The Ethics of End-of-Trial Obligations in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania

Ward, Claire Leonie; Shaw, David; Anane-Sarpong, Evelyn; Sankoh, Osman; Tanner, Marcel; Elger, Bernice Simone

doi:10.1177/1556264618771809

Cited by 4 publications

(3 citation statements)

References 32 publications

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“…Taking this finding seriously suggests that more attention could be given to how the resources accompanying health research trials - which can include the strengthening of local health infrastructure, staffing, surveillance, diagnostics and supplies - can potentially strengthen health systems. This could be reflected in more explicit planning and monitoring of this relationship ( Asante et al , 2016 ; Kingori, 2015 ; Ward et al , 2018 ) so that health research maximises the opportunities to strengthen local health systems and minimizes the danger of undermining them. At the same time, the relationships that CE facilitates provide an opportunity to mitigate the ethical challenges of the current dominant research paradigm; by building upon and strengthening their collaborative character further to broker better integration of health research and health systems strengthening.…”

Section: Discussionmentioning

confidence: 99%

‘Working relationships’ across difference - a realist review of community engagement with malaria research

Adhikari¹,

Duddy²,

Richardson³

et al. 2022

Wellcome Open Res

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Background: Community engagement (CE) is increasingly accepted as a critical aspect of health research, because of its potential to make research more ethical, relevant and well implemented. While CE activities linked to health research have proliferated in Low and Middle Income Countries (LMICs), and are increasingly described in published literature, there is a lack of conceptual clarity around how engagement is understood to ‘work’, and the aims and purposes of engagement are varied and often not made explicit. Ultimately, the evidence base for engagement remains underdeveloped. Methods: To develop explanations for how and why CE with health research contributes to the pattern of outcomes observed in published literature, we conducted a realist review of CE with malaria research – a theory driven approach to evidence synthesis. Results: We found that community engagement relies on the development of provisional ‘working relationships’ across differences, primarily of wealth, power and culture. These relationships are rooted in interactions that are experienced as relatively responsive and respectful, and that bring tangible research related benefits. Contextual factors affecting development of working relationships include the facilitating influence of research organisation commitment to and resources for engagement, and constraining factors linked to the prevailing ‘dominant health research paradigm context’, such as: differences of wealth and power between research centres and local populations and health systems; histories of colonialism and vertical health interventions; and external funding and control of health research. Conclusions: The development of working relationships contributes to greater acceptance and participation in research by local stakeholders, who are particularly interested in research related access to health care and other benefits. At the same time, such relationships may involve an accommodation of some ethically problematic characteristics of the dominant health research paradigm, and thereby reproduce this paradigm rather than challenge it with a different logic of collaborative partnership.

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Section: Discussionmentioning

confidence: 99%

‘Working relationships’ across difference - a realist review of community engagement with malaria research

Adhikari¹,

Duddy²,

Richardson³

et al. 2022

Wellcome Open Res

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“…The RTS, S is the first and only vaccine that has currently proven to significantly reduce malaria infection with an acceptable safety profile [ 16 , 17 ]. The vaccine is intended to be delivered as part of the Expanded Programme on Immunizations (EPI).…”

Section: Introductionmentioning

confidence: 99%

Caregivers’ perception and acceptance of malaria vaccine for Children

et al. 2023

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Background Malaria is a disease of public health concern and in endemic areas, pregnant women and children under-five years are vulnerable to the disease. The introduction of the pilot program of a malaria vaccine for children under-five years in Ghana is an intervention to further reduce the burden of the disease. However, the availability of the vaccine does not necessarily mean it will be accepted by the public. This is why the perceptions and acceptance of the vaccine among mothers of these children are worth exploring. Method A descriptive qualitative study, with the aid of a semi-structured interview guide, was utilized in collecting data from ten (10) purposively sampled mothers whose children were taking the malaria vaccine in a municipality in Ghana. Written informed consent was obtained from all participants. The audiotaped interviews were transcribed verbatim and inductively analyzed into themes describing their perceptions and acceptance. Results Participants were aged between 22 and 40 years with eight (8) of them married. Three themes emerged from the study. "Awareness of malaria and the malaria vaccine" (1), “Insight into the malaria vaccine” (2), where participants communicated the beliefs and judgments formed on the vaccine, its benefits, and the need for vaccinating their children. With the third theme "Reaction to vaccine” (3), participants communicated their motivation to vaccinate their children and their concerns about the administration of the vaccine. Conclusion The caregivers had positive perceptions about the malaria vaccine for children, with fewer hospital admissions and saving money as some benefits. Healthworkers played a significant role in influencing the acceptance of the vaccine. However, the fear of the unknown concerning the side effects of the vaccine serve as a possible barrier to recommending the vaccine to other caregivers. Health education must also address the fears of caregivers in order to enhance recommending the malaria vaccine to other caregivers and promote uptake of the vaccination.

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“…The idea that involvement in clinical research can develop local capacity has been proposed elsewhere (Chetwood et al, 2015; World Health Organization [WHO], 2012), along with the myriad of challenges faced by researchers in sub-Saharan Africa (Mwangoka et al, 2013). Common themes have emerged among stakeholders, such as the need for equitable partnerships entailing the respect for the needs, interests, and agendas of all partners; addressing the barriers and opportunities to sustain system capacity; addressing local health targets; and regional commitment to benefit sharing (Ogundahunsi, 2016; Ward, 2017), along with communicating end-of-trial information and disseminating study results (Ward 2018).…”

Section: Introductionmentioning

confidence: 99%

Impact of a Clinical Trial in Two District Hospitals in Ghana: Perspectives of Ghanaian Researchers

Wilson

Giessler

Morris

2018

Journal of Empirical Research on Human Research Ethics

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Conducting clinical trials in resource-poor settings may contribute to local capacity building. We describe the perspectives of local research personnel regarding the impact of collaborating in a clinical trial in rural Ghana. Forty-six Ghanaian research personnel were eligible to complete an anonymous survey, and 35 (76%) participated. Of the 35 respondents, 32 (91%) agreed that future patients will benefit because the hospital was part of the study. All 35 respondents reported a personal benefit derived from study involvement, most commonly citing skills or knowledge gained. Of the 35 individuals, 21 reported one or more burdens, most commonly citing nonspecific research responsibilities. Our data support the hypothesis that participation in clinical trials can contribute to capacity building in district hospitals in a lower middle-income country.

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The Ethics of End-of-Trial Obligations in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania

Cited by 4 publications

References 32 publications

‘Working relationships’ across difference - a realist review of community engagement with malaria research

‘Working relationships’ across difference - a realist review of community engagement with malaria research

Caregivers’ perception and acceptance of malaria vaccine for Children

Impact of a Clinical Trial in Two District Hospitals in Ghana: Perspectives of Ghanaian Researchers

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