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Health Research Ethics

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Browsing Health Research Ethics by Author "Mamotte, Nicole."

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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).
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    How do Kenyan research fieldworkers conceptualize the consenting process? implication for training in health research ethics.
    (2017) Kombe, Francis Kazungu.; Mamotte, Nicole.
    Fieldworkers are an important cadre of research staff due to the critical roles they play in health research not just in Africa but globally. In Africa, most international research centres employ fieldworkers to provide support in seeking informed consent; collecting basic samples and maintaining good relationships with communities involved in research. Seeking informed consent is an especially important role. It does not only ensure the promotion of autonomy for those involved in the research but has an important implication on the quality and reliability of data collected from research participants. According to most international ethical guidelines, ensuring potential research subjects voluntarily participate in research after fully understanding all key elements of the research they are involved in is essential. Although research in most international research centres is overseen by highly qualified and renowned researchers and scientists, the influence of fieldworkers, who are the cadre of health research staff involved in the day to day operationalization and ground application of this important ethical principle, has received little focus and continues to be understudied. Understanding how fieldworkers conceptualize the informed consent process can provide important insight on fieldworkers’ ethical practices and how ethical guidelines are operationalized on the ground. We conducted four Focus Group Discussions (FGDs) with health research fieldworkers and eight In-depth Individual Interviews with field managers/supervisors at the Kenya Medical Research Institute (KEMRI-Wellcome Trust Programme (KWTRP) to develop an in-depth understanding of how this cadre of staff conceptualize the process of informed consent. Data were captured using digital recorders and transcribed before being analyzed thematically. The results indicate a good understanding of health research for both fieldworkers and field managers. The relationship between KWTRP and the community was described to be of mutual benefit sharing, with the community benefiting from new interventions and improved health care while KWTRP got research subjects from the community. Informed consent was described as an important part of getting people to participate in research voluntarily. There was, however, some mixed attitude and perceptions regarding the value and key elements of the informed consent process. Several factors were said to influence informed consent process, including the environment where consenting was done, recruitment targets, support and supervision and the training that was given to fieldworkers. Fieldworkers perceived their work as critical in health research. However, lack of recognition, capacity building and clear approaches for professional development affected their motivation and attitude about their roles. The findings support the need for further research to identify specific mechanisms for supporting fieldworkers to undertake their roles more effectively.