Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries (LMICs) and high-income countries (HICs). In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks in LMICs (...) where biobanking activities contributed to the perpetuation of global inequities. We focus on how the ethical imperative to promote the common good during public health emergencies can conflict with protecting the interests of biobank participants. We discuss how conducting biobank research under a waiver of informed consent during public health emergencies is ethically permissible, provided guidance is in place to prevent biopiracy and exploitation of vulnerable communities. We also highlight the need for biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing. Finally, we offer guidance to promote the ethical oversight of biobanks and biobank research during the COVID-19 pandemic or other future public health emergencies. (shrink)

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. 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. 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 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. 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. (shrink)

BackgroundBiobanking 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.MethodsAn 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.ResultsThe 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.ConclusionThe 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. (shrink)

Accessing research participants within some social institutions for research purposes may involve a simple single administrative event. However, accessing some institutions to conduct research on their data, personnel, clients or service users can be quite complex. Research ethics committee chairpersons frequently field questions from researchers wanting to know when and why gatekeeper permission should be sought. This article examines the role and influence of gatekeepers in formal and organisational settings and explores pragmatic methods to improve understanding and facilitation of this (...) process. Conscientious and well-informed negotiations with gatekeepers are required in order to honour the ethical obligations to conduct appropriate stakeholder engagement before and during research, along with respect for the autonomy of institutions and their employees/clients/service recipients. Provision must be made to identify explicit and implicit gatekeepers to initiate and build collaborative networks that could best support the research process. Careful mutually respectful access agreements which consider the needs and vulnerabilities of both the gatekeeper and the researcher can improve the quality of the scientific data collected. Strategic planning in the research process must take these sometimes complex processes of gatekeeper permission into careful account. (shrink)