Submission Requirements

Submission Requirements

NOTE: Review this website regularly as we may be returning to our previous paper submission processes when COVID restrictions are lifted.

COVID-19 has created many challenges for our research community and the Research Ethics Board (REB) as we work remotely and electronically without an on-line submission software platform.  To ensure researchers will be ready to begin research as soon as possible following COVID-19 we have modified our processes temporarily by accepting submissions via e-mail. 

These processes outlined below are for submitting:

  • NEW STUDY SUBMISSIONS (Delegated and Full Board)
  • TABLED Responses
  • Full Board Amendments
  • Full Board Annual Reviews

Please review submission deadline dates to ensure your protocol will be reviewed in the month submitted.

Please review the main website for instructions relating to Submission and Review Procedures for Changes to the Protocol (Amendments) and Responses to Conditional Approvals, Safety Reports, etc. eligible for delegated review.

Please follow these step by step instructions for full board review to assist the REB office in preparing the submission for our board members to review:

    1. Prepare your submission using the appropriate checklists noted below to ensure all required documentation is included.

    2. COVID mitigation strategies. Any protocols requiring in-person visits will require Departmental Review or Dean approval as outlined on the University of Manitoba Office of Research website. The application must also include Standard Operating Procedures on mitigation strategies for preventing the spread of COVID and a COVID Risk statement for participants.

    3. If submitting a Retrospective Records Review form please use the Signature Page for the Regular submission form as it is able to accommodate electronics signatures.

    4. Create a folder of all applicable files and label it as follows:  PI’s name followed by the month of scheduled meeting deadline. 

    5. NOTE:  Prepare a separate folder for the Investigator’s Brochure(s), Product Monograph(s) or safety reports.  We are concerned the size of these files may create issues when sent via e-mail.

    6. Create a Zip file of your folder of documents.   The Zip folder reduces the size of the file and will hopefully make it easier when sending via e-mail. The instructions for creating Zip drives are as follows:  https://support.microsoft.com/en-ca/help/14200/windows-compress-uncompress-zip-files.

    7. Sent the Zip folder to the Bannreb@umanitoba.ca only. Do not send it to any of the REB staff’s personnel e-mail accounts.

    8. In the Subject line enter the following information as applicable for submission:

      Allowzip NEW SUBMISSION – Month and year of meeting deadline A – PI name and REB (HREB or BREB)

      Ethics HS # (followed by HREB or BREB #) TABLED RESPONSE

      Ethics HS # (followed by HREB or BREB #) Amendment – FULL BOARD

      Ethics HS # (followed by HREB or BREB #) Annual – FULL BOARD

          NOTE: It is very important that the Subject line is formatted as noted above.

          9. In the Subject line for COVID studies enter the following information - COVID Month and year of meeting deadline - PI name.

                  

NOTE:  Incomplete submissions or a poorly submission will be returned to the submitter and will not be reviewed at the submitted meeting. Also, the Bannatyne Campus Research Ethics Boards may need to set a limit to the number of submissions received that will be reviewed at the monthly meeting.  


 

New Studies/Projects
Protocol Amendments or Changes to Study 
Case Report
Change in Study Personnel and Contact Information
Annual Review
Adverse Event Reporting 
Study Closure and Termination 
Request for Preliminary Access (RPA) to Grant Funding


We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline.


We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline. New Studies/Projects 1. Review Bannatyne Campus Guidelines and Guidance on Initial Review

2. Review Submission Deadline Dates

3. Determine appropriate Research Ethics Board for review:

Members of the Colleges of Medicine, Dentistry, Pharmacy, and Medical Rehabilitation, the affiliated teaching hospitals, and their associated research foundations must submit their protocols to the appropriate REB at the Bannatyne campus. In addition to the Bannatyne campus protocols, the BREB and HREB will review any protocols that may be referred by the REBs on the Fort Garry Campus.

If you do not fall under any of the above listed categories please see the Fort Garry Campus Research Ethics Board website for further information.

Biomedical Research Ethics Board (BREB) - Research proposals involving clinical trials and other biomedical research interventions.

Health Research Ethics Board (HREB) - research involving behavioral sciences, databases, surveys, registries, specimen collection/banking and examination of medical records.

4. Review Categories and Procedures for Review of New Research Protocols (pdf) to determine Level of Review (i.e. Full Board or Delegated) required for your protocol.

5. Review the Bannatyne Campus Research Training Manual (pdf) and Common REB Submission Pitfalls - Tips for making a Good REB Submission and Avoiding Delays in Approval (pdf). Review of these documents will assist you in understanding the issues that need to be addressed in the ethics submission.

6. Prepare submission to Bannatyne Campus Research Ethics Board by using appropriate checklist

Checklist for Full Board Review of New Studies (pdf)
Checklist for Delegated Review of New Studies (pdf)
Submission Form for Retrospective Chart or Records Review (doc)
Checklist for Single Case Report (pdf)

7. Institutional Approval independent of the Bannatyne Campus Research Ethics Board review and approval process outlined above a separate institutional approval is usually required.

Please contact the research department of the institution in which you are conducting your research study for information regarding the appropriate procedures required to conduct research at the site. Research activities cannot begin until such approval is granted.

8. University of Manitoba Survey/Focus Groups and Interview Guidelines –  Independent of the Bannatyne Campus Research Ethics Board review and approval process, an Advisory Committee to the Provost was established to review proposed surveys, focus groups, and interviews of students, faculty, staff, and alumni.  As surveys, focus groups, and interviews reflect on the University of Manitoba, approval of the Survey Review Committee is required prior to contacting potential respondents. Please visit the link provided above for more information.


Protocol Amendments or Changes to Study

1. Review “Submission and Review Procedures for Amendment/Changes to Previously Approved Study” to determine Level of Review required (i.e. Delegated or Full Board )

2. Review Submission Deadline Dates if Full Board Review is required. Changes/Amendments that meet the criteria for delegated review can be submitted at any time.

3. Prepare submission using the appropriate checklist:

Checklist for Full Board Review of Amendments, Changes or Additions (pdf)
Checklist for Delegated Review of Amendments, Changes or Additions (pdf)


Change in Study Personnel and Contact Information

1. Changes to personnel and contact information will be reviewed in a delegated manner by the Research Ethics Board (REB) Chair and/or REB Coordinator when appropriate.

2.Complete Change in Study Personnel Amendment Form (pdf)

3.A checklist of required documents is outlined on the form.


Annual Review

1. Review Annual Procedures to determine Level of Review required (i.e. Delegated and Full Board)

2. Review Submission Deadline Dates if Full Board Review is required. Annual reviews that meet the criteria for delegated review can be submitted at any time.

3. Prepare submission using the appropriate checklist:

Checklist for Full Board Review for Annual Review (pdf)
Checklist for Delegated Review for Annual Review (pdf) 
Protocol Deviation Reporting 

4. Full Board Annual Reviews – Submission must be dropped off in person or couriered  to office by the monthly submission deadline date.

5. Delegated Annual Review– Signed (electronic or scanned pdfs) ASSR forms must be  submitted electronically via ASSR Portal.  For multiple Consent Forms, please scan as one document before uploading.


Adverse Event Reporting

            Adverse Event Reporting and Safety Information


Study Closure and Termination

1. Review Study Closure and Termination Guidance to assist in determining when a study should be closed.

2. All studies must have a Final Study Status Report (pdf) sent to the REB at the time of study closure as outlined in the guidelines.


Request for Preliminary Access to Grant Funding before Activity Requiring Ethics Approval is Undertaken (RPA)

1. Please contact the University of Manitoba Office of Research Service (ORS) to assist you in determining whether these forms are appropriate to complete.

2. If it is determined by het ORS an RPA is required please review the documents listed below

    RPA Guidelines (pdf)
    RPA Form (pdf) 
    RPA Amendment Form (pdf)

 

                   We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline.We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline. 1. Review  and 

 

 

                   We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline.We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline. 1. Review  and 

 

We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline.We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline. 1. Review  and 

 

We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline.We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline. 1. Review  and 

 

This process is only for submitting Delegated and Full Board submissions to the Board.  We ask for your assistance in helping us manage the increased volume of submissions related to COVID-19 by: We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline.We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline. 1. Review  and 

 

This process is only for submitting Delegated and Full Board submissions to the Board.  We ask for your assistance in helping us manage the increased volume of submissions related to COVID-19 by: We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline.We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline. 1. Review  and 

 

This process is only for submitting Delegated and Full Board submissions to the Board.  We ask for your assistance in helping us manage the increased volume of submissions related to COVID-19 by: We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline.We now accept Full Board and Delegated submission 20 days prior to the Submission Deadline. 1. Review  and 

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If problems persist, follow trouble shooting instructions here: Fillable PDF Forms (pdf)


 

 

TIPS FOR SUBMITTING YOUR ETHICS FORMS
Ethics applications forms and templates for consent forms undergo regular updating.  Always use the current forms found on the website of the REBs. Older versions will not be accepted for review. Ensure all questions are completed on the forms rather than referencing pages in the protocol as this ensures ease of review by REB members and staff.  All documents must be given a new version date when revisions are made to study documents.

TIPS SPECIFIC FOR CONSENT TEMPLATES
Review consent forms to ensure only applicable wording is included in version submitted to REB.

The BOLDING and UNDERLINING that appears in the consent templates is for ease of use only. Please remember to remove the Bolding and Underlining from the Informed Consent Forms before submitting them.


WHAT IS A PROTOCOL? (pdf)
All submissions should include a full protocol  which discusses the applicable scientific and ethical aspects of the study.

Examples of Protocol Templates 


MANDATORY CLINICAL TRIAL REGISTRATION  
TCPS 2 requires registration of certain clinical trials.  The international committee of medical journal editors also requires certain clinical trials be registered as a condition of publication


INSTITUTIONAL APPROVAL 
may also be required
Please contact the Research Department of the institution in which you are conducting your research study for information regarding the appropriate procedures required to conduct research at the site. Research activities cannot begin until such approval is granted.

Institutional Approval Committees


POSTING OF CLINICAL TRIAL RESULTS
To facilitate transparency of study results the University of Manitoba is strongly encouraging that all clinical trial study Results are posted on a publicly accessible results  website within 6-12 months of study completion.


Required Privacy Training Modules