HREB

Human Research Ethics Board (HREB)

 

 

Human Research Ethics Board

The Human Research Ethics Board (HREB) ensures that all research conducted at Mount Royal University is designed and conducted in such a manner that protects the rights, welfare and privacy of research participants in compliance with the Tri-Council Policy Statement (TCPS2).

HREB reviews applications submitted by MRU researchers and research undertaken by undergraduate students under the supervision of faculty members including Honours thesis and student-directed research.

HREB also reviews external applications submitted by MRU's researchers working as part of research teams at other institutions, and research involving Mount Royal University participants that has been approved at other post-secondary institutions in Canada.

HREB applications posing minimal risk are delegated to HREB reviewers. Applications bearing greater than minimal risk applications are reviewed by the entire Board at the HREB monthly meetings.

 

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:
  1. Applications are judged on the level of risk involved. In general, Full Board Reviews are required for high risk and ethically complex studies, or where diverse opinions across researchers are likely. This decision is admittedly subjective. Whether or not an application goes to Full Board or Delegated review, the decision rests with the REB Chair. Possible Full Board Review applications may also be flagged by an REB member during a delegated review or the Research Compliance Officer during the screening process.
  2. Board meetings are generally held the first Friday each month. Please check the website for the upcoming HREB meeting dates. An application requiring Full Board Review must be submitted at least two weeks before the monthly HREB meeting. NOTE: Meeting the Full board submission deadline does not guarantee review at the next HREB meeting. 

 

Note: Meeting the Full Board submission deadline does not guarantee review at the next HREB meeting. Full Board Review of the application will be dependent on the soundness of the application after screening, and/or any significant constraints on the HREB meeting agenda. 

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

  • September 9, 2022
  • October 14, 2022
  • November 11, 2022
  • December 16, 2022
  • January 13, 2023
  • February 10, 2023
  • March 17, 2023
  • April 14, 2023
  • May 12, 2023

 

 


Application Process

All research at MRU involving humans as participants requires review by the Human Research Ethics Board (HREB). Application forms can be accessed through the MRU ROMEO portal. Instructions on how to use the portal can be found in the ROMEO user guide page.

Note: Applications that are incomplete, or those where significant methods concerns are noted, will be returned to applicants with a request to revise and re-submit prior to ethics reviewed by the HREB.

Listed are the steps in submitting applications in the ROMEO system:

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. Link your HREB application to an Activity Form Number- Choose the most appropriate option

o   Create and use a new Research Activity Form Number - if your study is

        • funded through an external grant (e.g., CIHR, SSHRC, etc.).
        • not funded

o   Use your existing Research Activity Form Number – if your study is associated with an existing Research Activity Form

  1. 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.
  2. 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).
  3. 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.

 

Full Board Reviews are required for high risk and ethically complex studies. These reviews take place on the first Friday of each month. The Full Board Review takes approximately one month to get initial review feedback. The deadlines for applications that require HREB review for 2022/2023 are as follows:

 

  • September 9, 2022
  • October 14, 2022
  • November 11, 2022
  • December 16, 2022
  • 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.

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.
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. This includes submission of the revised *application form* with version date.
      • Use 'track changes' or 'colour highlights' to identify what you are removing/replacing in the *approved application form* (use the 'download' tab to access the word version of the approved application form.
      • Attach all supporting documents (e.g., survey questions, recruitment script, consent forms, etc.)
      • In addition to attaching tracked copies of your application form and other 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 and are needed for annual study extensions, while completion reports are required after the termination of the study.
Complete a Progress/Completion Report
  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.

External Research submitted by researchers affiliated with Canadian Institutions

  • All external researchers with ethical clearance from other Canadian post-secondary institutions conducting research involving MRU participants must submit an external application for review by the Human Research Ethics Board (HREB).
  • MRU researchers working as part of research teams for studies that have been ethically approved at other Canadian universities are also required to submit external applications for review by the Human Research Ethics Board (HREB).

 

International researchers

There are two processes for international research:

1).When research with humans is carried out internationally with collaborators, ethical clearance is needed at the host institution and harmonized with collaborators’ REBs. MRU researchers working in such teams must submit an external application for review by the Human Research Ethics Board (HREB).

2) When international researchers are recruiting or collecting data from MRU participants, the researchers must submit a full MRU ethics research application for review by the Human Research Ethics Board (HREB).

Complete an External Application 
  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:
    • Link an Activity Form Number (Required for MRU affiliated researchers)– choose the most appropriate option

      o   Use the Award File Number - if your study is funded through an MRU grant (IRGF, SoTL, Innovation grant, etc.).

      o   Create and use a new Research Activity Form Number - if your study is

            • funded through an external grant (e.g., CIHR, SSHRC, etc.).
            • not funded

      o   Use your existing Research Activity Form Number – if your study is associated with an existing Research Activity Form

       
    • 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, 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.

Health studies involving 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: Researchers must submit their CHREB approval letters, approved application forms, and all supporting documents (e.g., recruitment advertisements, consent forms, questionnaires, interview guides, debriefing forms, etc.) on the ROMEO system.
Complete a Health Information Act Application

  1. Click here to create a new ROMEO account. (MRU researcher login) (External applicant login)
  2. On the Home page, click Apply New.
  3. Under New Application Forms, select Health Information Act Ethics Application.
  4. Fill out required information for all the tabs. Notes to remember:
    • Link an Activity Form Number (Required for MRU affiliated researchers) – choose the most appropriate option

      o   Use the Award File Number - if your study is funded through an MRU grant (IRGF, SoTL, Innovation grant, etc.).

      o   Create and use a new Research Activity Form Number - if your study is

            • funded through an external grant (e.g., CIHR, SSHRC, etc.).
            • not funded

      o   Use your existing Research Activity Form Number – if your study is associated with an existing Research Activity Form

        • 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.

Sometimes researchers work in teams across institutions. Multi-jurisdictional research covers research that is associated with students, faculty, and staff intending to use MRU as their affiliation. This research also encompasses the use of MRU resources (e.g., recruiting through MRU faculties, departments, associations etc.), use of funds administered through MRU and research conducted using MRU’s physical resources (e.g., space).

It is important to decide which institution is the lead institution for the purposes of ethics review. If the PI is based at an external university, the ethics application should be submitted to the external institution first, listing MRU members as potential partners and describing how data is to be managed amongst the team. MRU researchers must submit the approval letter/certificate and supporting documents to HREB as external applications for expeditated review by the HREB Chair. 

If the lead institution is MRU, researchers are required to follow the normal HREB application process and are expected to list external research team members on and describe their roles in the research project and how data will be managed within the team on their HREB application. 

There are two processes for international research:

1).When research with humans is carried out internationally with collaborators, ethical clearance is needed at the host institution and harmonized with collaborators’ REBs. MRU researchers working in such teams must submit an external application for review by the Human Research Ethics Board (HREB).

2) When international researchers are recruiting or collecting data from MRU participants, the researchers must submit a full MRU ethics research application for review by the Human Research Ethics Board (HREB).


Appeal Process

We recognize that disagreements between researchers and the HREB over a decision can arise from time to time. If a disagreement cannot be resolved between the researcher and reviewer, the following process should be followed:

AppealProcess_3rdVersion-100


Training

Researchers have the responsibility to comply with the Tri-Council Policy Statement (TCPS2) guidelines outlined on the TCPS2: CORE (Research Ethics online course) or Ethics 101 training provided at Mount Royal University.

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)

 

New TCPS 2 Interpretations

May 17, 2021

The Human Research Ethics Board (HREB) Chair will offer its last Ethics 101 Workshop on November 23, 2021. It has been determined that Ethics training is best provided by the TCPS2 (2018) CORE Tutorial.   Custom sessions on specific topics from TCPS2 for groups are available by request post CORE tutorial training.

 

 

 


If you have any questions or require more information on ethics and compliance, please contact the Research Compliance Officer at 403.440.8470 or hreb@mtroyal.ca.|