If you have any questions about the application process, please feel free to call or email Carrie Faubert at (807) 684-6359 or researchprogram@tbh.net.

How to Obtain Institutional Authorization from the Research Program:

Step 1 – The Researcher must submit the following to researchprogram@tbh.net:

  1. A completed and signed Research Program Application
  2. Project Protocol (stand-alone study design)
  3. Other study documents as required (informed consent forms, recruitment materials, data abstraction forms etc.)
  4. The Research Ethics Board (REB) application for the REB of record (one of the following): the TBRHSC REB, the Lakehead University (LU) REB, or the REB of record through Clinical Trials Ontario (CTO).

Step 2 – The Research Program will review the initial submission to determine whether all requirements for institutional authorization have been met. Requirements are identified based on organizational policies as well as accepted standard guidelines for Good Clinical Practices. The below listed elements of the Research Program review encompass all requirements:

  • Organizational Impact Approvals
  • Funding, Contracts & Agreements
  • Researcher Training & Access
  • Scientific & Strategic Merit
  • Study Documents & Implementation
  • Ethics & Regulatory Approvals

The Research Program will send review requests to the Researcher via email within 5-10 business days of initial submission to ensure any outstanding requirements are addressed.

The following are examples of requests Researchers may receive:

  • “Please complete and submit the attached training requirements along with your TCPS2 certificate.”
  • “Please clarify your local implementation plan for recruitment and consent, detailing any impacted departments or units.”
  • “Please submit a signed contract and budget for the project.”

Note: The Research Program will promptly communicate any further requests to the Researcher as they are identified.

Step 3 - The Researcher must address all review requirements communicated by the Research Program. If all requirements are not addressed, or if further requests are identified, the project or project amendment will cycle back through Steps 2 and 3.

Step 4 – When the Researcher has provided the required information or documents, and all Research Program requirements have been satisfied, the project will be recommended for final review and authorization by the EVP Research and Development at TBRHSC. If final requests are identified these will be communicated to the researcher as soon as available, or within 5-10 business days.

Step 5 – Institutional authorization for projects and project amendments is issued via email from the Research Program, (upon approval from the EVP Research and Development). It is the responsibility of the Researcher to ensure authorization is maintained from project initiation to project closure.

The Researcher is obligated to contact the Research Program at researchprogram@tbh.net under the following circumstances:

  • If the project changes (including changes to the protocol, study-related documents, local implementation strategy, or the research team). Note: You must not institute any amendments prior to approval from the REB of Record and Research Program Authorization.
  • When the project receives annual re-approval from the REB of Record
  • When the project is complete and a closure report has been acknowledged by the REB of Record
  • If the Researcher has any questions or requires assistance
Note: The Research Program strives to complete project and project amendment reviews efficiently. That being said, as with any application process a turnaround time is to be expected. Given the diversity in research occurring here at TBRHSC, turnaround times can vary from project to project. We encourage Researchers to contact us at any time during the application process for status updates.