QA & Education Specialist; IRB Compliance Coordinator Teachers College at Columbia University; University of New England, United States
Background: Open science promotes transparency, accessibility, and reproducibility in research by advocating for open data sharing. However, this often conflicts with IRB mandates to protect human subjects, especially concerning sensitive data and vulnerable populations. To resolve these conflicts, IRBs play a critical role in ensuring that tiered access repositories are used to share data according to participants’ consent, thus harmonizing transparency with ethical oversight.
Methods: To explore solutions to these challenges, a multidisciplinary group of stakeholders, including researchers, IRB staff, and legal and IT experts, engaged in discussions and analyzed case studies. The group identified several key areas where IRBs are central to ensuring compliance, including managing indirect identifiers, ensuring data security, and addressing technical barriers involved in using tiered access repositories.
Conclusion: The proposed framework clarifies how IRBs can address the complex challenges posed by open science, particularly around participant consent and the risks posed by indirect identifiers. By utilizing tiered access repositories, IRBs can ensure that data-sharing decisions are guided by participants' consent while mitigating the risks of re-identification. The framework recommends that IRBs take an active role in facilitating ethical data-sharing by collaborating with researchers, IT teams, and legal departments to oversee secure repository use and to ensure proper de-identification of sensitive data.
This approach also involves providing researchers with clear guidance on how to align data-sharing practices with participant consent agreements, focusing on reducing risks from indirect identifiers. In smaller institutions, where resources are limited, the framework can be scaled to meet specific needs by leveraging existing repositories with built-in security features. However, larger institutions may have designated teams to manage these responsibilities more effectively.
Ultimately, this framework shifts the IRB's role from traditional oversight to an active facilitation model, where IRBs guide researchers in implementing ethical open science practices. This model strikes a balance between maintaining research transparency and protecting participant privacy, ensuring that open science is carried out in an ethically sound manner.
Limitations: While this framework has been effective for our relatively small IRB office, institutions with more resources may have designated teams or departments to handle oversight, data management, and compliance. The scalability of this framework will depend on the size and resource capacity of each institution, and larger institutions may implement more specialized structures for overseeing open science practices.
Discussion: The proposed framework positions IRBs as active facilitators in managing data-sharing practices in open science. By ensuring participant consent drives decisions related to tiered access and addressing re-identification risks posed by indirect identifiers, IRBs can help maintain the ethical integrity of data sharing. Future work should focus on standardizing these practices across institutions, including developing comprehensive guidelines and providing education on open science principles. This framework highlights the ongoing need for IRBs to adapt to evolving research practices and technology while fostering cross-institutional collaboration to ensure consistency and compliance.
