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Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

2018 GHBN Post Doctoral Fellow with KEMRI-WT & 2020 EDCTP Career Development Fellow

Biosketch: 

Primus Che Chi is a public health specialist and bioethicist with a particular interest in reproductive, maternal, newborn and child health (RMNCH), and health systems strengthening in low-resource and crisis settings. He holds a PhD in International Health from the University of Oslo, Norway and an MPH in Public Health and Research Ethics from the University of Pretoria, South Africa. He has contributed in planning and implementing a number of operational research projects in the domains of RMNCH, health systems and research ethics across central and eastern Africa, including fieldworks in Cameroon, Burundi, DRC, and Uganda. He will soon join the KEMRI Wellcome Trust Research Programme in Kilifi, Kenya as a social scientist. He is also an associate researcher at the department of Public Health Sciences, Karolinska Institute, Sweden and the Peace Research Institute Oslo, Norway. Primus is a contributor to the Cochrane’s Effective Practice and Organisation of Care Group, and the Cameroon Bioethics Initiative (CAMBIN), where he serves as the Chair of the CAMBIN ethics committee.

Project Title of EDCTP (European & Developing Countries Clinical Trials Partnership) Career Development Fellowship:

Social, Ethical and Regulatory implications of conducting a malaria Vaccine Efficacy trial in a human infection study in Kenya

Acronym: SERVE-kenya
Duration: 3 years (October 2020 – September 2023)

Project summary
This is a career development fellowship to undertake an embedded social science study that aims to contribute towards the development of locally responsive policies on the ethical conduct of malaria vaccine efficacy studies involving the use of a human infection studies (HIS) in Kenya. The study will be embedded within a Phase IIb malaria vaccine clinical trial within a malaria HIS at the KEMRI-Wellcome Trust Research Programme. Specifically, we will first explore the social, ethical and regulatory issues associated with an HIS-based malaria vaccine efficacy trial. Given the novelty of this form of research, we will then feed the empirical findings into a series of in-depth deliberative engagement processes to explore the informed views and values of different community and research-HIS stakeholders around core emerging social and ethical issues. The outputs of the deliberative processes will be fed back to purposively selected stakeholders involved in the earlier data collection processes to strengthen reliability and credibility. Furthermore, drawing on the outputs of the deliberative processes and the wider international ethics literature, we will propose recommendations on the nature of responsive policies for the ethical conduct of malaria vaccine HIS. Overall, data will be collected from a range of HIS stakeholders, including HIS participants and their families, community members, HIS research team, ethics committees, regulatory authorities and policy makers through surveys, interviews, group discussions, participatory workshops, observations and document review.

Other on-going research activities at the KWTRP, Kilifi:

In the coming years I will be developing and conducting research with a broad focus on ethics-related issues in the context of international health research in low-and-middle income country (LMIC) settings. My main research focus will be on developing and conducting social science research on the ethics of Controlled Human Infection Models (CHIM) in Kenya and possibly other LMICs; exploring the practical social and ethical implications of such studies with the goal of contributing to policy and practice.

To achieve this, we will use mixed methods, with a focus on empirical ethics approaches. Our planned research participants will be drawn from major CHIM stakeholders, including research participants, researchers/scientists, research ethics committees, regulatory authorities (local, regional and national) etc.
Some of my areas of interest include:
• Comparative study of ethical and socio-cultural challenges of CHIM studies across different models in SSA
• Compensation models/strategies across different CHIM models in SSA
• Motivation and decision-making practices to participate in CHIM studies (prior, during and after)
• Knowledge and capacity of RECs and RAs to review and authorize CHIM studies
• Unintended consequences of CHIM studies across different models

Comment by Napat Khirikoekkong on June 26, 2020 at 2:44

Congratulations Primus! Well wishes on your fellowship! 

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