Using the Emanuel et al. Framework to Assess Ethical Issues Raised by a Biomedical Research Ethics Committee in South Africa

Bibliographic Data

ID12807580
AuthorsJoyce Mahlako Tsoka-Gwegweni (0000-0002-4888-1973, Stellenbosch University, corresponding author), Douglas Wassenaar (0000-0003-0839-9231, University of KwaZulu-Natal)
Year2014
Volume9
Issue5
Pages36-45
Publication date2014-10-13
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueJournal of Empirical Research on Human Research Ethics (JOURNAL)
Journal identifiersISSN: 1556-2646 • E-ISSN: 1556-2654
PublisherSAGE Publishing (PUBLISHER • US)
DOI10.1177/1556264614553172
PMID25747689
OpenAlexW2108883470
LanguageEN
Citations received23
References cited25

The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC

Alternative medicine · Engineering ethics · Ethics committee · Informed consent · Normative · Pathology · Political science · Protocol (science · Psychiatry · Research ethics · Weighting · Biomedical Ethics and Regulation · Ethics in Clinical Research · Ethics in medical practice · Law · Medicine · Psychology

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