Lowering the regulatory barriers to clinical data reuse for research and quality improvement.

Abstract

Clinical and research data are increasingly collected and aggregated in clinical data warehouses (CDWs). Access to these data is subject to local, state and national regulations. For multiple reasons, institutions differ in how they interpret and apply these regulations. Sometimes, inter-institutional differences are unavoidable, such as when regulations clearly require specific practices. However, in some cases, institutional practices can change. Therefore, sharing of institutional practices may lower the barriers to clinical and translational research while still complying with applicable regulations.
The University of Texas Health Science Center at Houston (UTHSC-H) has maintained a CDW since 2006. The CDW currently contains fully-identified data on over 5.2 million individuals derived from multiple sources, including administrative/billing systems, multiple institutional EHRs dating back to 2004 and research data (e.g., from clinical trials or survey studies). In addition to structured data, the CDW contains over 30 million notes, updated on an as-needed basis.
Access to these data is governed by an “umbrella protocol” approved by the institutional review board (IRB) in 2013. Since then, investigators can access these data via a streamlined process administered by our CTSA informatics component. Research covered by the umbrella protocol must meet three criteria: 1) the data must remain on institutional servers with access to these servers controlled by the CTSA informatics group (i.e., data are read-only and cannot be copied from these servers), 2) no contact with patients/subjects (e.g., cannot obtain additional data) and 3) no protected health information can be released (e.g., published). As long as the research complies with the above, no further IRB approval is necessary.
Recently (October 2020), we implemented an additional feature to help the growing number of investigators who apply and receive funding for research that complies with the rules of the umbrella protocol. In many cases, investigators must demonstrate that their specific project is approved by the IRB; umbrella protocol documents are not sufficient. To address this need, and working with our IRB, we created a REDCap form that documents compliance with the umbrella protocol and generates an official letter that can be submitted to the funding agency. We do not yet have quantitative data regarding usage, but anecdotal feedback from investigators is very positive.
Authors: Elmer V. Bernstam; Susan C. Guerrero; Fatima Ashraf; Sujatha Sridhar; Cynthia Edmonds; Christina F. Solis; Jiajie Zhang; David D. McPherson
This poster was supported by the National Center for Advancing Translational Sciences (NCATS) grant 1UL1TR003167. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Authors
Elmer
Bernstam
CTSA Informatics Director, Professor and Associate Dean for Research
Susan
Guerrero
Staff System Analyst
Fatima
Ashraf
Programmer/Analyst
Sujatha
Sridhar
Executive Director, Research Compliance
Cynthia
Edmonds
Director, IRB
Christina
Solis
Senior Legal Officer and Privacy Officer