Frequently Asked Questions

About RITHIM

What does RITHIM stand for?

RITHIM is an acronym for Research Improvements Through Harmonization in Manitoba.

What does RITHIM do?

RITHIM is dedicated to supporting the health research ecosystem in Manitoba by identifying areas that can be changed and updated to create quicker, more accountable, and more efficient research, leading to a higher quality of life for researchers and reducing pressure on institutions.

How does RITHIM operate?

RITHIM operates through Research Manitoba, a provincial agency dedicated to health research in Manitoba that receives funding and guidance from the Department of Innovation and New Technology. Research Manitoba has both a board and organizational staff, several of whom work exclusively on the RITHIM initiative RITHIM is governed by the Provincial RITHIM Committee, made up of stakeholders in the health research ecosystem.

Is RITHIM a Research Ethics Board (REB)?

Not quite. RITHIM is not a REB. However, one of the components of our work involves coordinating the work of the Manitoba REB for human health research, known as CHIPER (Committee for Harmonized Health Impact, Privacy, and Ethics Review). For more information regarding CHIPER, visit our website here.

My Ethics review approval wait time is not shorter than before RITHIM, why is that?

RITHIM does more than coordinate ethics review, it integrates ethics, privacy, and institutional assessments into one consolidated decision communicated to the applicant. While the review time for an individual component may be similar to pre-RITHIM processes, the overall time to receive all required decisions is usually shorter and more streamlined.

Harmony System

 What is the status/history of my application?

To view the status of your application:

1. On the home page, under Project Title, select the arrow pointing to the application (project title).
2. Once you have selected the arrow, this should allow you to see the different forms under that project. Under Status it should state the status of your application.

To view the status and history of your application:

1. On the home page, under Project Title, select the application (project title) found in blue text, see image below for reference.
2. Once you have clicked the project title, this will redirect you to the Project Tree. On here you can click which form you would like to view the status on, see image below for reference.

3. Within the Project Tree page, you can view the application history by selecting the History tab. This tab displays a record of all changes made to your application.

Please note that the new Harmony system integrates all review streams: REB (Research Ethics Board), Health Impact Assessment (HIA), and Privacy, into a single application. As each review body follows its own internal review cycle, there is no fixed timeline for application approval. This applies to revisions and amendments as well. Meetings occur monthly and dates can be found here.

Applications are distributed to reviewers several weeks before each meeting, therefore, it is essential that applications are submitted before the deadline. This allows time for any required corrections to be identified and addressed during the Program Officer pre-review check.

What is the purpose of the personal profile?

The Personal Profile is referenced within the RITHIM application forms to allow the Program Officers to verify your training and qualifications. Your Personal Profile Project ID must be entered in the Research Personnel section.

The Personal Profile Form includes information such as required certifications (e.g. PHIA, CORE, and other relevant training), clinical and post-secondary affiliations, and your curriculum vitae (CV). If any changes to your Personal Profile are required, please refer to the question below for instructions on how to make updates. Please note that your Personal Profile must be reviewed and updated annually, as required.

Once you submit a Personal Profile, a Program Officer will review it to ensure all required information is complete and accurate. If corrections are needed, please refer to the question below for instructions on how to update your personal profile.

How do I make changes to my Personal Profile?

If corrections are requested by a Program Officer

If a Program Officer reviews your Personal Profile and corrections are requested. The status will be changed to: Personal Profile Unlocked for Update. This will allow you to make the required changes.

If you want to make changes after submitting your Personal Profile

If you have already submitted your Personal Profile and want to make changes, you must click Unlock For Update in the Actions column on the left. This will unlock your Personal Profile and you will be able to make changes.

How do I view the requested corrections?

To address the corrections requested by the Program Officer, select Reviewer Comments in the Actions column to view the corrections. You can select each request to see where the corrections are being asked. If you have any questions about the corrections, please refer to our ticketing system here.

What do I do after making changes?

Once the changes have been made, the form will need to be signed and resubmitted. Please note that we are unable to view the changes unless the profile has been submitted.

What is a version date and number?

A version date reflects the date a document was last updated, while the version number indicates how many times the document has been revised. This helps reviewers confirm that they are reviewing the current version. For initial applications, documents typically have a version date reflecting their most recent review and are usually identified as Version 1.

Which documents require a version date?

A version date is required on the following documents:

• The protocol or proposal
• All consent forms
• All recruitment materials – this includes, but is not limited to emails, letter of information, participant card, patient instructions, poster/ad/flyer/brochure/pamphlet, social media post, verbal script (telephone or in-person), website/video/audio ad (with scripts), and any other participant-facing materials.
• The master list template
• All data collection tools – this includes, but is not limited to case report forms, questionnaires, assessment forms, scales, interview guides, surveys, diaries, and data extraction forms.

How do I add a version date to my documents?

For Word or PDF documents, the version date and number may be included in the header or footer. For Excel documents, this information can be entered in cell A1 on the first worksheet, or on each tab if the file contains multiple worksheets.

What does it mean when the version date in my document must match the version date in the system upload box?

For auditing and reporting purposes, the version date listed in the document must exactly match the version date entered in the system upload box. For example, if the version date shown in your document is June 4, 2025, the version date entered in the system must also be June 4, 2025. 

What if my document only has a copyright date? What version date do I use?

If you are uploading a document that only includes a copyright date, the copyright date may be used as the version date in the system. For example, if the document states Copyright (c) 2009; the version date may be entered as January 1, 2009.

I am unsure of where to gather data sources but I know it’s from the Manitoba Centre for Health Policy (MCHP).

Please consult with MCHP directly and complete a feasibility review prior to submitting an application in Harmony.

What is a Master List? How do I know I need one?

A master list is a document that links participant or subject identifiers to a unique code, pseudonym, or ID number to identify the participant or subject’s data. The use of a master is deemed the best practice in research when personally identifiable information is collected from or about participants or subjects.

Typically, a master list includes only: the participant ID or code and the corresponding identifier(s) (i.e. name). Please note that if a master list is created and retained as part of a project, Section 5.5 (Data Access) can’t be classified as anonymous or anonymized, since participant identities can be linked to the data.

How do I make sure I am using the right templates when making study documents?

To ensure all requirements are met, refer to the guidance available on our website:

• Study protocol requirements: https://rithim.ca/ethics/ethics-guidelines/protocol-requirements/
• Informed consent requirements: https://rithim.ca/ethics/ethics-guidelines/required-elements-of-written-informed-consent/
  • Please note that any research affiliated with the University of Manitoba include the University of Manitoba logo on all informed consent form(s).

What if my sponsor, data source, or clinical affiliations are not on the drop-down list?

Please submit a request through our ticketing system. A Program Officer will follow up with you and provide the next steps.

What does patient and public engagement mean?

For more information, please refer to the links provided in Section 4.4 (Patient and Public Engagement) under the  icon.

• CIHR patient engagement: https://cihr-irsc.gc.ca/e/45851.html
• CHI tools and resources for patient engagement: https://umanitoba.ca/centre-for-healthcare-innovation/tools-and-resources

How do I upload documents when submitting an amendment?

When submitting document(s) with an amendment, please ensure that you only upload the most recent versions of the documents that correspond directly to the changes described in Section 1.3 (Amendment Details).

For each amended document, you must upload both versions in the appropriate sections:

• A clean (final) version
• A track change version clearly showing all the revisions from the previously approved version. A summary of changes may be uploaded alongside the track change document.

The clean version must be uploaded first. The version date should reflect the date the document was last revised and must match the version date entered in the system upload box (see above for questions relating to this). The version number should follow sequentially from the most recently approved version.

For example, revised document for amendment – January 23, 2025 (Version 3); previously approved document – January 20, 2025 (Version 2).

General considerations when submitting an amendment:

• If there were previous amendments that were not processed through the Harmony system, these do not need to be uploaded. Only revisions submitted as part of a Harmony amendment should be included.
• Ensure that all tracked changes are visible and not accepted or hidden.
• Confirm that version numbers and dates are consistent across the document.
• Do not re-upload documents that have not been revised as part of the amendment.
• Upload each document individually to ensure it is accurately reflected on the RITHIM approval certificate. The only exception is when uploading a track change version together with a summary of changes.