From Archetypes to Access: A Two-Axis Governance Framework and Decision-Support Tool for Rare Specimen Biobanking.

INTRODUCTION: Biobanks fulfill their scientific and ethical mandates when collected specimens are used effectively. Access policies govern researcher eligibility, allocation, oversight, and intellectual property (IP) considerations. Despite their importance, access policies vary substantially and lack a unifying practical framework. OBJECTIVES: We sought to identify commonalities and areas of under-specification across access policies in surgically oriented, pediatric, and/or national biobanks to describe real-world practices and develop a typology of rare biospecimen governance. METHODS: We conducted a targeted scoping review of access policies from 32 biobanks identified from the Biobank Resource Centre Biobank Locator, with 19 providing sufficient governance information (59% response). Responses were coded using 10 domains researcher eligibility, oversight, allocation rules, data/sample coupling, industry access, fees, reporting, authorship, unused sample handling, and IP. Descriptive statistics and comparative analysis were used to identify patterned co-variation. A large language model (ChatGPT and OpenAI) was used to organize coded attributes and generate potential governance typologies, which were refined and verified by the authors. RESULTS: Governance attributes clustered along two conceptually distinct dimensions Access Orientation (facilitative vs. stewardship-oriented) and Allocation Logic (procedurally neutral vs. strategically prioritized). Their interaction produced four corresponding governance archetypes: Academic Commons, Rare Specimen Stewardship, Investigator-Led Facilitation, and Protected National Strategic Asset. Unused sample handling and IP were the most frequently under-specified domains. No novel structural configurations emerged after 13 cases. CONCLUSION: Access policy variations reflect coherent governance orientations that reveal differing institutional priorities and conceptions of the biobank's role in research facilitation and stewardship. By articulating two analytic axes and four archetypes, we provide a practical framework for interpreting policy differences across biobanks and identifying areas of under-specification. New and evolving biobanks can use this typology to align policies with their mission, scarcity constraints, and ethical obligations, supporting transparent decision-making and responsible and effective use of research specimens.