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IRB Fees

FEE STRUCTURE FOR INDUSTRY SPONSORED SUBMISSIONS

The current Tulane University Human Research Protection Office’s (HRPO) fee structure for Industry Sponsored submissions became effective on July 1, 2018. Industry Sponsored studies submitted prior to July 1, 2018 should follow the fee structure in effect at the time of the original study approval. All Industry Sponsored Studies submitted on or after July 1, 2018 must follow the fee structure outlined here. The HRPO charges an administrative fee for document processing and IRB review of all Industry Sponsored human subjects research projects. Fees are due in full at the time of submission and are assessments of real costs associated with the HRPO pre-review and IRB review of submissions. These fees are non-refundable, regardless of whether the study is: assigned for IRB review; approved; withdrawn after submission to the HRPO; terminated before study milestones are met; has or has not enrolled participants; and/or has a finalized research contract.

Interdepartmental Transfer (IT) Forms:

The IRB fees must be paid to the office using the Oracle Access Manager via the TAMS E-IT Access Portal. The “Description” field must include the IRB Study Number, Principal Investigator’s Name, and IRB Study Title.

Convened Review Fees:

Initial Review Continuing Review Revisions initiated by the Sponsor IRB Authorization Agreements
$3000 $1500 $750 N/A

Expedited Review Fees:

Initial Review Continuing Review Revisions initiated by the Sponsor IRB Authorization Agreements
$3000 $1500 $750 N/A

Exempt Review Fees:

Initial Review Continuing Review Revisions initiated by the Sponsor IRB Authorization Agreements
$1000 N/A N/A N/A

Local Context Review Fees:

Initial Review Continuing Review Revisions initiated by the Sponsor IRB Authorization Agreements
$2750 $1250 $750 N/A

Notes:

1. Each additional study site for which the Tulane IRB exercises oversight will incur an additional fee of $500 for Initial Review, $350 for Continuing Review, and $275 for Revisions Initiated by the Sponsor.

2. Local Context Review fee applies to industry sponsored studies where the Tulane University IRB is not the IRB of record, but retains responsibility for local conduct and compliance oversight of the study.  

3. There are no IRB review fees for submissions sponsored by private or federal granting agencies or for non-industry sponsored Tulane investigator initiated submissions.

4. Sponsor initiated amendments require the payment of a $750 review fee.  Please note that amendments for local personnel changes, correspondence reviews and reviews of event reports are not charged a $750 fee. 

5. Fee Structure prior to July 1, 2018: Initial Review and Continuing Review industry sponsored submissions were charged a fee, regardless of whether or not the Tulane University IRB was the Lead IRB. There were no charges for Revisions Initiated by the Sponsor or IRB Authorization Agreements. Initial submissions were charged $2500 and Continuing Review submissions were charged $1000. For studies submitted prior to July 1, 2018, a $1000 IT Fee will continue to be charged at the time of Continuing Review, even if the Tulane University IRB is not the IRB of Record.

 

Natural code 8871 should be used when processing IRB fees for accounting purposes; it should be recorded using the Recharge and Recovery natural accounts. Please do not submit an IT using the previous codes of 6716 or 8811, as the IT will be returned and potentially delay your IRB submission.

 

Investigators are reminded to account for IRB fees during budget negotiations with industry sponsors. Please contact the HRPO at 504-988-2665 for any questions related to IRB Fees, not answered here.