Shared Health Research and Innovation
MS7 820 Sherbrook Street
Winnipeg, MB R3A 1R9
Phone: (204) 926-7020
shresearch@sharedhealthmb.ca
January 20, 2023
SH2022:104
REB: B2022:049
Project Title: Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft
Device in Spinal Fusion - A Canadian, Multicenter, Post-Market Clinical Investigation
Dear Dr. P. Dhaliwal,
The Shared Health Approval Committee for Privacy, Impact and Access in Research has considered your
request for the above project. Your request is approved for impact.
The following documents were reviewed during the assessment of this project. Note that any changes to
documentation listed below will require re-review by this committee.
Document Name
Research Application
Research Application - Amendment
Protocol
Consent Form
Consent Form
Consent Form – COVID-19 Appendix
Questionnaire Appendix
Data Capture Sheet
Master List
Version and/or Date
Signed 30-May-2022
Signed 29-Nov-2022
31 Oct 2021
November 16th, 2022
1.0
May 2022
May 2022
1.0
1.0
Approval is subject to the following stipulations:
 Notification by Shared Health Research and Innovation, in writing, that the project may open for
services as outlined in the protocol and/or supporting documentation.
 Appropriate acknowledgement of Shared Health, the WRHA and/or affiliated organizations in any
peer-reviewed publications resulting from this study is required.
 For any results that may have an impact on the health system, a summary of the final results for
the study must be submitted to Shared Health Research and Innovation along with a copy of any
peer-reviewed publications arising from the study.
 For any results where Shared Health has contributed significant information, appropriate
interpretation and/or privacy review may be required prior to publication. Shared Health
Research and Innovation must receive notification, in writing to SHReserach@sharedhealthmb.ca,
at least thirty (30) calendar days in advance for intended publication in learned journals or thesis
presentations; and at least ten (10) calendar days prior notice is require for every poster or oral
presentation unless otherwise mutually agreed between Shared Health Research and Innovation
and Principal Investigator. If there is an agreement/contract with stipulations regarding these
conditions, the conditions within the agreement/contract will prevail.
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Shared Health Research and Innovation must receive notification, in writing, within thirty (30)
calendar days of project closure and/or termination.
A fully executed contract/agreement must be in place prior to the initiation of any study related
activities, if applicable.
A completed Request for Account Information Form must be submitted to Shared Health
Research and Innovation prior to activation, if applicable.
A copy of the UofM FAAF form is submitted to Shared Health Research and Innovation upon
submission to the UofM ORS.
All supplies required to provide the services outlined in the protocol and/or supporting
documentation must be on hand prior to project initiation.
The annual REB approval and study status report is submitted to Shared Health Research and
Innovation as it is received each year for the duration of the active study period.
All members of the research team have completed PHIA training, and will maintain this training,
renewing it every 3 years from date of issue, as required.
For any confirmed breech to privacy, any costs incurred by Shared Health/WRHA for the
investigation and/or ratification of the breech will be at the expense of the researcher.
Shared Health reserves to cancel and/or suspend services without notice based on availability to
provide required services.
All current Public Health measures/restrictions must be adhered to, including entering all health
care facilities and/or program spaces.
We look forward to working with you on your project.
Sincerely,
Laura Curtis on behalf of
Dr. Paul Beaudin, MSc-SLP, PhD
Director of Research and Innovation, Shared Health
Chair, Approval Committee for Privacy, Impact and Access in Research, WRHA & Shared Health
PB/lc