A framework for Controlled Human Infection Model (CHIM) studies in Malawi: Report of a Wellcome Trust workshop on CHIM in Low Income Countries held in Blantyre, Malawi

Gordon, Stephen B.; Rylance, Jamie; Luck, Amy; Jambo, Kondwani; Ferreira, Daniela M.; Manda-Taylor, Lucinda; Bejon, Philip; Ngwira, Bagrey; Littler, Katherine; Seager, Zoe; Gibani, Malick M.; Gmeiner, Markus; Roestenberg, Meta; Mlombe, Yohannie

doi:10.12688/wellcomeopenres.12256.1

Cited by 78 publications

(104 citation statements)

References 14 publications

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“…HIS are often used for vaccine testing, with volunteers vaccinated before infection to test potential vaccine candidates. HIS can be conducted much more rapidly and with far smaller sample populations than standard efficacy trials, which means HIS can accelerate vaccine development [1,2]. HIS science has contributed to new vaccines in several areas, including typhoid and malaria [2][3][4].…”

Section: Introductionmentioning

confidence: 99%

“…HIS can be conducted much more rapidly and with far smaller sample populations than standard efficacy trials, which means HIS can accelerate vaccine development [1,2]. HIS science has contributed to new vaccines in several areas, including typhoid and malaria [2][3][4]. While HIS have been conducted for decades in High-Income Countries (HICs), they are much newer in Low and Middle-Income Countries (LMICs) [2,3].…”

Section: Introductionmentioning

confidence: 99%

“…HIS science has contributed to new vaccines in several areas, including typhoid and malaria [2][3][4]. While HIS have been conducted for decades in High-Income Countries (HICs), they are much newer in Low and Middle-Income Countries (LMICs) [2,3]. The highest burdens of vaccine-preventable disease are found in LMICs, and different biological and environmental conditions, including population genetics and pathogen strains, mean findings from vaccine trials in highincome settings do not always apply [5].…”

Section: Introductionmentioning

confidence: 99%

“…Challenges are particularly apparent in LMICs. For example, informed consent and fair compensation are complex in contexts of limited research experience and high poverty; health systems may lack adequate facilities to monitor and treat adverse events, and regulatory guidelines may be limited [2,4,[8][9][10]. The growing literature on HIS ethics suggests a range of ethical principles, including a strongly justified research question that can only be answered through HIS, independent review, qualified and experienced researchers, rigorous informed consent, safe selection of participants, minimisation of risks and no irreversible harm, protection of contacts and the environment, compensation that avoids undue influence, compensation for harm, and public involvement [4,6,8].…”

Section: Introductionmentioning

confidence: 99%

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Stakeholder views on the acceptability of human infection studies in Malawi

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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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Stakeholder views on the acceptability of human infection studies in Malawi

et al. 2020

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“…Two recent papers offer some guidance (in addition to the papers that they already cited): 1) Bambery et al (2016) 1 and 2) Gordon et al (2017) 2 .…”

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confidence: 99%

Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya

Njue¹,

Njuguna²,

Kapulu³

et al. 2018

Wellcome Open Res

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Background: The range and amount of volunteer infection studies, known as Controlled Human Infection Model (CHMI) studies, in Low-Middle Income Countries (LMICs) is increasing with rapid technological advancement, world-class laboratory facilities and increasing capacity development initiatives. However, the ethical issues these studies present in LMICs have not been empirically studied. We present findings of a descriptive social science study nested within a malaria volunteer infection study, on-going at the time of writing, at the KEMRI-Wellcome Trust Research Programme (KWTRP) on the Kenyan Coast. Methods: The study included non-participant observations, five group discussions with more than half of the CHMI study participants, two in-depth interviews with study team members, and an exit questionnaire administered to the participants. Results: Participants understood the key elements of the study, including that they would be deliberately infected with malaria parasites and may get malaria as a result, there would be regular blood draws, and they would spend up to 24 days in a residence facility away from their homes. The greatest motivation for participation was the monetary compensation of 20 USD per overnight stay given as a lump-sum at the end of their residency stay. Also appreciated were the health screening tests prior to enrolment and the positive relations with the study team. Concerns raised included the amount and regularity of blood draws experienced, and concerns that this type of research may feed into on-going rumours about research generally. Conclusion: With the increasing range and number of CHMI studies being conducted in LMICs, current ethical guidance for more than minimal risk studies is inadequate. This study highlights some of the ethical issues that could emerge in these settings, emphasizing the heavy responsibility placed on research review and regulatory systems, researchers and funders, as well as the importance of carefully tailored community engagement and consent processes.

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Ethical Requirements for Human Challenge Studies: A Systematic Review of Reasons

Katzer,

Salloch,

Schindler

et al. 2023

Clin Pharma and Therapeutics

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Human challenge studies (HCS) are controlled clinical trials in which participants are deliberately infected with a pathogen. Such trials are being developed for an increasing number of diseases. Partly as a result of the COVID‐19 pandemic, there has been a recent ethical debate about the reasons for and against HCS in general, or rather, about the requirements that individual HCS must fulfill to be ethically acceptable. A systematic review was conducted to categorize and summarize such requirements and the reasons given for them. Ethics literature was searched in PubMed, Google Scholar, BELIT and PhilPapers; eligibility criteria were articles published in a scientific/scholarly journal (original research, reviews, editorials, opinion pieces, conference/meeting reports). Of 1322 records identified, 161 publications were included, with 183 requirements (with associated reasons) in 10 thematic categories extracted via qualitative content analysis. In synthesizing and interpreting the requirements and their reasons, three issues emerge as particularly sensitive in the case of HCS: the meaning of the right to withdraw from research procedures, communication of researchers with the public and various stakeholders, and the conditions of informed consent. However, four other issues, not specific to HCS, stand out as the most controversial: the acceptable level of risk to participants, payment of participants, protection of vulnerable groups, and standards for international collaborations. Controversies in these areas indicate that further debate is warranted, possibly leading to more specific instructions in ethics guidance documents.

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A framework for Controlled Human Infection Model (CHIM) studies in Malawi: Report of a Wellcome Trust workshop on CHIM in Low Income Countries held in Blantyre, Malawi

Cited by 78 publications

References 14 publications

Stakeholder views on the acceptability of human infection studies in Malawi

Stakeholder views on the acceptability of human infection studies in Malawi

Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya

Ethical Requirements for Human Challenge Studies: A Systematic Review of Reasons

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