Browsing by Author "Singh, Shenuka"
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- ItemDeveloping 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.
- ItemIt’s all about trust : reflections of researchers on the complexity and controversy surrounding biobanking in South Africa(BioMed Central, 2016) Moodley, Keymanthri; Singh, ShenukaENGLISH SUMMARY : Background: Biobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented. Methods: In-depth qualitative interviews were conducted with a purposive sample of 21 researchers – 8 in the Western Cape, 3 in Gauteng and 10 in Kwa-Zulu Natal. Interviews lasted approximately 40–60 min and were audiotaped with consent. Thematic analysis of the transcribed interviews was conducted by the co-authors. Results: Researchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks. Given that biobanks differ considerably, guidelines and RECs need to stratify risk accordingly and governance processes and structures must be flexible. While RECs were regarded as an important component of the governance structure researchers expressed concern about their expertise in biobanking. Operational management of biobanks was regarded as an ethical imperative and a pre-requisite to building trust during consent processes. While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust. Material Transfer Agreements (MTAs) were often lacking when biosamples were exported and this was perceived to impact negatively on trust. On the other hand, researchers believed that authentic community engagement would help to build trust. Conclusion: Building trust will best be achieved via a system of governance structures and processes that precede the establishment of a biobank and monitor progress from the point of sample collection through to future use, including export. Such governance structures must be robust and must include comprehensive national legislation, policy and contextualised guidelines. Currently such governance infrastructure appears to be lacking in many African countries including South Africa. Capacity development of all stakeholders including REC members will enhance expeditious and efficient review of biobanking protocols which in turn will reinforce trust in the researcher-donor relationship. Science translation and community engagement in biobanking is integral to the success of biobanking in South Africa.
- Item"It’s all about trust" : reflections of researchers on the complexity and controversy surrounding biobanking in South Africa(BioMed Central, 2016) Moodley, Keymanthri; Singh, ShenukaBackground: Biobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented. Methods: In-depth qualitative interviews were conducted with a purposive sample of 21 researchers – 8 in the Western Cape, 3 in Gauteng and 10 in Kwa-Zulu Natal. Interviews lasted approximately 40–60 min and were audiotaped with consent. Thematic analysis of the transcribed interviews was conducted by the co-authors. Results: Researchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks. Given that biobanks differ considerably, guidelines and RECs need to stratify risk accordingly and governance processes and structures must be flexible. While RECs were regarded as an important component of the governance structure researchers expressed concern about their expertise in biobanking. Operational management of biobanks was regarded as an ethical imperative and a pre-requisite to building trust during consent processes. While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust. Material Transfer Agreements (MTAs) were often lacking when biosamples were exported and this was perceived to impact negatively on trust. On the other hand, researchers believed that authentic community engagement would help to build trust. Conclusion: Building trust will best be achieved via a system of governance structures and processes that precede the establishment of a biobank and monitor progress from the point of sample collection through to future use, including export. Such governance structures must be robust and must include comprehensive national legislation, policy and contextualised guidelines. Currently such governance infrastructure appears to be lacking in many African countries including South Africa. Capacity development of all stakeholders including REC members will enhance expeditious and efficient review of biobanking protocols which in turn will reinforce trust in the researcher-donor relationship. Science translation and community engagement in biobanking is integral to the success of biobanking in South Africa.
- ItemStakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa(BioMed Central, 2021) Singh, Shenuka; Moodley, KeymanthriBackground: Biobanking provides exciting opportunities for research on stored biospecimens. However, these opportunities to advance medical science are fraught with challenges including ethical and legal dilemmas. This study was undertaken to establish perspectives of South African stakeholders on the ethico-legal dimensions of biobanking. Methods: An in-depth exploratory study was conducted with 25 purposively selected biobankers, clinicians, researchers, postgraduate students in biobanking research, and research ethics committee (REC) members in South Africa. Potential study participants were recruited through known hubs for biobanking in the country, online searches and the snowball sampling technique. A semi-structured face-to-face or Skype interview was arranged. Data was analysed using thematic analysis. Results: The emergent themes included: inconsistency in understanding consent models, disconnect between biobank researchers and biosample donors, inadequate processes to support re-consenting minors, inconsistent governance processes for biobanking research; challenges with sample and data sharing, and suboptimal strategies for benefit sharing and return of results. Biobanking practice in general appeared to be inconsistent and fragmented. While the need for consent in research is explicitly outlined in legislative documents, some respondents were unclear on the type of consent model to apply in biosample collection. They also reported inconsistencies in research participants’ understanding of consent. Furthermore, these respondents’ own understanding of consent and consent models were dependent on where they were positioned in biobanking practice (roles occupied). Respondents were unsure about the process to follow to re-consent child participants once the age of majority (≥ 18 years) was reached. It was not surprising that consent was identified as one of the major ethical challenges in biobanking practice. In certain settings, some respondents reported suboptimal governance processes for sample collection. Participants were generally unsure about how to operationalise benefit sharing and how to approach the idea of returning results to research participants and biobank donors. Conclusion: The study findings indicated inconsistencies in stakeholder understanding of ethico-legal considerations related to biobanking in South Africa. A need for ongoing ethics capacity development among stakeholders was identified. Improving understanding of the ethics of biobanking could be facilitated by acknowledging the disconnect created by biosamples in the relationship between biobank researchers and donors.