Frequently Asked Questions (FAQs)
TAHSN BoR Application:
Q: I am a Principal Investigator at UofT and would like to conduct research at multiple TAHSN institutions. Can I apply to use the TAHSN Board of Record (BoR) process?
A: Only institutions whose REB has gone through a qualification process are eligible to apply through the TAHSN BoR model. To find out if your institution is qualified, or if your institution has qualified a particular TAHSN institution’s REB, please contact the TAHSN Navigator.
Q: I have submitted an application to use the TAHSN BoR to add a qualified TAHSN site to an existing REB-approved study. If my application is accepted, what approvals do I need before beginning the study at the new site?
A: The process does not change for studies who have already received an initial approval letter. You will still need to apply to the Lead REB, following their normal processes, to add a new site. If the Lead REB approves the addition of a new site, a new REB approval letter will be issued indicating the approval of the new site. You will not be able to begin your study at the new site until you have this new approval letter and a fully executed TAHSN BoR agreement.
Q: I am a Site Principal Investigator and was just informed by the Lead Applicant that our site is approved. They provided me with the Lead-REB-approved consent form – what changes can I make to the consent form?
A: As the Site Principal Investigator, only administrative changes can be made to the already approved consent form. Administrative changes can ONLY include centre specific logos, contact information and letter head.
Q: I am the Site Principal Investigator and have experienced a Reportable Event at our site. Do I submit to the Lead REB or does the Lead Applicant submit on my behalf?
A: You are responsible for submitting all local Reportable Events, privacy breaches, and protocol deviations to the Lead REB. The Lead Applicant is responsible for submitting amendments, revised consents, external and non-local Reportable Events, the Investigational Brochure and product monographs while you are responsible for the site-specific documents not previously submitted.
Q: As the Lead Applicant, am I responsible for submitting all material to be approved to the Lead REB on behalf of the sites for the duration of the study? Or do my responsibilities end after the initial Lead REB Approval/ TAHSN BoR Agreement?
A: As the Lead Applicant, you are responsible for submitting all study amendments, revised consents, changes to the Investigational Brochure, DSMB reports, etc. on behalf of all participating sites.