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Working Group Supporting Output November 17, 2025

Adding Data Visitation Language to an IRB protocol

  • Output Type: Working Group Supporting Output
  • Output Status: Endorsed
  • Review Period End: 2025-12-18
  • DOI: 10.15497/RDA00142
  • Primary Domain: Medical and Health Sciences
  • RDA Pathways: Data Infrastructures and Environments - Generalist,Data Infrastructures and Environments - Discipline Focused,Research Software,AI meets data: exploring use cases, applications and innovation
  • Group Technology Focus: Other, Performing Research, Re-Use, Virtual Research Environments (VREs)
  • Stakeholders: Industry & Private Sector, Infrastructure Providers, Research Performing Organisations, Researchers & Scientists
  • Language: English

Abstract

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.

Impact Statement

This output provides practical guidance on incorporating Data Visitation language into an IRB protocol providing utility for those anticipating implementing data visitation easing steps toward achieving IRB for research projects that may adopt data visitation solutions for data sharing and re-use by humans and machines.

Explanation of Sustainable Development Goals

The “Adding Data Visitation language to an IRB protocol” output aligns with SDG 9: [to] Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation. Particularly, 9.5  to “enhance scientific research, upgrade the technological capabilities of industrial sectors in all countries”  offering practical guidance in the context of submission to an institutional review board (IRB) for those anticipating management of consented data in data visitation systems.

Citations

Cite as: P Buendia, S Kim. “Adding Data Visitation language to an IRB protocol.” DV4RDA Project of the EOSC-Future/Research Data Alliance Artificial Intelligence and Data Visitation Working Group. Research Data Alliance.   November 15, 2025. DOI: 10.15497/RDA00142

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