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 research, REC/IRBs are confronted with new challenges when reviewing the downstream potential negative risks of AI on research participants a human society at large, the first of which is a dearth of concrete guidance for review of AI in research.

The recommendations set forth in this guidance outline basic ethical principles that will assist research ethics committees to understand the questions, methods, and procedures for reviewing Artificial Intelligence (AI), including use of Data Visitation (DV) in research with humans.

The recommendations are intended to inform Research Ethics Committees(RECs)/Institutional Review Board (IRB) members, researchers, data scientists, AI developers as well as other stakeholders who may be involved in development, use and, deployment of AI and data. Subject matter exerts from across the globe developed these consensus-driven and actionable recommendations to provide a European and global platform for engaging ethics, law, and social considerations in AI, data sharing, DV, and Open Science policy development and treatment of such by RECs/IRBs.

These recommendations emphasize individual rights and means for ensuring autonomy and appropriate expression of will regarding data visitation in scientific research for developing AI systems as a necessary step for establishing appropriate conditions for inclusive and responsible research and innovation. These recommendations can ultimately be instrumental for enhancing the process of Research Ethics Committees/Institutional Review Boards and the approved processes for visiting personal data held by different data holders in respect of individual fundamental rights for scientific purposes, in particular for AI technological development. Therefore, the recommendations contribute to UN SDG 3, especially 3.8 (Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all) insofar as AI Governance and use of AI in clinical medicine and clinical trials research makes AI and data visitation normalized components of medical research and practice.  These recommendations are also aligned with SDG 9 (Industry, Innovation and Infrastructure), 4 (Quality Education), 10 (Reduced Inequalities), 16 (Peace, Justice and Strong Institution) and 17 (Partnerships for the Goal).

Pahlevan-Ibrekic, C., Sokolchik, V., Sitorus, R., Elif Ekmekci, P., Razuvanau, A., Kaplan, Ü., Prawiroharjo, P., & RDa Artificial Intelligence and Data Visitation WG. (2025). Guidance for Ethics Committees Reviewing AI and DV. Research Data Alliance. https://doi.org/10.15497/RDA00122

Broader Working Group: Artificial Intelligence Data Visitation Working Group (AIDV WG)
Metadata information:
– Keywords: Artificial Intelligence (AI), Data Visitation (DV), Research Ethics Committees, Institutional Review Boards, Informed Consent, AIDV, Ethics, Law, Policy,
– Publication date: 14 Aug 2024.