Submission of a CORIHS application by the Principal Investigator (PI) for a pharmaceutical-sponsored (industry-sponsored), industry-initiated protocol means that:
- It is the intent of the sponsor and the PI to conduct the protocol at SBU;
- The sponsor is aware of, and has agreed to pay SBU:
- an institutional fee, in the amount of $750.00, if the IRB services of Chesapeake Research Review, Inc. (CRRI) are used. This fee is in support of SBU’s continuing responsibility for all administrative and regulatory compliance. This fee is separate from any IRB fee directly charged to the sponsor by CRRI.
OR
- a combined IRB/Institutional fee of $2,250.00 for full committee review, OR $950.00 for expedited review, if local IRBs (CORIHSa, CORIHSb) of SBU are used. This is a one-time fee which covers service for a time period consisting of initial approval and four (4) continuing review periods. Should the protocol last longer than five (5) years, a 5 year application will be completed for renewal. The then current IRB/Institutional fee will be charged unless a) the human subject aspects of the study are limited to data analysis OR b) enrollment has ended, subjects have completed all research-related intervention, AND the study is now limited to long-term follow-up of subjects.
- The sponsor understands that payment of the above applicable fee is not contingent on whether the protocol is approved or whether the protocol is funded;
- The PI and the Department Chair understand that if the sponsor fails to pay the fee (either to CRRI or SBU) within 90 days of initial review, the PI’s department will be responsible for payment using non-state funds of all accrued fees; AND
- The PI will provide invoicing information for the sponsor, including pharmaceutical name, sponsor contact person, address, phone, email and fax.
The "Authorization Form for Fee Collection" may be accessed on the SBU Forms page. This form must be submitted with the Approval Application if your research is industry-sponsored, industry-initiated.
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