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Under consent: Participation of people with HIV in an Ebola vaccine trial in Canada

David Pierre-Marie, Mathiot Benjamin, Thiongane Oumy, Graham Janice E.. 2021. Under consent: Participation of people with HIV in an Ebola vaccine trial in Canada. BMC Medical Ethics, 22 (1):42, 8 p.

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Quartile : Q1, Sujet : ETHICS / Quartile : Q2, Sujet : MEDICAL ETHICS / Quartile : Q2, Sujet : SOCIAL SCIENCES, BIOMEDICAL

Liste HCERES des revues (en SHS) : oui

Thème(s) HCERES des revues (en SHS) : Psychologie-éthologie-ergonomie

Résumé : 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.

Mots-clés Agrovoc : essai clinique, maladie à virus Ébola, vaccin, Virus de l'immunodéficience humaine, infection à VIH, sida (maladie), éthique, méthodologie

Mots-clés géographiques Agrovoc : Canada

Mots-clés libres : Ebola, Vaccine, HIV, Ethics, Vulnerable population, Clinical trial, Consentement

Classification Agris : S50 - Santé humaine
U30 - Méthodes de recherche

Champ stratégique Cirad : CTS 4 (2019-) - Santé des plantes, des animaux et des écosystèmes

Auteurs et affiliations

  • David Pierre-Marie, Université de Montréal (CAN) - auteur correspondant
  • Mathiot Benjamin, Université de Montréal (CAN)
  • Thiongane Oumy, CIRAD-BIOS-UMR ASTRE (FRA)
  • Graham Janice E., Dalhousie University (CAN)

Source : Cirad-Agritrop (https://agritrop.cirad.fr/599184/)

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