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Health Research Ethics

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Browsing Health Research Ethics by Subject "Ethical issues."

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    An evaluation of ethical concerns raised by a Ugandan Research Ethics Committee using the principles and benchmarks proposed by Emanuel et al. (2008).
    (2020) Kirimuhuzya, Claude.; Wassenaar, Douglas Richard.
    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.
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    An evaluation of the ethical concerns of a South African Research Ethics Committee using the principles and benchmarks proposed by Emanuel, Wendler, Killen and Grady (2004): Evaluating 2017–2018 minutes.
    (2022) Sithole, Khutso.; Mamotte, Nicole.
    Historical ethical transgressions in research with human participants led to the development of ethical principles and guidelines to protect research participants. Research Ethics Committees (RECs) then emerged to further protect the rights of research participants and alert the researcher to the need to ensure compliance with legal requirements for research. (Silaigwana & Wassenaar, 2015). This study aimed to identify ethical issues raised during ethics review of research protocols and assess their relative weight using the Emanuel et al. (2004) recommended principles for ethical review of clinical research. The 2017–2018 meeting minutes of a South African Social Science Research Ethics committee were identified, accessed and coded using the eight principles and benchmarks of the Emanuel et al. (2004) framework. This allowed observable patterns in ethical concerns raised during ethics review of research protocols to be recorded. A total of 20 REC meeting minutes entailing 176 submitted protocols in 2017 and 2018 were purposively included in the study sample. Content analysis was used to analyse the data in terms of the Emanuel et al. (2004) framework. The data obtained during content analysis was captured using Microsoft Excel and analysed using frequency counts and simple descriptive analysis. The study found that the most frequently raised ethical issues were around informed consent (n=300; 35%). The remaining principles were ranked as follows: scientific validity (n=159; 18%), fair selection of participants (n=122; 14%), independent reviews (n=76; 9%), ongoing respect of participants (n=71; 8%), risk-benefit ratio (n=41; 5%), collaborative partnership (n=35; 4%) and social value (n=31; 4%). The study further revealed that the Emanuel et al. (2004) framework was useful in identifying and categorising the questions and concerns typically raised by the study REC during protocol review, with only a small number of queries not fitting into the framework. The framework provides a method and logical process to conduct further comparative analyses of RECs’ concerns and can be used as a standard tool for REC members when reviewing protocols (Emanuel et al., 2004).