Fees subject to change at any time without notice
| Items | Descriptions | Cost |
| Determination of non-human subject research | Evaluation of a protocol for non-human subject determination; if determined to be human subjects research, then the fee is applied toward the higher level of review | $450.00 |
| US Research, Review of IRB Exemption | Evaluation of a protocol for exemption; if not exempt, the fee is applied toward the higher level of review. (Includes one informed consent and includes one iteration from 1 primary reviewer) | $650.00 |
| Each Additional CO-PI | $125.00 | |
| Each Additional Consent Form | $125.00 | |
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) | $150.00 | |
| Adverse Events (If physician review not required) | $250.00 | |
| Adverse Events (Physician Review Required) | $375.00 | |
| Protocol Deviations (If physician review not required) | $250.00 | |
| Protocol Deviations (physician review required) | $375.00 | |
| Minor Mitigated COI | $250.00 | |
| COI Fee (If reviewed with other FB studies/reviewed by already convened board) |
$550.00 | |
| Additional COI Fee (Multiple COI) | $125.00 | |
| Exempt Amendments/Modification | ||
| Review of Protocol Modifications | $200.00 | |
| Review of Consent Modifications/Each Form | $125.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $125.00 | |
| Review of each additional/modified study personnel | $125.00 | |
| Exempt Annual Check-Ins | Exempt studies do not require annual check-ins (If the study is determined to be more than exempt this fee depends on the level of review determined) | If your study comes to a close it would be appreciated if you let us know. |
| US Research, Expedited Review | Initial review (if determined not expedited, the fee is applied toward the higher level of review. (includes one informed consent and includes one iteration from 1 primary reviewer) | $925.00 |
| Each Additional CO-PI | $125.00 | |
| Each Additional Consent Form | $125.00 | |
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) | $150.00 | |
| Adverse Events (If physician review not required) | $250.00 | |
| Adverse Events (Physician Required) | $375.00 | |
| Protocol Deviations (If physician review not required) | $250.00 | |
| Protocol Deviations (physician required) | $375.00 | |
| Minor Mitigated COI | $250.00 | |
| COI Fee (If reviewed with other FB studies/reviewed by already convened board) |
$550.00 | |
| Additional COI Fee (Multiple COI) |
$125.00 | |
| Initial Review of Additional site (expedited multi-site studies) | Review of Principal investigator and 1 location | $500.00 |
| Expedited Amendments/Modification | ||
| Review of Protocol Modifications | $200.00 | |
| Review of Consent Modifications/Each Form | $125.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $125.00 | |
| Review of each additional/modified study personnel | $125.00 | |
| Expedited Annual Check-Ins |
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| Annual Report study continuation | $550.00 | |
| Annual Report study continuation for additional sites | $375.00 | |
| Expired study fee (If Annul check-in report is submitted by study team after expiration) | $150.00+ Annual check-in fee | |
| Expired study late fee (If study closure report is submitted by study team after expiration) | $300.00 | |
| Expired study fee (If study is administratively closed due to no response from Study team) | $300.00(late fee)+ $200.00 (Admin fee) =$500.00 total | |
| Review of Each Study Closure | $75.00 | |
| US Research, Full Board Review (Non-Clinical) | Initial review + convened board meeting (includes one informed consent and includes one iteration from 2 primary reviewers) | $1500.00 |
| Each Additional CO-PI | $125.00 | |
| Each Additional Consent Form | $225.00 | |
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) | $250.00 | |
| Additional iterations of submission post full board review | $350.00 | |
| Adverse Events (Physician review not required) | $250.00 | |
| Adverse Events (Physician Review Required) | $375.00 | |
| Protocol Deviations (Physician review not required) | $250.00 | |
| Protocol Deviations (Physician review required) | $375.00 | |
| Minor mitigate COI | $250.00 | |
| COI fee (If reviewed with other FB studies/reviewed by the already convened board) | $550.00 | |
| Additional COI fee (multiple COI) | $125.00 | |
| Initial Review of Additional Site (Full Board Multi-Site Studies) | Review of Principal Investigator and 1 Location | $650.00 |
| Full Board (Non-Clinical) Amendments/Modification |
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| Review of Protocol Modifications | $500.00 | |
| Review of Consent Modifications/Each Form | $225.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $125.00 | |
| Review of each additional/modified study personnel | $125.00 | |
| Full Board (Non-Clinical) Annual Check-Ins |
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| Annual Report study continuation | $850.00 | |
| Annual Report study continuation for additional sites | $475.00 | |
| Expired study fee (If Annul check-in report is submitted by study team after expiration) | $150.00+ Annual check-in fee | |
| Expired study late fee (If study closure report is submitted by study team after expiration) | $300.00 | |
| Expired study fee (If study is administratively closed due to no response from Study team) | $300.00(late fee)+$200.00(Admin fee) =$500.00 total | |
| Review of Each Study Site Closure | $75.00 | |
| US Research, Full Board Review (Clinical) | initial review + convened board meeting (includes one informed consent and includes one iteration from 2 primary reviewers) | $1950.00 |
| Each Additional CO-PI | $125.00 | |
| Each Additional Consent Form | $225.00 | |
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) | $250.00 | |
| Additional iterations of submission post full board review | $350.00 | |
| Adverse Events (If physician review not required) | $250.00 | |
| Adverse Event (Physician Review Required) | $375.00 | |
| Protocol Deviations (If physician review not required) | $250.00 | |
| Protocol Deviations (physician review required) | $375.00 | |
| Minor Mitigated COI | $250.00 | |
| COI fee (If reviewed with other FB studies/reviewed by already convened board) | $550.00 | |
| Additional COI fee (multiple COI) | $125.00 | |
| Full Board (Clinical) Amendments/Modification |
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| Review of Protocol Modifications | $500.00 | |
| Review of Consent Modifications/Each Form | $225.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $125.00 | |
| Review of each additional/modified study personnel | $125.00 | |
| Initial Review of Additional Site (Full Board Multi-Site Studies) | Review of Principal Investigator and 1 Location | $650.00 |
| Full Board (Clinical) Annual Check-Ins |
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| Annual Report study continuation | $850.00 | |
| Annual Report study continuation for additional sites | $475.00 | |
| Expired study fee (If Annul check-in report is submitted by study team after expiration) | $150.00+ Annual check-in fee | |
| Expired study late fee (If study closure report is submitted by study team after expiration) | $300.00 | |
| Expired study fee (If study is administratively closed due to no response from Study team) | $300.00(late fee)+ $200.00(Admin fee) =$500.00 total | |
| Review of Each Study Closure | $75.00 | |
| International Study Fees | Initial Review and validation of international sites and requirements. | $1750.00 |
| Full Board Review of International Study | International fee + $450.00 | |
| Each Additional CO-PI | $125.00 | |
| Each Additional Consent Form | $225.00 | |
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) | $250.00 | |
| Additional iterations of submission post full board review | $350.00 | |
| Adverse Events (If physician review not required) | $250.00 | |
| Adverse Events (Physicians Review Required) | $375.00 | |
| Protocol Deviations (If physician review not required) | $250.00 | |
| Protocol Deviations (physician review required) | $375.00 | |
| Minor Mitigated COI | $250.00 | |
| COI Fee (If reviewed with other FB studies/reviewed by already convened board) | $550.00 | |
| Additional COI Fee (Multiple COI) | $125.00 | |
| International Amendments/Modification |
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| Review of Protocol Modifications | $500.00 | |
| Review of Consent Modifications/Each Form | $225.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $125.00 | |
| Review of each additional/modified study personnel | $125.00 | |
| International Annual Check-Ins |
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| Annual Report study continuation | $850.00 | |
| Annual Report study continuation for additional sites | $475.00 | |
| Expired study fee (If Annul check-in report is submitted by study team after expiration) | $150.00+ Annual check-in fee | |
| Expired study late fee (If study closure report is submitted by study team after expiration) | $300.00 | |
| Expired study fee (If study is administratively closed due to no response from Study team) | $300.00(late fee)+$200.00(Admin fee) =$500.00 total | |
| Review of each Study Closure | $75.00 | |
| Consultation Services | ||
| Protocol consultation – minimal revisions | $250.00 | |
| Full protocol consultation – medium revisions | $500.00 | |
| Full protocol consultation – major revisions | $750.00 | |
| Other Service Fees | ||
| Study Pre-Review (prior to formal submission, IRB of record letter) | $250.00 | |
| Certified Translation Services | Cost – plus 20% | |
| Administrative services as required FDA Studies | Varies | |
| Adverse Event Investigation | $175.00/hour plus expenses | |
| Device Determination of non-significant risk | $850.00 | |
| If device determination requires Full Board Review (if reviewed with other FB studies/reviewed by the already convened board) | $550.00 | |
| Determination of IND | $850.00 | |
| Rapid Board Convening | $1150.00 | |
| Study suspension by already convened board | $1000.00 | |
| Study Termination by already convened board | $1200.00 | |
| Investigation of participant complaints | Varies | |
| Reliance review (Includes 1 principal investigator credential review and 1 consent form) | $750.00 | |
| Each additional personnel | $125.00 | |
| Each additional consent form | $125.00 |
Fees subject to change at any time without notice