Jake D Eberts disagrees, saying payment should not incentivise risk-taking. Shigella & Zika CHIS studies paid $7,350 & less than $5K, respectively. Malaria & COVID-19 CHIS studies paid £1,800 & £5,250, respectively. Compensation should reflect local wages for time & risk, not incentivise risk-taking.

Based on their experience in participating in human challenge studies — technically called the Controlled Human Infection Studies (CHIS) — (where participants are deliberately infected with disease-causing pathogens) and responses from 117 potential participants, the authors of an August 2023 paper have argued that $20,000 for a six-month hepatitis C virus challenge study in the U.S. is “reasonable”.

Among the many contentious ethical issues that riddle the human challenge studies, disproportionate payment amounting to inducements for participation tops the list. The ICMR’s Bioethics Unit, which introduced a consensus policy statement on CHIS, says that payment should take into account the loss of wages and incidental expenses, and the time spent and efforts made while participating in CHIS. But it has made altruism central to participation. “The researcher must evaluate the true nature of altruistic motives to participate and select only altruistic participants that meet the selection criteria of the study,” the policy statement says.

Jake D Eberts, Communications Director at 1Day Sooner and a participant in the Shigella and Zika virus CHIS studies and one of the authors of the August 2023 paper disagrees with ICMR’s policy statement that centres altruistic motives to participate in a CHIS study. “If someone joins a CHIS for the money, as long as they understand the risks, I don’t think that’s inherently bad.” Jake was paid $7,350 for the Shigella CHIS study and less than $5,000 for the Zika study. 1Day Sooner serves as an independent monitor in CHIS so participants can reach out with their concerns and complaints. Dr. Anna Durbin, Professor of International Health at the Johns Hopkins Bloomberg School of Public Health and the principal investigator of the Zika CHIS study says that the payment is based on the time of each visit, the number of specimens collected, and what other studies in the area are paying; she had earlier undertaken dengue human challenge studies.

“Imposing a ceiling on compensation does not actually protect low-income people. What protects low-income people (and everyone) is an informed consent process and an ethics review process that makes sure the risks of the study, whether it is a CHIS or other study, are not excessive, and makes sure that participants understand what they are signing up for. Theoretically, if those two conditions are met, compensation could be extremely high and still be ethical (though that would raise different problems),” says Jake. She says that compensation for the hepatitis C CHIS study will be under $10,000 and not $20,000 as proposed by her and others in the August 2023 paper. “We proposed that figure in part because we think it’s important to start a conversation about why compensation in general for CHIS in the U.S. should be higher,” Jake says.

The Shigella study was to determine if the candidate vaccine (SF2a-TT15) was safe and effective in the prevention of Shigella infection, while the Zika study currently being done is to identify the most suitable virus strain and dose for use in a Zika CHIS. The Zika CHIS will then be used to evaluate the protective efficacy of candidate vaccines prior to evaluation in Phase-2 clinical trials.

“There is definitely a spectrum of motivators [financial and/or altruism] for participants, but the important thing is that we do not set the compensation at a scale that we believe would induce someone to engage in a ‘risk’ that they otherwise would never agree to experience, Dr. Wilbur H. Chen, Professor of Medicine at the University of Maryland School of Medicine, Baltimore, U.S. says in an email to The Hindu. Dr. Chen has conducted human challenge studies for cholera, Campylobacter, Shigella, and enterotoxigenic Escherichia coli (ETEC) in the last five years.

Dr. Durbin says that the payment is based on the time of each visit, the number of specimens collected, and what other studies in the area are paying. Dr. Chen who was the principal investigator of the Shigella study says: “Our approach to the compensation of research participants follows an ethical framework of the Wage-Payment model which provides a payment scheme according to what an unskilled labourer who engages in somewhat risky jobs (e.g., a day labour construction worker) might be paid.” The wage-payment model described in detail in a 1999 paper states that “payment of subjects [should] be on a scale commensurate with that of other unskilled but essential jobs”.