Please note that by September 1, 2011 all submissions made to any of the five (5) University of Manitoba Research Ethics Boards (REBs) for protocol review and approval will require completion of the TCPS 2: Course on Research Ethics(CORE). Please include a copy of the certificate with your submissions. The final approval certificates for new studies will not be released until the REB receives a copy of the certificate. Health Research Ethics Board (HREB) submission communication - all HREB submissions, amendments, annual renewals and all other documentation on CD/Memory stick
NOTE: HEALTH RESEARCH ETHICS RESEARCHERS (HREB) - please read the following link for a message that pertains solely to Health Research Ethics Board (HREB) submissions to the Bannatyne Campus Human Ethics REB Office:
***NOTE: New CV Templates for 2013 are required with all submissions (one per calendar year)***
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Required Documents for Initial Review of New Studies New submissions must be HAND DELIVERED or COURIERED to the REB |
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Documents for NEW STUDIES requiring FULL BOARD REVIEW |
BREB
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HREB (Everything to HREB |
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| Covering Letter - Must list all items submitted to the Board including version numbers and dates. | 15 copies |
10 copies |
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| TCPS 2: Course on Research Ethics (CORE) - see above Important New Submission Criteria | 1 copy | 1 copy | ||
| Submission Form
All information must be typewritten in space provided. Complete all questions in the form. Do not reference the protocol or attach pages of the protocol unless specifically indicated in the form. SUBMISSION FORM MUST BE STAPLED. If the Principal Investigator or Co-Principal Investigator is also the Department Head then a delegate must sign off attesting to the scientific merit of the study. |
15 copies Stapled |
10 copies Stapled |
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| Protocol Synopsis - (if applicable) - Only include if supplied by a pharmaceutical company. The Board prefers that the information provided in the protocol synopsis is outlined in the submission form and the appropriate number of protocols are included for review. |
15 copies |
10 copies |
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| Pre-Screening and Screening Form(s) /Questionnaires (Including Phone Screening Forms) |
5 copies |
5 copies |
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| Participant Information and Consent Form(s) - (if applicable) | 15 copies Stapled |
10 copies Stapled |
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| Participant Letters and/or e-mails of Invitation to Participate - (if applicable) - Such documentation may be appropriate in lieu of signed consent for collection of anonymous data via a mail returned survey or on-line survey. | 5 copies | 5 copies | ||
| Protocol - Required for all submissions | 5 copies Stapled |
5 copies Stapled |
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| Questionnaires and Other Material(s) to be given to participants - (if applicable) | 5 copies Stapled |
5 copies Stapled |
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| Advertisements and other recruitment material - (if applicable) | 5 copies Stapled |
5 copies Stapled |
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| Study Budget |
5 copies |
5 copies |
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| Any Supporting Documents | 5 copies Stapled |
5 copies Stapled |
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Principal Investigator's Curriculum Vitae Template - required to be submitted with first submission and annually (calendar year). New CV Templates for 2013 required. ONE per year |
1 copy Stapled |
1 copy Stapled |
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| Investigator's Brochure - (if applicable). This is required for clinical trials involving an investigational study medication or natural health product | 1 copy |
1 copy (if applicable) |
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| Letter of "No Objection" or "Acknowledgement of Receipt of Amendments" for trials that require a Clinical Trial application to Health Canada - (if applicable) | 1 copy |
1 copy (if applicable) |
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| **All documents must be dated. (Protocol, Informed Consents, Investigator's Brochures, Advertisements, Questionnaires, etc.) |
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Documents for NEW STUDIES that may qualify for DELEGATED REVIEW. (Please ensure you have reviewed the delegated review guidelines prior to preparing your submission) |
BREB | HREB | ||
| Covering Letter - Must list all items submitted to the Board including version numbers and dates | 3 copies |
3 copies |
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| TCPS 2: Course on Research Ethics (CORE) - see above Important New Submission Criteria | 1 copy | 1 copy | ||
| Submission Form All information must be typewritten in the space provided. Complete all questions in the form. Do not reference the protocol or attach pages of the protocol unless specifically indicated in the form. SUBMISSION FORM MUST BE STAPLED. If the Principal Investigator or Co-Principal Investigator is also the Department Head then a delegate must sign off attesting to the scientific merit of the study. |
3 copies Stapled |
3 copies Stapled |
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| Participant Information and Consent Form(s) - (if applicable) | 3 copies Stapled |
3 copies Stapled |
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| Basic Elements of Consent Disclosure Statements for Survey Research - Written consent may not be required as willingness of the participant(s) to complete the survey may be adequate evidence of informed consent provided the disclosure statement is informative. | 3 copies | 3 copies | ||
| Participant Letters and/or e-mails of Invitation to Participate - (if applicable) - Such documentation may be appropriate in lieu of signed consent for collection of anonymous data via a mail returned survey or on-line survey. | 3 copies | 3 copies | ||
| Protocol - Required for all submissions. NOTE: A protocol may not be required when following the new procedures for submitting a retrospective records review study. | 3 copies |
3 copies |
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| Questionnaires and Other Material(s) to be given to participants - (if applicable) | 3 copies Stapled |
3 copies Stapled |
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| Data Collection Form (for retrospective chart review studies only) | 3 copies Stapled |
3 copies Stapled |
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| Advertisements and other recruitment material - (if applicable) | 3 copies Stapled |
3 copies Stapled |
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| Study Budget | 3 copies |
3 copies |
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| Any Supporting Documents | 3 copies Stapled |
3 copies Stapled |
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Principal Investigator's Curriculum Vitae Template - required to be submitted with first submission and annually (calendar year). New CV Templates for 2013 required. One per year. |
1 copy Stapled |
1 copy Stapled |
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Documents for submission for RETROSPECTIVE CHART OR RECORDS REVIEW |
BREB | HREB | ||
| Submission Form for Retrospective Chart or Records Review The HREB has developed a new form and procedures for reviewing retrospective chart/record(s) review or a retrospective database review where there is no intention of contacting individuals. The full Bannatyne Campus Research Ethics Board submission form must be completed for all other studies.
Details regarding specific submission instructions and requirements are outlined in the form and in the Health Research Ethics Board (HREB) Policy Statement on Retrospective Chart or Record Reviews (NEW procedures). Please call Shelly Rempel-Rossum at 789-3389 if you have any further questions regarding the new processes. |
2 copies Stapled
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2 copies Stapled On CD or Memory Stick |
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Required Documents for Review of Amendments and Other Changes to the Study (Please ensure all revised documents are provided with a new version date) |
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Documents for AMENDMENTS requiring FULL BOARD REVIEW. (Please ensure that you have reviewed the amendment guidelines prior to preparing your submission). |
BREB | HREB | ||
| Cover Letter - This is optional if the items submitted for review are clearly listed on the amendment form. | 15 copies |
10 copies |
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| Amendment Form All information must be typewritten in the space provided. Complete all questions in the form. Do not reference the protocol or attach pages of the protocol unless specifically indicated in the form. |
15 copies Stapled |
10 copies Stapled |
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| Amendment Summary | 5 copies Stapled |
5 copies Stapled |
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| Amended and/or new Participant Information and Consent Form(s) - (if applicable) | 15 copies Stapled |
10 copies Stapled |
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| Amended Protocol | 5 copies |
5 copies |
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| Amended and/or new Questionnaires and Other Material(s) to be given to participants - (if applicable) | 5 copies Stapled |
5 copies Stapled |
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| Amended and/or new Advertisements and other recruitment material - (if applicable) | 5 copies Stapled |
5 copies Stapled |
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| Any Supporting Documents | 5 copies Stapled |
5 copies Stapled |
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Principal Investigator's Curriculum Vitae Template - required if there is a change in the local Principal Investigator. New CV Templates for 2013 required. One per year. |
1 copy Stapled |
1 copy Stapled |
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| Letter of "No Objection" or "Acknowledgement of Receipt of Amendments" for trials that require a Clinical Trial application to Health Canada - (if applicable) | 1 copy |
1 copy |
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**Please contact Lynne at 789-3255 or Denise at 789-3883 to determine whether some copies of the Amendment form and consent forms can be submitted on a CD for amendments and annual reviews that require full Board review. |
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Documents for AMENDMENTS qualifying for DELEGATED REVIEW. (Please ensure you have reviewed the amendment guidelines prior to preparing your submission) |
BREB | HREB | ||
| Amendment Form All information must be typewritten in the space provided. Complete all questions in the form. Do not reference the protocol or attach pages of the protocol unless specifically indicated in the form. |
1 copy Stapled |
1 copy Stapled |
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| Amendment Summary | 1 copy Stapled |
1 copy Stapled |
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| Amended and/or new Participant Information and Consent Form(s) - (if applicable) | 1 copy Stapled |
1 copy Stapled |
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| Amended Protocol | 1 copy |
1 copy |
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| Amended and/or new Questionnaires and Other Material(s) to be given to participants - (if applicable) | 1 copy Stapled |
1 copy Stapled |
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| Amended and/or new Advertisements and other recruitment material - (if applicable) | 1 copy Stapled |
1 copy Stapled |
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| Any Supporting Documents | 1 copy Stapled |
1 copy Stapled |
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|
Principal Investigator's Curriculum Vitae Template - required if there is a change in the local Principal Investigator. New CV Templates for 2013 required. One per year. |
1 copy Stapled |
1 copy Stapled |
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| Letter of "No Objection" or "Acknowledgement of Receipt of Amendments" for trials that require a Clinical Trial application to Health Canada - (if applicable) | 1 copy |
1 copy |
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Required Documents for Annual Review of a Study Previously Approved by the BREB or HREB |
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Documents for ANNUAL REVIEW requiring FULL BOARD REVIEW. (Please ensure you have reviewed the annual review guidelines prior to preparing our submission) |
BREB | HREB | ||
| Covering Letter - Must list all items submitted to the Board including version numbers and dates | 15 copies |
10 copies |
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| Annual Study Status Form All information must be typewritten in the space provided. Complete all questions in the form. Do not reference the protocol unless specifically indicated in the form. |
15 copies Stapled |
10 copies Stapled |
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| Participant Information and Consent Form(s) - (if applicable and only if recruiting is ongoing) | 15 copies Stapled |
10 copies Stapled |
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| Protocol **see note below for electronic submissions | 3 copies |
3 copies |
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| Latest Data Safety Monitoring Board - (if applicable) | 3 copies |
3 copies |
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| Minor Protocol Deviation Log - (if applicable) | 3 copies | 3 copies | ||
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Principal Investigators' Curriculum Vitae Template. New CV Templates for 2013 required. One per year. |
1 copy | 1 copy | ||
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**Please contact Lynne at 789-3255 or Denise at 789-3883 to determine whether some copies of the Annual Approval form and consent forms can be submitted electronically for annual reviews that require full Board review. |
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Documents for ANNUAL REVIEW that qualify for DELEGATED REVIEW |
BREB | HREB | ||
| Annual Study Status Form All information must be typewritten in the space provided. Complete all questions in the form. Do not reference the protocol or attach pages of the protocol unless specifically indicated in the form. |
1 copy |
1 copy |
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| Participant Information and Consent Form(s) - (if applicable and only if recruitment is ongoing) |
1 copy |
1 copy |
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| Latest Data Safety Monitoring Board - (if applicable) | 1 copy | 1 copy | ||
| Minor Protocol Deviation Log - (if applicable) | 1 copy | 1 copy | ||
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.
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?
All submissions should include a full protocol which discusses the applicable scientific and ethical aspects of the study.