Abstract

(1) Primary Purpose

The SPAN: Purpose, Structure, and Operations document (The Document) was developed to detail SPAN Network principles, structure, and expectations of participating sites and investigators. The Document explains Network governance; reviews guidelines for data access and use; emphasizes data privacy and confidentiality requirements; outlines a data incident response plan; describes the process to address conflicts of interest and scientific misconduct; and emphasizes the importance of translating research results into practice.

(2) Addressing a common challenge

For a multi-institutional research collaboration to succeed, norms and “rules of engagement” are imperative. For example, it is critical to be explicit about how local sites’ data will be requested, accessed, used and protected. Establishing principles at the outset fosters trust, collaboration and transparency.

(3) Results/Impact

As the network developed, questions arose around data access, privacy, and security. Although these issues were discussed broadly within the network and decisions made with input from the SC, Site investigators and study teams, The Document provides a mechanism to record decisions and communicate consistently. The Document was designed to be updated reflecting evolution of the network over the three-year funding period.

Publication Date

2013

Type of Governance Resource

Process Guidance

Healthcare Setting(s) in which Data were Collected

Community health center(s), Emergency department(s), Inpatient facility(ies), Primary care or ambulatory clinic(s), Specialty clinic(s)

Data Types

Electronic Health/Medical Records (EHR or EMR), Diagnostic data, Pharmacy databases, Claims, Patient Registries, Patient-Reported Outcomes

Generalizability to Other Settings

The Document could be useful to new as well as existing multi-site research networks. For new networks, This Document could serve as a template for types of issues that need to be addressed and agreed upon when designing and implementing the network. Information about both the general types of issues (such as system security, conflicts of interest) addressed, as well as specific principles articulated, could prove useful. For existing networks, many issues may have already been addressed. However, if new issues arise (such as developing a data incident plan), this document could serve as a reference, so that networks do not need to “reinvent the wheel” as unanticipated issues arise.

Network Description

This document helped create and maintain a common vision and purpose for the SPAN network, which provided important grounding as the data infrastructure was developed and the SPAN CER studies were conducted. The SPAN Network is comprised of 11 sites covering over 7,000,000 lives. Participating sites include Kaiser Permanente Colorado (lead site), Denver Health and Hospital Authority, Essentia Institute of Rural Health, Geisinger Health System, Group Health Research Institute, Harvard Pilgrim Health Care, HealthPartners, Kaiser Permanente Georgia, Kaiser Permanente Hawaii, Kaiser Permanente Northern California, and Kaiser Permanente Northwest. These sites are located in California, Colorado, Hawaii, Georgia, Massachusetts, Pennsylvania, Oregon, Washington, and Minnesota; and cover both rural and urban populations.

Acknowledgement of Funders

This project was supported by grant number R01HS019912 from the Agency for Healthcare Research and Quality. We are indebted to Matthew F. Daley, MD, Principal Investigator, for his leadership on this project and for his contributions to this abstract. In addition, we would like to thank project managers Michael R. Shainline, MBA and Lisa Pieper, MSHA, MBA, for their contributions to document revisions and to this abstract.