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	$500.00
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.	$715.00
	Each Additional CO-PI	$140.00
	Each Additional Consent Form	$140.00
	Additional iterations (2nd, 3rd, 4th iterations, if required after initial review)	$250.00 – $350.00
	Adverse Events (If physician review not required)	$275.00
	Adverse Events (Physician Review Required)	$425.00
	Protocol Deviations (If physician review not required)	$750.00
	Protocol Deviations (physician review required)	$1,000.00
	Minor Mitigated Conflict of Interest	$275.00
	Major Conflict of Interest Fee (If reviewed with other FB studies/reviewed by already convened board)	$625.00
	EACH Additional Conflict of Interest Fee	$140.00
Exempt Amendments/Modification
	Review of Protocol Modifications	$300.00
	Review of Consent Modifications/Each Form	$140.00
	Review of Advertisements or other documents post-approval/Each Form	$140.00
	Review of each additional/modified study personnel	$140.00
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.	$1,015.00
	Each Additional CO-PI	$140.00
	Each Additional Consent Form	$140.00
	Additional iterations (2nd, 3rd, 4th iterations, if required after initial review)	$250.00 – $350.00
	Adverse Events (If physician review not required)	$275.00
	Adverse Events (Physician Required)	$425.00
	Protocol Deviations (If physician review not required)	$750.00
	Protocol Deviations (physician required)	$1,000.00
	Minor Mitigated Conflict of Interest Fee	$275.00
	Major Conflict of Interest Fee	$625.00
	EACH Additional Conflict of Interest Fee	$140.00
Initial Review of Additional site (expedited multi-site studies)	Review of Principal investigator and 1 location	$550.00
Expedited Amendments/Modification
	Review of Protocol Modifications	$300.00
	Review of Consent Modifications/Each Form	$140.00
	Review of Advertisements or other documents post-approval/Each Form	$140.00
	Review of each additional/modified study personnel	$140.00
Expedited Annual Check-Ins
	Annual Report study continuation	$600.00
	Annual Report study continuation for additional sites	$420.00
	Expired study fee (If Annul check-in report is submitted by study team after expiration)	$500.00 + 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)	$500.00(Late Fee)+ $500.00 (Admin Fee) =$1000.00 Total
	Review of Each Study Closure	$125.00
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.	$1650.00
	Each Additional CO-PI	$140.00
	Each Additional Consent Form	$250.00
	Additional iterations (2nd, 3rd, 4th iterations, if required after initial review)	$275.00-$375.00
	Additional iterations of submission post full board review	$385.00
	Adverse Events (Physician review not required)	$275.00
	Adverse Events (Physician Review Required)	$425.00
	Protocol Deviations (Physician review not required)	$750.00
	Protocol Deviations (Physician review required)	$1,000.00
	Minor mitigate Conflict of Interest Fee	$275.00
	Major Conflict of Interest Fee	$625.00
	EACH Additional Conflict of Interest Fee	$140.00
Initial Review of Additional Site (Full Board Multi-Site Studies)	Review of Principal Investigator and 1 Location	$715.00
Full Board (Non-Clinical) Amendments/Modification
	Review of Protocol Modifications	$550.00
	Review of Consent Modifications/Each Form	$250.00
	Review of Advertisements or other documents post-approval/Each Form	$140.00
	Review of each additional/modified study personnel	$140.00
Full Board (Non-Clinical) Annual Check-Ins
	Annual Report study continuation	$935.00
	Annual Report study continuation for additional sites	$525.00
	Expired study fee (If Annul check-in report is submitted by study team after expiration)	$500.00+ Annual check-in fee
	Expired study late fee (If study closure report is submitted by study team after expiration)	$500.00
	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	$125.00
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.	$2,150.00
	Each Additional CO-PI	$140.00
	Each Additional Consent Form	$250.00
	Additional iterations (2nd, 3rd, 4th iterations, if required after initial review)	$275.00 – $375.00
	Additional iterations of submission post full board review	$385.00
	Adverse Events (If physician review not required)	$275.00
	Adverse Event (Physician Review Required)	$425.00
	Protocol Deviations (If physician review not required)	$750.00
	Protocol Deviations (physician review required)	$1,000.00
	Minor Mitigated Conflict of Interest	$275.00
	Major Conflict of Interest Fee	$625.00
	Each Additional Conflict of Interest Fee	$140.00
Full Board (Clinical) Amendments/Modification
	Review of Protocol Modifications	$550.00
	Review of Consent Modifications/Each Form	$250.00
	Review of Advertisements or other documents post-approval/Each Form	$140.00
	Review of each additional/modified study personnel	$140.00
Initial Review of Additional Site (Full Board Multi-Site Studies)	Review of Principal Investigator and 1 Location	$1,000.00
Full Board (Clinical) Annual Check-Ins
	Annual Report study continuation	$935.00
	Annual Report study continuation for additional sites	$650.00
	Expired study fee (If Annul check-in report is submitted by study team after expiration)	$750.00+ Annual check-in fee
	Expired study late fee (If study closure report is submitted by study team after expiration)	$750.00
	Expired study fee (If study is administratively closed due to no response from Study team)	$1,000.00(late fee)+ $500.00(Admin fee) =$1,500.00 total
	Review of Each Study Site Closure	$150.00
International Study Fees	Initial review and validation of international sites and requirements. Please see bottom of page for other possible service fees.	$1,925.00
	Full Board Review of International Study	International fee + $750.00
	Each Additional CO-PI	$140.00
	Each Additional Consent Form	$250.00
	Additional iterations (2nd, 3rd, 4th iterations, if required after initial review)	$325.00 – $425.00
	Additional iterations of submission post full board review	$400.00
	Adverse Events (If physician review not required)	$350.00
	Adverse Events (Physicians Review Required)	$450.00
	Protocol Deviations (If physician review not required)	$1,000.00
	Protocol Deviations (physician review required)	$1,250.00
	Minor Mitigated Conflict of Interest	$275.00
	Major Conflict of Interest Fee (If reviewed with other FB studies/reviewed by already convened board)	$625.00
	Each Additional Conflict of Interest Fee	$140.00
International Amendments/Modification
	Review of Protocol Modifications	$550.00
	Review of Consent Modifications/Each Form	$250.00
	Review of Advertisements or other documents post-approval/Each Form	$140.00
	Review of each additional/modified study personnel	$140.00
	Physician Review of COVID-19 Saftey/Rrecautions for Face to Face Activities	$750.00
International Annual Check-Ins
	Annual Report study continuation	$935.00
	Annual Report study continuation for additional sites	$525.00
	Expired study fee (If Annul check-in report is submitted by study team after expiration)	$750.00+ Annual check-in fee
	Expired study late fee (If study closure report is submitted by study team after expiration)	$1,000.00(Late Fee)+ $500.00 (Admin Fee) =$1,500.00 Total
	Expired study fee (If study is administratively closed due to no response from Study team)	$1,000.00(late fee)+$500.00(Admin fee) =$1,500.00 total
	Review of each Study Closure	$150.00
Consultation Services
	Minor Consultation	$275.00
	Moderate Consultation	$550.00
	Extensive Consultation	$825.00
	Phycisian Consultation	$1,250.00
Other Service Fees
	Study Pre-Review (prior to formal submission, IRB of record letter)	$275.00
	Certified Translation Services	Cost – plus 20%
	Administrative services as required FDA Studies	Varies
	Adverse Event Investigation	$250.00/hour plus expenses
	Device Determination Verification of Non-Significant Risk	$600.00
	Device Determination of Non-Significant Risk (If reviewed by the already convened board)	$1,000.00
	Determination of IND	$1,250.00
	Rapid Board Convening	$1,250.00
	Study suspension by already convened board	$1,100.00
	Study Termination by already convened board	$1,320.00
	Investigation of participant complaints	$250.00/Hour Plus Expenses ($400/hr if physician review required)
	Reliance review (Includes 1 principal investigator credential review and 1 consent form)	$825.00
	Each additional personnel	$140.00
	Each additional consent form	$140.00

Fees subject to change at any time without notice. This fee list is not suggestive of being comprehensive.