Six dimensions of research trial acceptability: how much, what, when, in what circumstances, to whom and why?

Abstract

Ethics guidelines emphasise that research should be acceptable to the people invited to take part. However, acceptability is subjective and dependent on context, complicating its assessment and use as an ethical standard. This paper examines the concept of acceptability in relation to parents' perspectives on a paediatric vaccine trial in Malawi. We examined decisions on participation and experiences of the trial through interviews with parents in 41 households invited to enrol their children and participant observation of trial processes. Fieldwork took place in Chikwawa, Southern Malawi from February-October 2016. Parents were not neatly split between those who saw the trial as acceptable and those who did not; instead there were mixed and changing feelings among parents who enrolled their children, and among those who withdrew or did not take part. Some parents agreed to participate but had concerns about the trial, while others expressed satisfaction with the trial but still did not take part. These experiences indicate substantial variation in the nature of acceptance. We describe these variations in relation to six dimensions of acceptability: how acceptable the trial is, what aspects are acceptable, changes over time, circumstances affecting acceptability, variations between people, and reasons for participation or non-participation. The findings illustrate the difficulty of determining whether a trial is sufficiently acceptable to potential participants. We suggest that clarifying definitions of acceptability and examining how acceptability varies in degree, between trial components, over time, and between people and contexts may help researchers generate more nuanced descriptions of acceptability that support responsive and ethical trial design.

Stakeholder views on the acceptability of human infection studies in Malawi

“…Using flyers as a first step in the information chain could potentially miss people who are illiterate but who would be interested in taking part. Experience with other research in Malawi suggests that information about opportunities to participate in HIS would spread by word of mouth, so it may reach people unable to read flyers [20]. Inclusive forms of communication that reach all potential participants should be considered for future HIS, for example, ensuring providing engagement material in local languages.…”

“…In considering the acceptability of HIS, we were interested in a definition of acceptability that involves more than tolerance [20]. MLW's aim is that communities and other stakeholders should feel highly positive about HIS research in Malawi, seeing HIS as relevant and ethical, rather than just allowing HIS to take place.…”

Implementation and evaluation of nonclinical interventions for appropriate use of cesarean section in low- and middle-income countries: protocol for a multisite hybrid effectiveness-implementation type III trial

“…Final themes and key quotations will be translated into English for sharing with the researchers of the QUALI-DEC consortium. Framework analysis will be used to provide an in-depth understanding of acceptability 30,31 by providers and women/companions and the empowerment 32,33 of both stakeholders to act on CS decision-making. We will de ne acceptability as the perception of providers and women that the QUALI-DEC intervention is agreeable, entails an acceptable burden, is ethical and economically feasible, and leads to positive outcomes.…”

Stakeholder views on the acceptability of Human Infection Studies in Malawi

“…This approach is in line with suggestions that recruitment for HIS participants should involve the distribution of advertisements on flyers and posters, followed by a comprehensive information package and information meeting[29].Using flyers as a first step in the information chain could potentially miss people who are illiterate but who would be interested in taking part. Experience with other research in Malawi suggests that information about opportunities to participate in HIS would spread by word of mouth, so it may reach people unable to read flyers[20]. Inclusive forms of communication that reach all potential participants should be considered for future HIS, for example, ensuring providing engagement material in local languages.…”