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Fee CriteriaThe OHSN-REB review fees (initial, continuing review and major amendment) apply to studies meeting one of the following criteria:
The fees apply for the review of the application and not REB approval. The fee will have no impact on the Board's decision. The fee will be refunded if the submission is withdrawn prior to review. When the fee applies, and the amount, shall be determined at the sole discretion of the REB. Initial Review FeeA $3500 review fee is charged for the initial ethics review of Full Board and delegated applications meeting one of the fee criteria outlined above. A $500 review fee is charged for the initial ethics review of secondary use or database research applications meeting one of the criteria outlined above. The initial review fee may be increased due to complex design, such as multiple sub-studies included in the protocol. Continuing Review FeeA $500 fee is charged for each continuing review application of studies meeting one of the fee criteria outlined above. The annual fee covers the work associated with ongoing correspondence, i.e. continuing reviews, reportable events and minor amendments over the subsequent year. Major Amendment Fee (only applies if the initial ethics application was received on or after January 1, 2023)A $500 review fee is charged for major amendments of studies meeting one of the fee criteria outlined above. A $2500 review fee is charged for major amendments submitted for adaptive, basket, umbrella and platform trials meeting one of the fee criteria outlined above when the amendment involves the addition of new protocols, drugs, consent forms and/or other substantive changes. What is considered a “major” amendment?
Archived Review FeeA $100 fee will be charged to retrieve a closed and archived file. HOW TO PAY THE REVIEW FEE?Investigators are responsible for invoicing the company for ethics review fees and will manage the collection and payment process. Ethics review fees will be automatically charged to the investigator project cost centre upon completion of ethics review (rather than approval). For the initial ethics review fee, once the investigator receives the Institutional Approval letter, the cost centre will be available for eligible project expenses (e.g. for salary payments, Protocol-related procedures, etc.). The Investigator’s cost centre will temporarily be in “deficit” until the initial ethics review fee is paid by the company. How will the Investigator manage the collection and payment process?Option 1:
Option 2:
Ethics review fees are not subject to overhead. Investigator’s will be responsible for communicating ethics fee requirements to the company during budget negotiations. Please contact your financial analyst for assistance with this process. |