Submission requirements

With all submissions, we suggest that you include a full protocol that discusses the applicable scientific and ethical aspects of the study as outlined here.

The scientific aspects of the protocol should include a discussion of:

• the research problem, background analysis and hypothesis
• the relevant literature including animal and adult literature (where appropriate)
• study objectives
• the research design and methodology, such as inclusion or exclusion criteria, sample size or justification of statistical methods for assessing results
• a schematic timeline when the protocol proposes multiple interventions or multiple time points
• definition of adverse and serious adverse events
• all studies requiring a Health Canada Applications (CTAs) must include details on monitoring duties
• details on safety plans
• detailed data management plans to ensure security of data during storage and sharing of research data
• budget details and available resources
• contract with sponsor, when available

The ethical aspects of the protocol should include a discussion of:

• potential benefits to participants and others
• potential harms to participants and others
• alternative treatments or procedures
• how potential harms will be minimized, including the risk of breach of privacy and confidentiality
• the process for seeking consent and assent

Protocol Templates by NIH

The deadline for the response to a research protocol that has been previously reviewed and tabled by the Research Ethics Board is three weeks prior to the meeting dates as listed above.

Submission deadlines

All additional documents presented for review/approval must include a version date.

• Summarize the revisions and provide clarification to the issues outlined in response to each bullet of the Research Ethics Board (REB) conditional approval letter in a cover letter.
• Cite the full title and ethics reference number of your study on the Tabled Response Letter.
• Provide electronic copies of the revised portions of your study.
• Revisions must be highlighted so they can be identified in the text of the revised documents (for example, any deleted text should have a strikethrough and new text bolded or underlined).
• All revised documents will require a new version date. Note that for Informed Consent Forms this must be updated in the footer of each page.
• Final approval will be delayed if the dates are not corrected.

1. Send the response to the bannreb@umanitoba.ca only. Do not send it to any of the REB staff’s personnel email accounts.
2. In the Subject line of the email enter the following information as applicable to the submission:
   
   Ethics HS # (followed by HREB or BREB #) tabled response

All additional documents presented for review/approval must include a version date.

• Summarize the revisions and provide clarification to the issues outlined in response to each bullet of the REB conditional approval letter in a cover letter.
• Cite the full title and ethics reference number of your project in the Letter of Response.
• Provide electronic copies of the revised portions of your study Revisions must be highlighted so they can be identified in the text of the revised documents (for example, deleted text should have a strike through and new text bolded or underlined).
• All revised documents will require a new version date. For Informed Consent Forms, this must be updated in the footer of each page.
• Final approval will be delayed if the dates are not corrected.

1. Send the response to the bannreb@umanitoba.ca only. Do not send it to any of the REB staff’s personnel email accounts. 
    
2. In the subject line of the email enter the following information as applicable for to the submission: 
   
   Ethics HS # (followed by HREB or BREB #) RESPONSE to Conditional approval
    
3. In the subject line for COVID-19 biological clinical trials, enter the following information:
   
   COVID - Ethics HS # (followed by HREB or BREB #) RESPONSE to Conditional approval

Researchers are obliged to follow the procedures outlined in the protocol or proposal approved by the Research Ethics Board (REB).

If the researcher or sponsor recognizes the need for modification to the protocol or proposal, they are obliged to file a protocol amendment with the REB prior to implementing the change.

This guideline outlines:

1. The necessary information that is required of the applicant when submitting a request to the REB
2. Details of the operating procedures of the Bannatyne Campus REBs review process related to amendments.

Examples of amendments that require REB review include, but are not limited to, changes in:

• key personnel, such as principal investigators, co-investigators, study physicians
• research protocol objectives
• advertising materials, such as flyers, radio spots
• research procedures
• participant populations, such as age range
• location where research will be conducted
• consent or assent form
• recruitment procedures
• date for completion of study
• procedures for monitoring safety data

• Complete and review the Bannatyne Campus REB Submission Requirement Checklists for Amendments, Additions or Changes to Approved Studies Delegated Review or Full Board Review.
• All changes, with the exception of changes in personnel, must be submitted on the Amendment Form.
• For changes in study personnel, complete the Change in Study Personnel Amendment Form (PDF). A checklist of required documents is outlined on the form.
• IMPORTANT:  Review consent forms to ensure new required language for Data and Biological sharing is updated as applicable to the study.
• Additions to amended documents must be underlined or in bold text and any deletions indicated by strikethrough.
• Remember to revise the version date in the footer of each page of amended consent forms or title page on supporting documents.

If a No Objection Letter (NOL) from Health Canada was received for the initiation of the clinical trial, then a copy of the NOL from Health Canada for proposed changes to the protocol must be submitted before the REB will approve the proposed amendment or an appropriate justification from the sponsor is outlined in the submission.

The Bannatyne Campus REB office must be notified of closure of any study previously submitted for ethical review regardless of whether the study received final approval or not.

Premature termination or suspension of a trial

If a study is terminated prematurely or suspended for any reason, the Principal Investigator (PI) must promptly inform the REB in writing this suspension; the reasons for the suspension and the appropriate measures in place to assure appropriate therapy and follow-up for the participants; and the procedures considered for notifying the participants. If the reason for suspension is related to an emergent safety issue, the notification should be either faxed to the REB office or preceded by a telephone call to the Chair or REB Coordinator.

The Bannatyne Campus Final Study Status Report is also required at the time the sponsor conducts the close-out visit as indicated below:

Multi-centre studies

The local site may close if there are no further implications to local participants even though the study continues in other sites. For industry-sponsored studies, a Final Study Status Report should only be submitted to the REB office after the sponsor has conducted the close-out visit. If the sponsor has no plans to conduct a close-out visit, the Final Study Status Report must be submitted after all data clarifications have been completed and the sponsor has indicated to the Principal Investigator (PI) that study files can be archived for long term storage.

Local single-centre studies

A Final Study Status Report must be submitted to the REB office after the study when all study-related activities including long-term follow-up of data are completed.

For studies that do not involve direct participant participation for example, secondary use of data, a Final Study Status Report can be submitted when data acquisition is completed.

In some cases if the study is receiving funding there may be a requirement to keep the study file open while funds are being accessed. It also is suggested the study file remain open during the initial data analysis for potential first publication should journal editors request additional information. This will facilitate the review of the amendment by the Research Ethics Board to collect this additional information.

For local registries or research databases, a Final Study Status Report must only be submitted after the database is destroyed or there is no intent to access the dataset in the future for research purposes.

The Research Ethics Board office will process the Final Study Status Form and an email will be sent when the report is uploaded to our system. Please keep this for your records.

There is no regulatory requirement for acknowledgment of notices re: study closure or premature termination.

The REB will not send an initialed report to the site.

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 six to 12 months of study completion.