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Grand Round: RITHIM — A New Approach to Research in Manitoba

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Grand Round: RITHIM — A New Approach to Research in Manitoba

  2. 2. Conflict of Interest •Paul Beaudin - Member of Board of Directors, HSC Foundation •Rest of panel participants - No conflicts to disclose.
  3. 3. Freyja Arnason Director, Research ImprovementsThrough Harmonization in Manitoba
  4. 4. Karen Herd Deputy Minister, Manitoba Health and Seniors Care Jason Berry Acting Director for Information Management and Governance, Manitoba Health and Seniors Care
  5. 5. Strong support since 2015 • Strong support spans two different governments and multiple ministers • July 28, 2015 Letter to Chair of Research Manitoba from Minister of Health and Minister of Jobs and the Economy: • Interested in ensuring that local clinical trials research is successful • Rigorous AND efficient processes that balance privacy protection with access to key information to promote innovative research • Learn from other jurisdictions that have advanced this agenda • Position Manitoba as a site that welcomes clinical research
  6. 6. 2015 Mandate from the Ministers • Review and map existing administrative processes • Environmental scan of best practices in Canada and global • Work with stakeholders in clinical research to identify barriers and provide recommendations to improve the coordination and efficiency of clinical research administrative processes in Manitoba • Recommend the best mechanism that can build and administer research partnerships with industry
  7. 7. 2017 Research Manitoba Report to Ministers Issues: • Uncoordinated authority and governance • Variability in processes across the system • Lack of sufficient human resources Recommendations • Improving the process (one committee that does ethics, impact and privacy reviews in Winnipeg) • Identify an organizational designate for each specific approving organization • Standardization of submissions and processes • Training • Sustainable working groups to deal with challenges • Connect with national initiatives to keep current on leading practices • Investments in infrastructure and staffing
  8. 8. 2017 Research MB Meeting with Ministers • Research MB received the following endorsement from the ministers of health and economic development portfolios: • A streamlined provincial privacy approval committee that includes all Service Delivery Organizations (RHAs, CCMB, etc.) • A PHIA amendment required for this • Streamlined application form and technology tool that is automated at a provincial level • To reduce duplication of information collection • Allow transparent tracking to reduce the time used in the processes
  9. 9. 2021 Amendments to PHIA • Received Royal Assent on May 20, 2021, and are to be proclaimed into force in their entirety effective January 1, 2022. • Were developed based on a comprehensive review of the Act, which included public consultations. • Provides for the establishment of a single committee to review health research proposals, which require the disclosure of personal health information by a trustee, to replace the multiple committees established by trustees across the province for this purpose. • Proposed changes to the Personal Health Information Regulation are currently on the Manitoba Regulatory Consultation Portal. • Will be posted until December 6, 2021. • Required to operationalize the PHRPC/CHIPER process on January 1, 2022.
  10. 10. HIPC to PHRPC What is Changing? • Research Manitoba is taking over the role of providing administrative support to PHRPC. This will allow: • Coordinated communications and submissions. • Joint reviews between PHRPC and CHIPER. • Decisions from PHRPC and CHIPER to be provided at the same time.
  11. 11. HIPC to PHRPC Transition Plan • The last HIPC meeting is scheduled for December 15, 2021. • The nomination process for PHRPC is underway. Current HIPC members have been invited to participate on the PHRPC, which will require new appointments. • Any applications submitted to the HIPC before January that received conditional approval can still be approved by the HIPC for up to 1 year. • Amendments to research projects previously approved by the HIPC will be submitted to the PHRPC.
  12. 12. Dr. Paul Beaudin Director of Research and Innovation, Shared Health Manitoba
  13. 13. Paul Beaudin, PhD Director of Research and Innovation Shared Health November 2, 2021 Shared Health Research and Innovation Update for RITHIM
  14. 14. Shared Health Research and Innovation Moving Forward • Recent accomplishments • Shared Health and RITHIM 1. Role of Shared Health upon full implementation with PRAS 2. Phase 1 implementation on January 1, 2022 Introduction to Shared Health Research and Innovation • Research Current State – Hospital Perspectives • Shift in culture of research at Shared Health
  15. 15. Shared Health Research and Innovation Shared Health Research and Innovation HSC Hospital SH Administrative Supports Privacy, Legal, Supply Chain, HHR ‘Lead and Coordinate’ Clinical Preventive Services Service Delivery Organizations Provincial Services Breast Health Centre Diagnostic Services Digital Health Emergency Response Services Medical Assistance in Dying Mental Health and Addictions Tissue Bank Manitoba Transplant Manitoba Supports Research and Innovation Directly and Indirectly across Manitoba
  16. 16. Recent Accomplishments RITHIM Ready for 2022! Transition to Digital Operations New Research Contract Processes Engagement Internal and External Access to PHI for Research Committed to Continuous Improvements
  17. 17. Shared Health Research and Innovation Role of Shared Health upon full implementation of PRAS (Spring 2022): • ‘Lead and Coordinate’ in support of provincial implementation of RITHIM • Develop standards for impact reviews, create templates, guidelines and Standard Operating Procedures (SOPs) • Consult and collaborate with other Service Delivery Organizations (SDOs) • Lead Institutional Impact Community of Practice (ICOP) • Support SDO post approval processes, including research contracts and agreements
  18. 18. Shared Health Research and Innovation Implementation of RITHIM on January 1, 2022: • Institutional impact approval processes stay the same!  Institutions will continue to use existing forms and review processes  Site level processes and accountabilities remain unchanged  Research activation processes remains unchanged  Outputs of CHIPER/PHRPC will be provided to the researcher and impact committee(s)
  19. 19. Dr. Jay Doering AssociateVice-President (Partnerships), University of Manitoba
  20. 20. The RAS Project [Research Administration System] 2 November 2021
  21. 21. RAS and RITHIM Overview  Animal Ethics  Biosafety  Contracts  Environmental Health and Safety  Grants  Human Ethics [REB1, REB2, HREB, BREB]
  22. 22. Overview • The Need • Objectives of the Project • The Solution • Timeline • RAS and RITHIM
  23. 23. The Need • handling of grants, contracts, and protocols (human, animal, biosafety) has been paper- based • > 100 forms on ORS website • for the uninitiated the form(s) required for approval and the process can be overwhelming • difficulty collecting (physical) signatures • not leveraging technology
  24. 24. Objectives of Project • ease of use • one set of login credentials • context sensitive software (implications)
  25. 25. Objectives of Project • ease of use • one set of login credentials • context sensitive software (implications) • reduction in effort, errors, and process • enter once, use many, field validation • linked to VIP • electronic workflow with configurable ”to do list”
  26. 26. Objectives of Project • ease of use • one set of login credentials • context sensitive software (implications) • reduction in effort, errors, and process • enter once, use many, field validation • linked to VIP • electronic workflow with configurable “to do list” • increased transparency • ability to view where submissions and related tasks are within the process [date and time stamp]
  27. 27. The Solution • survey of U15 showed no more than two institutions used the same software; some had developed their own software system • looked at 4 vendors [only 2 had context sensitive software] • awarded to in 2019 • product of EnterpriseWeb® • Senior team • Project Executive: Jay Doering, AVP (Partnerships) • Senior User: Gary Glavin Annemieke Farenhorst, AVP (Research) • Senior Supplier: Mario Lebar, CIO
  28. 28. Advisory Board • review and provide feedback on the “look”, ”feel”, and functionality of RAS • ensure all relevant interfaces meet user/approver needs • members • Hope Anderson [ADR Pharmacy] • Annemieke Farenhorst [ADR Agriculture] • Rob Hoppa [ADR Arts] • Brian Mark [ADR Science] • Jude Uzonna [ADR Medicine] • Leisha Strachan [ADR Kinesiology]
  29. 29. • 3200 users: • PIs, delegated users, authorize/advise users, ORS, OREC, and EHS staff • 25 processes to build • 1600 data fields to capture • 24 MRT modules affected/replaced • 125 reports to automate • 9 interfaces with existing UM systems: • Banner, EHS, HRIS, … Project Scope Project is a significant undertaking!
  30. 30. Stakeholder Engagement • understand the reasons for the change • understand the impact on day-to-day activities • motivated to be part of the change • users have the skills, knowledge & ability to be successful - using and adopting software • Training sessions (live and UM Learn) to prepare users • IST Help Desk • RAS email for support
  31. 31. HE FG Overview
  32. 32. High Level Schedule *Includes Core software functionality for all Phases Phase 1: Human Ethics FG* Phase 2: Animal Care Phase 3: Grants and Contracts RITHIM Human Ethics Bannatyne May 2019 June 2021 Early 2022 Mid 2022 25 months
  33. 33. RITHIM + RAS • RITHiM will run from the University’s RAS servers, but with its own customized separate install • a series of questions will determine whether ethics will be undertaken by UM (i.e., HE FG) or RM’s RITHIM • HREB + BREB will transition as per RM timeline
  34. 34. RAS + RITHIM UM  Animal Ethics  Biosafety  Contracts  Environmental Health and Safety  Grants  Human Ethics RITHIM  Health Ethics Non UM Entry point
  35. 35. Dr. Dylan MacKay ClinicalTrialist, George & FayYee Centre for Healthcare Innovation
  36. 36. End users
  37. 37. Provincial Research Application System (PRAS)
  38. 38. Provincial Research Application System (PRAS)

Editor's Notes

  • Welcome everyone – I want to start by acknowledging that the CHI offices (when we are in them) are located at the University of Manitoba Bannatyne campus on the original lands of the Anishinaabeg, Cree, Oji-Cree, Dakota and Dene peoples and on the homeland of the Metis Nation. We respect the Treaties that were made on these territories, we acknowledge the harms and mistakes of the past and present and we dedicate ourselves to moving forward in partnership with Indigenous communities in a spirit of reconciliation and collaboration.
  • Dr. Postl has no conflicts to disclose.