Reporting of Research Ethics Committee approval and participant consent in South African biomedical journal articles (2007-2018).

Abstract

The commencement of a study involving human participants may only happen when the study has been approved by a registered research ethics committee and when consent of participants has been obtained. Most biomedical journals require confirmation of this requirement by authors in their publication of research results, not just as a mere formality, but as a culmination of a long process and careful attention to every step and detail in the process. This is an ethical requirement that guides researchers throughout the world. For example, the Declaration of Helsinki (2013), despite its numerous revisions and adjustments, is clear on this point, as are current South African ethics guidelines (Department of Health, 2015). The issue of obtaining informed consent from prospective participants does not just lead to the signing of the document but should also reflect that all processes that are meant to safeguard rights of prospective participants are not compromised in any way. Publishing authors are expected to report those details in their articles but the frequency of such reporting in South African health research articles remains unclear. Reporting and publication of studies in peer-reviewed journal articles, does not only communicate findings of the study but it is also a source of information for judging the ethical quality of the study. Publications are assessed by various audiences such as peer researchers, sponsors, policy makers and industry practitioners. All these audiences apply different criteria in assessing the information, as some material might be considered less significant than others, depending on the needs of the audience. This factor should be taken into consideration during article reviews. The study is aimed at exploring whether authors of South African biomedical journal articles mention research ethics approval and informed consent in their research publications and explores whether there were any temporal changes in such reporting between 2007 and 2018.