Public perceptions on Controlled Human Infection Model (CHIM) studies—a qualitative pilot study from South India

Abstract

Research using Controlled Human Infection Models is yet to be attempted in India. This study was conducted to understand the perceptions of the lay public and key opinion makers prior to the possible introduction of such studies in the country. 110 respondents from urban and rural Bangalore district were interviewed using qualitative research methods of Focus Group Discussions and In-depth Interviews. The data was analyzed using grounded theory. Safety was a key concern of the lay public, expressed in terms of fear of death. The notion of infecting a healthy volunteer, the possibility of continued effects beyond the study duration and the likelihood of vulnerable populations volunteering solely for monetary benefit, were ethical concerns. Public good outcomes such as effective treatments, targeted vaccines and prevention of diseases was necessary justification for such studies. However, the comprehension of this benefit was not clear among non-medical, non-technical respondents and suggestions to seek alternatives to CHIMs repeatedly arose. There was a great deal of deflection—with each constituency feeling that people other than themselves may be ideally suited as participants. Risk takers, those without dependents, the more health and research literate, financially sound and those with an altruistic bent of mind emerged as possible CHIM volunteers. While widespread awareness and advocacy about CHIM is essential, listening to plural voices is the first step in public engagement in ethically contentious areas. Continued engagement and inclusive deliberative processes are required to redeem the mistrust of the public in research and rebuild faith in regulatory systems.

“At first, I was very afraid”—a qualitative description of participants’ views and experiences in the first Human Infection Study in Malawi

“…The issue of riskallowances and health insurance pointed to participants' concern about how researchers would take care of unforeseen or unanticipated research-related illnesses. Similar problems were noted in a study done in India that reported on public perceptions of HIS 27 . The study paid for no-fault insurance for participants to compensate for those who would sustain researchrelated injuries.…”

“At first, I was very afraid”—a qualitative description of participants’ views and experiences in the first Human Infection Study in Malawi

“…The issue of risk-allowances and health insurance pointed to participants' concern about how researchers would take care of unforeseen or unanticipated research-related illnesses. Similar problems were noted in a study done in India that reported on public perceptions of CHIM 29 . The MARVELS feasibility study paid for no-fault insurance for participants to compensate for those who would sustain research-related injuries.…”

Ethical and practical considerations arising from community consultation on implementing controlled human infection studies using Schistosoma mansoni in Uganda

“…This process of engagement was recommended by Ugandan stakeholders in preparation for CHI-S (Elliott et al, 2018 ). Similarly, other CHI studies have also recommended and conducted community engagements with the target communities in disease-endemic countries such as Zambia (Kunda-Ng’andu et al, 2021 ), Vietnam (Kestelyn et al, 2019 ), India (Vaz et al, 2019 , 2020 ), Malawi (Kapumba et al, 2020 ), Kenya (Njue et al, 2018 ), and Gabon (Alabi et al, 2021 ). The studies showed that participants are able to understand the processes involved during a CHI.…”

“…Participant selection for CHI gives prominence to the ethical need for equity in the process (Bambery et al, 2016 ) and exploitation of vulnerable groups (Rose, 2018 ). Purposeful participant inclusion and exclusion enables that those selected are able to understand the nature of the CHI-S (Rose, 2018 ) and covers a representative group of people (Vaz et al, 2020 ). The former allows particpants to raise their views and concerns as seen elsewhere (Hodgson et al, 2015 ).…”