Health Canada is currently considering changes to its requirement with respect to Research Ethics Board (REB) approval for sponsors of clinical investigations (i.e., investigational testing) involving medical devices. Due to the current Medical Device Regulations, the Medical Devices Bureau (MDB) cannot issue an authorization for investigational testing until evidence of REB approval has been received. Based on our experience, some REBs request an “Authorization Letter” from MDB before they approve a study at their institution. Industry stakeholders have expressed concerns about delays in the initiation of their clinical investigations due to these back and forth requests, and have pressed Health Canada to issue authorizations without prior REB approval.
To inform Health Canada’s analysis, we are seeking your views on the issue and have formulated questions of interest.
Would issuing a Health Canada “Authorization Letter” prior to REB approval facilitate your review?
• If so, why?
Do you foresee any negative impacts, risks or concerns if Health Canada were to authorize an Investigational Testing Authorizations (ITA) prior to REB approval?
In general, how frequently are changes made to the study documents (e.g., protocol, Informed Consent Form, labelling, etc.) with regard to the device information, study design, or other aspects, as a result of REB review?
• What are the most common changes?
• Do you consider these changes as significant in nature?
We would appreciate your feedback by March 23, 2018.
If you would like to discuss this project in more detail, please contact Alexandra Bray at [email protected]