Fees

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 $925.00

US Research, Review of IRB Exemption

US Research, Review of IRB Exemption

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) $1,025.00
Each Additional CO-PI $175.00
Each Additional Staff Member $50.00
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)

$800.00
Regulatory Oversight Fee- (FDA/OHRP/DOE/DoJ) $750.00
EACH Additional Conflict of Interest Fee $175.00
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) $500.00
Adverse Events (Physician Review Required) $750.00
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

US Research, Expedited Review

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) $1,800.00
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) $2,100.00
Each Additional CO-PI $175.00
Each Additional Staff Member $50.00
Each Additional Consent Form $175.00
Review of Each Translation attestation/certificates $90.00
Vulnerable Population Fee $195.00
Minor Mitigated Conflict of Interest Fee $340.00
Major Conflict of Interest Fee (if reviewed by an already convened board) $800.00
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/DoE/DoJ) $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) $500.00
Adverse Events (Physician review required) $750.00
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 $750.00
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

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

US Research, Full Board Review Social Behavioral

Initial Review Fees Initial review + convened board meeting (includes one informed consent and includes one iteration from 2 primary reviewers) $2,750.00
Each Additional CO-PI $175.00
Each Additional Staff Member $60.00
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

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 $1,000.00
Reportable Items Adverse Events (Physician review not required) $500.00
Adverse Events (Physician Review Required) $750.00
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 $1,200.00
Annual Report Study Continuation- Greater than Minimal Risk Studies $1,525.00
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)

US Research, Full Board Review (Clinical)

Initial Review Fees Initial review + convened board meeting (Includes one informed consent and includes one iteration from 2 primary reviewers) $3,300.00
Each Additional CO-PI $175.00
Each Additional Staff Member $60.00
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/DoE/DoJ) $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) $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) $600.00
Adverse Event (Physician Review Required) $800.00
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 $175.00
Full Board Review of Amendment (If reviewed with already convened board) $735.00
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
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 $1,200.00
Annual Report Study Continuation- Greater than Minimal Risk Studies $1,525.00
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

International Study Fees

Initial Review Fees Initial review and validation of international expedited sites and requirements. $2,570.00
Initial review and validation of international expedited Clinical Single country $3,000.00
Full Board Review of Social Behavioral International Study Full Board non- clinical study +

$1030.00

Full Board Review of Clinical International Study Full Board Clinical Study Fee +

$1465.00

Review of each additional Country $500.00
Each Additional CO-PI $175.00
Each Additional Staff Member $60.00
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) $800.00
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/DoE/DoJ) $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) $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) $500.00
Adverse Events (Physicians Review Required) $750.00
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/Precautions 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 $1,525.00
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
Physician Consultation $1,495.00
Administrative\Technical Consultation $135.00

Legal Consultation

$350.00/hour with a $1,900.00 Retainer

Brief Legal Consultation/ Check

$200.00

Other Service Fees

Other Service Fees

IRB of Record Letter or Letter of Intent Review $375.00
Certified Translation Services Cost – plus 20%
Administrative services as required FDA Studies Varies
Adverse Event Investigation $1085.00 Minimum

+ $325/hr if Extensive

Study Suspension Fee $2,000.00
Investigation $2500.00 Minimum

+ $325/hr if Extensive

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 $1,050.00
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.