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
• budget details and available resources
• contract with sponsor, when available

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

• potential benefits to subjects and others
• potential harms to subjects 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

In accordance with The Tri-Council Policy Statement 2, ICH Good Clinical Practice Guidelines, Health Canada regulations and University of Manitoba policies, submissions to the Bannatyne campus Research Ethics Boards (REBs) will receive a proportionate review, based on the degree of risk. That is, the depth and extent of the ethics review will be proportional to the anticipated degree of risk to study participants.

Studies determined to be of negligible or low risk may undergo delegated (previously referred to as expedited) or departmental review, while protocols that involve greater than minimal risk must undergo full REB review.

The Categories and Procedures for Review of New Research Protocols (PDF) guidelines will assist the researcher/Principal Investigator (PI) determine the following:

• whether a new protocol qualifies for delegated (previously referred to as expedited/departmental review); and 
• the submission requirements for full board and delegated review of new protocols

All research submitted for initial review will require full board review unless it is specifically outlined as a study qualifying for delegated review in the Categories and Procedures for Review of New Research Protocols (PDF) guidelines.

Some studies may qualify for delegated ethical review.

Research deemed to be minimal risk and falling in the categories listed here may be reviewed by a delegated process. The REB chair will make the final decision as to whether a delegated or full review is required.

Generally all research projects or studies involving genetic analysis are not eligible for the delegated review processes.

Ensure that you indicate the level of review you are requesting based on the criteria of studies listed in these guidelines that qualify for delegated review and not based on the speed with which you would like to receive approval.

New studies qualifying for initial delegated review

• Investigations are primarily epidemiological in nature and where data is anonymous or anonymized (i.e. not linked to personally identifying information such as name address, initials, date of birth) involving retrospective or prospective study of existing data, documents or records. Review TCPS 2 for definitions on anonymous data.
• Research involving a mail returned survey(s) or questionnaire(s) provided the questions are not unduly alarming, intrusive, sensitive or embarrassing and there is a limited collection of potentially identifying information such as name, address, email address or identifiers such as SIN or PHIN.
• Secondary analysis of anonymized or de-identified data collected from a previously approved research project by a Bannatyne campus REB at the discretion of the chair.
• Retrospective chart or records review study where data is anonymous,  anonymized or de-identified.
• Research protocols from the National Research Council, which qualify as per SOP REB 24 “National Research Council and Bannatyne campus REB coordination.”
• Request to establish an electronic or paper database of individuals who agree to be contacted for consideration in future research studies. The data collected is limited to information required to contact individuals and to establish eligibility criteria for future studies.
  Note: Research databases or registries designed to monitor or evaluate clinical care shall usually undergo full board review.
• New investigators or sites for protocols that have already received approval from the BREB/HREB at a full board meeting within the past year.
• Expanded access or compassionate use protocols (for pharmaceutical studies) may be considered for delegated review with prior consultation of the REB coordinator.
• Research involving analysis of anonymous, anonymized, or de-identified biological samples in the custody of well-established tumor or tissue banks supported by an Advisory Committee, such as the Manitoba Breast Tumor Bank, for which participants have previously consented to use of their biological samples for research. In consultation with the Chair, a graduate course-based project which has previously undergone a departmental review and approval process per University of Manitoba policies.
• In consultation with the Chair, graduate course-based projects may be considered for delegated review provided they have undergone ethics review as per the departmental review process outline in SOP REB 07 Departmental Review.  Consultation with REB may be required to organize the departmental review committee.
• In consultation with the Chair, minimal risk studies not included in the above list may be considered for delegated review that does not involve direct contact with potentially vulnerable populations — for example, children or adolescents (under 18 years), mentally incompetent, prisoners and others.

This policy statement specifically describes the procedures and submission criteria required to obtain Health Research Ethics Board (HREB) approval to conduct a retrospective chart or record review.

These procedures are not applicable to any other studies or including chart or record review studies that are prospective in nature.

HREB Policy Statement on Retrospective Chart or Records Reviews - new procedures (PDF)

New federal regulations require that researchers cannot access funding for research projects with activities that require ethics approval at any point of the award term prior to receiving preliminary approval from the appropriate ethics committee.

Researchers must provide the ethics committee with sufficient information by completing the RPA form to permit interim access to funding until the research activities requiring ethics approval are to begin.

RPA Form (PDF)

Full review of the protocol will still be required, and the documentation for this should be submitted well in advance of the RPA end date to ensure access to funding is not discontinued.

Our general approach to case reports is to request that authors obtain the patient's consent whenever possible, write up the case study and then submit it to the Health Research Ethics Board (HREB) before sending it for publication. We review the case report largely to assess the risk that patient or individual identity may be inadvertently revealed by the author(s) in the write-up.

This is our primary concern in this situation. If the probability of inadvertent identification of an individual based on the write-up is judged to be low, we generally approve it. If we think that the probability of individuals identification is unacceptably high — for example, if the individual has a very rare condition, or a lot of demographic data is provided in the write-up — we will request changes (that we hope do not result in the loss of critical information) designed to lower the risk of inadvertent individual identification from the publication of the case report.

In cases in which patient or individual or family consent is either impossible or extremely difficult (and thus quite impractical to obtain) as well as cases in which attempting to obtain consent from a living or from the family of a deceased patient or individual would be too traumatic for those involved we may waive the requirement for consent on a case-by-case basis.

Please contact Shelly Rempel-Rossum, Research Ethics Board Coordinator, at shelly.rempel-rossum@umanitoba.ca or 204-789-3389 if you have any questions regarding ethics review and approval of case report studies.

Case report submission requirements

• Cover letter: Include brief description of consent process, list your attached documents and provide Principal Investigator (PI) contact information
• Consent form: Unsigned template presented to patient or individual
• Case report article
• Checklist for Single Case Report (PDF)

Template

This template will help you prepare a simple case report consent form to present to individuals, as applicable. Other consent templates may be acceptable for use.

Sample Case Report Consent Template (PDF)

The ethical review of research that is to be carried out by undergraduate students in a course-based (not independent study) may be delegated to a departmental level process as outlined in Categories and Procedures for Review of New Research Protocols (PDF).

Research conducted by graduate students in a course-based project may qualify for delegated review following a departmental review process, which is outlined in the delegated review guidelines.

TCPS 2 requires registration of certain clinical trials. The International Committee of Medical Journal Editors requires certain clinical trials be registered as a condition of publication.

Mandatory Clinical Trial Registration (PDF)

If a Principal Investigator (PI) is uncertain whether REB review is required, they must outline the main intent of the project in a one-page summary addressed to the appropriate chair and specifically request whether REB approval is required.

This must be submitted to the REB coordinator in a letter or by email at least four weeks before the submission deadline for full board review, to provide sufficient time to advise whether an ethics review is required.

Start by reviewing the Bannatyne Campus guidelines and the Guidance on Initial Review.

Review the manual and tips document below.

They will help you understand the issues that need to be addressed in the ethics submission.

• Common Research Ethics Board Submission Pitfalls (PDF)
• Bannatyne Campus Research Training Manual (PDF)

Please review the delegated review and submission requirements for new studies above under "Initial review requirements".

2. Review the meeting dates and submission deadline dates.

1. 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.
    
2. In addition to the Bannatyne campus protocols, the BREB and HREB will review any protocols that may be referred by the REBs on theFort Garry campus.
    
3. If you are not in the above-listed categories, please see the Fort Garry Campus Research Ethics Board page for further information.

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

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

Review the Categories and Procedures for Review of New Research Protocols document to determine if the level of review for your protocol should be Full board or delegated.

• Categories and Procedures for Review of New Research Protocols (PDF) 

Prepare submissions to the Bannatyne Campus Research Ethics Board by using the appropriate checklist below:

• 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)

Please follow these step-by-step instructions for new study submissions:

1. Create a zip folder of all applicable files per checklist and label it as the PI’s name followed by the month of the scheduled meeting deadline.
   
   The zip folder reduces the size of the file and will hopefully make it easier when sending via email. If you need assistance with create a zip file please review Microsoft's instructions for creating a zip drive here.

2. 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. 

3. Send the zip folder to the bannreb@umanitoba.ca only. Do not send it to any of the REB staff’s personnel email accounts.

4. Enter the following information as the email subject line as applicable to the submission: 
   
   Allowzip new submission – Month and year of meeting deadline A – PI name and REB (HREB or BREB) 
   
   Allowzip new submission - CASE Report –– PI name and month of submission

5. In the subject line for COVID-19 biological clinical trials enter the following information:
   
   COVID new submission Month and year of meeting deadline - PI name

It is very important that the subject line of your email is formatted exactly as noted above. Incomplete submissions or poor submissions will be returned to the submitter and will not be reviewed at the submitted meeting. The Bannatyne Campus Research Ethics Boards may need to limit the number of submissions received that will be reviewed at the monthly meeting.

Until further notice, all protocols  involving in-person visits/contact require Standard Operating Procedures on the mitigation strategies for preventing the spread of COVID-19 and the presentation of COVID -19 Risks to participants via the University of Manitoba COVID-19 Consent Appendix.

Note that in some cases UM's protocols may exceed current Public Health requirements.

Please review common COVID-19 questions for researchers to determine whether University of Manitoba Research Recovery Team (CRRT) approval is required.

Institutional approval is independent of the Bannatyne Campus Research Ethics Board review. In the 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.

Research approval and access (Winnipeg Regional Health Authority)

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.

Office of Institutional Analysis surveys

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

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.
• 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 send a received receipt via email. 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.

Submit a completed and signed copy of the Final Study Status Report to the REB Bannatyne office. This document must be completed for all studies regardless of whether the project is a clinical trial or not.

Download the Final Study Status Form (PDF)

The completed form can be submitted via the FSSR Submission Portal. Instructions can be found at the bottom of the FSSR form.