FAQ: Continuing Review

Answer
An amendment is a revision to an ongoing study. If the procedures and data collection described in the application for ethical review have been completed, changes that involve new procedures, new measures, or a new subject pool should be submitted in a new application for ethical review [IHC-GCP 1.45]. If you have any questions about when to submit an amendment or a new application, contact Dina Shafey, Research Ethics Coordinator.

Answer

Any change to the details described in the application and attached documents (including additions of new procedures and measures) should be submitted for review prior to their use. Amendments to Study:
• Amendments are changes to an ongoing study. If you are changing any part of the study (e.g. co-investigators, title, agency, documentation) you must submit an amendment.
• Amendments to studies should be changes within the scope of the original study, not new studies that are simply related to the original study.
• Amendments that involve adding procedures that are not considered minimal risk must be referred to the Full Board for review and approval. To submit such requests via the minor amendment system will create an unnecessary delay for the researcher.
• Any changes in the co-investigators (as opposed to research staff) must be accompanied by appropriately updated recruitment, consent, and any other materials given to subjects.
• Any changes to documents should be clearly explained in the PAA and highlighted on the attached, revised document.
• Where the amendment is limited to an 'administrative change' (e.g. changes in granting status, staff personnel, contact person, etc.), please include an explicit statement to the effect that the research procedures (including recruitment, consent, etc.) have not been changed in any way.

The following questions should be considered when proposing an amendment:
o Does the amendment affect the risk/benefit ratio?
o Does the amendment affect recruitment? If so, is a revised recruitment ad or letter attached?
o Does the amendment affect what the subject is asked to do or confidentiality of the data? If so, is a revised consent form attached?
o Does the consent form adequately reflect the change in time, risk, or confidentiality?
o When reviewed initially did the BREB have any significant concerns about this study that should be considered when reviewing the amendment?
o Briefly explain the rationale behind any changes in the protocol.

Answer

Annual renewal is not required if the researcher will have no further contact with subjects for the purpose of data collection or research (e.g. for follow-up or verification). Renewal is not required to analyze data or write a paper. Before the Certificate of Approval’s Expiry date declare to the FHREB by completing a Close-Out Notification that the remaining research no longer requires certification because all data collection procedures described in the previously approved project have been completed.

Article 6.1.4 of the TCPS states that “at minimum, continuing ethics review shall consist of an annual status report on the research, followed by an end-of-study report.”

Answer
Research that continues after the approval period expires is considered research conducted without REB approval. Research activities must stop, unless the REB determines that continued involvement is in the best interest of enrolled subjects who are still receiving study-related interventions. Continuing review applications must be submitted in sufficient time to ensure the non-interruption of studies.

Answer

A Request for Annual Renewal should be submitted prior to the expiry date on the current Certificate of Approval. The investigator will be sent an email reminder for renewal 2-8 weeks ahead of expiry. If you have not submitted a Request for Annual Renewal or a Close-Out Notification, the Certificate of Approval will be suspended.

FINAL NOTICE REGARDING REQUIRED RENEWAL OF ETHICAL APPROVAL
Failure to respond within four business days of the date of this notice, will result in the suspension of the Study, and in one or more of the following actions being taken:
• FHREB may hold the review/approval of current or future submissions by the Principal Investigator or the Department until the status of these studies has been addressed.
• The FHREB may be required to notify the funding agency/industry sponsor of the expiry of ethics approval for the study.
• The FHREB may terminate the ethical approval. Reactivation of the study thereafter would require a new application for ethical review.
• After due consultation with the REB Chair and senior administration, the funding for the study would be frozen.

Answer
Drug, device or natural health products studies that are regulated by Health Canada require 25-year study-related record retention. There are no defined regulations or standards for other research studies (i.e., non-regulated). The FHREB’s standard is five years for non-regulated studies.