Only requests for identifiable hospital discharge (SPARCS) data files require an Institutional Review Board (IRB) determination – limited data requests do not. 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.
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-human research.
If your IRB 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 soon as you have them. SPARCS must receive both the protocol and determination letter before 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 offer recommendations for IRB service providers.