Fees subject to change at any time without notice
Current Fees:
|
|
Description |
Cost |
|
Review for non-human-subjects determination |
Evaluation of protocol for human subjects research determination. Additional fee for co-principal investigators (see below). |
$250.00 |
|
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 |
|
|
|
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 |
|
| International Research Same as above, validation of international sites and requirements. Additional fee for co-principal investigators (see below).
|
$1,500.00 |
Fees subject to change at any time without notice