Sharma Jeevan Raj, Khatri Rekha, Harper Ian
Dev World Bioeth. 2016 Dec;16(3):140-147. doi: 10.1111/dewb.12109. Epub 2016 Feb 3.
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.
与南亚其他国家不同,尼泊尔卫生领域的研究历史相对较短。该国大多数卫生研究活动由援助机构和大学的国际合作团体赞助。尼泊尔卫生研究委员会的数据显示,1991年至2014年期间,官方开展了1212项卫生研究活动。这些活动涵盖从通过运筹学解决国家层面的紧迫卫生问题,到旨在生成证据的评估和项目干预措施,再到为全球科学和政策辩论提供信息的更系统的研究活动。尼泊尔卫生研究委员会(NHRC)伦理审查委员会成立于1991年,是该国所有卫生研究活动的正式监管中央机构,其权力通过议会法案授予。基于2010年至2013年期间开展的研究,以及作者于2012年7月在尼泊尔作为正在进行的研究的一部分举办的一次研究伦理研讨会,本文突出了这个见证了卫生研究活动增加的低收入国家中新兴的监管和伦理领域。出现的问题反映了这种特殊的研究政治经济学(什么构成卫生研究、资源来自何处、谁确定研究议程、合同研究文化、审查成本、发展尼泊尔的研究能力,直至数据/研究结果的发表政治),并包括对新兴监管和伦理框架的质疑。