Submission tips

Tips for submitting ethics forms

  • Ethics applications forms and templates for consent forms undergo regular updating. Always use the current forms found on the web pages of the REBs.
  • 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.
  • Older versions will not be accepted for review.
  • Fillable PDF Form Tips

Tips for consent templates

  • Ensure lay simple language is used and all acronyms  are spelled on first use.   Reading level should be at approximately Grade 7. 
  • Ensure consistency between submission, protocol and supporting documents ( e.g.  timing of and length of visits, procedures, etc.).
  • Review consent forms to ensure only applicable wording is included in version submitted to Research Ethics Board..
  • The bold and underlined portions in the consent templates are for ease of use only. Please remember to remove them from the Informed Consent Forms before submitting them.
  • If multiple consent forms are used ensure each is labelled as to target population or procedures (e.g. Genetic Consent Form, Focus Group Consent Form,  Patient Consent Form, Control Consent Form, etc).

Protocols

All submissions should include a full protocol that discusses the applicable scientific and ethical aspects of the study.

Aspects of protocol writing and templates

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

Initial review requirements

Use these criteria to find the type of initial review you are initiating.

Categories and procedures for review of new research protocols

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

Full board review

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.

Delegated review

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.

HREB Policy Statement on Retrospective Chart or Records Reviews

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)

Access to grant funding before receiving ethics approval (RPA)

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.

Case report studies

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  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 -December 2023 (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)

Departmental review

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.

Mandatory clinical trial registration

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)

Uncertain if ethics review is required?

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.

Meeting dates and submission deadlines

Submission and meeting dates are tentative and subject to change. Adjustments may be required to enable the full launch of RITHIM and the alignment of impact, privacy and ethics reviews.

The deadline for receipt of all new research protocol submissions including studies that qualify for delegated review and any full board amendment or annual review submissions are on the submission deadline dates listed below. The submission must be received electronically by 4:30 p.m.

The deadline for the response to a research protocol that has been previously reviewed and Tabled by the Research Ethics Board is the same monthly date for new submissions (i.e. three weeks prior to the meeting dates).

All other requests for review and/or approval can be submitted at any time.

Submission deadline dates

2024

Meeting dates

2024

March 4, 2024 March 25, 2024
April 2, 2024 April 22, 2024
May 6, 2024 May 27, 2024
June 3, 2024 June 24, 2024
  NO MEETING IN JULY
July 29, 2024 August 26, 2024
September 3, 2024 September 23, 2024
October 7, 2024 October 28, 2024
November 4, 2024 November 25, 2024
November 25, 2024 December 16, 2024

The August meeting submission deadline is now four weeks prior to the meeting date.

New submissions

Review these steps for new studies to ensure you follow the correct process and submit your project by the deadline. 

1. Review guidelines and research manual

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.

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

2. Review submission deadlines

3. Determine appropriate Research Ethics Board for review

  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.

4. Review the categories and procedures for review of new research protocols

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.

5. Review checklists to prepare submissions

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

Please disregard any references to the need for paper copies on checklists/or website instructions.  We only require electronic copies via e-mail at this time.

6. Step-by-step instructions for submitting electronically

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.

7. COVID-19 requirements for in-person research

Please follow Public Health and institutional policies relating to COVID-`19 mitigation strategies for protocols  involving in-person contact. 

 

8. Seek institutional approval

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)

9. Seek Provincial Health Research Privacy Committee (PHRPC) if required

The PHRPC reviews all health research protocols that require use of personal health information maintained by any Manitoba Trustee, including government and government agencies, and renders a decision (i.e. approved, conditionally approved or not approved/requires revision).

Learn more about PHRPC approval

10. 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.

Office of Institutional Analysis surveys

Response to tabled letters

Tabled submissions require the review of the full committee. Use the instructions below to correctly format and submit your tabled response.

1. Review the board meeting deadlines

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

2. Prepare your 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 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.

3. Submit electronically

  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

Response to conditional approval

If the initial review was not tabled, there is no deadline for submitting your response. Follow these instructions when preparing your response for conditional approval.

1. Prepare your response of conditional approval

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.

2. Submit electronically

  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

Protocol amendments or changes to study

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.

Amendments or changes to an approved protocol

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

Tips when submitting amendments or changes to a protocol

  • 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.

When are No Objection Letters (NOL's) required for amendments?

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.

  1. Review Submission and Review Procedures for Amendment/Changes to Previously Approved Study to determine the level of review required — full board or delegated.
  2. Review submission deadline dates if full board review is required. Amendments that meet the criteria for delegated review can be submitted at any time.
  3. Prepare your submission using the amendment form and appropriate checklist.
  4. Send the Amendment to the bannreb@umanitoba.ca email address. Do not send it to any of the REB staff’s personnel email accounts. Enter the following information in the subject line of the email as applicable to whether it is a delegated or full board review.

    Ethics HS # (followed by HREB or BREB #) Amendment – full board 
    or
    Ethics HS # (followed by HREB or BREB #) Amendment – delegated

Change in study personnel and contact information

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. Certificates of approval  are only issued if there is a change in the Principal Investigator.

The University of Manitoba requires  that all research personnel involved in the collection and review of research data complete the online TCPS 2 CORE tutorial. 

Complete the Change in Study Personnel Amendment form and follow instructions for submitting via e-mail for amendments.

Change in Study Personnel Amendment Form (PDF)

Request for preliminary access to grant funding

Use the forms below to request preliminary grant funding before activity requiring ethics approval is undertaken if Research Services determines that a request for preliminary access (RPA) is required.

  1. Please contact the University of Manitoba Office of Research Services (ORS) to help you determine whether these forms are appropriate to complete.
  2. If it is determined by Research Services that an RPA is required, please review these documents:

Annual review procedures

All research studies, databases, registries or specimen repositories that received initial approval from a Bannatyne campus Research Ethics Board (REB) must be resubmitted for annual approval to the appropriate REB no later than four weeks prior to the expiry date noted on the initial certificate of final approval. This includes all research studies, databases or specimen repositories that may be closed to accrual or enrolment and/or where there is an ongoing follow-up of study participants, such as the continued collection of mortality or morbidity information related to the initial study, research databases or registries.

Studies that do not involve participant participation, such as secondary use of data, must be submitted for renewal up until the point that the data acquisition is completed. Local research databases or registries or specimen repositories should submit an application for annual approval up until the point the data or specimens are destroyed.

The Bannatyne campus REB office must be notified of closure via the Bannatyne campus Research Ethics Board Final Study Status Report of any study previously submitted for ethical review regardless of whether the study received final approval or not.

Process

  1. Review annual procedures to determine the level of review required — either delegated or full board.
  2. Review submission deadline dates if a full board review is required. Annual reviews that meet the criteria for delegated review can be submitted at any time.
  3. Prepare your submission using the appropriate checklist from the HREB/BREB forms.

Submit the request for annual approval 4-6 weeks prior to the expiry date noted on the initial certificate of approval or last annual approval certificate to ensure there is no lapse in approval.

Submit your Annual Study Status Report (ASSR)

All requests for annual approval, including research approved by the HREB and BREB, must be submitted using the Bannatyne campus Research Ethics Office Annual Study Status Report (ASSR) listed here. Ensure you use this version of the PDF form, as older versions will not be accepted.

Studies electronically for full board annual review

Send the Annual Review documents to bannreb@umanitoba.ca only. Do not send it to any of the REB staff’s personnel e-mail accounts.

Enter the following information as the subject line of your email as applicable: 
Ethics HS # (followed by HREB or BREB #) Annual – FULL BOARD

Studies for delegated annual review

Submit your ASSR for delegated review electronically, using the Submit your Annual Study Status electronic form below.

Submit your requests for annual approval as a scanned (signed by PI or electronic signatures) Bannatyne campus REB ASSR form.

For multiple consent forms, please scan them as one document before uploading.

NOTE:  After you submit the documents, you will be redirected to the University of Manitoba homepage.  If you do not receive confirmation from the Research Ethics Board in 3 days contact the office at bannreb@umanitoba.ca

Only delegated ASSRs will be accepted using the electronic form. Any other submissions (such as new protocols, final reports, amendments, safety reports or protocol deviations) will not be accepted at this site.

Submit your Annual Study Status Report (Delegated)

Study closure and termination

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

Study closure is the time at which data is archived at the local site, or in the case of multi-centre trials, when all data has been transferred to the sponsor after the close-out visit.

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.

Requirements for notification of premature termination or study closure

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.

Acknowledgement of receipt

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.

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 six to 12 months of study completion.

Submit your Final Study Status Report Form (FSSR)

The University of Manitoba Bannatyne Campus Research Ethics Board (REB) is accepting Final Study Status Reports (FSSR) electronically. These closure notices must be submitted as a scanned (signed by PI or electronic signatures) Bannatyne Campus REB FSSR form.

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.

Please ensure you are using the most current version of the FSSR. Older versions will be returned to the researcher. If including supporting documentation we ask that it be submitted along with the FSSR as a single combined document.

NOTE:  After you submit the documents, you will be redirected to the University of Manitoba homepage.  If you do not receive confirmation from the Research Ethics Board in 3 days contact the office at bannreb@umanitoba.ca

Download the Final Study Status Form (PDF)

Only FSSRs will be accepted via this format. Any other submissions (such as new protocols, annual reviews, amendments, safety reports, protocol deviations, etc.) will not be accepted at this site.

Submit your Final Study Status Report

Protocol deviations

Protocol deviations and privacy breach reporting

As per ICH GCP 4.5.2, "The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in monitor(s), change of telephone number(s).

A protocol deviation is defined as any action or inaction that does not correspond to the approved protocol. A protocol deviation may include accidental/unintentional or intentional changes, including changes made to eliminate an immediate hazard to participants or others. Protocol deviations may be major or minor and serious or not serious.

All protocol deviations (both minor and major) for all research projects, that is, clinical trials, observational studies, retrospective records review, registries, biobanks and others that had not received prior approval by a Bannatyne Campus Research Ethics Board through an amendment, must be reported to the Bannatyne Campus REB office as per the guidelines.

As we develop more detailed requirements for reporting privacy breaches or confidentiality breaches, please report such as a protocol deviation on the Major Protocol Deviation Form.

Adverse event reporting

Review the University of Manitoba Bannatyne Campus Research Ethics Board's procedures relating to the reporting of adverse events and safety information.

Adverse event reporting forms and guidelines