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 | $625.00 |
| 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. | $925.00 |
| Each Additional CO-PI | $175.00 | |
| Each Additional Staff Member | $45.00 | |
| Each Additional Consent Form | $175.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $350.00-$550.00 | |
| Adverse Events (If physician review not required) | $340.00 | |
| Adverse Events (Physician Review Required) | $545.00 | |
| Protocol Deviations (If physician review not required) | $900.00 | |
| Protocol Deviations (physician review required) | $1,250.00 | |
| Minor Mitigated Conflict of Interest | $340.00 | |
| Major Conflict of Interest Fee (If reviewed with other FB studies/reviewed by already convened board) |
$760.00 | |
| EACH Additional Conflict of Interest Fee | $170.00 | |
| Exempt Amendments/Modification | ||
| Review of Protocol Modifications | $360.00 | |
| Review of Consent Modifications/Each Form | $175.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $175.00 | |
| Review of each additional/modified study personnel | $175.00 | |
| Review of EACH Personnel Removal | $45.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| 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. | $1,360.00 |
| Each Additional CO-PI | $175.00 | |
| Each Additional Staff Member | $45.00 | |
| Each Additional Consent Form | $175.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $355.00-$550.00 | |
| Adverse Events (If physician review not required) | $340.00 | |
| Adverse Events (Physician review required) | $545.00 | |
| Protocol Deviations (If physician review not required) | $900.00 | |
| Protocol Deviations (Physician review required) | $1,250.00 | |
| Minor Mitigated Conflict of Interest Fee | $340.00 | |
| Major Conflict of Interest Fee (if reviewed by an already convened board) | $760.00 | |
| EACH Additional Conflict of Interest Fee | $175.00 | |
| Initial Review of Additional site (expedited multi-site studies) | Review of Principal Investigator and 1 Location | $680.00 |
| Expedited Amendments/Modification | ||
| Review of Protocol Modifications | $370.00 | |
| Review of Consent Modifications/Each Form | $175.00 | |
| Review of Advertisements or Other Documents Post-Approval/EACH form | $175.00 | |
| Review of EACH Additional/Modified Study Personnel | $175.00 | |
| Review of EACH Personnel Removal | $45.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| Expedited Annual Check-Ins |
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| Annual Report Study Continuation | $815.00 | |
| Annual Report Study Continuation for Additional Sites | $455.00 | |
| Expired Study Fee (If annul check-in report is submitted after expiration- or Study team allows study to expire after report has been submitted) | $600.00 + Annual Check-In Fee | |
| Expired Study Fee (If study closure report is submitted by study team after expiration) | $600.00 | |
| Expired Study Fee (If study is administratively closed due to no response from Study team) | $600.00(Late Fee)+ $550.00 (Admin Fee) =$1150.00 Total | |
| Review of EACH Study Closure | $155.00 | |
| 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. | $2335.00 |
| Each Additional CO-PI | $175.00 | |
| Each Additional Staff Member | $45.00 | |
| Each Additional Consent Form | $300.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $405.00-$515.00 | |
| Additional Iterations of Submission Post Full Board Review | $465.00 | |
| Adverse Events (Physician review not required) | $340.00 | |
| Adverse Events (Physician Review Required) | $545.00 | |
| Protocol Deviations (Physician review not required) | $1030.00 | |
| Protocol Deviations (Physician review required) | $1360.00 | |
| Minor Mitigated Conflict of Interest Fee | $340.00 | |
| Major Conflict of Interest Fee | $760.00 | |
| EACH Additional Conflict of Interest Fee | $175.00 | |
| Initial Review of Additional Site (Full Board Multi-Site Studies) | Review of Principal Investigator and 1 Location | $855.00 |
| Full Board (Non-Clinical) Amendments/Modification |
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| Review of Protocol Modifications | $660.00 | |
| Review of Consent Modifications/Each Form | $300.00 | |
| Full Board Review of Amendment (If reviewed with already convened board) | $725.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $175.00 | |
| Review of EACH Additional/Modified Study Personnel | $175.00 | |
| Review of EACH Personnel Removal | $50.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| Full Board (Non-Clinical) Annual Check-Ins |
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| Annual Report Study Continuation | $1,115.00 | |
| Annual Report study continuation for additional sites | $635.00 | |
| Expired Study Fee (If annul check-in report is submitted after expiration- or Study team allows study to expire after report has been submitted) | $705.00+ Annual check-in fee | |
| Expired Study Fee (If study closure report is submitted by study team after expiration) | $600.00 | |
| Expired Study Fee (If study is administratively closed due to no response from study team) | $545.00(late fee)+$545.00(Admin fee) =$1,090.00 Total | |
| Review of Each Study Site Closure | $200.00 | |
| 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. | $2,770.00 |
| Each Additional CO-PI | $175.00 | |
| Each Additional Staff Member | $50.00 | |
| Each Additional Consent Form | $300.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $410.00-$515.00 | |
| Additional Iterations of Submission Post Full Board Review | $460.00 | |
| Adverse Events (If physician review not required) | $355.00 | |
| Adverse Event (Physician Review Required) | $570.00 | |
| Protocol Deviations (If physician review not required) | $895.00 | |
| Protocol Deviations (physician review required) | $1,195.00 | |
| Minor Mitigated Conflict of Interest | $340.00 | |
| Major Conflict of Interest Fee | $760.00 | |
| Each Additional Conflict of Interest Fee | $175.00 | |
| Greater than Minimal Risk Studies | DSMP Summary review | $815.00 |
| Adverse Event Summary Report Review | $500.00-$2170.00 depending on number of AE’s | |
| Spot Audit Review (review at IRB discretion to confirm protocol adherence) | $1030.00 | |
| Full Board (Clinical) Amendments/Modification |
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| Review of Protocol Modifications | $655.00 | |
| Review of Consent Modifications/Each Form | $300.00 | |
| Review of Advertisements or other documents post-approval/Each Form | $170.00 | |
| Full Board Review of Amendment (If reviewed with already convened board) | $735.00 | |
| Review of EACH Additional/Modified Study Personnel | $170.00 | |
| Review of EACH Personnel Removal | $50.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| Initial Review of Additional Site (Full Board Multi-Site Studies) | Review of Principal Investigator and 1 Location | $1,200.00 |
| Full Board (Clinical) Annual Check-Ins |
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| Annual Report Study Continuation | $1,140.00 | |
| Annual Report Study Continuation for Additional Sites | $775.00 | |
| Expired Study Fee (If annul check-in report is submitted after expiration- or Study team allows study to expire after report has been submitted) | $925.00+ Annual Check-In Fee | |
| Expired Study Fee (If study closure report is submitted by study team after expiration) | $895.00 | |
| Expired Study Fee (If study is administratively closed due to no response from study team) | $1085.00(Late Fee)+ $545.00 (Admin Fee) =$1630.00 total | |
| Review of Each Study Site Closure | $200.00 | |
| International Study Fees | Initial review and validation of international sites and requirements. Please see bottom of page for other possible service fees. | $2,445.00 |
| Full Board Review of Social Behaivoral International Study | Full Board non-clinical study + $1030.00 | |
| Full Board Review of Clinical International Study | Full Board Clinical Study Fee + $1465.00 | |
| Each Additional CO-PI | $175.00 | |
| Each Additional Staff Member | $50.00 | |
| Each Additional Consent Form | $300.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $460.00 – $570.00 | |
| Additional iterations of submission post full board review | $490.00 | |
| Adverse Events (If physician review not required) | $420.00 | |
| Adverse Events (Physicians Review Required) | $570.00 | |
| Protocol Deviations (If physician review not required) | $1,195.00 | |
| Protocol Deviations (physician review required) | $1,495.00 | |
| Minor Mitigated Conflict of Interest | $340.00 | |
| Major Conflict of Interest Fee (If reviewed with other FB studies/reviewed by already convened board) | $760.00 | |
| Each Additional Conflict of Interest Fee | $175.00 | |
| Greater than Minimal Risk Studies | DSMP Summary review | $815.00 |
| Adverse Event Table Review | $545.00-$2175.00 depending on number of AE’s | |
| Any level study | Spot Audit Review (review at IRB discretion to confirm protocol adherance) | $1035.00 |
| International Amendments/Modification |
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| Review of Protocol Modifications | $675.00 | |
| Review of Consent Modifications/Each Form | $300.00 | |
| Review of Advertisements or Other Documents Post-Approval/EACH Form | $175.00 | |
| Review of EACH Additional/Modified Study Personnel | $175.00 | |
| Review of EACH Personnel Removal | $50.00 | |
| Physician Review of COVID-19 Saftey/Rrecautions for Face to Face Activities | $900.00 | |
| Review of Each Translation attestation/certificates | $90.00 | |
| International Annual Check-Ins |
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| Annual Report Study Continuation | $1,115.00 | |
| Annual Report Study Continuation for Additional Sites | $625.00 | |
| Expired Study Fee (If annul check-in report is submitted after expiration- or Study team allows study to expire after report has been submitted) | $815.00+ Annual Check in Fee | |
| Expired Study Fee (If study closure report is submitted by study team after expiration) | $1195.00(Late Fee)+ $545.00 (Admin Fee) =$1740.00 Total | |
| Expired Study Fee (If study is administratively closed due to no response from study team) | $1195.00(Late Fee)+ $545.00 (Admin Fee) =$1740.00 Total | |
| Review of Each Study Closure | $200.00 | |
| Consultation Services | ||
| Minor Consultation | $355.00 | |
| Moderate Consultation | $655.00 | |
| Extensive Consultation | $975.00 | |
| Phycisian Consultation | $1,495.00 | |
| Administrative\Technical Consultation | $135.00 | |
| Legal Consultaiton | $325.00/hour with a $1,700.00 Retainer | |
| Brief legal consultation/check | $200.00 | |
| Other Service Fees | ||
| IRB of Record Letter or Letter of Intent Review | $340.00 | |
| Certified Translation Services | Cost – plus 20% | |
| Administrative services as required FDA Studies | Varies | |
| Adverse Event Investigation | $1085.00 Minimum + $325/hr if Extensive | |
| Investigation | $1085.00 Minimum + $325/hr if Extensive | |
| Audit of Clinical Study for cause | $1,625.00 | |
| Audit on Social Behavioral Study for cause | $1,085.00 | |
| Device Determination Verification of Non-Significant Risk | $735.00 | |
| Device Determination of Non-Significant Risk (If reviewed by the already convened board) | $1,315.00 | |
| Determination of IND | $1,630.00 | |
| Rapid Board Convening | $1,495.00 | |
| Full Board Review of Amendment (If reviewed with already convened board) | $735.00 | |
| Study Suspension by Already Convened Board | $1,360.00 | |
| Study Termination by Already Convened Board | $1,575.00 | |
| Investigation of Participant Complaints | $815.00 | |
| Physician Safety Review | $865.00 | |
| DoD Funded Research Review | $3,525.00 | |
| Reliance Agreement Fees | ||
| Reliance review (Includes 1 principal investigator credential review and 1 consent form) | $990.00 | |
| EACH Additional Personnel | $175.00 | |
| Each Additional Consent Form | $175.00 |
Fees subject to change at any time without notice. This fee list is not suggestive of being comprehensive.