Governance & Regulatory

The ENACT Network only shares aggregate patient counts, and never shares (or accesses) patient-level data. Each site monitors and reports on local usage of the ENACT Network to ensure compliance with the ENACT Data Use Agreement.

ENACT Terms of Query Access (DUA)

Part of the ENACT implementation process at each site involves applying for approval from the site’s IRB. No additional study-specific IRB approval is needed for investigators using ENACT.

Cohort Exploration Enclave Research Determinations
Cohort Discovery Regulatory Guidance Overview
i2b2-SHRINE Repository Protocol

Each ENACT user must agree to the Terms of Query Access before gaining access to the ENACT tool. The terms of access ensure that only approved users are accessing the network and using it for its intended purpose. Each site manages this approval process differently. To read the terms in their entirety, please refer to the Terms of Query Access.

Each ENACT site is expected to adhere to the following:

• Stay current on software versioning as guided by ENACT Network Operations
• Ensure integrity of data use by regularly monitoring local query activity
• Adhere to expected uptime policies and work through issues in a timely manner
• Refresh data on at least a monthly basis

The decision to participate in any study using ENACT is at the discretion of the ENACT Network site. There is no obligation for a site to participate in a study proposed by another ENACT site.

ENACT governance also outlines five standard operating procedures for ENACT sites, listed below.

SOP 1: Adding New or Modifying Existing Data Domains. The Data Harmonization work group defined a set of data domains (e.g. demographics, diagnoses, procedures) and standards for representing data in these domains. As ENACT continues to evolve, there is the need to modify current domains and add new domains. This SOP lists the process required to suggest additions and modifications to the ENACT data domains. 

SOP 2: Process for User Registration and Management. This SOP ensures that the ENACT Network is accessed only by individuals authorized by a participating ENACT site. User registration and management is handled locally at each ENACT site.

SOP 3: Monitoring and Auditing. To ensure ENACT achieves its goals and participating sites operate in accordance with ENACT governance, query activity will be periodically audited by local site Data Stewards. Only authorized individuals will have access to information that can identify the user. Network usage metrics will also be collected on a regular basis, but will not include user identifying information.

SOP 4: Research Using Deidentified Aggregate Data. In accordance with the ENACT Aims, as of February 1st, 2023, an amendment to the original ACT Network Agreement permits research to be conducted across the network’s deidentified data. This amendment enables access to all network deidentified data for purposes of cohort exploration, analysis, and publication.

SOP 5: Publication. To ensure sound use of the ENACT Network data and subsequent analyses for publication, preliminary guidelines have been put in place. These guidelines will be regularly reviewed and refined by the ENACT Governance Work Group to ensure publication best practices are in use.

For more information, please reference the ENACT Governance Document. If you have further questions, you may reach out to your Site Operations Coordinator and Data Steward.

Publications based on research using the ENACT Network must cite the NCATS ENACT grant: "This project was supported by the National Institutes of Health through grant U24 TR00411." Publications should also cite the appropriate CTSA Hub grant numbers from participating institutions.

Any Intellectual Property derived from use of the ENACT Network must cite the NCATS ENACT grant: "This project was supported by the National Institutes of Health through grant U24 TR00411."

Publications in which data source partners (hospitals) are to be identified by name will be reviewed for use of name only by each identified hospital prior to submission of a manuscript. At no time will specific participating data source partners be named unless explicitly approved by the data partner. Such approval must be requested and received in writing between the requestor and the Senior Vice President of Research, the Chief Information Officer, or their respective designee. Any entity (e.g., hospital) that does not agree to be identified by name as a data source will be instead identified as a "CTSA-affiliated hospital."