Requests for Identifiable data files require an Institutional Review Board (IRB) determination.
Limited data file requests do not require an IRB determination.
In addition to their application, Identifiable data requests must include with their application (1) the IRB protocol submitted for review and (2) a determination letter from an IRB stating one of the following regarding their protocol: (a) has patient consent to perform the research; (b) has been provided a waiver of patient consent; (c) is “exempt”, or (d) has been determined non-research.
If your IRB protocol has yet to make a final decision, you can still submit a SPARCS data request application. Please submit the protocol and/or determination letter as you have them. SPARCS must receive both the protocol and determination letter prior to adding the request to the Data Governance Committee (DGC) meeting agenda.
While most educational institutions have access to an IRB, private or non-profit organizations, and other entities may not. In these cases, there are companies that provide IRB services for a cost. The Department of Health does not recommend IRB services.
Background:
SPARCS is governed by applicable laws and regulations, including but not limited to the Common Rule for the Protection of Human Subjects 45 CFR Part 46