The ethics of research involving biobanking specimens from Kenyan children and adolescents living with HIV: discrepancies between individual perceptions and policy considerations

Biobanking is common in research involving young people living with HIV (YPLHIV). The ethics and policies guiding this practice require careful consideration, especially given the population’s multiple vulnerabilities, like age, HIV status, and limited resources. We examined how well the perspectives of YPLHIV and other stakeholders are reflected in current policies in sub-Saharan Africa, aiming to inform more ethically grounded policy development for specimen biobanking. We conducted a review of biobanking-related policy documents from sub-Saharan Africa, primarily from the East African region, and compared them to qualitative findings from interviews with YPLHIV in western Kenya, their caregivers, and subject matter experts (SMEs) regarding perspectives on biobanking. We synthesized the policy and interview data to identify key similarities, differences, and gaps. Themes were organized into three main categories related to biospecimens: (1) collection and analysis, (2) storage and identification, and (3) testing and sharing. Interviews were conducted with 99 participants – 40 YPLHIV, 20 caregivers, and 39 SMEs (community leaders, healthcare providers, clinical researchers, social scientists, international research experts, and laboratory experts). Participants across all groups stressed the importance of informed consent, results dissemination, confidentiality, transparency, and secure storage. Additional themes included concerns about long-term storage, unauthorized use, sharing with ill-intentioned individuals, requests for participant benefits, expressions of trust in researchers, and disagreement over using identifiers in biospecimen labeling. Interview themes were reflected to varying degrees in policy documents. Our policy search revealed articles from 12 countries, published between 2004 and 2023. All countries addressed consent and confidentiality (n = 12) and most covered results dissemination (n = 11) and biospecimen sharing (n = 9); fewer addressed participant benefits (n = 4), labeling (n = 4), and direct guidance on use, location, and duration of storage (n = 4). Some gaps between stakeholder views and existing policies were evident. Perceptions of research involving biobanking among African YPLHIV were mixed, revealing inconsistencies in participants’ responses, and highlighting gaps between these perceptions and existing policies, which were often limited, outdated, and incomprehensive. Findings highlight the need for clear, timely and inclusive policy updates that reflect stakeholder input, particularly as research involving this vulnerable population continues.