Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely (...) variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping. (shrink)

ABSTRACTBuilding trust between researchers and communities involved in research is one goal of community engagement. This paper examines the implications of community engagement for trust within communities, including trust among community volunteers who assist with research and between these volunteers and other community members. We describe the experiences of two groups of community volunteers recruited as part of an HIV and TB intervention trial in Malawi: cluster representatives, recruited both to act as key informants for TB suspects and mortality reporting (...) and to identify and report community concerns, and community counsellors, recruited to provide semi-supervised HIV self-testing. We examine tensions experienced due to playing multiple roles, and the implications of volunteer responsibilities for short- and long-term community relationships. Data was collected through a workshop, in-depth interviews and focus group discussions with volunteers and community members. While the volunteer system init... (shrink)

The integrity of biomedical research depends heavily on the quality of research data collected. In turn, data quality depends on processes of data collection, a task undertaken by frontline research staff in many research programmes in Africa and elsewhere. These frontline research staff often have additional responsibilities including translating and communicating research in local languages, seeking informed consent for study participation and maintaining supportive relationships between research institutions and study participants and wider communities. The level of skills that fieldworkers need (...) to undertake these responsibilities clearly affects the quality of data collected, the ethics of research ‘on the ground’ and the short and long term acceptability of research.We organised an international workshop in Kenya in July 2014 to discuss the role of frontline staff in scientific research. A total of 25 field managers from 9 African countries and the UK met for 2.5 days to discuss the relationship between data quality and institutional performance management systems and how they affect career progression and supportive supervision policies of research frontline staff.From this workshop, and supporting an expanding literature on the role of fieldworkers in international health research, participants agreed that fieldworkers’ roles present them with practical and ethical challenges that their routine training does not adequately prepare them for. We argue that the common and complex challenges facing fieldworkers should in part be addressed through increased investment and collaborative agreements across types of research institutions in Africa. We call for standardization of core elements of training for this critically important cadre of research staff who perform similar roles and encounter similar challenges in many African settings. Although many valuable training elements are offered in institutions, there is a need to develop broader, more grounded and innovative strategies to address complex realities for fieldworkers, and support the integrity and ethics of health research in these settings. (shrink)

The rapid growth of pharmaceutical markets in the 20th century has increased the demand for human research participants in clinical trials. However, with the globalization of clinical research, most clinical trials are conducted in low-income countries (LICs) with political and economic instability, and lack of basic healthcare, but easy access to human subjects. This paper explores the unique ethical challenges faced during the pre-enrollment phase of cross-cultural research in a country like Pakistan, and how these challenges make the Pakistani population (...) vulnerable to exploitation. It also outlines recommendations regarding conducting research in Pakistan within ethical parameters adopted according to local culture. This discussion is important because researchers must focus on the pre-enrollment phase of the research process for it’s cultural suitability and acceptability so that the research conducted is credible and valid and has social value for the research population. (shrink)

Community engagement has been recognised as an important aspect of the ethical conduct of biomedical research, especially when research is focused on ethnically or culturally distinct populations. While this is a generally accepted tenet of biomedical research, it is unclear what components are necessary for effective community engagement, particularly in the context of genomic research in Africa.