Integrated but Isolated: Implications from a Systematic Review of the Access Control Ecosystem for Individual Participant Data in Clinical Studies

Abstract

While the importance of open science is further highlighted during the pandemic, the challenges of managing and sharing individual participant data (IPD) derived from clinical studies never cease. The nature of IPD, e.g., confidentiality or sensitivity, makes it difficult to maintain a good balance between data sharing and individual privacy protection. To date, many access control mechanisms for IPD do exist, but conventional solutions and services are deemed scattered and still not in place. To gain a more comprehensive understanding of the IPD sharing tensions, we conducted a systematic literature review with 64 academic publications that discuss the access control mechanisms built for IPD in clinical studies. Via the knowledge infrastructure (KI) framework, we identified nine key aspects involved and the relationships between major stakeholders in the IPD access control ecosystem. Our results anticipate informing the future design of an IPD management checklist that data professionals can use to guide their clients when releasing sensitive biomedical data.