Fees

Current Fees:

 

Includes

Cost

Review for non-human-subjects determination

Evaluation of protocol for human subjects research determination

$250.00

Review for IRB Exemption

Evaluation of protocol for exemption; if not exempt, cost applies toward further review

$550.00

US Research, Minimal Risk Studies

Initial review of protocolInitial review of site informationReview and/or minor modification of informed consent formReview of up to 3 proposed advertisements Review of PI credentials Review of modifications prior to approval

$850.00

US Research, Greater than Minimal Risk Studies (Non-Clinical)

US Research, Greater than Minimal Risk Studies (Clinical)

Same as above, plus convened meeting

 

Same as above, plus convened meeting, and verification of PI licensure

$1,350.00

$1750.00

International Research

Same as above, validation of international sites and requirements

$1,500.00

Changes or Modifications to Approved Research

Includes

Cost

Greater than Minimal Risk Studies

Review of protocol modification or amendment

$500.00

Review of revised or additional informed consent documents

$225.00

Review of advertisements or other documents post-approval

$125/doc

Minimal Risk Studies

Review of protocol modification or amendment

$200.00

Review of revised or additional informed consent documents

$125.00

Review of advertisements or other documents post-approval

$125.00

Continuing Review

Includes

Cost

Continuing review, minimal risk

$450.00

Continuing review, greater than minimal risk

$750.00

Continuing review, international

$750.00

Review of any interim reports

$75.00

Study closure

$25.00

Other Services

Includes

Cost

Certified Translation Services

Cost plus 20%

Site visit (if required by state regulation, nature of protocol, or for cause)

Cost + $500

Administrative services as required FDA Studies

Varies

 

 

Includes

Cost

 

Brief consultation (one time, up to 30 min)

$80.00

Consultation Services

Full protocol consultation – more than minimal risk

$500.00

 

Full protocol consultation – less than minimal risk

$300