The University of Pennsylvania IRB charges fees to industry sponsors to cover the costs associated with the IRB's review and related administrative responsibilities.No fees are charged for studies funded by grants, non-profits, or internal funding.
Fees do not influence the decisions of the Board. When the IRB decides to table or disapprove a research protocol, no additional fee will be charged for reconsideration.
Research review fees fall into 2 categories: 1. Initial Review: $2400 2. Continuing Review: $1000
The actual costs of the review are still incurred if subjects are never enrolled, the study closes before milestones are met, expenditures exceed revenue, or a contract is never finalized.
The fees should be included in contract negotiations, including initial review whether the study contract is finalized or not; they should be a line item in the budget of the formal contract as an upfront and non-refundable item. ORS will help you with this if needed. An invoice is sent to the sponsor representative, and is considered due and payable upon receipt by the sponsor.Please note that an invoice will be sent to the industry sponsor at the time the protocol is set for review on the IRB agenda, and in conjunction with the annual continuing review.
The information needed by the IRB to complete the billing should be included in the HS ERA application section regarding sponsorship.This should be included at the initial submission, whether the contract is pending or not.The application should also be updated when the contract is complete, that is, changed from pending to finalized.The information requested includes name and contact information of the sponsor as well as information on the CRO, if any.Please be sure to clearly indicate to whom the invoices should be sent; this is the final question in the sponsor section.
