Development and pilot testing of an online module for ethics education based on the Nigerian National Code for Health Research Ethics

Abstract

BackgroundThe 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.MethodologyThis 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.ResultsThe 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.ConclusionThe 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.

Strengthening stakeholder engagement through ethics review in biomedical HIV prevention trials: opportunities and complexities

“…Both might benefit from training that highlights engagement as a legitimate focus of ethics review [35]. This might complement existing research ethics modules [36][37][38][39][40][41] developed by several institutions [42][43][44][45][46][47][48] that highlight practical skills using interactive features [36,39,41,[49][50][51][52][53][54][55][56]. This might also complement existing modules featuring engagement as a key part of ethical research (FHI 360) [46]; of ethical HIV vaccine trials, of ethical adolescent trials, and of public health research (TRREE) [42].…”

Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision

“…Indeed, such occurences are likely to be rare with appropriate educational support, as clinical populations of all types can demonstrate knowledge of informed consent information when given such support (Nishimura et al, 2013) including clinical trial participants with cognitive impairments due to conditions such as schizophrenia-related psychosis (Wirshing, Wirshing, Marder, Liberman, & Mintz, 1998). Nevertheless, more research speaking to this point would help inform future investigators in planning for using consent quizzes in this manner.…”

“…To achieve this, researchers must disclose relevant information, including information about risks, potential benefits, alternatives, and the nature of research, and ideally participants should understand the disclosed information. However, studies show that these ideals are imperfectly achieved across a variety of conditions (Nishimura et al, 2013; Tam et al, 2015). …”

Policy Uncertainty, Sequencing, and Cell Lines

“…Much of the relevant media coverage associated with the Skloot book touched on specific issues of consent and ownership, as noted by Nisbet and Fahy in their interesting analysis of the significant popular culture response (Nisbet and Fahy 2013). The implied message seemed to be, rightly or not, that individuals should retain some degree of control over biological specimens that are removed from their bodies.…”

“…The best-selling book by Rebecca Skloot, The Immortal Life of Henrietta Lacks (Skloot 2010), detailed both the creation of the cell line and the associated ethical and social controversies. The Skloot book received a great deal of praise and media attention–which often used the book to surface a range of ethical issues associated with biomedical research (Nisbet and Fahy 2013). The recent sequencing and publication of the genome of one HeLA cell line (Landry et al , 2013) has further intensified public attention on the circumstances surrounding the Lacks case and the associated ethical challenges, particularly in relation to ownership and control of samples and data (Skloot 2013).…”