Fees

Fees subject to change at any time without notice

Current Fees:

Description

Cost

Review for IRB Exemption

Evaluation of protocol for exemption; if not exempt, cost applies toward further review. Additional fee for co-principal investigators (see below).

$550.00

*Exempt or Expedited review, Additional iterations of submission for revision (2nd, 3rd, 4th iterations, if required after initial review).

Expedited 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. Additional fee for co-principal investigators (see below).

$850.00

*Exempt or Expedited review, Additional iterations of submission for revision (2nd, 3rd, 4th iterations, if required after initial review).

US Research, Full Board Review (Non-Clinical)

Same as above, plus convened meeting. Additional fee for co-principal investigators (see below).

Includes one informed consent.

Includes one iteration from 2 primary reviewers.

$1,455.00

US Research, Full Board Review (Clinical)

Same as above, plus convened meeting, and verification of PI licensure. Additional fee for co-principal investigators (see below).

$1950.00

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

Review of Principle Investigator and 1 Location

$650.00

*Additional iterations of submission full board meeting submission (2nd, 3rd, 4th iterations, if required after initial review)

$250.00

*Additional iterations of submission post full board review

$350.00

Protocol consultation, minimal revisions

$250.00

Protocol consultation, medium revisions

$500.00

Protocol consultation, major revisions

$750.00

Changes or Modifications to Approved Research

Includes

Cost

Full board clinical or non-clinical 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

Exempt or Expedited 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\Annual Check-in

Includes

Cost

Continuing review\Annual Check-in, exempt/expedited

$450.00

Continuing review\Annual Check-in, Study that required full board review

$750.00

Continuing review\Annual Check-in, international

$750.00

Review of any interim reports

$75.00

Study closure

$25.00

Other Services

Study Pre-Review (prior to submission)

150.00

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

Study Personnel Changes

$125.00/per person

Minor Adverse Event

$125.00

Adverse Event Investigation

$175.00/hour plus expenses

Additional Investigators (Co-PI’s)

$125.00

Expired Study

$75.00

Review of advertisements or other documents post-approval

$125/doc

Device Determination of non significant risk

$500

Determination of IND

$500

COI Review Fee

$250

Additional COI Review Fee

$125

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

International Study Fees

Includes

Cost

Review of protocol modification or amendment

$500.00

Review of revised or additional informed consent documents

$225.00

Full Board Review of International Study

International fee + $450.00

International Research
Same as above, validation of international sites and requirements. Additional fee for co-principal investigators (see above).

$1,750.00

Fees subject to change at any time without notice