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.

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
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
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
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
Full Board (Clinical)
Amendments/Modification
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
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
International
Amendments/Modification
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
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
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
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.