Maintaining Ethics Approval
Human ethics and animal care approvals are issued for a maximum duration of 12 months for the protocol and corresponding documents as described in the application.
Changes to any aspect of a study during the approval period require approval from the appropriate REB/ACUC (i.e. a change in protocol, research methodology, recruitment of participants, participant population, consent form, etc.). Changes/updates can be submitted via an Amendment in the online system.
Ethics approval must be maintained for the entire duration of the activities requiring ethics certification, in other words while animals are being used or the researcher is interacting with participants or their data. For funded projects, this may or may not be the duration of the award. Funds are normally only accessible to the researcher if the REB and ACUC approvals are in place for the duration of those activities that require ethics approval.
Projects approved by ACUCs are also subject to Post Approval Monitoring (PAM). Projects will be randomly selected for formal PAM review, which could include a detailed review of SOPs, observation of procedures and/or a laboratory visit (the results of which are documented in the PAM tab in ARISE). Unannounced lab visits may occur at any time, wherever animals are present.
As part of the maintenance process, it is highly recommended that researchers regularly review their project staff permissions in ARISE and update staff access to protocols to reflect their current personnel.
It is the responsibility of the PI to renew his/her ethics approval through a renewal application in the ARISE system. The system will send three reminders to the PI prior to the expiration of the approval. If the researcher does not complete a renewal, the approval will expire. In the case of funded projects, the system will automatically notify the Research Services Office to inactivate the project, thus terminating access to funding.* Renewals should be initiated well before the expiry date to allow time for review. For animal use protocols, we recommend submitting 60 days before the protocol expires. For renewals with human participant research, we recommend submitting at least 2 weeks prior to the deadline.
*For projects involving animals, expiry notices are also sent to the relevant animal services unit.