Table 2 Key motivations and concerns of enrolees in the tuberculosis vaccine trial
Coded theme | Dynamic | Response |
|---|---|---|
Knowledge (direct/indirect) of tuberculosis | Many subjects were motivated to participate due to awareness of the tuberculosis epidemic and the role of tuberculosis vaccines in disease prevention | Educate potential subjects about public health problem addressed by study & how intervention aims to help people |
Altruism | Subjects participated in study to aid development of tuberculosis vaccine | Mention potential for study participation to help at-risk communities |
Personal relationships | Study subjects with connections to clinicians involved in study or trusted intermediaries who recommend participation were motivated to participate | Non-coercive invitation to participate in study by known clinicians where possible |
Personal gain | Some subjects expect to benefit clinically from participation | Transparency about potential study benefits, if any. It is important for subjects to understand that their decision to participate in study (or not) should have no impact on quality of clinical care |
Privacy | Many subjects limited release of information about study participation & its indications | Protect subject privacy in accordance with their preferences |
Collective decision-making | The opinions of respected peers, including family members, influenced many approached individuals to participate or not | During consent conversation, ask potential subjects if they would like study staff to discuss study with respected peers as well (unless privacy of decision already mentioned) |
Remuneration | Financial incentives to participate in the study were viewed positively by some subjects & with suspicion by others | Select a non-coercive incentive to participate in collaboration with representation from communities from which recruiting subjects |
Convenience | Time required of subjects in trial can dis-incentivise participation | Be parsimonious with subject time investments; align financial incentives to them |
Risk aversion | Some subjects declined out of fear the vaccine could harm them | Educate subjects about risks/benefits of study intervention & measures taken to observe & mitigate them during conduct of trial |