Understanding Health Research Ethics in Nepal

Abstract

Unlike other countries in South Asia, in Nepal research in the health sector has a relatively recent history. Most health research activities in the country are sponsored by international collaborative assemblages of aid agencies and universities. Data from Nepal Health Research Council shows that, officially, 1,212 health research activities have been carried out between 1991 and 2014. These range from addressing immediate health problems at the country level through operational research, to evaluations and programmatic interventions that are aimed at generating evidence, to more systematic research activities that inform global scientific and policy debates. Established in 1991, the Ethical Review Board of the Nepal Health Research Council (NHRC) is the central body that has the formal regulating authority of all the health research activities in country, granted through an act of parliament. Based on research conducted between 2010 and 2013, and a workshop on research ethics that the authors conducted in July 2012 in Nepal as a part of the on-going research, this article highlights the emerging regulatory and ethical fields in this low-income country that has witnessed these increased health research activities. Issues arising reflect this particular political economy of research (what constitutes health research, where resources come from, who defines the research agenda, culture of contract research, costs of review, developing Nepal's research capacity, through to the politics of publication of data/findings) and includes questions to emerging regulatory and ethical frameworks.

Accountability and Generating Evidence for Global Health: Misoprostol in Nepal

“…Elsewhere we have charted the history of scientific research in the health sector in Nepal and its close ties to development aid (Sharma, Khatri and Harper 2016). Much of this research activity in the health sector is sponsored by bilateral aid agencies such as USAID and/or carried out by development institutions, often in collaboration with universities and research institutions.…”

“…These assemblages and institutional forms involving donors and their advisors (bilaterals; international non-governmental organisations (INGOs)), government policymakers, programme managers working for governments, INGOs, and NGOs, and researchers are not only critical in the generation of evidence but also provide much-needed networks of support for the successful up-scaling of pilot projects (Sharma et al 2016;Harper 2014). In Nepal, several NGOs and a few private research firms specialising in health systems research have emerged that mainly work on short-term sub-contractual agreements with the government, bilateral, multilateral, and private philanthropic organisations.…”

Health research priorities and gaps in South Asia

“…A review of published studies from Sri Lanka revealed that only a third had documented ethics approval, 18 and a similar pattern is likely in other South Asian countries. Although ethics guidelines have been issued, [19][20][21][22][23] implementation and monitoring of compliance are inadequate and have led to instances of violation of rights of research participants, in particular disadvantaged groups of society. The context of disadvantaged groups must be considered when setting health research priorities to avoid harm, enable trust and participation, and maximise benefits for the entire society.…”

Untitled

“…Elsewhere we have charted the history of scientific research in the health sector in Nepal and its close ties to development aid (Sharma, Khatri and Harper 2016 This form of generation of evidence around programmatic interventions has been sustained by assemblages of local and international organisations and universities, and supported and funded by aid institutions. These assemblages and institutional forms involving donors and their advisors (bilaterals; international non-governmental organisations (INGOs)), government policymakers, programme managers working for governments, INGOs, and NGOs, and researchers are not only critical in the generation of evidence but also provide much-needed networks of support for the successful up-scaling of pilot projects (Sharma et al 2016;Harper 2014). In Nepal, several NGOs and a few private research firms specialising in health systems research have emerged that mainly work on short-term sub-contractual agreements with the government, bilateral, multilateral, and private philanthropic organisations.…”

“…). These evidence generation activities are dispersed and hidden under various programmatic interventions and it is almost impossible to map all the ongoing activities(Sharma et al 2016). There is no clear definition as to what is regarded as health research activity and thus what needs approval from the Nepal Health Research Council (NHRC) and what does not.…”