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实施国家卫生研究伦理法规体系:尼日利亚的经验

Implementing National System of Health Research Ethics Regulations: The Nigerian Experience.

作者信息

Yakubu Aminu, Adebamowo Clement A

机构信息

National Health Research Ethics Committee of Nigeria, Federal Ministry of Health, Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja, P.M.B. 083, Garki-Abuja, FCT, Nigeria.

出版信息

BEOnline. 2012;1(1):4-15.

Abstract

Efforts by Nigerian authorities to institutionalize health research dates back to the early 70's with the establishment of the Medical Research Council. Subsequently efforts to strengthen a national health research system in line with the concept of Essential National Health Research (ENHR) were made but albeit un-successfully. This may have been as a result of poor political support, and lack of regulations to promote health research in the country. However little is known about health research regulations and their implementation in Nigeria. Health and health research in Nigeria is not regulated via a set of clearly defined legislation. While the country has developed a regulation document for health research ethics, compliance to this document is likely to be affected by the lack of legislation in for the health system as an entity. In this paper we narrate the developments in health, health research, and health regulations; we describe process for, and extent of implementation of the National Code of Health Research Ethics. We conclude that several factors affect the extent of implementation of the ethics code amongst which legislation is an important one.

摘要

尼日利亚当局将卫生研究制度化的努力可追溯到70年代初,当时成立了医学研究理事会。随后,该国努力按照基本国家卫生研究(ENHR)的概念加强国家卫生研究系统,但未获成功。这可能是由于政治支持不足以及缺乏促进该国卫生研究的法规。然而,对于尼日利亚的卫生研究法规及其实施情况,人们知之甚少。尼日利亚的卫生和卫生研究并非通过一套明确界定的立法进行监管。虽然该国已制定了一份卫生研究伦理监管文件,但由于缺乏作为一个整体的卫生系统立法,对该文件的遵守情况可能会受到影响。在本文中,我们讲述了卫生、卫生研究和卫生法规的发展情况;我们描述了《国家卫生研究伦理准则》的实施过程和实施程度。我们得出结论,有几个因素会影响伦理准则的实施程度,其中立法是一个重要因素。

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