Fees subject to change at any time without notice
Note: If listed fees are used for a purchase order- the issued purchase order is valid for the initial review of the study, any reviews after initial approval (e.g. amendments, annual check-ins, adverse events) original purchase order must be revised to reflect the current listed fees.
| 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 | $575.00 |
| 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. | $850.00 |
| Each Additional CO-PI | $160.00 | |
| Each Additional Staff Member | $40.00 | |
| Each Additional Consent Form | $160.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $325.00-$500.00 | |
| Adverse Events (If physician review not required) | $310.00 | |
| Adverse Events (Physician Review Required) | $500.00 | |
| Protocol Deviations (If physician review not required) | $825.00 | |
| Protocol Deviations (physician review required) | $1,150.00 | |
| Minor Mitigated Conflict of Interest | $310.00 | |
| Major Conflict of Interest Fee (If reviewed with other FB studies/reviewed by already convened board) |
$700.00 | |
| EACH Additional Conflict of Interest Fee | $155.00 | |
| Exempt Amendments/Modification | ||
| Review of Protocol Modifications | $330.00 | |
| Review of Consent Modifications/Each Form | $160.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $160.00 | |
| Review of each additional/modified study personnel | $160.00 | |
| Review of EACH Personnel Removal | $40.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| 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. | $1,250.00 |
| Each Additional CO-PI | $160.00 | |
| Each Additional Staff Member | $40.00 | |
| Each Additional Consent Form | $160.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $325.00-$500.00 | |
| Adverse Events (If physician review not required) | $310.00 | |
| Adverse Events (Physician review required) | $500.00 | |
| Protocol Deviations (If physician review not required) | $825.00 | |
| Protocol Deviations (Physician review required) | $1,150.00 | |
| Minor Mitigated Conflict of Interest Fee | $310.00 | |
| Major Conflict of Interest Fee (if reviewed by an already convened board) | $700.00 | |
| EACH Additional Conflict of Interest Fee | $160.00 | |
| Initial Review of Additional site (expedited multi-site studies) | Review of Principal Investigator and 1 Location | $625.00 |
| Expedited Amendments/Modification | ||
| Review of Protocol Modifications | $340.00 | |
| Review of Consent Modifications/Each Form | $160.00 | |
| Review of Advertisements or Other Documents Post-Approval/EACH form | $160.00 | |
| Review of EACH Additional/Modified Study Personnel | $160.00 | |
| Review of EACH Personnel Removal | $35.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| Expedited Annual Check-Ins |
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| Annual Report Study Continuation | $750.00 | |
| Annual Report Study Continuation for Additional Sites | $420.00 | |
| Expired Study Fee (If annul check-in report is submitted after expiration- or Study team allows study to expire after report has been submitted) | $550.00 + Annual Check-In Fee | |
| Expired Study Fee (If study closure report is submitted by study team after expiration) | $550.00 | |
| Expired Study Fee (If study is administratively closed due to no response from Study team) | $550.00(Late Fee)+ $500.00 (Admin Fee) =$1000.00 Total | |
| Review of EACH Study Closure | $140.00 | |
| 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. | $2150.00 |
| Each Additional CO-PI | $160.00 | |
| Each Additional Staff Member | $40.00 | |
| Each Additional Consent Form | $275.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $375.00-$475.00 | |
| Additional Iterations of Submission Post Full Board Review | $425.00 | |
| Adverse Events (Physician review not required) | $310.00 | |
| Adverse Events (Physician Review Required) | $500.00 | |
| Protocol Deviations (Physician review not required) | $950.00 | |
| Protocol Deviations (Physician review required) | $1,250.00 | |
| Minor Mitigated Conflict of Interest Fee | $310.00 | |
| Major Conflict of Interest Fee | $750.00 | |
| EACH Additional Conflict of Interest Fee | $160.00 | |
| Initial Review of Additional Site (Full Board Multi-Site Studies) | Review of Principal Investigator and 1 Location | $785.00 |
| Full Board (Non-Clinical) Amendments/Modification |
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| Review of Protocol Modifications | $605.00 | |
| Review of Consent Modifications/Each Form | $275.00 | |
| Full Board Review of Amendment (If reviewed with already convened board) | $665.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $160.00 | |
| Review of EACH Additional/Modified Study Personnel | $160.00 | |
| Review of EACH Personnel Removal | $45.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| Full Board (Non-Clinical) Annual Check-Ins |
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| Annual Report Study Continuation | $1,025.00 | |
| Annual Report study continuation for additional sites | $585.00 | |
| Expired Study Fee (If annul check-in report is submitted after expiration- or Study team allows study to expire after report has been submitted) | $650.00+ Annual check-in fee | |
| Expired Study Fee (If study closure report is submitted by study team after expiration) | $550.00 | |
| 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 | $185.00 | |
| 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. | $2,550.00 |
| Each Additional CO-PI | $160.00 | |
| Each Additional Staff Member | $45.00 | |
| Each Additional Consent Form | $275.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $375.00-$475.00 | |
| Additional Iterations of Submission Post Full Board Review | $425.00 | |
| Adverse Events (If physician review not required) | $325.00 | |
| Adverse Event (Physician Review Required) | $525.00 | |
| Protocol Deviations (If physician review not required) | $825.00 | |
| Protocol Deviations (physician review required) | $1,100.00 | |
| Minor Mitigated Conflict of Interest | $310.00 | |
| Major Conflict of Interest Fee | $700.00 | |
| Each Additional Conflict of Interest Fee | $155.00 | |
| Greater than Minimal Risk Studies | DSMP Summary review | $750.00 |
| Adverse Event Summary Report Review | $500.00-$2000.00 depending on number of AE’s | |
| Spot Audit Review (review at IRB discretion to confirm protocol adherance) |
$950.00 |
|
| Full Board (Clinical) Amendments/Modification |
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| Review of Protocol Modifications | $605.00 | |
| Review of Consent Modifications/Each Form | $275.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $155.00 | |
| Full Board Review of Amendment (If reviewed with already convened board) | $675.00 | |
| Review of EACH Additional/Modified Study Personnel | $155.00 | |
| Review of EACH Personnel Removal | $45.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| Initial Review of Additional Site (Full Board Multi-Site Studies) | Review of Principal Investigator and 1 Location | $1,100.00 |
| Full Board (Clinical) Annual Check-Ins |
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| Annual Report Study Continuation | $1,050.00 | |
| Annual Report Study Continuation for Additional Sites | $715.00 | |
| Expired Study Fee (If annul check-in report is submitted after expiration- or Study team allows study to expire after report has been submitted) | $850.00+ Annual Check-In Fee | |
| Expired Study Fee (If study closure report is submitted by study team after expiration) | $825.00 | |
| 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 | $185.00 | |
| International Study Fees | Initial review and validation of international sites and requirements. Please see bottom of page for other possible service fees. | $2,250.00 |
| Full Board Review of Social Behaivoral International Study | Full Board non-clinical study + $950.00 | |
| Full Board Review of Clinical International Study | Full Board Clinical Study Fee + $1350.00 | |
| Each Additional CO-PI | $160.00 | |
| Each Additional Staff Member | $45.00 | |
| Each Additional Consent Form | $275.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $425.00 – $525.00 | |
| Additional iterations of submission post full board review | $450.00 | |
| Adverse Events (If physician review not required) | $385.00 | |
| Adverse Events (Physicians Review Required) | $525.00 | |
| Protocol Deviations (If physician review not required) | $1,100.00 | |
| Protocol Deviations (physician review required) | $1,375.00 | |
| Minor Mitigated Conflict of Interest | $310.00 | |
| Major Conflict of Interest Fee (If reviewed with other FB studies/reviewed by already convened board) | $700.00 | |
| Each Additional Conflict of Interest Fee | $160.00 | |
| Greater than Minimal Risk Studies | DSMP Summary review | $750.00 |
| Adverse Event Table Review | $500.00-$2000.00 depending on number of AE’s | |
| Any level study | Spot Audit Review (review at IRB discretion to confirm protocol adherance) | $950 |
| International Amendments/Modification |
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| Review of Protocol Modifications | $625.00 | |
| Review of Consent Modifications/Each Form | $275.00 | |
| Review of Advertisements or Other Documents Post-Approval/EACH Form | $160.00 | |
| Review of EACH Additional/Modified Study Personnel | $160.00 | |
| Review of EACH Personnel Removal | $45.00 | |
| Physician Review of COVID-19 Saftey/Rrecautions for Face to Face Activities | $825.00 | |
| Review of Each Translation attestation/certificates | $80.00 | |
| International Annual Check-Ins |
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| Annual Report Study Continuation | $1,025.00 | |
| Annual Report Study Continuation for Additional Sites | $575.00 | |
| Expired Study Fee (If annul check-in report is submitted after expiration- or Study team allows study to expire after report has been submitted) | $750.00+ Annual Check in Fee | |
| Expired Study Fee (If study closure report is submitted by study team after expiration) | $1100.00(Late Fee)+ $500.00 (Admin Fee) =$1600.00 Total | |
| Expired Study Fee (If study is administratively closed due to no response from study team) | $1100.00(Late Fee)+ $500.00 (Admin Fee) =$1600.00 Total | |
| Review of Each Study Closure | $185.00 | |
| Consultation Services | ||
| Minor Consultation | $325.00 | |
| Moderate Consultation | $605.00 | |
| Extensive Consultation | $900.00 | |
| Phycisian Consultation | $1,375.00 | |
| Administrative\Technical Consultation | $125.00 | |
| Legal Consultaiton | $300.00/hour with a $1,500.00 Retainer | |
| Other Service Fees | ||
| IRB of Record Letter or Letter of Intent Review | $310.00 | |
| Certified Translation Services | Cost – plus 20% | |
| Administrative services as required FDA Studies | Varies | |
| Adverse Event Investigation | $1000.00 Minimum + $300/hr if Extensive | |
| Investigation | $1000.00 Minimum + $300/hr if Extensive | |
| Audit of Clinical Study for cause | $1,500.00 | |
| Audit on Social Behavioral Study for cause | $1,000.00 | |
| Device Determination Verification of Non-Significant Risk | $675.00 | |
| Device Determination of Non-Significant Risk (If reviewed by the already convened board) | $1,200.00 | |
| Determination of IND | $1,500.00 | |
| Rapid Board Convening | $1,375.00 | |
| Full Board Review of Amendment (If reviewed with already convened board) | $675.00 | |
| Study Suspension by Already Convened Board | $1,250.00 | |
| Study Termination by Already Convened Board | $1,450.00 | |
| Investigation of Participant Complaints | $300.00/Hour Plus Expenses ($450/hr if physician review required) | |
| Physician Safety Review | $825.00 | |
| DoD Funded Research Review | $3,250.00 | |
| Reliance Agreement Fees | ||
| Reliance review (Includes 1 principal investigator credential review and 1 consent form) | $910.00 | |
| EACH Additional Personnel | $160.00 | |
| Each Additional Consent Form | $160.00 |
Fees subject to change at any time without notice. This fee list is not suggestive of being comprehensive.