Working Group Other Output Geographies of Trust: AI, Biomedicine, and the Next Era of Federated and Visiting Data Models

This report examines the rapidly evolving landscape of biomedical research platforms that facilitate secure, privacy-preserving access to sensitive datasets—such as genomic sequences and clinical records—without the need to move, download, or replicate data across multiple locations. These platforms adopt models such as Data Visitation and Federation, which enable computational tools to move to the data—allowing analysis to occur within its original environment or, in the case of centralized platforms that provide analysis tools, within a single, securely governed repository. This paradigm not only... View More

November 18, 2025

Working Group Supporting Output Adding Data Visitation Language to an IRB protocol

Review Status: Endorsed

Adding Data Visitation (DV) language to an IRB protocol requires placing the description within the sections that address data handling, privacy protections, security, and external data access. Although IRB protocol templates vary across institutions (e.g., HRP-503 for biomedical studies, HRP-583 for social/behavioral studies, HRP-593 for drug/device trials), all templates share common core sections where DV language can be incorporated. This document provides adaptable DV language designed to fit the most common IRB protocol sections, regardless of the specific template used.

November 17, 2025

Working Group Supporting Output Adding Data Visitation language to ICFs

Review Status: Endorsed

Incorporating Data Visitation language into an Informed Consent Form (ICF) requires clear, non-technical language that explains the concept and, importantly, how it benefits the participant by protecting their privacy. This document contains instructions and helpful information on how to do so including proposed language for additions to the ICF, structured to fit within a standard ICF format for two sections: Confidentiality and  Data Handling. When re-using, remember to adapt this language to the specific details of your study, including the type of data,... View More

November 17, 2025

Working Group Supporting Output System Security Assessment Plan Template

Review Status: Endorsed

The  System Security Assessment Plan Template is a standardized framework developed by the EOSC-Future/RDA Artificial Intelligence and Data Visitation Working Group  (AIDV-WG) and others to evaluate and approve the security of data visitation systems (i.e., platforms that enable controlled, temporary access to sensitive research data without transfer). The template requires an outline of team composition, assessment scope, procedures, and deliverables for evaluating system code, security documentation, and AI model safeguards against standards such as NIST SP 800-171 and ISO/IEC 27018. The template also... View More

November 17, 2025

Working Group Recommendation Secure Processing Environments for Open Science: Proposing Legal Foundations

Review Status: Endorsed

Open science incentives exist in difficult tension with countervailing requirements to hold data secure, and to mitigate downstream disclosures of data. Federated data analysis, and data visitation, has been proposed as a possible solution that captures the benefits of both open and restricted disclosures. This paper assesses the alignment between E.U. and global data protection institutions, and federated analysis. We conclude that the structure of data protection insufficiently accounts for how federated analysis networks are implemented in practice, from both an organizational and... View More

February 10, 2025

Working Group Supporting Output AIDV-WG Shared Citation Library

Review Status: Endorsed

The AIDV-WG Shared Citation Library on the zotero platform available at https://www.zotero.org/groups/4922635/aidv-wg/library was developed to support working group members’ research and particularly to support  these three concurrent AIDV-WG  outputs:  Bill of Rights Recommendation[i], Guidance on Informed Consent[ii], and the Guidance for Ethics Committees Reviewing AI and Data Visitation[iii] The AIDV WG’s open, shared citation library explores emerging Jurisdictional and Special Interest AI Rights and Protections for AI/LLM/Model creators, deployers, and harmed/ impacted parties at the International, Regional, National, and Municipal levels and within... View More

August 20, 2024

Working Group Recommendation AI Bill of Rights Recommendation

Review Status: Endorsed

The AI Bill of Rights team goal is to present recommendations to the EOSC Community and Research Data Alliance on the needs for AI Governance/AI Bill of Rights in various jurisdictional, disciplinary and research scenarios taking into account the potential rights of data creators, model developers, model and data re-users, and citizens/communities/patients whose lives/privacy/wellbeing are impacted by AI and data sharing modalities. Our team looks at how AI governance should shape what data is gathered and used in AI systems, what the rights... View More

August 20, 2024

Working Group Recommendation Guidance for Ethics Committees Reviewing AI and DV

Review Status: Endorsed

Research Ethics Committees(RECs) and Institutional Review Boards (IRBs) are charged with the responsibility to protect the rights, dignity and welfare of research volunteers, including use of their data that may have been collected for other, non-research purposes. Generally speaking, REC/IRBs review research involving humans according to a principled approach and usually refer to a specific set of regulatory criteria to document their assessment of the potential risks and benefits of the proposed research. With the advancement of AI and its growing use in... View More

August 15, 2024

Working Group Recommendation Guidance for Informed Consent in the context of Artificial Intelligence and Data Visitation

Review Status: Endorsed

The development and use of artificial intelligence (AI) require access to large amounts of different types of data (data visitation) for training, validation, and refinement of models. This includes data visitation that can be regulated under data protection law, the so-called personal data, which is directly or indirectly identifiable personal information that is subject to confidentiality and to the rights of the individuals concerned (data subject’s rights). In particular, data subjects should be able to express their will regarding their contribution to research... View More

July 23, 2024