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Compile IRB Submission
An Institutional Review Board (IRB) submission is required for any human subject research study. The CHOP IRB has implemented an electronic system for IRB submissions. All new protocols submitted to the IRB must use the eIRB system.
The CHOP IRB web presence contains information to assist investigators, study coordinators and other users complete and work with the eIRB electronic IRB management system. eIRB has a Help section on every page but does not have room for illustrative examples or longer explanations. The IRB Office will continue to add new topics to this section as issues are identified.
The IRB templates and guidance are updated regularly; as such, it is important to refer to the IRB website prior to each submission to ensure that you are following the current procedures for IRB submission and that you have the most current protocol and informed consent form templates.
Questions? Contact the Institutional Review Board.
Key Reminders
- It important to initiate the IRB submission process in tandem with submitting for contract and budget approval.
- The Investigational Drug Service (IDS) will be alerted about a new study when Section 1.04 (Drug Information) is submitted in eSIFTER. It is helpful to meet with IDS pharmacy once the study obtains IRB approval. Contact IDS at InvestigationalPharmacy@chop.edu
- Certificates of Confidentiality (CoC) are granted by the National Institutes of Health (NIH) or the Food and Drug Administration (FDA) to protect identifiable research information from forced disclosure that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. All human subjects research studies funded by the NIH will automatically be issued a CoC. Follow the instructions on the Certificates of Confidentiality page for obtaining a CoC from the NIH for non-NIH funded studies and from the FDA.
- All new and existing studies with a CoC with research data in Epic must be built into the OnCore system. OnCore's integration with Epic can automate the process of flagging all applicable patient records. The CoC flag allows Health Information Management or their delegates to ensure that patient records protected by a CoC are not inappropriately released. This new requirement facilitates the appropriate and necessary protection of research data in Epic from disclosure.
eSIFTER is a centralized repository for study start up information required to support various ...