Altruism, Scepticism, and collective decision-making in foreign-born U.S. residents in a tuberculosis vaccine trial

Abstract

BackgroundThe current vaccine against tuberculosis, BCG, is effective when given in most TB-endemic countries at birth but has diminished efficacy against pulmonary TB after 15–20 years. As a result, new booster vaccines for adolescents and adults are being developed to realize the World Health Organization target of global elimination of TB by 2035. Multiple TB candidates thus are in active clinical development.MethodsOne of these, DAR-901, is advancing in human clinical trials. These clinical trials are conducted in BCG immunized adults with and without HIV infection in order to assess safety and efficacy among the people most in need of a new vaccine. A Phase I dose escalation trial of DAR-901 in BCG-immunized adults with or without HIV infection was conducted between 2014 and 2016. This offered an unusual opportunity to qualitatively examine why foreign-born adults living in the United States – a poorly studied population – decide to participate, or not, in clinical trials.ResultsWe conducted a qualitative study of individuals who were recruited to participate in this Phase I vaccine trial, interviewing those who agreed and declined to participate. We found diverse motivations for participation or refusal; varied understandings of tuberculosis and vaccines; and complex views about how ‘informed consent’ can be at odds with cultural understandings of power, authority, and medical decision-making. These dynamics included: knowledge (direct or indirect) of tuberculosis, a desire to be altruistic and simultaneous hopes for personal gain as well as concerns over what remuneration for participation could mean, the importance of personal relationships with care providers in shaping volunteerism, concerns over privacy, and evidence of how culture and history shape medical decision-making.ConclusionsThis US-based trial, aimed at addressing a crucible global health issue, raises productive questions about the interface between altruism and scepticism regarding clinical research participation.Trial registrationNCT02063555.

Exploring willingness to participate in future Human Infection Studies in Lusaka, Zambia: A nested qualitative exploratory study

“…Participants were willing to take part as long as they were provided with adequate information to make an informed decision. Other participants indicated that not only would they participate for their own sake and monetary compensation but also for the love of others and to contribute to science, motives also expressed by studies in other LMIC settings [22,23].…”

Exploring willingness to participate in future Human Infection Studies in Lusaka, Zambia: A nested qualitative exploratory study

“…Participants were willing to take part as long as they were provided with adequate information to make an informed decision. Other participants indicated that not only would they participate for their own sake and monetary compensation but also for the love of others and to contribute to science, motives also expressed by studies in other LMIC settings [11,12].…”

Challenges in Recruiting African-Born, US-Based Participants for HIV and Tuberculosis Research

“…These include concerns about privacy, language barriers, a lack of belief in the benefit of research to community, research procedures such as informed consent process which are unfamiliar or culturally inappropriate, and study working hours or locations which are inconvenient for participants. 9,[17][18][19][20][21][22][23] There are additional structural level barriers to participation in research that likely also hinder research participation among marginalized populations, including differential access to health care or other services where recruitment might take place, the legacy of research misconduct and human rights abuses associated with studies such as the Tuskegee Syphilis Study, power imbalances between researchers and participants, including beliefs researchers gain more from research than the communities that participate in their studies, and specific to immigrants, fear that uptake of health services or research participation might have negative immigration-related consequences. 9,17,19,22,[24][25][26][27][28][29][30][31] Some of these barriers have been successfully addressed by engaging community advisory boards, undertaking other forms of community engagement such as health fairs or working with community leaders, ethnic and linguistic "matching" of recruiters to the population of interest, making the consent process transparent and straightforward, providing hours and locations that are convenient, providing translated information and interpreters for those with low English proficiency, and ensuring that research participants are adequately compensated for their time.…”

“…9,17,19,22,[24][25][26][27][28][29][30][31] Some of these barriers have been successfully addressed by engaging community advisory boards, undertaking other forms of community engagement such as health fairs or working with community leaders, ethnic and linguistic "matching" of recruiters to the population of interest, making the consent process transparent and straightforward, providing hours and locations that are convenient, providing translated information and interpreters for those with low English proficiency, and ensuring that research participants are adequately compensated for their time. 9,20,21,23,32 Recruitment practices to address some of the more structural-level barriers have been less well documented in the literature. Recruiting participants in the community or via community-based organizations that serve specific populations rather than at facilities has been successful in many instances.…”