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Stakeholder views on the acceptability of human infection studies in Malawi

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Kapumba, Blessing, Jambo, Kondwani ORCID: https://orcid.org/0000-0002-3195-2210, Rylance, Jamie ORCID: https://orcid.org/0000-0002-2323-3611, Gmeiner, Markus, Sambakunsi, Rodrick, Parker, Michael, Gordon, Stephen ORCID: https://orcid.org/0000-0001-6576-1116 and Gooding, Kate ORCID: https://orcid.org/0000-0003-4926-0287 (2020) 'Stakeholder views on the acceptability of human infection studies in Malawi'. BMC Medical Ethics, Vol 21, Issue 1.

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Abstract

Background
Human infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMICs.
Methods
We conducted 6 deliberative focus groups and 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members, and district health government officials.
Results
Stakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to the safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example, balancing equity, safety, and relevance in inclusion criteria.
Conclusions
Our findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out.

Item Type: Article
Subjects: QW Microbiology and Immunology > Immune Responses > QW 700 Infection. Mechanisms of infection and resistance.
QW Microbiology and Immunology > Immunotherapy and Hypersensitivity > QW 805 Vaccines. Antitoxins. Toxoids
WA Public Health > Health Problems of Special Population Groups > WA 395 Health in developing countries
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Clinical Sciences & International Health > Malawi-Liverpool-Wellcome Programme (MLW)
Digital Object Identifer (DOI): https://doi.org/10.1186/s12910-020-0454-y
Depositing User: Marie Hatton
Date Deposited: 16 Mar 2020 15:39
Last Modified: 16 Mar 2020 15:39
URI: https://archive.lstmed.ac.uk/id/eprint/13989

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