Department of Medical Laboratory Sciences, School of Health Science, College of Medicine and Health Sciences, Bahir Dar University, Ethiopia.
Health Biotechnology Division, Institute of Biotechnology, Bahir Dar University, Ethiopia.
Ethiop J Health Sci. 2023 May;33(3):413-422. doi: 10.4314/ejhs.v33i3.4.
Rapid Ethical Assessment (REA) is a rapid qualitative study anticipated to understand the ethical sphere of the research setting prior to recruiting study subjects. This study assessed the communities' knowledge about tuberculosis (TB) and research, understand the social arrangements advisable for recruiting research participant and appraised the information provision and consent process.
The study was conducted in Amhara region, Ethiopia from 5-30 January 2021. Google-based survey, face-to-face in-depth interview and focus group discussion were carried out to collect the data from researchers, data collectors, health professionals, TB program officers. A structured questionnaire was administered to assess the knowledge of TB patients and healthy controls about TB, research, gene, (co)evolution and consent process.
Over 71% of researchers were not satisfied with the current consent process, and 82.7% of researchers agreed that the best interest of the research participants was not adequately addressed in the current research practices in ANRS. TB patients and healthy controls misunderstood research and its goals. Participants advised the researchers to approach the community with the assistance of health extension workers (HEW) or religious/local leaders. Combined use of verbal and written based information provision at individual participant level is the preferred way for information provision.
The adherence of researchers to standard information provision and consent process was very low. Healthy controls and TB patients have low level of knowledge and awareness about research, ethics and genomic research-related common terms. Hence, public education is required to strengthen the research ethics in the region.
快速伦理评估（REA）是一种快速的定性研究，旨在在招募研究对象之前了解研究环境的伦理领域。本研究评估了社区对结核病（TB）和研究的了解，了解了招募研究参与者的适当社会安排，并评估了信息提供和同意过程。
该研究于 2021 年 1 月 5 日至 30 日在埃塞俄比亚阿姆哈拉地区进行。通过基于 Google 的调查、面对面深入访谈和焦点小组讨论收集了来自研究人员、数据收集者、卫生专业人员、TB 项目官员的数据。采用结构化问卷评估 TB 患者和健康对照者对 TB、研究、基因、（共）进化和同意过程的了解。
超过 71%的研究人员对当前的同意过程不满意，82.7%的研究人员同意，在 ANRS 目前的研究实践中，研究参与者的最佳利益没有得到充分考虑。TB 患者和健康对照者对研究及其目标存在误解。参与者建议研究人员在卫生推广工作者（HEW）或宗教/当地领导人的协助下与社区接触。在个人参与者层面上，口头和书面信息提供的结合使用是信息提供的首选方式。
研究人员对标准信息提供和同意过程的遵守程度非常低。健康对照者和 TB 患者对研究、伦理和基因组研究相关术语的了解和认识程度较低。因此，需要进行公众教育，以加强该地区的研究伦理。
