Federalwide Assurances and IRB Registration

Penn operates under Federalwide Assurances (FWAs) in accordance Subpart A 46.103a which requires any institution engaged in non-exempt human subjects’ research, conducted or supported by HHS, to submit a written assurance of compliance to OHRP. Renewal is required every 5 years. Any updates made to the FWAs begins a new 5-year effective period.

 

All of the Penn IRBs listed under the FWAs are registered electronically in accordance with 45 CFR 46§501-505. Renewal of IRB Registration is required every 3 years. Any updates made to the IRB Registration begins a new 3-year registration period.

 

In certain circumstances, a funding agency or sponsor may request the FWA, institutional or IRB registration identifiers for Penn IRBs.

Penn Federalwide Assurances

Penn has five Federalwide Assurances. The University of Pennsylvania FWA is the default for all research at the University and Penn Medicine. The secondary Penn Medicine FWAs below are utilized ONLY for research relying on NCI CIRB and conducted at Princeton Health, Chester County Hospital, Lancaster General Hospital, and Virtua, respectively.

University of Pennsylvania

FWA00004028, Expires 4/5/2026

Penn Medicine Princeton Health

FWA00009852, Expires 2/9/2027

Penn Medicine Chester County Hospital

FWA00000059, Expires 2/2/2028

Penn Medicine Virtua Cancer Program

FWA00032367, Expires 5/2/2027

Lancaster General Hospital

FWA00006038, Expires 6/11/2029

IORG Number

The Institution or Organization (IORG) number is a unique number assigned by OHRP to an institution or organization the first time an institution or organization registers an IRB. The IORG number for the University of Pennsylvania is IORG0000029.

IRB Registration Information

Each IRB registered under an FWA has a unique registration number which is listed below. IRBs 1-7 are fully compliant with the FDA registration requirements. To view the Penn IRB registrations, search the OHRP Database. Select the IRB Organizations (IORG) radio button for document type. Enter the IORG Number above.

Expires: 06/06/2025

 

Board Registration Identifier IRB Type
IRB #1 IRB00000038 OHRP/FDA
IRB #2 IRB00000039 OHRP/FDA
IRB #3 IRB00000040 OHRP/FDA
IRB #4 IRB00000041 OHRP/FDA
IRB #5 IRB00000042 OHRP/FDA
IRB #6 IRB00000043 OHRP/FDA
IRB #7 IRB00000044 OHRP/FDA
IRB #8 IRB00002997 OHRP only

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