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.
The processes outlined below are for submitting:
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 NEW STUDY submissions 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-19 Research Recovery Team (CRRT) approval is required for any protocol that includes in person visits or an amendment requesting resumption of in person visits via a Request to Undertake Research Involving Human Participants at On- or Off-Campus Research Sites. If applicable, indicate in your REB submission that the CRRT submission has been completed. NOTE: CRRT approval will be required prior to the REB issuing a final approval certificate.
3. COVID mitigation strategies. 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-19 and a COVID -19 Risk information included in the consent form or via the University of Manitoba COVID-19 Consent Appendix.
4. 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.
Protocol Amendments or Changes to Study
Change in Study Personnel and Contact Information
Adverse Event Reporting
Study Closure and Termination
Request for Preliminary Access (RPA) to Grant Funding
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.
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:
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.
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:
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.
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.
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
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.
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
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.
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.