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University of KwaZulu-Natal

1. Mwaka, Erisa Sabakaki. Stakeholder perspectives on informed consent and ethics review of research involving human specimen resource repositories (biobanks) in South Africa : a quantitative study.

Degree: 2017, University of KwaZulu-Natal

On-going research has made the use of human biological materials and genetic material/data for biomedical research an area of high interest to researchers, bioethicists, philosophers, lawyers and various regulatory bodies. In this era of globalization, there are profound ethical, legal and social implications for the evolving nature of biobank research; these have to be considered during the ethics review process. The main objective of this study was to explore stakeholders’ perspectives of informed consent and ethics review of biobank research in South Africa, with the aim of obtaining information that could contribute to the harmonization of ethical guidelines of the consent process and biobank governance. This was a descriptive cross-sectional study that employed a positivist approach involving qualitative data collection methods. The study was conducted at Stellenbosch University, the University of KwaZulu-Natal, and seven research ethics committees in the KwaZulu-Natal and Western Cape provinces in South Africa. A purposive sampling technique was used to recruit significant stakeholders in biobank research in South Africa. Data was collected using self-administered online survey instruments. Completion of the survey implied consent. Quantitative data were summarized using descriptive summary statistics. Conventional content analysis was used for data collected from open ended questions. The response rate was low; 19 research ethics committee members and 62 researchers and other stakeholders participated in the study. All stakeholders agreed that there is need for functional regulatory frameworks to govern biobank research, particularly the strengthening of research ethics committees, to ensure comprehensive ethics review of biobank-based research. There were several areas of agreement and divergence in respondents’ perspectives on the collection, storage and future use of human biological materials. There was no consensus on the issue of re-consent and the likelihood of donor identification and harm during the use of human biological materials for secondary research. Stakeholders also identified a number of challenges in the ethics review process and the sharing of human biological materials. Generally, the attitude of research ethics committee members, researchers and other stakeholders on informed consent, ethics review of biobank research, and the export and sharing of de-identified HBM is positive and ethically informed. Stakeholders believe that there is need for robust regulatory frameworks to govern the collection, storage, sharing and future use of HBM both within South Africa and across borders. Several recommendations are proposed that could contribute to the harmonization of ethical guidelines on the relevant consent process and biobank governance. Advisors/Committee Members: Horn, Lyn. (advisor).

Subjects/Keywords: Informed consents.; Researchers.; Biobank.; Research Ethics Committees.; Biological specimens.

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6th Edition):

Mwaka, E. S. (2017). Stakeholder perspectives on informed consent and ethics review of research involving human specimen resource repositories (biobanks) in South Africa : a quantitative study. (Thesis). University of KwaZulu-Natal. Retrieved from http://hdl.handle.net/10413/14456

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Chicago Manual of Style (16th Edition):

Mwaka, Erisa Sabakaki. “Stakeholder perspectives on informed consent and ethics review of research involving human specimen resource repositories (biobanks) in South Africa : a quantitative study.” 2017. Thesis, University of KwaZulu-Natal. Accessed September 25, 2020. http://hdl.handle.net/10413/14456.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

MLA Handbook (7th Edition):

Mwaka, Erisa Sabakaki. “Stakeholder perspectives on informed consent and ethics review of research involving human specimen resource repositories (biobanks) in South Africa : a quantitative study.” 2017. Web. 25 Sep 2020.

Vancouver:

Mwaka ES. Stakeholder perspectives on informed consent and ethics review of research involving human specimen resource repositories (biobanks) in South Africa : a quantitative study. [Internet] [Thesis]. University of KwaZulu-Natal; 2017. [cited 2020 Sep 25]. Available from: http://hdl.handle.net/10413/14456.

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

Council of Science Editors:

Mwaka ES. Stakeholder perspectives on informed consent and ethics review of research involving human specimen resource repositories (biobanks) in South Africa : a quantitative study. [Thesis]. University of KwaZulu-Natal; 2017. Available from: http://hdl.handle.net/10413/14456

Note: this citation may be lacking information needed for this citation format:
Not specified: Masters Thesis or Doctoral Dissertation

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