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Forms for studies submitted to the Institutional Review Board (IRB)

The Department of Public Health participates in research to improve services and care for the public. Research studies that involve human subjects must be reviewed by the Institutional Review Board (IRB) before and during the study.

All forms required for new and continuing studies under the IRB’s oversight must be filled through the OneAegis submission system.

The Department/Division manager approval statement below must be completed and uploaded as part of the submission process.

Other documents below are provided for your information to assist in preparing the submission.

 

 

Some of these forms may be used in the process of submitting a study to the Institutional Review Board (IRB). Others may be used while conducting studies that have been approved by the IRB.

Name Description Released Format
OneAegis user guide for the OneAegis submission system PDF OneAegis is an online submission, workflow, and data management system for PDPH’s Institutional Review Board (IRB). OneAegis is a fully web-based system, meaning users can login anywhere they have internet access. March 19, 2025
Data security management information sheet docx Information that will be required for submissions. March 19, 2025
Department/division manager approval statement doc Form to indicate support by involved department/division manager. November 21, 2023
Studies not requiring IRB review PDF Explanation of categories that may not require review. March 19, 2025
Summary of data covered by HIPAA PDF A summary of kinds of data covered by HIPAA. July 2014

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