Using the Emanuel et al. framework to assess ethical issues raised by a biomedical research ethics committee in South Africa.

Journal of Empirical Research on Human Research Ethics : JERHRE
Joyce M Tsoka-Gwegweni, Douglas Richard Wassenaar

Abstract

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 thi...Continue Reading

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Citations

Nov 30, 2018·Journal of Empirical Research on Human Research Ethics : JERHRE·Farirai MutenherwaTulio de Oliveira
Mar 15, 2019·Journal of Empirical Research on Human Research Ethics : JERHRE·Lisa RooneyBirdena Samuel
Apr 9, 2019·Journal of Empirical Research on Human Research Ethics : JERHRE·Peter Cleaton-Jones
Oct 10, 2018·Journal of Empirical Research on Human Research Ethics : JERHRE·Min-Fu Tsan
May 31, 2015·Environmental Health : a Global Access Science Source·Kathleen Ruff
Jan 27, 2019·Journal of Empirical Research on Human Research Ethics : JERHRE·Blessing Silaigwana, Douglas Wassenaar
Sep 13, 2020·Journal of Empirical Research on Human Research Ethics : JERHRE·Min-Fu TsanDaniel E Hall
Dec 14, 2018·Journal of Empirical Research on Human Research Ethics : JERHRE·Holly Fernandez LynchUNKNOWN Consortium to Advance Effective Research Ethics Oversight (AEREO)
Oct 20, 2018·Journal of the International AIDS Society·Catherine SlackPaul Ndebele
Mar 12, 2021·Current Medical Research and Opinion·Khaldoon Aljerian
Jul 29, 2021·Nursing Ethics·Julie Morton

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