ACT Network Governance and Regulatory Information

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All institutions participating in the ACT Network must have agree to and officially signed an ACT Network Site Agreement that incorporates the following principles of participation:
  • ACT Network Sites will secure IRB review and approval for their i2b2/Shrine participation in the ACT network.
  • ACT Network Sites will implement the Terms of Query Access and Standard Operating Procedures that will permit approved users access to the SHRINE federated query tool for the purpose of requesting aggregate clinical data from participating ACT organizations.

HIPAA Compliance

IRB Approval

Key Documents

The ACT Network only shares aggregate patient counts, and never shares (or accesses) patient data at its sites. Each site monitors and reports on local usage of the ACT Network to ensure compliance with the ACT Terms of Query Access.

HIPAA Compliance

IRB Approval

Key Documents

Part of the ACT implementation process at each site involves applying for approval from the site’s local IRB. 

HIPAA Compliance

IRB Approval

Key Documents

Terms of Query Access
The Terms of Query Access is designed to permit approved users access to the NCATS Accrual for Clinical Trials (ACT) federated network SHRINE federated query tool for the purpose of requesting and receiving cohort counts from participating ACT Network Sites. Each Organization individually contributes and allows access to aggregate clinical data for research purposes only with an intention to accrue for clinical trials or for feasibility of clinical trials. This section provides a framework intended to ensure that research collaborations among the NCATS ACT Network investigators are realized in an ethical, respectful and transformative fashion.