Doctoral Degrees (Centre for Medical Ethics and Law)

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    Developing online educational modules on the ethical, legal and social issues related to biobanking – a resource for clinicians, researchers and research ethics committees in South Africa
    (Stellenbosch : Stellenbosch University, 2022-04) Singh, Shenuka; Moodley, Keymanthri; Cadigan, Jean J.; Stellenbosch University. Faculty of Medicine and Health Sciences. Centre for Medical Ethics and Law.
    ENGLISH SUMMARY: Biobanking practice provides exciting opportunities for scientific advancement through the use and sharing of stored biological material on a rapidly changing global landscape, however the associated ethical, legal and social aspects highlight the need for greater stakeholder awareness and engagement with these issues. The ethical, legal and social issues (ELSI) of biobanking require balancing of individual and community rights and protecting privacy, confidentiality and autonomous decision making as far as possible. Consequently, consent processes and policies on data sharing, return of results, and benefit sharing are important, as is recognition of stakeholder engagement. While much has been documented on the need to recognize the identified ELSI of biobanking from a global perspective, very little focus has been placed on the people involved in the operationalization of biobanking activities or in the oversight of research in this field, namely, researchers, clinicians, biobankers and research ethics committee members. This gap in the literature is further pronounced by a lack of empirical evidence in South Africa on available educational support for the identified stakeholders on the ELSI of biobanking. For this purpose, a short online course on the ELSI of biobanking was developed, using participatory action research. This course is the first of its kind in South Africa. The project involved multiple iterations in the conceptualization, planning, development, and review of the developed educational modules through ongoing engagement with purposively selected study participants who were drawn from identified stakeholder groups (researchers, clinicians, biobankers and research ethics committee members). The study first sought to identify available online educational opportunities on the ELSI of biobanking. Thereafter, the researcher engaged with the identified stakeholders that formed part of the study sample to determine the nature of biobanking in the country, unmet educational needs, and educational priorities in the ELSI of biobanking. The researcher deductively drew up a pre-determined list of educational topics on the ELSI of biobanking and research participants had the opportunity to critique this list and suggest other learning preferences. The short course was developed based on information provided by research participants and through debates presented in the literature. The short course on the ELSI of biobanking comprised five modules. Module 1: Introduction to Biobanking focused on the scope and nature of biobanking as well as the ethical and legal considerations. Module 2: Biobanking Governance covered the principles and need for governance as well as access to biosamples and data; biosafety and biosecurity. Module 3: Consent Models and Confidentiality focused on the ethical and legal dimensions of the informed consent process within the South African setting. Module 4: Sample and data sharing explored the scope and nature of collected data and samples. Module 5: Stakeholder engagement, benefit sharing, and return of results highlighted the need to recognize the various stakeholders involved in biobanking and to engage in issues such as benefit sharing; and return of results to biobank participants. The short course included an online assessment to determine learner competence. This dissertation argues that for educational learning opportunities to be successful, they must be relevant, appropriate and meet the needs of the stakeholders. Research participants in this study were drawn from biobanking related settings in South Africa and had multiple opportunities to review and critique the developed modules, thereby ensuring that a real-world perspective was provided on the applicability of the educational course to local settings. Additionally, the dissertation highlights that given the hands-on nature of biobanking practice, such educational courses need to be integrated into other learning opportunities and skills development. These could include online and face-to-face contact learning as well as practical skills development. Some recommendations are also made, such as ensuring that the developed educational course is reviewed and updated regularly so that the course remains relevant and appropriate for the identified stakeholders. There is a need to also ensure ongoing Information Technology (IT) support for the biobanking course so that technology-related challenges are addressed and rectified immediately. Additionally, the time allocation for learners to complete the short course should be extended from four weeks to eight weeks to ensure that these learners have adequate time to engage with the learning activities. Future research efforts should include further engagement with other stakeholders such as local communities to ascertain their learning needs related to biobanking practice, to ensure that other unmet learning needs in biobanking are addressed.