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 9/19/2030
Penn Medicine Princeton Health
FWA00009852, Expires 9/16/2030
Penn Medicine Chester County Hospital
FWA00000059, Expires 9/24/2030
Penn Medicine Virtua Cancer Program
FWA00032367, Expires 9/19/2030
Lancaster General Hospital
FWA00006038, Expires 9/19/2030
IRB Registration Information
Each IRB registered under an FWA has a unique registration number which is listed below. IRBs 1-7, 9 & 10 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. IORG #: IORG0000029 expires: 09/24/2028 and IORG #: IORG0000011 expires: 09/16/2028.
| Board | Registration Identifier | IORG | IRB Type |
|---|---|---|---|
| IRB #1 | IRB00000038 | IORG0000029 | OHRP/FDA |
| IRB #2 | IRB00000039 | IORG0000029 | OHRP/FDA |
| IRB #3 | IRB00000040 | IORG0000029 | OHRP/FDA |
| IRB #4 | IRB00000041 | IORG0000029 | OHRP/FDA |
| IRB #5 | IRB00000042 | IORG0000029 | OHRP/FDA |
| IRB #6 | IRB00000043 | IORG0000029 | OHRP/FDA |
| IRB #7 | IRB00000044 | IORG0000029 | OHRP/FDA |
| IRB #8 | IRB00002997 | IORG0000029 | OHRP only |
| IRB #9 (Executive Board) | IRB00008395 | IORG0000029 | OHRP/FDA |
| IRB #10 (Previously LGH IRB) | IRB00000015 | IORG0000011 | OHRP/FDA |