Biobanks in the low- and middle-income countries of the Arab Middle East region: challenges, ethical issues, and governance arrangements-a qualitative study involving biobank managers.

ABSTRACT

BACKGROUND: Biobanks have recently been established in several low- and middle-income countries (LMICs) in the Arab region of the Middle East. We aimed to explore the views of biobank managers regarding the challenges, ethical issues, and governance arrangements of their biobanks. METHODS: In-depth semi-structured qualitative interviews were conducted with a purposive sample of eight biobank managers from Egypt (6), Jordan (1), and Sudan (1). Interviews were performed either face-to-face, by phone, or via Zoom and lasted approximately 45-75 min. After verbal consent, interviews were recorded and then transcribed. The authors performed a thematic analysis of the transcripts independently and then integrated the themes via a consensus process. RESULTS: Biobank managers discussed the main challenges in establishing their biobanks. These included the staff's lack of experience and training, limited funds, deficit awareness of biobanks, obtaining funding from different sources. Only four reported they were active in distributing biospecimens and health data to researchers. Six biobanks used a broad consent model, one used tiered consent, and another allowed participants to opt-out of being recontacted. Five managers avoided partnerships with pharmaceutical companies due to concerns with unfavorable reactions from the community. Five managers did not have clear policies for returning research results to the donors. Five expressed challenges with sample and data sharing with international collaborators; all five used material transfer agreements. The biobank managers revealed variable governance arrangements and activities with community involving awareness and educational efforts rather than active engagement. Several expressed the importance of transparency with the operations of their biobanks and gaining the trust of their stakeholders. CONCLUSION: Managers of biobanks in LMICs in the Arab Middle East encounter financial, operational, and social challenges toward their sustainability efforts. Discussions with key stakeholders are warranted to manage ethical issues involving informed consent, privacy, data sharing, and the return of results. We recommend that biobank managers in the Arab Middle East form collaborative networks within the region and internationally, develop trusting governance relationships with their stakeholders, and pursue engagement activities with their communities to enhance trust.