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Ethical and practical considerations in HIV drug trial closure: perspectives of research staff in Uganda

Sylivia Nalubega, Karen Cox, Henry Mugerwa & Catrin Evans

Research Ethics 17 (4):423-434 (2021)

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Payments and Direct Benefits in HIV/AIDS Related Research Projects in Uganda.Julius Ecuru, Douglas Wassenaar & Betty Kwagala - 2010 - Ethics and Behavior 20 (2):95-109.details Paying research participants in developing countries like Uganda raises ethical concerns over potential for undue inducement. This article, based on an exploratory study, reviewed 49 research protocols from a national HIV/AIDS research ethics committee database. Payments mainly adhered to the reimbursement and compensation payment models. Offers made were diverse but basic in order to limit undue inducement. Implications in terms of undue inducement and possible impact on participants and research are discussed. We end by recommending standardization across comparable studies in (...) Download Export citation Bookmark 2 citations
Microbicides Development Programme: Engaging the community in the standard of care debate in a vaginal microbicide trial in Mwanza, Tanzania.Andrew Vallely, Charles Shagi, Shelley Lees, Katherine Shapiro, Joseph Masanja, Lawi Nikolau, Johari Kazimoto, Selephina Soteli, Claire Moffat, John Changalucha, Sheena McCormack & Richard J. Hayes - 2009 - BMC Medical Ethics 10 (1):17-.details BackgroundHIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania.MethodsA mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern (...) Download Export citation Bookmark 8 citations
Closing the translation gap for justice requirements in international research.Bridget Pratt, Deborah Zion, Khin Maung Lwin, Phaik Yeong Cheah, Francois Nosten & Bebe Loff - 2012 - Journal of Medical Ethics 38 (9):552-558.details Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low- and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice. Practical guidance on how to fulfil these obligations is needed if research groups and (...) Download Export citation Bookmark 6 citations
Broadening the Debate About Post-trial Access to Medical Interventions: A Qualitative Study of Participant Experiences at the End of a Trial Investigating a Medical Device to Support Type 1 Diabetes Self-Management.J. Lawton, M. Blackburn, D. Rankin, C. Werner, C. Farrington, R. Hovorka & N. Hallowell - 2019 - AJOB Empirical Bioethics 10 (2):100-112.details Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood glucose (...) Download Export citation Bookmark 5 citations

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