Documentation of ethical considerations in published articles in Sudanese medical journals

Abstract

Abstract:
Introduction: Guidelines for Biomedical Research Involving Human Subjects require that research should be conducted in accordance with ethical principles. The International Committee of Medical Journal Editors guidelines have required authors to indicate ethics and approval and informed consent. Sudanese scientific medical journals require authors to declare in their published reports informed consent and ethical approval by ERC.
Methods: We reviewed original research articles published in five Sudanese peer review medical and health journals to examine reporting ethical considerations.
Results: A subtitle on "ethical considerations" occurred in 5 (4.3%) articles. Obtaining informed consent from study participants was documented in 35 (30.7%) articles. Thirteen (11.4%) articles admitted that the study was approved by independent ERC. Although all five journals explicitly ask authors to document ethical approval and informed consent, 88.6% and 69.3% of the examined articles failed to document ethical approval and informed consent respectively.
Discussion: Failure to obtain or report obtaining ethical approval by ERC and informed consent from study participants was the most prominent finding in this study. Our study revealed that failure to report ethical approval or consent was equal in all study designs reported by authors, so there were no differences in reporting ethical consideration regarding different study designs. Failure to document ethical consideration, ethics committee approval and obtaining informed consent in particular, do not necessarily mean that these procedures did not take place in the reviewed research.
Limitations: We reviewed only Sudanese journals therefore we are not aware of how Sudanese authors behaviour in international scientific journals.