Investigators may submit the Determination of Human Subjects Research Worksheet to the IRB to determine if a proposed activity meets the definition of research involving human subjects. There is no such thing as retroactive IRB approval, so it is imperative that investigators submit this to the IRB if there is any question as to whether IRB review of a proposed activity is required.
When investigators seek to review PHI preparatory to research (such as to prepare a research protocol), the investigator must submit verification of such activity in iRIS for Privacy Board Review. The Preparatory to Research HIPAA Form is accessible from the HSC IRB Application in iRIS.
When investigators seek to review deceased individuals' PHI, the investigator must submit a Decedent PHI HIPAA Form to authorize this access and review. This form does not allow access to or review of PHI belonging to living individuals, including family members of the deceased. Investigators must certify that this data is necessary for the purposes of the research. This HIPAA Form is accessible via the HSC IRB Application in iRIS.
One-time emergency use of a test article prior to IRB review is allowed. Such use must be reported to the IRB via the One-Time Emergency Use Report in iRIS within 5 busines days of the use. This form is accessed via the HSC IRB Application.
IMPORTANT: Additional and subsequent uses of the test article requires prior IRB review of a full research application. See IRB SOP 502G on the Policies and Procedures page for more information.
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