Strengthening ethical community engagement in contemporary Malawi

Nyirenda, Deborah; Gooding, Kate; Sambakunsi, Rodrick; Seyama, Linley; Mfutso-Bengo, Joseph; Manda-Taylor, Lucinda; Gordon, Stephen B.; Parker, Michael

doi:10.12688/wellcomeopenres.14793.2

“…While sharing information will be part of public engagement, ongoing two-way dialogue is needed, as started through this consultation. This two-way approach is core to guidance on public engagement in LMICs [37], and needed both to inform the acceptable design of future HIS and for the intrinsic value and ethical importance of public involvement.…”

Section: Discussionmentioning

confidence: 99%

Stakeholder views on the acceptability of human infection studies in Malawi

Kapumba

¹

,

Jambo

²

,

Rylance

³

et al. 2020

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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.

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“…LMICs [37], and needed both to inform the acceptable design of future HIS and for the intrinsic value and ethical importance of public involvement.…”

Section: Discussionmentioning

confidence: 99%

Stakeholder views on the acceptability of Human Infection Studies in Malawi

Kapumba

¹

,

Jambo

²

,

Rylance

³

et al. 2020

Preprint

Self Cite

0

View full text Add to dashboard Cite

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.

show abstract

“…While sharing information will be part of public engagement, ongoing two-way dialogue is needed, as started through this consultation. This two-way approach is core to guidance on public engagement in LMIC [34], and needed both to inform acceptable design of future HIS and for the intrinsic value and ethical importance of public involvement.…”

Section: Discussionmentioning

confidence: 99%

Stakeholder views on the acceptability of Human Infection Studies in Malawi

Kapumba

¹

,

Jambo

²

,

Rylance

³

et al. 2019

Preprint

Self Cite

View full text Add to dashboard Cite

Background Human infection studies (HIS) are essential in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMIC) where CHIM 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 LMIC. 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. Findings Stakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to 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 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 can be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required as HIS are implemented.

show abstract

Strengthening ethical community engagement in contemporary Malawi

Cited by 23 publications

References 23 publications

Stakeholder views on the acceptability of human infection studies in Malawi

Stakeholder views on the acceptability of human infection studies in Malawi

Stakeholder views on the acceptability of Human Infection Studies in Malawi

Stakeholder views on the acceptability of Human Infection Studies in Malawi

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