The social and ethical implications of data-prompted ancillary care in southern Africa, Malawi

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Date
2021-03-04
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Kamuzu University of Health Sciences
Abstract
type of research study: This is a qualitative research study. The problem: Data-driven Ancillary Care is increasingly emphasised as an ethical approach in medical research. It, however, raises complex ethical concerns when research is conducted in resource-constrained settings (RCS) where participants may have additional health care needs outside the scope of the research, not usually provided by the local health care system. Limited information is available on observational research findings and understanding on practices of ancillary care provision during research, particularly in RCS. The objectives: To explore research stakeholders’ views and perspectives on the social and ethical issues surrounding the provision of ancillary care during research in Malawi. To explore research stakeholders’ views and perspectives on the provision of ancillary care, if any are encountered by researchers in Malawi, and how they respond to them. Specific 1. To describe experiences and perspectives of research stakeholders on the practices of the provision of ancillary care during research. 1. To document experiences and perspectives of research stakeholders on the process and practice of provision of ancillary care 2. To describe how researchers decide whether or not to respond to the ancillary care needs of their research participants. To determine the process researchers follow to decide whether or not to provide ancillary care to their research participants 2. To explore views among research stakeholders on the values and practices beyond perceived ancillary care obligations of researchers which may need to be balanced in decisions about study demands and ethical requirements. To determine the values and practices beyond perceived ancillary care obligations of medical researchers which may need to be balanced in decisions about study demands and ethical requirements. 3. To develop a framework and standard guidelines for ancillary care practices that address complexing social and ethical questions in RCS. Methodology: We will conduct qualitative in-depth interviews with key research stakeholders in Malawi, including researchers, Ministry of Health officials, research ethics committees (REC) members, and research participants; and grant officers from international research funding institutions including Wellcome Trust, European & Developing Countries Clinical Trials Partnership (EDCTP) and Bill and Melinda Gates foundation, to understand their views and perspectives on the provision of ancillary care. Potential constraints We do not envisage major problems in conducting this study as it involves qualitative research with a relatively small sample. There are potential challenges around ensuring consent is fully voluntary, as MLW staff and some study participants enrolled in other studies may see participation in interviews as compulsory. We will mitigate this by emphasising that participation is their own free choice, and that nonparticipation will have no implications for their work, access to services or relationship with MLW. Expected findings and their dissemination. We will produce findings on practices of ancillary care provision during medical research in Malawi, ethical issues arising, and approaches to ethical provision of ancillary care to study participants in RCS. Findings will be shared with participant groups and the wider public through discussion with the ministry health officials and Malawi research ethics committees including College of Medicine Research Ethics Committee (COMREC) and written up in journal articles and disseminated at national and international conferences, including the College of Medicine Research Dissemination conference.
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Research Subject Categories::MEDICINE
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