Collective Care Amid US Individualism Through COVID-19 Vaccine Trial Participation

Abstract Background Little is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate. Methods Observation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants’ stories to develop two ideal portraits based on "composite characters" based on study participants features. These provide ethnographically rich details of participants’ meaningful social worlds while protecting individual identities. Results Ten of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation. Conclusions Our findings support Fisher’s argument of “structural coercion” in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie “under consent” of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North.

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Pregnant women’s attitudes toward Zika virus vaccine trial participation

Vaccine ◽

10.1016/j.vaccine.2018.09.042 ◽

2018 ◽

Vol 36 (45) ◽

pp. 6711-6717 ◽

Cited By ~ 3

Author(s):

Ilona Telefus Goldfarb ◽

Elana Jaffe ◽

Kaitlyn James ◽

Anne Drapkin Lyerly

Keyword(s):

Virus Vaccine ◽

Zika Virus ◽

Vaccine Trial ◽

Trial Participation

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Selectively willing and conditionally able: HIV vaccine trial participation among women at “high risk” of HIV infection

Vaccine ◽

10.1016/j.vaccine.2011.06.064 ◽

2011 ◽

Vol 29 (36) ◽

pp. 6130-6135 ◽

Cited By ~ 13

Author(s):

Chelsea D. Voytek ◽

Kevin T. Jones ◽

David S. Metzger

Keyword(s):

High Risk ◽

Hiv Infection ◽

Vaccine Trial ◽

Hiv Vaccine ◽

Trial Participation

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Personality correlates of HIV vaccine trial participation

Personality and Individual Differences ◽

10.1016/s0191-8869(99)00206-8 ◽

2000 ◽

Vol 29 (3) ◽

pp. 459-467 ◽

Cited By ~ 9

Author(s):

Mallory O Johnson

Keyword(s):

Vaccine Trial ◽

Hiv Vaccine ◽

Trial Participation ◽

Personality Correlates

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The social experience of participation in a COVID-19 vaccine trial: Subjects’ motivations, others’ concerns, and insights for vaccine promotion

10.1101/2020.12.30.20249051 ◽

2021 ◽

Author(s):

Emily Wentzell ◽

Ana-Monica Racila

Keyword(s):

Decision Making ◽

Side Effects ◽

Lived Experiences ◽

Vaccine Development ◽

Rapid Development ◽

Vaccine Trial ◽

Vaccine Hesitancy ◽

Trial Participation ◽

Race Ethnicity ◽

Vaccine Promotion

AbstractBackgroundVaccine hesitancy could undermine the effectiveness of COVID-19 vaccination programs. Knowledge about people’s lived experiences regarding COVID-19 vaccination can enhance vaccine promotion and increase uptake.AimTo use COVID-19 vaccine trial participants’ experiences to identify key themes in the lived experience of vaccination early in the vaccine approval and distribution process.MethodsWe interviewed 31 participants in the Iowa City, Iowa US site of the Pfizer/BioNTech COVID-19 vaccine phase 3 clinical trial. While trial participation differs from clinical receipt of an approved vaccine in key ways, it offers the first view of people’s lived experiences of potentially receiving a COVID-19 vaccine. The trial context is also useful since decision-making about vaccination and medical research participation often involve similar hopes and concerns, and because the public appears to view even approved COVID-19 vaccines as experimental given their novelty. Semi-structured interviews addressed subjects’ experiences, including decision-making and telling others about their trial participation. We analyzed verbatim transcripts of these interviews thematically and identified common themes relevant for vaccination decision-making.ResultsParticipants across demographic groups, including age, sex/gender, race/ethnicity, and political affiliation, described largely similar experiences. Key motivations for participation included ending the pandemic/restoring normalcy, protecting oneself and others, doing one’s duty, promoting/modeling vaccination, and expressing aspects of identity like being a helper, career-related motivations, and support of science/vaccines. Participants often felt uniquely qualified to help via trial participation due to personal attributes like health, sex/gender or race/ethnicity. They reported hearing concerns about side effects and the speed and politicization of vaccine development. Participants responded by normalizing and contextualizing side effects, de-politicizing vaccine development, and explaining how the rapid development process was nevertheless safe.ConclusionThese findings regarding participants’ reported motivations for trial participation and interactions with concerned others can be incorporated into COVID-19 vaccine promotion messaging aimed at similar populations.

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