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 | $500.00 |
| 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) Please see bottom of page for other possible service fees. | $715.00 |
| Each Additional CO-PI | $140.00 | |
| Each Additional Consent Form | $140.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $250.00 – $350.00 | |
| Adverse Events (If physician review not required) | $275.00 | |
| Adverse Events (Physician Review Required) | $425.00 | |
| Protocol Deviations (If physician review not required) | $750.00 | |
| Protocol Deviations (physician review required) | $1,000.00 | |
| Minor Mitigated Conflict of Interest | $275.00 | |
| Major Conflict of Interest Fee (If reviewed with other FB studies/reviewed by already convened board) |
$625.00 | |
| EACH Additional Conflict of Interest Fee | $140.00 | |
| Exempt Amendments/Modification | ||
| Review of Protocol Modifications | $300.00 | |
| Review of Consent Modifications/Each Form | $140.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $140.00 | |
| Review of each additional/modified study personnel | $140.00 | |
| Review of EACH Personnel Removal | $35.00 | |
| 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) Please see bottom of page for other possible service fees. | $1,015.00 |
| Each Additional CO-PI | $140.00 | |
| Each Additional Consent Form | $140.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $250.00 – $350.00 | |
| Adverse Events (If physician review not required) | $275.00 | |
| Adverse Events (Physician review required) | $425.00 | |
| Protocol Deviations (If physician review not required) | $750.00 | |
| Protocol Deviations (Physician review required) | $1,000.00 | |
| Minor Mitigated Conflict of Interest Fee | $275.00 | |
| Major Conflict of Interest Fee (if reviewed by an already convened board) | $625.00 | |
| EACH Additional Conflict of Interest Fee | $140.00 | |
| Initial Review of Additional site (expedited multi-site studies) | Review of Principal Investigator and 1 Location | $550.00 |
| Expedited Amendments/Modification | ||
| Review of Protocol Modifications | $300.00 | |
| Review of Consent Modifications/Each Form | $140.00 | |
| Review of Advertisements or Other Documents Post-Approval/EACH form | $140.00 | |
| Review of EACH Additional/Modified Study Personnel | $140.00 | |
| Review of EACH Personnel Removal | $35.00 | |
| Expedited Annual Check-Ins |
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| Annual Report Study Continuation | $600.00 | |
| Annual Report Study Continuation for Additional Sites | $420.00 | |
| Expired Study Fee (If annul check-in report is submitted by study team after expiration) | $500.00 + Annual Check-In Fee | |
| Expired Study Late Fee (If study closure report is submitted by study team after expiration) | $500.00 | |
| Expired Study Fee (If study is administratively closed due to no response from Study team) | $500.00(Late Fee)+ $500.00 (Admin Fee) =$1000.00 Total | |
| Review of EACH Study Closure | $125.00 | |
| US Research, Full Board Review (Non-Clinical) | Initial review + convened board meeting (includes one informed consent and includes one iteration from 2 primary reviewers) Please see bottom of page for other possible service fees. | $1650.00 |
| Each Additional CO-PI | $140.00 | |
| Each Additional Consent Form | $250.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $275.00-$375.00 | |
| Additional Iterations of Submission Post Full Board Review | $385.00 | |
| Adverse Events (Physician review not required) | $275.00 | |
| Adverse Events (Physician Review Required) | $425.00 | |
| Protocol Deviations (Physician review not required) | $750.00 | |
| Protocol Deviations (Physician review required) | $1,000.00 | |
| Minor Mitigated Conflict of Interest Fee | $275.00 | |
| Major Conflict of Interest Fee | $625.00 | |
| EACH Additional Conflict of Interest Fee | $140.00 | |
| Initial Review of Additional Site (Full Board Multi-Site Studies) | Review of Principal Investigator and 1 Location | $715.00 |
| Full Board (Non-Clinical) Amendments/Modification |
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| Review of Protocol Modifications | $550.00 | |
| Review of Consent Modifications/Each Form | $250.00 | |
| Full Board Review of Amendment (If reviewed with already convened board) | $605.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $140.00 | |
| Review of EACH Additional/Modified Study Personnel | $140.00 | |
| Review of EACH Personnel Removal | $35.00 | |
| Full Board (Non-Clinical) Annual Check-Ins |
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| Annual Report Study Continuation | $935.00 | |
| Annual Report study continuation for additional sites | $525.00 | |
| Expired Study Fee (If annul check-in report is submitted by study team after expiration) | $500.00+ Annual check-in fee | |
| Expired Study Late Fee (If study closure report is submitted by study team after expiration) | $500.00 | |
| Expired Study Fee (If study is administratively closed due to no response from study team) | $500.00(late fee)+$500.00(Admin fee) =$1,000.00 Total | |
| Review of Each Study Site Closure | $125.00 | |
| US Research, Full Board Review (Clinical) | Initial review + convened board meeting (Includes one informed consent and includes one iteration from 2 primary reviewers) Please see bottom of page for other possible service fees. | $2,150.00 |
| Each Additional CO-PI | $140.00 | |
| Each Additional Consent Form | $250.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $275.00 – $375.00 | |
|
Additional Iterations of Submission Post Full Board Review |
$385.00 | |
| Adverse Events (If physician review not required) | $275.00 | |
| Adverse Event (Physician Review Required) | $425.00 | |
| Protocol Deviations (If physician review not required) | $750.00 | |
| Protocol Deviations (physician review required) | $1,000.00 | |
| Minor Mitigated Conflict of Interest | $275.00 | |
| Major Conflict of Interest Fee | $625.00 | |
| Each Additional Conflict of Interest Fee | $140.00 | |
| Full Board (Clinical) Amendments/Modification |
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| Review of Protocol Modifications | $550.00 | |
| Review of Consent Modifications/Each Form | $250.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $140.00 | |
| Full Board Review of Amendment (If reviewed with already convened board) | $605.00 | |
| Review of EACH Additional/Modified Study Personnel | $140.00 | |
| Initial Review of Additional Site (Full Board Multi-Site Studies) | Review of Principal Investigator and 1 Location | $1,000.00 |
| Full Board (Clinical) Annual Check-Ins |
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| Annual Report Study Continuation | $935.00 | |
| Annual Report Study Continuation for Additional Sites | $650.00 | |
| Expired Study Fee (If annul check-in report is submitted by study team after expiration) | $750.00+ Annual Check-In Fee | |
| Expired Study Late Fee (If study closure report is submitted by study team after expiration) | $750.00 | |
| Expired Study Fee (If study is administratively closed due to no response from study team) | $1000.00(Late Fee)+ $500.00 (Admin Fee) =$1500.00 total | |
| Review of Each Study Site Closure | $150.00 | |
| International Study Fees | Initial review and validation of international sites and requirements. Please see bottom of page for other possible service fees. | $1,925.00 |
| Full Board Review of Social Behaivoral International Study | International Fee + $750.00 | |
| Full Board Review of Clinical International Study | International Fee + $1000 | |
| Each Additional CO-PI | $140.00 | |
| Each Additional Consent Form | $250.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $325.00 – $425.00 | |
| Additional iterations of submission post full board review | $400.00 | |
| Adverse Events (If physician review not required) | $350.00 | |
| Adverse Events (Physicians Review Required) | $450.00 | |
| Protocol Deviations (If physician review not required) | $1,000.00 | |
| Protocol Deviations (physician review required) | $1,250.00 | |
| Minor Mitigated Conflict of Interest | $275.00 | |
| Major Conflict of Interest Fee (If reviewed with other FB studies/reviewed by already convened board) | $625.00 | |
| Each Additional Conflict of Interest Fee | $140.00 | |
| International Amendments/Modification |
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| Review of Protocol Modifications | $550.00 | |
| Review of Consent Modifications/Each Form | $250.00 | |
| Review of Advertisements or Other Documents Post-Approval/EACH Form | $140.00 | |
| Review of EACH Additional/Modified Study Personnel | $140.00 | |
| Review of EACH Personnel Removal | $35.00 | |
| Physician Review of COVID-19 Saftey/Rrecautions for Face to Face Activities | $750.00 | |
| International Annual Check-Ins |
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| Annual Report Study Continuation | $935.00 | |
| Annual Report Study Continuation for Additional Sites | $525.00 | |
| Expired Study Fee (If annual check-in report is submitted by study team after expiration) | $750.00+ Annual Check in Fee | |
| Expired Study Late Fee (If study closure report is submitted by study team after expiration) | $1000.00(Late Fee)+ $500.00 (Admin Fee) =$1500.00 Total | |
| Expired Study Fee (If study is administratively closed due to no response from study team) | $1000.00(Late Fee)+ $500.00 (Admin Fee) =$1500.00 Total | |
| Review of Each Study Closure | $150.00 | |
| Consultation Services | ||
| Minor Consultation | $275.00 | |
| Moderate Consultation | $550.00 | |
| Extensive Consultation | $825.00 | |
| Phycisian Consultation | $1,250.00 | |
| Other Service Fees | ||
| IRB of Record Letter or Letter of Intent Review | $275.00 | |
| Certified Translation Services | Cost – plus 20% | |
| Administrative services as required FDA Studies | Varies | |
| Adverse Event Investigation | $250.00/hour plus expenses | |
| Investigation | Varies | |
| Device Determination Verification of Non-Significant Risk | $600.00 | |
| Device Determination of Non-Significant Risk (If reviewed by the already convened board) | $1,000.00 | |
| Determination of IND | $1,250.00 | |
| Rapid Board Convening | $1,250.00 | |
| Full Board Review of Amendment (If reviewed with already convened board) | $605.00 | |
| Study Suspension by Already Convened Board | $1,100.00 | |
| Study Termination by Already Convened Board | $1,320.00 | |
| Investigation of Participant Complaints | $250.00/Hour Plus Expenses ($400/hr if physician review required) | |
| Physician Safety Review | $750.00 | |
| Reliance Agreement Fees | ||
| Reliance review (Includes 1 principal investigator credential review and 1 consent form) | $825.00 | |
| EACH Additional Personnel | $140.00 | |
| Each Additional Consent Form | $140.00 |
Fees subject to change at any time without notice. This fee list is not suggestive of being comprehensive.