Ethical issues raised by a Malawian research ethics committee.
MetadataShow full item record
In 2004 Emanuel and colleagues analysed most major existing ethics codes and produced a framework of eight principles and benchmarks to guide Research Ethics Committees (RECs) during review of research proposals. Although the framework was intended for use in all settings, it is not known whether the ethical issues raised by a Malawian REC are compatible with the framework. This study sought to identify the main ethical issues raised during review of research proposals submitted to a Malawian REC and assess their comparability with the Emanuel et al. (2004) principles and benchmarks. Protocol review minutes of 2013 and 2014 meetings were analysed. The minutes contained the concerns that applicants received. Only minutes of newly submitted applications were included in the study. We excluded expedited and continuing reviews, annual reports, protocol resubmissions and reports. During the study period there were 139 protocols for initial submission. In total, the REC raised 1274 concerns. Of these, 88.8% were accommodated or coded using the eight principles of the Emanuel et al. Framework (2004) as follows; scientific validity (38.3%), informed consent (22.1%), independent review (9.3%), collaborative partnership (4.7%), respect for recruited participants (3.8%), social value (3.7%), favourable risk benefit ratio (3.5%) and fair selection of study population (2.9%). Other non-ethical or administrative concerns frequently raised were language errors (9.7%) and inappropriate referencing and plagiarism (2%). Most ethical concerns raised by the Malawian REC were compatible with the Emanuel et al. framework (2004). Scientific design and inappropriate research methods are major concerns raised during protocol review implying that the REC is protecting human subjects from participating in studies that require strengthening of their scientific merit.