Project Overview
There is very little literature on the perspectives of policymakers and ethicists on improving ethical research during disease outbreaks and epidemics in African countries. Engagement with various relevant stakeholders, including research ethics committees (RECs), policymakers, study communities, and researchers is identified as an important strategy for promoting ethical research, especially during disease outbreaks and epidemics.
In this study, we explored the perspectives of policymakers and research ethics committee members in Nigeria, as well as international bioethics experts on the ethics of conducting research during infectious disease outbreaks in Nigeria. First, we interviewed six policymakers in Nigeria. Second, we held structured discussions with research ethics committee members and experts in bioethics on the findings from the interviews. Third, we synthesized and analyzed these findings.
Our participants reiterated the importance of conducting research during disease outbreaks and emergencies. They highlighted the need for context-dependent research prioritization using a sliding scale and proposed a "System Approach" for research during disease outbreaks and epidemics among other recommendations.
Data and Data Collection Overview
A qualitative study was conducted to explore the ethics of conducting research during disease outbreak situations in African countries. Six Key Informant Interviews (KIIs) were conducted with policymakers and technocrats involved in disease outbreak response in Nigeria. The interviews were conducted between July and August 2018 using a structured interview guide and audio-recorded responses. The KII explored six themes:
systems and structures for facilitating research during infectious disease outbreaks,
availability and competency of local researchers,
regulatory institutions' competence for oversight,
the need for and types of studies,
ethics review approaches during epidemic outbreaks, and
recommendations for integrating research into outbreak response.
The second to fifth themes were further explored in a day-long discussion with bioethics experts in West Africa and internationally. Twelve participants, including research ethics committee members from Nigeria and Liberia, bioethics experts from Geneva, Australia, Cameroon, and Nigeria, and the study investigators, participated in the discussion sessions. The findings were synthesized with those from the KIIs to develop a comprehensive report on the perceptions of policymakers and REC members regarding the ethics of conducting research during disease outbreak situations in African countries.
Shared Data Organization
The project contains one aggregated data file in two formats (.pdf and .xlsx) containing de-identified transcript excerpts from the interviews conducted. Data in it is presented according to the following themes/questions:
Perceptions about [important considerations] Systems and structures in the country now to conduct complex and alternative clinical trial during infectious diseases outbreak like that of Ebola,
Perceptions on the competency of researchers in the country in conducting such complex and alternative clinical trials during infectious outbreak like that of Ebola?,
Competency of regulatory institutions to support complex and alternative clinical trials during such outbreaks?
Steps taken to strengthen the management of infectious disease outbreaks such as Ebola,? And what were the reasons for taking or not taking any measures?,
Perception on the need for research conduct during infectious disease outbreak? If they are necessary, what do you think about that sir?,
Types of research that should be done during disease outbreaks?,
How differently sir should ethics committee approach the review of research studies that are proposed for conduct different studies during an outbreak situation?,
Specific ways to integrate research into outbreak responses and how to ensure it does not interrupt with the response,
Ways to ensure that results from research conducted can inform outbreak responses.
In addition, the following documentation files are also included: the study’s ethics board approval, the informed consent form used, an interview guide, a Data Narrative and administrative README file. |
