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In This Section
All new protocols must use the electronic submission process in the eIRB module of eResearch. Investigators benefit from the elimination of all paper documents, the automatic routing of protocols to ancillary committees, the ability to follow the status of each submission as it moves through the approval process and the storage and tracking of all documents.
The IRB does not accept paper applications or materials that are emailed outside of the eIRB system. All applications and supplemental materials to accompany new protocols, amendments, continuing reviews and reportable events must be submitted via the eIRB electronic IRB management system.
For information on the criteria the IRB uses to determine if a study is approvable, please read more about requirements for approval.
What type of submission is this?
The investigator must determine which review pathway they believe their research should follow. Human subjects research can either meet the criteria for Exemption, it can be eligible for review using Expedited procedures, or it can require review by the Full Board.
- Determination of Exemption - Investigators are not permitted to make this determination themselves. The categories are enumerated in 45 CFR 46.104(d)(1-8). Like all submissions, requests for a determination of exemption must be submitted using the eIRB system.
- Expedited Review Procedures- Submissions qualifying for review using expedited procedures are reviewed in the order of their arrival in the IRB Office. The majority of submissions to the CHOP IRB including new protocols, amendments, continuing reviews and other reports are reviewed using expedited procedures. The categories of research eligible for expedited review are detailed on OHRP's website Expedited Review Categories and on Expedited Review.
- Full Board Review- Submissions that require full board review are scheduled for the next available IRB meeting. They must be received at least 8 days prior to the scheduled meeting. This allows time for a pre-review by the IRB Analysts prior to placement on a meeting agenda.
When the meeting agenda is full, additional submissions go to the next available convened meeting.
The IRB Committees are constituted as general biomedical committees capable of reviewing any protocol.
Human subjects research that is minimal risk and fits the exempt categories in the regulations.
Minimal risk research that is limited to procedures in the expedited review categories.
Human subjects research that is neither exempt nor eligible for expedited review.