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.