Research Improvements Through Harmonization in Manitoba (RITHIM) is the next step in streamlining and improving the research process. Together, we can improve the lives of Manitobans.

1. GRAND ROUND: RITHIM - A NEW
APPROACH TO RESEARCH IN MANITOBA
November 2, 2021

3. Conflict of Interest
•Paul Beaudin - Member of Board of Directors, HSC
Foundation
•Rest of panel participants - No conflicts to disclose.

5. Freyja Arnason
Director, Research ImprovementsThrough Harmonization in Manitoba

21. Karen Herd
Deputy Minister, Manitoba Health and Seniors Care
Jason Berry
Acting Director for Information Management and Governance,
Manitoba Health and Seniors Care

22. 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

23. 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

24. 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

25. 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

26. 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.

27. 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.

28. 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.

30. Dr. Paul Beaudin
Director of Research and Innovation, Shared Health Manitoba

31. Paul Beaudin, PhD
Director of Research and Innovation
Shared Health
November 2, 2021
Shared Health
Research and Innovation
Update for RITHIM

32. 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

33. 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

34. 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

35. 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

36. 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)

38. Dr. Jay Doering
AssociateVice-President (Partnerships), University of Manitoba

39. The RAS Project
[Research Administration System]
2 November 2021

40. RAS and RITHIM
Overview
 Animal Ethics
 Biosafety
 Contracts
 Environmental Health and Safety
 Grants
 Human Ethics
[REB1, REB2, HREB, BREB]

41. Overview
• The Need
• Objectives of the Project
• The Solution
• Timeline
• RAS and RITHIM

42. 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

43. Objectives of Project
• ease of use
• one set of login credentials
• context sensitive software (implications)

44. 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”

45. 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]

46. 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

47. 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]

48. • 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!

49. 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

50. HE FG Overview

51. 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

54. 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

55. RAS + RITHIM
UM
 Animal Ethics
 Biosafety
 Contracts
 Environmental
Health and Safety
 Grants
 Human Ethics
RITHIM
 Health Ethics
Non UM
Entry point

57. Dr. Dylan MacKay
ClinicalTrialist, George & FayYee Centre for Healthcare Innovation

58. End users

59. Provincial Research Application System (PRAS)

60. Provincial Research Application System (PRAS)