Research ethics is predominantly taught and practiced in Anglophone countries, particularly those in North America and Western Europe. Initiatives to build research ethics capacity in developing countries must attempt to avoid imposing foreign frameworks and engage with ethical issues in research that are locally relevant. This article describes the process and outcomes of a capacity-building workshop that took place in Kinshasa, Democratic Republic of Congo in the summer of 2011. Although the workshop focused on a specific ethical theme – the (...) responsibilities of researchers to provide health-related care to their research participants – we argue that the structure of the workshop offers a useful method for engaging with research ethics in general, and the theme of ancillary care encourages a broad perspective on research ethics that is highly pertinent in low-income countries. The workshop follows an interactive, locally driven model that could be fruitfully replicated in similar settings. (shrink)

Introduction Numerous guidelines and policies for ethical research practice have evolved over time, how this translates to global health practice in resource-constrained settings is unclear. The purpose of this paper is to describe how the concept of ancillary care has evolved over time and how it is included in the ethics guidelines and policy documents that guide the conduct of research in the global south with both an international focus and providing a specific example of Malawi, where the first author (...) lives and works, as a case study. Methods Discourse analysis was conducted on 34 international ethics guidelines and policy documents. Documents were purposively selected if they contained a set of key terms that reflect the concept of ancillary care. Following a process of inductive discourse analysis, five key interrelated text phrases relating to ancillary care were extracted from the documents. The evolution of these phrases over time was explored as they represented the development of the concept of ancillary care as a component of ethical health research guidance and practice. Results We found key interrelated phrases that represent discourses regarding the evolution of ancillary care including participant protection; provide care as appropriate; supererogation; patient needs prevail over science; and ancillary care as an obligation. Arguments for the provision of ancillary care were characterised by safeguarding the safety, health rights and well-being of study participants. However, despite the evolution of discourse around ethical obligations to provide ancillary care, this is rarely made explicit within guidance documents, leaving interpretive space for differential application in practice. Conclusion While there have been major changes to the ethics guidance that reflect significant evolution in the ethical conduct of research, the specific vocabulary or language used to explain the ethics of researchers' ancillary care obligations to the health needs of their research participants, lacks clarity and consistency. As a result, the concept of ancillary care continues to be under-represented in local ethical guidelines and regulations, with no clear directives for country-level research ethics committees to apply in regulating ancillary care responsibilities. (shrink)

Researchers conducting large community-based studies among underserved populations may collect data on health conditions that are little-acknowledged in the local setting, and for which there are few if any services for referral of participants who need follow-up diagnosis and care. In the design and planning of studies for such settings, investigators and research ethics committees may struggle to determine what constitutes effective referral and whether it is reasonably available. We offer a guiding framework for referral planning, informed by our experiences (...) of research in the field and of service on research ethics committees, to support evaluation of local referral resources and consideration of the benefits, burdens and risks of referral in the local setting. The framework addresses both the impact of referral on the well-being of the people who would be referred and the impact that referral of study participants would have on local people outside the study. We use a sustained discussion of three field-based case examples to illustrate the ethical concerns at issue and to demonstrate the use of the referral planning framework. (shrink)