An evaluation of ethical concerns raised by a Ugandan Research Ethics Committee using the principles and benchmarks proposed by Emanuel et al. (2008).

Abstract

Research Ethics Committees (RECs) serve several important public functions, including ensuring that research participants are protected in addition to provision of a public forum for the accountability of researchers. As such they are required to follow established national and international standards when they are carrying out protocol reviews. However, there is no standardised model on which to base their reviews. In order to help RECs in their work, Emanuel and colleagues analysed existing ethics codes and produced a framework of eight principles and benchmarks, to give eight principles to guide RECs in the process of reviewing research proposals for ethical issues. However, prior to this study, there was little empirical research into the actual issues that RECs in Uganda raise when reviewing research proposals, leave alone determining whether the issues raised during the review process were in line with those envisaged by the Emanuel and colleagues or not. This study was therefore undertaken to establish the concerns raised during the review of study protocols, using archived minutes of one REC in Uganda. The study analysed the minutes for initial full reviews of protocols for the years 2102 to 2013 using the eight principles and benchmarks proposed by Emanuel and colleagues. Expedited and ongoing reviews were excluded. The results indicated that of 2008 issues raised in the 28 meetings that reviewed the 110 protocols, 90.5% could be accommodated under the eight principles in Emanuel et al. (2008) framework. The most commonly raised issues were scientific validity (54.1%) and informed consent (11.4%). Other additional issues included administrative and feasibility issues at 9.5% and 6.0% respectively. The Emanuel et al. framework provides a useful tool that can be used to categorise the issues and concerns raised during research protocol review meetings of RECs in Uganda. The results further demonstrate that it is possible to use this model to carry out comparative studies to evaluate the review outcomes of RECs in the country and other countries in Africa and the world at large.