Fees

Fees subject to change at any time without notice

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 $450.00
     
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) $650.00
  Each Additional CO-PI $125.00
  Each Additional Consent Form $125.00
  Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) $150.00
  Adverse Events (If physician review not required) $250.00
  Adverse Events (Physician Review Required) $375.00
  Protocol Deviations (If physician review not required) $250.00
  Protocol Deviations (physician review required) $375.00
  Minor Mitigated COI $250.00
  COI Fee
(If reviewed with other FB studies/reviewed by already convened board)
$550.00
  Additional COI Fee (Multiple COI) $125.00
Exempt Amendments/Modification    
  Review of Protocol Modifications $200.00
  Review of Consent Modifications/Each Form $125.00
  Review of Advertisements or other documents post-approval/Each Form $125.00
  Review of each additional/modified study personnel $125.00
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)  $925.00
  Each Additional CO-PI $125.00
  Each Additional Consent Form $125.00
  Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) $150.00
  Adverse Events (If physician review not required) $250.00
  Adverse Events (Physician Required) $375.00
  Protocol Deviations (If physician review not required) $250.00
  Protocol Deviations (physician required) $375.00
  Minor Mitigated COI $250.00
  COI Fee
(If reviewed with other FB studies/reviewed by already convened board)
$550.00
  Additional COI Fee
(Multiple COI)
$125.00
Initial Review of Additional site (expedited multi-site studies) Review of Principal investigator and 1 location $500.00
Expedited Amendments/Modification    
  Review of Protocol Modifications $200.00
  Review of Consent Modifications/Each Form $125.00
  Review of Advertisements or other documents post-approval/Each Form $125.00
  Review of each additional/modified study personnel $125.00
Expedited
Annual Check-Ins
   
  Annual Report study continuation $550.00
  Annual Report study continuation for additional sites $375.00
  Expired study fee (If Annul check-in report is submitted by study team after expiration) $150.00+ Annual check-in fee
  Expired study late fee (If study closure report is submitted by study team after expiration) $300.00
  Expired study fee (If study is administratively closed due to no response from Study team) $300.00(late fee)+ $200.00 (Admin fee) =$500.00 total
  Review of Each Study Closure $75.00
     
     
US Research, Full Board Review (Non-Clinical) Initial review + convened board meeting (includes one informed consent and includes one iteration from 2 primary reviewers) $1500.00
  Each Additional CO-PI $125.00
  Each Additional Consent Form $225.00
  Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) $250.00
  Additional iterations of submission post full board review $350.00
  Adverse Events (Physician review not required) $250.00
  Adverse Events (Physician Review Required) $375.00
  Protocol Deviations (Physician review not required) $250.00
  Protocol Deviations (Physician review required) $375.00
  Minor mitigate COI $250.00
  COI fee (If reviewed with other FB studies/reviewed by the already convened board) $550.00
  Additional COI fee (multiple COI) $125.00
Initial Review of Additional Site (Full Board Multi-Site Studies) Review of Principal Investigator and 1 Location $650.00
Full Board (Non-Clinical)
Amendments/Modification
   
  Review of Protocol Modifications $500.00
  Review of Consent Modifications/Each Form $225.00
  Review of Advertisements or other documents post-approval/Each Form $125.00
  Review of each additional/modified study personnel $125.00
Full Board (Non-Clinical)
Annual Check-Ins
   
  Annual Report study continuation $850.00
  Annual Report study continuation for additional sites $475.00
  Expired study fee (If Annul check-in report is submitted by study team after expiration) $150.00+ Annual check-in fee
  Expired study late fee (If study closure report is submitted by study team after expiration) $300.00
  Expired study fee (If study is administratively closed due to no response from Study team) $300.00(late fee)+$200.00(Admin fee) =$500.00 total
  Review of Each Study Site Closure $75.00
     
     
US Research, Full Board Review (Clinical) initial review + convened board meeting (includes one informed consent and includes one iteration from 2 primary reviewers) $1950.00
  Each Additional CO-PI $125.00
  Each Additional Consent Form $225.00
  Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) $250.00
  Additional iterations of submission post full board review $350.00
  Adverse Events (If physician review not required) $250.00
  Adverse Event (Physician Review Required) $375.00
  Protocol Deviations (If physician review not required) $250.00
  Protocol Deviations (physician review required) $375.00
  Minor Mitigated COI $250.00
  COI fee (If reviewed with other FB studies/reviewed by already convened board) $550.00
  Additional COI fee (multiple COI) $125.00
Full Board (Clinical)
Amendments/Modification
   
  Review of Protocol Modifications $500.00
  Review of Consent Modifications/Each Form $225.00
  Review of Advertisements or other documents post-approval/Each Form $125.00
  Review of each additional/modified study personnel $125.00
Initial Review of Additional Site (Full Board Multi-Site Studies) Review of Principal Investigator and 1 Location $650.00
Full Board (Clinical)
Annual Check-Ins
   
  Annual Report study continuation $850.00
  Annual Report study continuation for additional sites $475.00
  Expired study fee (If Annul check-in report is submitted by study team after expiration) $150.00+ Annual check-in fee
  Expired study late fee (If study closure report is submitted by study team after expiration) $300.00
  Expired study fee (If study is administratively closed due to no response from Study team) $300.00(late fee)+ $200.00(Admin fee) =$500.00 total
  Review of Each Study Closure $75.00
     
     
International Study Fees Initial Review and validation of international sites and requirements. $1750.00
  Full Board Review of International Study International fee + $450.00
  Each Additional CO-PI $125.00
  Each Additional Consent Form $225.00
  Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) $250.00
  Additional iterations of submission post full board review $350.00
  Adverse Events (If physician review not required) $250.00
  Adverse Events (Physicians Review Required) $375.00
  Protocol Deviations (If physician review not required) $250.00
  Protocol Deviations (physician review required) $375.00
  Minor Mitigated COI $250.00
  COI Fee (If reviewed with other FB studies/reviewed by already convened board) $550.00
  Additional COI Fee (Multiple COI) $125.00
International
Amendments/Modification
   
  Review of Protocol Modifications $500.00
  Review of Consent Modifications/Each Form $225.00
  Review of Advertisements or other documents post-approval/Each Form $125.00
  Review of each additional/modified study personnel $125.00
International
Annual Check-Ins
   
  Annual Report study continuation $850.00
  Annual Report study continuation for additional sites $475.00
  Expired study fee (If Annul check-in report is submitted by study team after expiration) $150.00+ Annual check-in fee
  Expired study late fee (If study closure report is submitted by study team after expiration) $300.00
  Expired study fee (If study is administratively closed due to no response from Study team) $300.00(late fee)+$200.00(Admin fee) =$500.00 total
  Review of each Study Closure $75.00
     
Consultation Services    
  Protocol consultation – minimal revisions $250.00
  Full protocol consultation – medium revisions $500.00
  Full protocol consultation – major revisions $750.00
     
Other Service Fees    
  Study Pre-Review (prior to formal submission, IRB of record letter) $250.00
  Certified Translation Services Cost – plus 20%
  Administrative services as required FDA Studies Varies
  Adverse Event Investigation $175.00/hour plus expenses
  Device Determination of non-significant risk $850.00
  If device determination requires Full Board Review (if reviewed with other FB studies/reviewed by the already convened board) $550.00
  Determination of IND $850.00
  Rapid Board Convening $1150.00
  Study suspension by already convened board $1000.00
  Study Termination by already convened board $1200.00
  Investigation of participant complaints Varies
  Reliance review (Includes 1 principal investigator credential review and 1 consent form) $750.00
  Each additional personnel $125.00
  Each additional consent form $125.00

Fees subject to change at any time without notice