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Health Research Ethics

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Browsing Health Research Ethics by Subject "Compliance with national ethics guidance."

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    Evaluating ethics approval and informed consent in selected online Nigerian medical journals.
    (2021) Alimasunya, Joseph Ethagbe.; Wassenaar, Douglas Richard.
    Overview to this study. This was a quantitative, retrospective study which sought to determine the frequency of research ethics approval and informed consent reporting in selected online Nigerian medical journals. The need to regulate research activities involving human subject participation led to the establishment of Institutional Review Boards (IRBs), also known as Research Ethics Committees (RECs) in most research institutions globally. It is a universal requirement that all biomedical research studies involving human subjects be reviewed by an independent REC/IRB (World Medical Association, 2013). One of the fundamentals of research activities involving human participants, including identifiable human materials, data or information, is the provision for ethical protections. The Declaration of Helsinki (WMA, 2013) clearly states the need for researchers to obtain informed consent from study participants as one of the prerequisites that should be met in the study protocol before approval can be granted by an REC or IRB. Similarly, the Council for International Organizations of Medical Sciences (CIOMS, 2016) in its international guidelines has made provision for the ethical protection of participants involved in biomedical research activities. In recent years there has been an increase in social and biomedical research activities throughout the world, with particular emphasis in developing countries where the disease burden is at its highest (Nyika, Kilama, Tangwa et al., 2009). With the increase in biomedical research activities involving human participants in developing countries, Nigeria is no different; there is an increasing need to publish and disseminate research findings in accessible regional and local journals. Studies have been conducted among some western biomedical and health-related journals to examine compliance with adherence to the Declaration of Helsinki (2013). The International Committee of Medical Journal Editors working in conjunction with numerous biomedical journals have developed guidelines which require that “…when reporting experiments on human participants, authors should indicate whether the procedures followed were in accordance with ethical standards of the responsible committee on human experimentation (institutional and national) and with Helsinki Declaration of 1975, as revised in 2000” (Schroter et al., 2006, p. 718–723). Most countries have developed and adhere to their own national framework for human subject research based on these guidelines (Tangwa, 2004). There are no known empirical studies of Nigerian journals which assess the extent to which regional or national biomedical health related journals report adherence to existing research ethics guidelines; in particular regarding whether REC review and informed consent are expressly mentioned in publications reporting research which involves human participants. A study to evaluate the reporting of research ethics approval and informed consent in articles from samples of biomedical Journals in Nigeria may shed light on their reported compliance with national and international ethics guidance. Using a quantitative approach, a consecutive series of articles from five Nigerian online medical and biomedical journals publications were reviewed for reporting of research ethics approval and informed consent. This study attempts to replicate a study by Schroter et al. (2006).