We aimed to identify prioritized actions, tools, and responsibilities necessary to establish a functional and FAIR-VBS. Specifically, our objectives were to develop actionable, consensus-based recommendations for building and maintaining an inclusive, diverse, and equity-driven FAIR-VBS and to generate ongoing findings as the project evolves to ensure continued alignment with stakeholder needs and global priorities.

The research team collected information from professional contacts and organizations; conducted surveys and interviews [1]; held workshops; searched the literature; set up websites; and connected with others in the field, including biorepository experts, public health practitioners, policymakers, industry leaders, funders, students, and members of the public. The research team conducted internal audits to systematically evaluate the effectiveness and alignment of its activities with the project’s goals. These audits reviewed the outcomes of workshops and stakeholder engagements, assessed gaps in the literature and expert input, and identified actionable next steps [1]. Through this reflective process, we deliberated and concluded that an online Delphi process could offer a practical approach to bridge cultural, linguistic, and geographical divides; foster autonomous local consensus [11]; and ensure cost-effectiveness [12]. Figure 1 shows the timeline for FAIR-VBS and the steps we used to prepare for the Delphi process.

The Delphi method is a structured, iterative communication tool designed to facilitate consensus-building, forecasting, or shared decision-making. Through a series of rounds, whether delivered onsite or by using virtual survey software, respondents evaluate and prioritize presented questions, typically participating in at least 2 rounds [9]. The Delphi method was offered online through a secure interface. After each round, participants received an anonymous summary of the group’s input, enabling them to refine and prioritize their previous responses based on others’ feedback. This iterative process narrows the range of variation until common ground is reached. The underlying principle is that structured group input yields more accurate and actionable results than unstructured discussions [6].

The Delphi development was guided by an advisory group specializing in infectious diseases, diagnostic manufacturing, and research methodology. The advisory group provided strategic oversight for the study design and its implementation. The advisory group and the researchers, together, formed the steering group to make decisions for the process. To ensure clarity, the Delphi questions were also reviewed by graduate students and advocates.

Fifty-seven respondents were recruited using snowball sampling to ensure a diverse and inclusive panel. Stakeholders included public health experts, researchers, clinicians, community members, policymakers, regulators, and industry representatives, as well as respondents from 6 continents.

The Delphi process comprised 2 rounds, with each round serving a distinct purpose in the development and evaluation of the items:

A consensus was reached after 2 rounds, and the results were reviewed and accepted by the advisory group. All results, including respondent comments with identifiers removed, were compiled and shared with participants. Consensus was defined as at least 70% of responses rating an item 4 or higher and no more than 15% rating an item below 2 on a 1 to 5 scale.

The responses were scored and prioritized using a Likert scale, with a 5-point format [14]. Respondents rated their level of agreement with each statement, with higher scores reflecting stronger agreement. This approach enabled a nuanced understanding of consensus among experts participating in the Delphi process. To further enrich the findings, qualitative content analysis was conducted. Five researchers (AP, LA, MC, JG, and JP) independently reviewed and categorized the textual responses provided by respondents, identifying themes, key concepts, and recurring opinions [6,12]. They reached a consensus on these interpretations, and the deidentified comments and analysis were presented to the steering group and then to the respondents. This contextual guidance informed the development of round 2 [15].

This method proved valuable in assessing how consensus evolves by considering levels of agreement or disagreement expressed in the comments alongside quantitative data, such as mean ratings or consensus thresholds. The analysis and all deidentified feedback were shared with respondents after the first and second rounds, fostering transparency and enabling a reflective and shared understanding of the group’s perspectives. All respondents and the steering group were presented with round 2 results. Following the Delphi rounds, a consensus conference was held via videoconferencing with the advisory group to finalize recommendations and define key next steps.

Ethical approval was obtained from the University of Oxford Central University Research Ethics Committee (CUREC; application reference number R58550/RE001 [16]). Informed consent was secured from all participants through a secure digital informed consent process. Contributors to the research, at their discretion, could be named as coauthors in the publication while maintaining the confidentiality of their data. To maximize transparency while maintaining participant privacy, all quantitative metrics and descriptive textual feedback were completely deidentified and anonymized prior to steering group appraisal and round-to-round dissemination. No participant compensation or financial incentives were provided for completion of the Delphi survey panels. Authors disclosed competing interests in accordance with ICMJE (International Committee of Medical Journal Editors) guidelines [17]. All data were securely stored online with restricted access limited to project-dedicated personnel.

Invitation letters, recruiting materials, forms, and Delphi questions were piloted by volunteers internally and externally. The CHERRIES (Checklist for Reporting Results of Internet E-Surveys [18]) guideline was used to structure and report the survey aspects of the study. The ACCORD (Accurate Consensus Reporting Document) was used to guide our methods for reporting the Delphi process [15].

The respondents and the authorship team spanned multiple continents and brought diverse perspectives to the study. This included partners and stakeholders with an interest in the FAIR-VBS, some of whom had personal experiences during the COVID-19 pandemic. Additionally, the study engaged research, public health, and medical students, as well as members of the public, all of whom actively contributed to the study design, protocol development, Delphi question testing, data analysis, and manuscript coauthorship.

The FAIR-VBS research will be shared with repository groups; policymaking agencies; regional, national, and international conferences; government agency briefing sessions; the WHO BioHub; social media sites; and on the institutional websites of coauthors and members of our advisory group. Results will be open access and publicly available with a DOI. They will be shared with all respondents ahead of publication.

The Delphi process evaluated a cumulative total of 34 unique items across 2 operational rounds to identify critical gaps and priorities in biorepository systems. Over the entire life cycle of the study, a final system consensus was achieved for 24 out of 34 items, while 10 items overall did not meet the consensus criteria.

In round 1, the questionnaire evaluated 30 initial items, with 22 successfully meeting the consensus threshold. During this exploratory first round, panel participants organically proposed 4 additional items. These 4 new items were refined and presented to the cohort in round 2, where 2 achieved full consensus. These late-consensus items explicitly addressed institutional benefit-sharing challenges (11/15, 73% agreement) and the prioritization of whole blood, plasma, and serum samples (40/42, 95% agreement; Tables 1 and 2; Figure 3).

We analyzed and summarized comments for both rounds in our qualitative analysis. For both rounds, we presented respondents with the quantitative responses and the comments from respondents. The items below are those that reached consensus by percentage. All detailed results including all deidentified, comments numbers or percentages, and items that did not reach consensus, are available in Multimedia Appendix 1.

Panel participation followed a fluid, noninterfering sequential format. A total of 57 experts were enrolled in the initial snowball cohort. While overall survey round retention was tracked via secure login tokens, individual item denominators naturally varied across the 2 tables (ranging from n=15 to n=47). Because participants completed the panels autonomously, they frequently skipped highly technical or localized subquestions where they felt they lacked specific institutional or geographic expertise. Rather than introducing arbitrary data noise, this organic respondent flow ensures that the final consensus statistics strictly reflect the uncoerced input of qualified domain experts. Pairwise deletion was used to handle missing variables, maintaining data precision for each discrete question (Tables 1 and 2).

To ensure thematic integrity, a collaborative, multicoder qualitative content analysis was integrated into the iterative Delphi rounds. Textual data from the open-comment fields were evaluated independently by a core coding team of 5 researchers (AP, LA, MC, JG, and JP). The team used a consensus-driven coding framework centered on our 3 target domains: specimen prioritization, structural barriers, and resource sustainability. All researchers had current ethics training and practice and received further instruction on Delphi method coding in compliance with ACCORD guidelines.

To prevent steering group bias or top-down paternalism, discrepancies in theme categorization were resolved through a formal reconciliation process where a team agreement threshold of 100% was required before a code was finalized. This qualitative engine served a strict procedural purpose between rounds: when an item failed to achieve quantitative consensus in round 1, its associated open-text codes were systematically used to uncover semantic ambiguities. The steering group then used these exact participant insights to structurally rephrase the items for clear evaluation in round 2, guaranteeing that the subsequent consensus rounds strictly reflected uncoerced, organic stakeholder intent. All comments were deidentified and shared with all participants in the form in which they were written to reduce unintentional bias. Please note that these comments may contain perceptions that are not representative of consensus. This is common in emergent fields and is helpful in finding unintentional pain points, biases, and errors.

The Delphi method revealed a rich tapestry of insights about the potential of a FAIR-VBS. The enthusiasm among respondents not only highlighted the transformative possibilities but also brought to light critical areas that must be addressed to ensure its success. One of the most striking benefits of the FAIR-VBS lies in its ability to foster international collaboration. Respondents expressed optimism about how the system could break down traditional barriers in sample sharing, facilitate meaningful cross-border partnerships, and provide opportunities for training and capacity building. This is particularly exciting for underresourced regions, where the FAIR-VBS could play a pivotal role in reducing disparities and promoting equity in global health research [1].

A key strength of the system lies in its ability to connect users with biorepository expertise. By aligning operations with international standards and developing standard operating procedures with quality requirements [22], the FAIR-VBS can elevate the reliability of biospecimen management for infectious disease research worldwide. Respondents envisioned a future with the FAIR-VBS as a cornerstone for consistent, high-quality international research.

Nevertheless, this vision comes with its challenges. A notable emergent theme was the regulatory knowledge gap across countries, highlighting the need for codeveloped resources to align understanding of local and national regulations. This is particularly relevant to the application of benefits under the Nagoya Protocol, as outlined in the Convention on Biological Diversity, which specifies explicit requirements for signatory countries [21]. While this lack of shared knowledge could hinder cross-border collaborations, it also offers an opportunity to develop a system that addresses these gaps through accessible guidance and coproduced documentation.

Concerns about infrastructure and resource limitations were prominent in the discussions. Stable power supplies, reliable storage solutions, and contingency plans for system failures are essential for maintaining sample integrity [22]. Sustainable funding models were another area of concern, as respondents noted the challenges of securing long-term financial support for infrastructure, supplies, and personnel. These issues underline the importance of a robust operational foundation to support the FAIR-VBS’s goals.

Logistics posed another layer of complexity, particularly considering past experiences during outbreaks. Shipping delays, high costs, and cumbersome regulations were frequently cited as barriers that needed to be addressed. Respondents called for innovative solutions to streamline these processes, ensuring that the movement of specimens is both timely and cost-effective.

The discussions also explored the unique difficulties of operating in conflict zones or disaster-stricken areas. Strategies to improve access in such environments, such as establishing proxy centers, were proposed as potential solutions to ensure inclusivity and equity.

Ethical considerations emerged as a critical theme, with respondents advocating for careful negotiation of broad consent frameworks [23]. The balance between enabling research and respecting participants’ rights was a shared priority, with consensus around the need to limit consent to intended uses and avoid misuse by third parties [23]. Another area of concern was the power dynamics inherent in global collaborations. Smaller biorepositories often face challenges in negotiating on equal terms with larger entities, highlighting the need for governance structures that prioritize fairness and inclusion. Similarly, the importance of equitable benefit-sharing was universally acknowledged, though the variability in challenges across regions pointed to the complexity of designing solutions that work for everyone.

Finally, questions about data and sample quality underscored the importance of consistency and rigor. Ensuring accurate clinical data, maintaining high diagnostic standards, managing samples effectively, and providing timely reference materials were seen as vital to the FAIR-VBS’s success [24]. These discussions point to a powerful vision for the FAIR-VBS, one that could transform global health research by promoting collaboration, equity, and innovation. Innovations in safe and secure storage materials that are free of expensive ultralow cold storage could alleviate costs for power, equipment, and shipping. Yet, the path forward requires thoughtful, inclusive strategies to address the challenges and ensure the system’s benefits are accessible to all. By fostering transparency, sustainability, and shared ownership, the FAIR-VBS has the potential to become a model for how global health infrastructure can evolve to meet the needs of an interconnected world.

The first Delphi round found broad support for a combined biorepository model, incorporating federated standards with local governance to optimize standardization and agility. This approach can address administrative delays inherent in federated systems while allowing for the rapid mobilization of resources necessary for public health emergencies. Consensus was reached on specimen types and quality standards, although defining the normal sample, along with education about why this is critical for research and practice, will be a priority for the FAIR-VBS. Normal control or reference samples may bring the fewest legislative hurdles and could be an appropriate foundation for testing intercountry sharing of specimens, as they are not subject to the same restrictions as infected samples. These samples can also serve as a testing ground for defining terms and differences. Although 1 participant expressed concerns that people living in Africa and working in laboratories were expatriates rather than native, locally educated African individuals, we acted on this assumption by ensuring that native, locally educated people would lead or colead the repositories, thus ensuring local country representation and protection for the laboratories should evacuation or government unrest, or conflict occur. One of the goals of the FAIR-VBS is to ensure strong, trained, and local representation in each country.

The Delphi process allowed us to further query our stakeholders concerning institutional and personal benefits. We found that differing national policies, localized terminology barriers, and ambiguities regarding exactly who would benefit (eg, local collection sites, national governments, or the centralized FAIR-VBS infrastructure) were prominent friction points. Rather than forcing an artificial consensus by shifting our predetermined analytical standards, which would compromise scientific precision, we used our iterative multicoder qualitative framework to map these underlying anxieties.

Recognizing these structural barriers, our ongoing implementation project explicitly codeveloped localized solutions. Specifically, FAIR-VBS sites requested a low operational entry bar featuring an equitable, sliding fee scale tailored for underresourced centers unable to absorb additional costs. Furthermore, stakeholders required a binding assurance that all protocol features remain entirely compatible with their unique national regulatory standards and be mutually agreed upon by all global partners. This participant-driven approach ensures complete data sovereignty while building international trust in emergent biobanking architectures.

While snowball sampling was highly practical for rapidly engaging a specialized global network, it can introduce inherent network bias. This methodology may limit the overall generalizability of the final consensus due to the potential overrepresentation of specific professional networks, which inherently shapes the demographic and professional diversity of respondents. Language barriers were discussed. We learned that other language respondents were comfortable in filling out the Delphi in English; however, respondents shared that language barriers are more challenging to overcome in oral discussions. Ongoing discussions are needed to address these logistical and ethical challenges. Benefits sharing will require investigation and collaboration locally and within the federated system. Round 2 highlighted the need for reaching people native to the countries, rather than only expatriates assigned to the regions. Respondents expressed anticipated hesitation concerning the FAIR-VBS role and structure, and these findings will guide future discussions as we continue to refine the FAIR-VBS model. As this is an exploratory and participatory Delphi study, we do not pretend to be representative of biorepositories at large and generalizability is limited. For the same reasons, we are not equipped to discuss international rulings or the benefits or barriers of the Nagoya Protocol. Our purpose in asking these questions was to query how this protocol impacted this international sample. We are unpacking nonconsensus items; however, this information is not yet ripe for publication.

Guided by the Delphi findings, we have launched a 3-year demonstration project involving representatives from 10 countries (Bangladesh, Colombia, Guatemala, Indonesia, Jordan, Malaysia, Moldova, Senegal, Sierra Leone, and Tahiti) and the United States (as the founding and currently facilitating country). This initiative, built around the “10 × 10” model—10 large-volume samples from 10 donors per site for serology testing, focuses on governance, member benefits, and a sustainable operations plan. Early efforts prioritize standardizing terminology, such as clarifying “biorepository” vs “biobank,“ [25,26] and defining “healthy normal” to ensure consistency across sites.

Reflecting respondents’ preferences, the project emphasizes ethical sharing, sustainable access, and locally guided sample collection, supported by a buddy system to expand membership. Contingency plans include sharing calibrated test kits and harmonized standards across sites when specimen sharing proves impractical. During the period between manuscript review and acceptance, our team acted on the Delphi findings. These coordinated efforts aim to advance the FAIR-VBS as a global platform for equitable, ethical, and collaborative specimen sharing.

These findings highlight the transformative potential of the FAIR-VBS to address critical gaps in international biorepository efforts and the significant challenges that remain to be navigated for implementation. The enthusiasm for enhanced collaboration and capacity building aligns with the FAIR-VBS’s mission to promote inclusion and equity in specimen sharing. At the same time, the complexities of infrastructure, regulations, and logistics underscore the need for a strategic and comprehensive approach. Concerns about power dynamics and data quality call for robust and respectful cocreated governance frameworks and agreed-upon quality-control measures. Future efforts will focus on practical solutions, including regulatory harmonization, infrastructure development in resource-limited settings, and equitable governance structures. Pilot work will provide actionable insights into overcoming these challenges. The FAIR-VBS global equity slideshow is presented in Multimedia Appendix 1.