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Obtain Scientific Review Committee Approval
Independent scientific review is required for certain protocols prior to the CHOP IRB submission. Departments and Divisions have established appropriate Scientific Review Committees (SRC) to conduct these reviews in a timely manner.
The following types of protocols are exempt from scientific review, unless a review is requested by the IRB, the study involves a CHOP or CHOP investigator held IND/IDE or the study involves interaction with SARs-CoV2 positive patients or their samples:
- Protocol/grants peer-reviewed by a Federal-funding agency (e.g. NIH, CDC, DOD).
- Protocol/grants peer-reviewed by a national foundation (e.g. American Heart Association).
- Protocol/grants conducted by an industry sponsor.
- Protocol/grant peer reviewed by a group with a composition equivalent to a CHOP scientific review committee (the PI will have to demonstrate equivalence to the Chief Clinical Research Officer, or the Chief Clinical Research Officer designee).
- Research that does not require direct involvement of human subjects (e.g. chart review or research exempt from IRB review).
- Research that meets one (or more) of the exempt categories.
For all other protocols, or for any protocol that the IRB specifically requests a separate review, internal scientific review should be conducted by one of the following:
- Existing CHOP or UPenn Scientific Review Committees (e.g. Cancer Center).
- Existing Divisional or Departmental Scientific Review Committees.
- Scientific review committees constituted by or between Departments, Divisions, or Centers of Emphasis.
Submit the Scientific Review Form completed by an established scientific review committee together with the investigator response to the committee to the IRB at the time of IRB submission.
- There is now a new COVID-19 SRC. This committee reviews All COVID-19 related research (regardless of funding and other scientific review).
- This scientific review will also be required for amendments to previously approved studies which are adding a COVID-19 research component.
Investigator Held IND/IDE Protocols Require Special Scientific Review
A separate scientific committee will provide scientific review for protocols that are being conducted under an investigator-held IND/IDE. The IRB will not review your protocol without approval of this IND/IDE Scientific Review Committee. Contact firstname.lastname@example.org for further assistance.