Publication:
Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders

5

Issued Date

2021-12-01

Resource Type

Article

ISSN

17456215

DOI

10.1186/s13063-021-05455-7

Other identifier(s)

2-s2.0-85112575389

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Trials. Vol.22, No.1 (2021)

Suggested Citation

Primus Che Chi, Esther Awuor Owino, Irene Jao, Fredrick Olewe, Bernhards Ogutu, Philip Bejon, Melissa Kapulu, Dorcas Kamuya, Vicki Marsh, Abdirahman I. Abdi, Yonas Abebe, Agnes Audi, Peter Billingsley, Peter C. Bull, Mainga Hamaluba, Zaydah de Laurent, Susanne H. Hodgson, Stephen Hoffman, Eric James, Gathoni Kamuyu, Silvia Kariuki, Nelson Kibinge, Rinter Kimathi, Sam Kinyanjui, Cheryl Kivisi, Nelly Koskei, Mallika Imwong, Brett Lowe, Johnstone Makale, Kevin Marsh, Khadija Said Mohammed, Moses Mosobo, Sean C. Murphy, Linda Murungi, Jennifer Musyoki, Michelle Muthui, Jedidah Mwacharo, Daniel Mwanga, Joyce Mwongeli, Francis Ndungu, Maureen Njue, Patricia Njuguna, George Nyangweso, Domitila Kimani, Joyce M. Ngoi, Janet Musembi, Omar Ngoto, Edward Otieno, Faith Osier, James Oloo, Donwilliams Omuoyo, John Ongecha, Martin O. Ongas, Michael Ooko, Jimmy Shangala, Betty Kim Lee Sim, Joel Tarning, James Tuju, Juliana Wambua, Thomas N. Williams, Markus Winterberg Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders. Trials. Vol.22, No.1 (2021). doi:10.1186/s13063-021-05455-7 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/77547

Research Projects

Organizational Units

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Journal Issue

Thesis

Title

Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders

Author(s)

Primus Che Chi
 Esther Awuor Owino
 Irene Jao
 Fredrick Olewe
 Bernhards Ogutu
 Philip Bejon
 Melissa Kapulu
 Dorcas Kamuya
 Vicki Marsh
 Abdirahman I. Abdi
 Yonas Abebe
 Agnes Audi
 Peter Billingsley
 Peter C. Bull
 Mainga Hamaluba
 Zaydah de Laurent
 Susanne H. Hodgson
 Stephen Hoffman
 Eric James
 Gathoni Kamuyu
 Silvia Kariuki
 Nelson Kibinge
 Rinter Kimathi
 Sam Kinyanjui
 Cheryl Kivisi
 Nelly Koskei
 Mallika Imwong
 Brett Lowe
 Johnstone Makale
 Kevin Marsh
 Khadija Said Mohammed
 Moses Mosobo
 Sean C. Murphy
 Linda Murungi
 Jennifer Musyoki
 Michelle Muthui
 Jedidah Mwacharo
 Daniel Mwanga
 Joyce Mwongeli
 Francis Ndungu
 Maureen Njue
 Patricia Njuguna
 George Nyangweso
 Domitila Kimani
 Joyce M. Ngoi
 Janet Musembi
 Omar Ngoto
 Edward Otieno
 Faith Osier
 James Oloo
 Donwilliams Omuoyo
 John Ongecha
 Martin O. Ongas
 Michael Ooko
 Jimmy Shangala
 Betty Kim Lee Sim
 Joel Tarning
 James Tuju
 Juliana Wambua
 Thomas N. Williams
 Markus Winterberg

Other Contributor(s)

Faculty of Tropical Medicine, Mahidol University
 Sanaria Inc.
 Pwani University
 Strathmore University
 Centre for Geographic Medicine Research
 Kenya Medical Research Institute
 University of Cambridge
 University of Oxford
 University of Washington
 Nuffield Department of Medicine
 Universitätsklinikum Heidelberg

Abstract

Background: Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and appropriately accounted for. Building on earlier work, we embedded social science research within an ongoing malaria human infection study in coastal Kenya to understand the study benefits and burdens experienced by study stakeholders in this low-resource setting and assess the wider implications for future research planning and policy. Methods: Data were collected using qualitative research methods, including in-depth interviews (44), focus group discussions (10) and non-participation observation. Study participants were purposively selected (key informant or maximal diversity sampling), including volunteers in the human infection study, study staff, community representatives and local administrative authorities. Data were collected during and up to 18 months following study residency, from sites in Coastal and Western Kenya. Voice recordings of interviews and discussions were transcribed, translated, and analysed using framework analysis, combining data- and theory-driven perspectives. Findings: Physical, psychological, economic and social forms of benefits and burdens were experienced across study stages. Important benefits for volunteers included the study compensation, access to health checks, good residential living conditions, new learning opportunities, developing friendships and satisfaction at contributing towards a new malaria vaccine. Burdens primarily affected study volunteers, including experiences of discomfort and ill health; fear and anxiety around aspects of the trial process, particularly deliberate infection and the implications of prolonged residency; anxieties about early residency exit; and interpersonal conflict. These issues had important implications for volunteers’ families, study staff and the research institution’s reputation more widely. Conclusion: Developing ethically and scientifically strong HIS relies on grounded accounts of volunteers, study staff and the wider community, understood in the socioeconomic, political and cultural context where studies are implemented. Recognition of the diverse, and sometimes perverse, nature of potential benefits and burdens in a given context, and who this might implicate, is critical to this process. Prior and ongoing stakeholder engagement is core to developing these insights.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/123456789/77547

Collections

Scopus 2021