Fees

Fees subject to change at any time without notice

Current Fees:

Items

Descriptions

Cost

Determination of Non-Human Subject Research

Evaluation of 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 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)

 

 

$550.00

 

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

$125.00

 

Protocol Deviations

$125.00

 

COI Fee

$250.00

 

Additional COI Fee

$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)

 

 

$850.00

 

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

$125.00

 

Protocol Deviations

$125.00

 

COI Fee

$250.00

 

Additional COI Fee

$125.00

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

 

$450.00

 

If the study is allowed to expire

 

$75.00

 

Review of Study Closure

$25.00

 

 

 

US Research, Full Board Review (Non-Clinical)

Initial Review + Convened Board Meeting (Includes one informed consent and includes one iteration from 2 primary reviewers)

 

$1455.00

 

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

$125.00

 

Protocol Deviations

$125.00

 

COI Fee

$250.00

 

Additional COI Fee

$125.00

Initial Review of Additional Site (Full Board Multi-Site Studies)

Review of Principle 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

 

$750.00

 

If the study is allowed to expire

 

$75.00

 

Review of Study Closure

$25.00

 

 

 

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

$125.00

 

Protocol Deviations

$125.00

 

COI Fee

$250.00

 

Additional COI Fee

$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 Principle Investigator and 1 Location

 

$650.00

Full Board (Clinical)
Annual Check-Ins

 

 

 

Annual Report study continuation

 

$750.00

 

If the study is allowed to expire

 

$75.00

 

Review of Study Closure

$25.00

 

 

 

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

$125.00

 

Protocol Deviations

$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

 

Adverse Events

$125.00

 

Protocol Deviations

$125.00

 

COI Fee

$250.00

 

Additional COI Fee

$125.00

International
Annual Check-Ins

 

 

 

Annual Report study continuation

 

$750.00

 

If the study is allowed to expire

 

$75.00

 

Review of Study Closure

$25.00

 

 

 

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)

 

$150.00

 

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

 

$500.00

 

Determination of IND

$500.00

Fees subject to change at any time without notice