HREB

Delegated Review
A delegated review takes approximately three weeks. A researcher can expect to receive an initial review response from HREB reviewers after this time.

Full Board Review
Full Board Review takes approximately one month to get an initial review response. Here are some details about a Full Board Review process:

General HREB Application Process

1. Log in to ROMEO.
   • Click here to create a new ROMEO account. If you already have a ROMEO account, click here to log in. For further instructions, please see the ROMEO user guide.
2. Create a new Research Activity Form under the Awards section.
   • If you already have an activity number associated with the project (e.g., because you applied for an Internal Research Grant) you don't need to create another form. Proceed to Step 3 and compete the HREB application.

3. Complete the HREB application in ROMEO and submit.
   • Use the Attachment Tab to upload consent and debriefing forms, ethics training certificate and other materials associated with your application.
   • You will not be receiving a confirmation number after submitting the HREB application.
4. An acknowledgement email will be sent to you from the Compliance Officer stating that the application has been received and is undergoing initial screening.
   • The Initial screening process will take approximately 3-10 days depending on the volume of the received applications.
   • If the received application is incomplete, you will receive an email from the Compliance Officer asking for clarification (e.g., please send a consent form with your application).
5. Once the screening process is complete and the Compliance Officer's concern have been addressed, the Compliance Officer will send the application out for review. It may delegated to one or two people, or a full board.
   • The default is a blind review process, but it is possible that reviewers will identify themselves.

Delegated Review

1. A Reviewer Report will be completed by HREB reviewer(s) approximately two weeks after an application has been submitted and copied into ROMEO.
2. The Chair will assess the completed Reviewer Report. If any additional concerns are noted, they will be discussed with the reviewer.
3. An email will be sent to the researcher stating that the review is available in ROMEO and will include instructions to review the Reviewer Report and make any necessary changes to the application in ROMEO:
   • The changes will be visible to both the researcher and his/her reviewer(s) using the Log tab in ROMEO.
4. When the revisions are complete, click the Submit button to re-submit your application.
5. The Compliance Officer will be notified and the revised application will be sent to reviewer(s).
6. The HREB application will be reviewed again. If any requested changes have been missed, the reviewer(s) will indicate this at the top of the review in ROMEO.
7. When the reviewer is satisfied that the application meets the requirements of TCPS-2, the reviewer will notify the Compliance Officer and HREB Chair. The Chair will review and approve the application.
8. The researcher will receive an email with the clearance letter attached generated by ROMEO. The letter will also be available on the researcher's Attachment tab. The project may be started once the letter has been received.
9. Progress and completion form templates are available in ROMEO.
   • Researchers may log in to the Research Portal at any time to check the status of their application and to determine when the progress on study completion reports are due.
   • Note: Any ethical concerns that arise during the project should be reported directly to HREB (Compliance Officer and Chair).
10. Modification requests will be submitted via ROMEO. These will be reviewed by the Compliance Officer and/or the Chair (estimated review time is one week).

Full Board Review

1. The process for a Full Board Review is similar to the delegated review process, except that all members of HREB will review an application.
2. Researchers will be informed when their application is going to a full board review.
3. The Compliance Officer and HREB Chair makes the final decision about whether a full board review is required.

Notes to Remember

1. ROMEO has a 10MB limit. Large PDF files (supporting materials) might need to be split into several smaller documents before they are uploaded.
2. Course Based Applications are reviewed by the Student Human Research Ethics Committee and must be submitted on ROMEO.

The deadlines for applications that require HREB review for 2022/2023 are as follows: 

• January 13, 2023
• February 10, 2023
• March 17, 2023
• April 14, 2023
• May 12, 2023 

The deadline for guaranteed full-board review prior to the summer break is mid-May.

Researchers are required to submit modification requests to HREB before making any changes to previously approved protocols. The requested modification should not be implemented until clearance approval has been received. Complete a Modification Report

1. Log in to ROMEO.
2. Under the Role: Principal Investigator tab, click Applications: Post-Review.
3. A list of all your reviewed projects will show up on the screen. Select the file you want to modify and click Events.
4. Under Create New Event, click on Ethics Modification.
5. Fill out required information for all the tabs. Notes to remember:
   
   • Attachments tab
     
     • Upload all revised documents (PDF versions) here
     • Use 'track changes' or 'colour highlights' to identify what you are removing/replacing in all supporting documents (e.g., survey questions, recruitment script, consent forms, etc.)
     • In addition to attaching tracked copies of your documents, attach their corresponding clean/final (no mark-up/highlighting showing) versions where the proposed changes have been implemented
   • Logs tab
     
     • This can be used to follow the application through the approval process
     • No information is needed on this tab
     • Dates will be completed automatically throughout the modification process
6. When all required information have been filled, click Submit.
   • A pop-up Comment box will appear. You must type something in the box to proceed.
7. You will receive an email confirmation stating your application has been successfully submitted. Your application will be forwarded to the Compliance Officer for further processing. You can keep track of your approval process through the Logs tab within your application.
8. If clarifications on your modifications are required, your application may be returned to you again. If no further clarification are required, you will receive a ROMEO notification on the Logs tab granting approval of the requested modification and an email with your clearance letter enclosed.

Steps on submitting progress and completion reports are mostly the same despite have different purposes.

Progress reports are annual progress reports required by the TCPS2 ethics guidelines during your studies, while completion reports are required after the termination of the study.

1. Click here to log in to ROMEO.
2. Under the Role: Principal Investigator tab, click Applications: Post-Review.
3. A list of all your reviewed projects will show up on the screen. Select the file you want to modify and click Events.
4. Under Create New Event,
   • For progress reports: Click Ethics Progress Report
   • For completion reports: Click Ethics Completion Report
5. Fill out all required information. Notes to remember:
   
   • Attachments tab: Upload all additional documents (PDF versions) that needs to accompany your progress report
   • Logs tab: Use this to follow the application through the approval process. No information is needed on this tab. Dates will be completed automatically through the modification process
   • Errors tab: Lists all the fields that need to be completed before the progress can be successfully submitted
6. When all required information have been filled, click Submit.
   • A pop-up Comment box will appear. You must type something in the box to proceed
7. You will receive an email confirmation stating your application has been successfully submitted. Your application will be forwarded to the Compliance Officer for further processing. You can keep track of your approval process through the Logs tab with your application.
8. If clarifications are required, your application may be returned back to you again. If no further clarifications are required,
   • For progress reports: You will receive your one year extension notification clearance through a ROMEO notification on the Logs tab granting extension approved for your study or through email.
   • For completion reports: You will receive your notification through a ROMEO notification on the Logs tab or through email.

All research by external researchers with ethics clearance from other post-secondary institutions that involves MRU participants requires review by the Human Research Ethics Board (HREB).

MRU researchers working as part of research teams for studies that have been approved at other universities are also required to submit external applications.

Note: Full HREB applications are required for studies with ethics clearance from international institutions.

1. Login to ROMEO by clicking here.
   • When registering for a new account, select External as your affiliation
2. On the Home page, click Apply New.
3. Under New Application Forms, click Human Research Ethics External Application Form.
4. Fill out the required information for all the tabs. Notes to remember:
   • Related Awards (under Project Info)
     • If you have completed the Research Grants or Contracts Administration Form for a project associated with your ongoing application, click Search to bring up a list of all current projects then select from the list
     • This will link your project form with your ethics approval making any funds available to be released for use
   • Project Team tab
     • Make sure to click Retrieve Info first before Adding Investigator information. If an investigator is added to the database twice, the system will have problems properly managing communications
   • Attachments tab
     • Upload additional documents that need to accompany your application (e.g., approved application forms from your institution, approval letter/certificate, ethics training certificate, recruitment scripts, interview guides, surveys, confidentiality agreements, debriefing and consent forms, etc.)
     • Include a study recruitment plan for MRU with details on specific offices, programs or services that will be contacted to access students, faculty and staff on the Attachments section, if recruiting from MRU
   • Logs tab
     • This can be used to follow the application through the approval process
     • No information is needed from the researcher on this tab. Dates will automatically be completed throughout the application process
   • Errors tab
     • Lists all the fields that need to be completed before the application can be successfully submitted
     • The tab will disappear once all required fields have been completed at which time the application can be successfully submitted
5. When all required information has been filled, click Submit.
   • A pop-up Comment box will appear. You must type something in the box to proceed
6. You will receive an email confirmation stating your application has been successfully submitted. You can keep track of your approval process through the Logs tab within your application.
7. If clarifications are required, you can revise your documents by clicking Applications: Requiring Attention under Role: Principal Investigator on the Home page.

Biomedical studies the Health Information Act of Alberta cannot be reviewed at Mount Royal University, as only five boards in the province are legally able to perform such reviews.

Mount Royal University has signed a Memorandum of Understanding with the University of Calgary's Conjoint Health Research Ethics Board (CHREB) that allows MRU researchers to access their services.

Note: You must submit your CHREB approval letters, approved application forms, and all supporting documents (e.g., recruitment advertisements, advertisements, consent forms, questionnaires, interview guides, debriefing forms, etc.) on the ROMEO system.

1. Click here to create a new ROMEO account. (MRU researcher login) (External applicant login)
   
   • Please see the ROMEO user guide for further instructions.
2. On the Home page, click Apply New.
3. Under New Application Forms, select Conjoint Health Research Ethics Board (CHREB) Approved Ethics Applications.
4. Fill out required information for all the tabs. Notes to remember:
   
   • Related Awards (under Project Info)
     
     • If you have completed the Research Grants or Contracts Administration Forms for a project associated with your ongoing application, click Search to bring up a list of all current projects then select from the list
     • This will link your project form with your ethics approval making any funds available to be released for use
   • Project Team tab
     
     • Make sure to click Retrieve Info first before Adding Investigator information. If an investigator is added to the database twice, the system will have problems properly managing communication
   • Attachments tab
     • Upload additional documents that needs to accompany your application (e.g., CHREB approved application forms, approval letter/certificates, recruitment scripts, interview guides, surveys, confidentiality agreements, debriefing and consent forms, etc.)
   • Logs tab
     • This can be used to follow the application through the approval process
     • No information is needed on this tab. Dates will automatically be completed throughout the application process
   • Errors tab
     • Lists all the fields that need to be completed before the application can be successfully submitted
     • The tab will disappear once all required fields have been completed at which time the application can be successfully submitted
5. When all required information have been filled, click Submit.
   • A pop-up Comment box will appear. You must type something in the box to proceed
6. You will receive an email confirmation stating your application has been successfully submitted. You can keep track of your approval process through the Logs tab within your application.
7. If clarifications are required, you can revise your documents by clicking Applications: Requiring Attention under the Role: Principal Investigator on the Home page.

When doing research working in teams across institutions, it is important to decide which is the lead institution for the purposes of ethics review. The ethics application should be submitted there first, indicating the potential partners and how data is to be managed among the team.

Note: If the lead institution is MRU, please follow the normal application process. If the lead institution is NOT MRU, please follow the external application process.

As of June 2019, TCPS 2 (2018) replaced TCPS 2 (2014) as the official research ethics policy of the federal research agencies (CIHR, NSERC, and SSHRC). The Secretariat is in the midst of developing a new CORE tutorial that will incorporate many of the changes found in the new Policy. A summary of the revisions that were published in TCPS (2018) is available in the Highlights of Changes document, however, there were no fundamental changes to the Policy. The three core principles -- Respect for Persons, Concern for Welfare, and Justice -- continue to be the foundation of both the new Policy and CORE.

During this transition phase, users are encouraged to continue accessing the current CORE. Please note that links to the former version of the Policy have been disabled. The online tutorial TCPS2: CORE (Course on Research Ethics) is an introduction to the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Human (TCPS2). It consists of eight modules focusing on the guidance in TCPS2 that is applicable to all research regardless of discipline or methodology. Other modules:

1. Research Involving First Nations, Inuit and MétisPeoples of Canada (CORE tutorial module 9)
   
2. Multi-Jurisdictional Research (CORE tutorial module 10)

The Human Research Ethics Board (HREB) Chair will facilitate an Ethics 101 Workshop this fall. The session will consider principles of Ethical Conduct for Research Involving Humans as required by the Canadian Tri-Council Policy Statement, and will assist researchers planning to apply for Ethics Clearance from HREB. Custom sessions for groups are available by request.

Faculty Workshop – Ethical Conduct for Human Research: Fall Semester

• Monday, September 20, 2021 | 2p.m. -3 p.m. | Google Online

            Register: https://mtroyaladc.libcal.com/event/3622413 

•  Tuesday, November 23, 2021 | 11 a.m.-12 p.m. | Google Online  

             Register: https://mtroyaladc.libcal.com/event/3622415 

 

Faculty Workshop – Ethical Conduct for Human Research: Winter

• Monday, January 24, 2022 | 11 a.m.-12 p.m. | Google Online 

           Register: https://mtroyaladc.libcal.com/event/3622416 

•  Thursday, March 24, 2022 | 9a.m. -10 a.m. | Google Online

           Register: https://mtroyaladc.libcal.com/event/3622418 

 

Student Workshop – Ethical Conduct for Human Research: Fall

• Wednesday, September 22, 2021 | 10 a.m. – 11 a. m | Google Online 

            Register: https://mtroyaladc.libcal.com/event/3622971 

•  Thursday, September 23, 2021 | 4p.m -5 p.m. | Google Online 

             Register: https://mtroyaladc.libcal.com/event/3622974

 

Student Workshop – Ethical Conduct for Human Research: Winter

• Wednesday, January 26, 2022 | 10a.m -11 a.m. | Google Online 

           Register: https://mtroyaladc.libcal.com/event/3622976

•  Thursday, January 27, 2022 | 4p.m. -5 p.m. | Google Online 

             Register: https://mtroyaladc.libcal.com/event/3622978 

 

 

• For more information on this workshop, please contact Research Ethics Compliance Officer at (403) 440-8470 or via email at hreb@mtroyal.ca