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.
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
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US Research, Review of IRB Exemption |
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| Initial Review Fees | 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) | $975.00 | |
| 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 | ||
| Vulnerable Population Fee | $195.00 | ||
| 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 | ||
| Regulatory Oversight Fee- (FDA/OHRP) | $750.00 | ||
| EACH Additional Conflict of Interest Fee | $170.00 | ||
| Brief Legal Consultation/ Check | $200.00 | ||
| Additional Revisions Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $350.00-$550.00 | ||
| Review of revisions- 30+ days | $300.00 | ||
| Reportable Information | 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 | ||
| 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
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US Research, Expedited Review |
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| Initial Review Fees | Initial Review- Social Behavioral (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) | $1,500.00 | |
| Initial Review- Clinical (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) | $1,800.00 | ||
| 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 | ||
| 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 | ||
| Other Possible Initial Review Fees | Physician Safety/Ingredient Review | $865.00 | |
| DoD Funded Research Review | $3,525.00 | ||
| Regulatory Oversight Fee- (FDA/OHRP) | $750.00 | ||
| 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 | ||
| Brief Legal Consultation/ Check | $200.00 | ||
| Additional Iterations (2nd, 3rd, 4th iterations, if required after initial review. Fee dependent upon extent) | $355.00-$550.00 | ||
| Review of revisions- 30+ days | $400.00 | ||
| Reportable Information | 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 | ||
| 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 | ||
| ACI Regulatory Oversight Fee-(FDA/OHRP/DoD) | $250.00 | ||
| Annual Report Study Continuation for Additional Sites | $455.00 | ||
| Expired Study Fee | $650.00 | ||
| Review of EACH Study Closure | $155.00 | ||
US Research, Full Board Review Social Behavioral
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US Research, Full Board Review Social Behavioral |
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| Initial Review Fees | Initial review + convened board meeting (includes one informed consent and includes one iteration from 2 primary reviewers) | $2,450.00 | |
| 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 | ||
| Vulnerable Population Fee | $195.00 | ||
| Minor Mitigated Conflict of Interest Fee | $340.00 | ||
| Major Conflict of Interest Fee | $760.00 | ||
| EACH Additional Conflict of Interest Fee | $175.00 | ||
| Other Possible Initial Review Fees | Physician Safety/Ingredient Review | $865.00 | |
| DoD Funded Research Review | $3,525.00 | ||
| Regulatory Oversight Fee- (FDA/OHRP) | $750.00 | ||
| 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 | ||
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Brief Legal Consultation/ Check |
$200.00 | ||
| 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 | ||
| Review of revisions- 30+ days | $500.00 | ||
| Initial Review of Additional Site (Full Board Multi-Site Studies) | Review of Principal Investigator and 1 Location | $855.00 | |
| Reportable Items | Adverse Events (Physician review not required) | $340.00 | |
| Adverse Events (Physician Review Required) | $545.00 | ||
| Protocol Deviations (Physician review not required) | $1,030.00 | ||
| Protocol Deviations (Physician review required) | $1,360.00 | ||
| Full Board (Non-Clinical) Amendments/Modification | |||
| 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 | ||
| Greater than minimal risk studies-Full Board Review of Amendment (If reviewed with already convened board) | $735.00 | ||
| Full Board (Non-Clinical) Annual Check-Ins | |||
| Annual Report Study Continuation- No Greater than Minimal Risk Studies | $1,140.00 | ||
| Annual Report Study Continuation- Greater than Minimal Risk Studies | $1,450.00 | ||
| Annual Report study continuation for additional sites | $635.00 | ||
| Expired Study Fee | $650.00 | ||
| Review of Each Study Site Closure | $200.00 | ||
US Research, Full Board Review (Clinical)
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US Research, Full Board Review (Clinical) |
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| Initial Review Fees | Initial review + convened board meeting (Includes one informed consent and includes one iteration from 2 primary reviewers) | $2,900.00 | |
| Each Additional CO-PI | $175.00 | ||
| Each Additional Staff Member | $50.00 | ||
| Each Additional Consent Form | $300.00 | ||
| Vulnerable Population Fee | $195.00 | ||
| Minor Mitigated Conflict of Interest | $340.00 | ||
| Major Conflict of Interest Fee | $760.00 | ||
| Each Additional Conflict of Interest Fee | $175.00 | ||
| Review of Each Translation attestation/certificates | $90.00 | ||
| Other Possible Initial Review Fees | Physician Safety/Ingredient Review | $865.00 | |
| DoD Funded Research Review | $3,525.00 | ||
| Regulatory Oversight Fee- (FDA/OHRP) | $750.00 | ||
| 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 | ||
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Brief Legal Consultation/ Check |
$200.00 | ||
| 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 | ||
| Review of revisions- 30+ days | $500.00 | ||
| Reportable Information | 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 | ||
| Full Board (Clinical) Amendments/Modification | |||
| 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 | ||
| Greater than minimal risk studies-Full Board Review of Amendment (If reviewed with already convened board) | $735.00 | ||
| 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 | |||
| Annual Report Study Continuation- No Greater than Minimal Risk Studies | $1,140.00 | ||
| Annual Report Study Continuation- Greater than Minimal Risk Studies | $1,450.00 | ||
| ACI Regulatory Oversight Fee-(FDA/OHRP/DoD) | $250.00 | ||
| Annual Report Study Continuation for Additional Sites | $775.00 | ||
| Greater than minimal risk studies- DSMP Summary review | $815.00 | ||
| Greater than minimal risk studies-Adverse Event Summary Report Review | $500.00-$2170.00 depending on number of AE’s | ||
| Greater than minimal risk studies-Spot Audit Review (review at IRB discretion to confirm protocol adherance) | $1,030.00 | ||
| Expired Study Fee | $650.00 | ||
| Review of Each Study Site Closure | $200.00 | ||
International Study Fees
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International Study Fees |
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| Initial Review Fees | Initial review and validation of international expedited sites and requirements. | $2,445.00 | |
| Full Board Review of Social Behaivoral International Study | Full Board non- clinical study +
$1030.00 |
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| Full Board Review of Clinical International Study | Full Board Clinical Study Fee +
$1465.00 |
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| 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 | ||
| Vulnerable Population Fee | $195.00 | ||
| 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 | ||
| Other Possible Initial Review Fees | Physician Safety/Ingredient Review | $865.00 | |
| DoD Funded Research Review | $3,525.00 | ||
| Regulatory Oversight Fee- (FDA/OHRP) | $750.00 | ||
| 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 | ||
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Brief Legal Consultation/ Check |
$200.00 | ||
| 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 | ||
| Review of revisions- 30+ days | $500.00 | ||
| Reportable Items | 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 | ||
| International Amendments/Modification | |||
| 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 | ||
| Greater than minimal risk studies-Full Board Review of Amendment (If reviewed with already convened board) | $735.00 | ||
| International Annual Check-Ins | |||
| Annual Report Study Continuation- No Greater than Minimal Risk Studies | $1,200.00 | ||
| Annual Report Study Continuation- Greater than Minimal Risk Studies | $1,500.00 | ||
| ACI Regulatory Oversight Fee-(FDA/OHRP/DoD) | $250.00 | ||
| Annual Report Study Continuation for Additional Sites | $625.00 | ||
|
Greater than minimal risk studies- DSMP Summary review |
$815.00 | ||
|
Greater than minimal risk studies-Adverse Event Table Review |
$545.00-$2175.00 depending on number of AE’s | ||
|
Any Level of Review-Spot Audit Review (review at IRB discretion to confirm protocol adherance) |
$1,035.00 | ||
| Expired Study Fee | $650.00 | ||
| 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
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Other Service Fees |
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| 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 |
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| Study Suspension Fee | $2,000.00 | ||
| Investigation | $2500.00 Minimum
+ $325/hr if Extensive |
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| IRB Administrative Investigation Conference 30 Minute | $500.00 | ||
| Board Convening for Review of a Social Behavioral Suspension/Investigation | $2,000.00 | ||
| Board Convening for Review of a Clinical Suspension/Investigation/Appeal | $2,500.00 | ||
| Appeal of Board Determination | $2,500.00 | ||
| Audit of Clinical Study for cause | $2,850.00 | ||
| Audit on Social Behavioral Study for cause | $2,500.00 | ||
| 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 | ||
| Investigation of Participant Complaints | $300.00/Hour Plus Expenses ($450/hr if physician review required) | ||
| Physician Safety/Ingredient Review | $865.00 | ||
| DoD Funded Research Review | $3,525.00 | ||
Fees subject to change at any time without notice. This fee list is not suggestive of being comprehensive.