Department of Medicine, Neurology Unit, University of Benin, Benin City, PMB 1154, Nigeria.
BMC Med Ethics. 2013 Jan 2;14:1. doi: 10.1186/1472-6939-14-1.
The formulation and implementation of national ethical regulations to protect research participants is fundamental to ethical conduct of research. Ethics education and capacity are inadequate in developing African countries. This study was designed to develop a module for online training in research ethics based on the Nigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedical researchers in Nigeria.
This was a three-phased evaluation study. Phase one involved development of an online training module based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the Collaborative Institutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module for comprehensibility, readability and ease of use by 45 Nigerian biomedical researchers. The third phase involved modification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination of test-retest reliability of the module using Cronbach's alpha.
The online module was easily accessible and comprehensible to 95% of study participants. There were significant differences in the pretest and posttest scores of study participants during the evaluation of the online module (p = 0.001) with correlation coefficients of 0.9 and 0.8 for the pretest and posttest scores respectively. The module also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbach's alpha coefficients of 0.92 and 0.84 for the pretest and posttest respectively.
The module based on the Nigerian Code was developed, tested and made available online as a valuable tool for training in cultural and societal relevant ethical principles to orient national and international biomedical researchers working in Nigeria. It would complement other general research ethics and Good Clinical Practice modules. Participants suggested that awareness of the online module should be increased through seminars, advertisement on government websites and portals used by Nigerian biomedical researchers, and incorporation of the Code into the undergraduate medical training curriculum.
制定和实施保护研究参与者的国家伦理法规是研究伦理行为的基础。在非洲国家，伦理教育和能力不足。本研究旨在根据尼日利亚国家卫生研究伦理规范（NCHRE）开发一个在线研究伦理培训模块，并评估其在尼日利亚生物医学研究人员中的易用性和可靠性。
这是一项三阶段评估研究。第一阶段基于尼日利亚卫生研究伦理规范（NCHRE）开发了一个在线培训模块，并将其上传到协作机构培训倡议（CITI）网站，第二阶段则由 45 名尼日利亚生物医学研究人员评估该模块的理解性、可读性和易用性。第三阶段由 30 名尼日利亚生物医学研究人员对该模块进行修改和重新评估，并使用 Cronbach 的 alpha 确定该模块的测试-重测可靠性。
在线模块对 95%的研究参与者来说易于访问且易于理解。在评估在线模块时，研究参与者的预测试和后测试分数存在显著差异（p=0.001），预测试和后测试分数的相关系数分别为 0.9 和 0.8。该模块还表现出出色的测试-重测可靠性和内部一致性，预测试和后测试的 Cronbach 的 alpha 系数分别为 0.92 和 0.84。
基于尼日利亚规范的模块已被开发、测试并在线提供，是培训在文化和社会相关伦理原则方面的宝贵工具，旨在为在尼日利亚工作的国内外生物医学研究人员提供指导。它将补充其他一般研究伦理和良好临床实践模块。参与者建议通过研讨会、在政府网站和尼日利亚生物医学研究人员使用的门户网站上做广告以及将规范纳入本科医学培训课程来提高对在线模块的认识。
