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 $625.00

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) $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
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

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
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

Initial Review Fees 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) $1,425.00
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
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
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

Annual Report Study Continuation $815.00
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

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
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
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
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 $1,115.00
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)

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
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
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
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 $1,140.00
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

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

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
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
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
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 $1,115.00
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

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 $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.