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加强撒哈拉以南非洲与健康相关研究的伦理委员会:范围综述方案。

Strengthening ethics committees for health-related research in sub-Saharan Africa: a scoping review protocol.

机构信息

King's Centre for Global Health and Health Partnerships, School of Population Health and Environmental Sciences, King's College London, London, UK.

College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.

出版信息

BMJ Open. 2021 Aug 12;11(8):e046546. doi: 10.1136/bmjopen-2020-046546.

Abstract

INTRODUCTION

Health research in low-income and middle-income countries, which face the greatest burden of disease, is a vital component of efforts to combat global health inequality. With increased research, there has also been concern about ethical and regulatory issues and the state of research ethics committees, with various attempts to strengthen them. This scoping review examines the literature on ethics committees for health-related research in sub-Saharan Africa, with a focus on regulatory governance and leadership, administrative and financial capacity, and conduct of ethical reviews.

METHODS AND ANALYSIS

We will use the methodological approach proposed by Arksey and O'Malley and adapted by Levac and the Joanna Briggs Institute. Inclusion and exclusion criteria are based on the 'Population-Concept-Context' framework. Literature (from January 2000 to December 2020) will be searched in multiple databases including Embase and PubMed and websites of relevant organisations. All records will be screened by applying the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review flowchart: two reviewers will independently screen titles and abstracts, and full text of included records. Using an inductive approach, we will synthesise the literature, identify best practice and gaps in evidence on strengthening research ethics committees.

ETHICS AND DISSEMINATION

Ethical approval is not required as the review will include only published literature. The findings will be published in a peer-reviewed journal and presented at stakeholder meetings and conferences.

摘要

简介

在承担着最大疾病负担的低收入和中等收入国家开展卫生研究,是应对全球卫生不平等努力的重要组成部分。随着研究的增加,人们也越来越关注伦理和监管问题以及研究伦理委员会的状况,并尝试了各种方法来加强这些委员会。本范围综述审视了撒哈拉以南非洲与卫生相关的研究伦理委员会的文献,重点关注监管治理和领导、行政和财务能力以及伦理审查的实施。

方法和分析

我们将采用 Arksey 和 O'Malley 提出并经 Levac 和 Joanna Briggs 研究所改编的方法。纳入和排除标准基于“人群-概念-背景”框架。文献(从 2000 年 1 月至 2020 年 12 月)将在多个数据库中进行搜索,包括 Embase 和 PubMed 以及相关组织的网站。所有记录都将按照系统评价和荟萃分析扩展的优先报告项目进行筛选流程图:两名评审员将独立筛选标题和摘要,以及纳入记录的全文。我们将采用归纳方法综合文献,确定加强研究伦理委员会的最佳实践和证据差距。

伦理和传播

由于本综述仅包括已发表的文献,因此不需要伦理批准。研究结果将发表在同行评议的期刊上,并在利益相关者会议和会议上进行介绍。

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