Submission Requirements
Important New Submisison Criteria:

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.


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:

Health Research Ethics Board (HREB) submission communication - all HREB submissions, amendments, annual renewals and all other documentation on CD/Memory stick

  ***NOTE:  New CV Templates for 2013 are required with all submissions (one per calendar year)***

Required Documents for Initial Review of New Studies
 (All documents must be dated)

New submissions must be HAND DELIVERED or COURIERED to the REB


Documents for NEW STUDIES requiring FULL BOARD REVIEW

BREB

 

HREB (Everything to HREB
on CD/Memory stick) INCLUDING the required hard copies

Covering Letter - Must list all items submitted to the Board including version numbers and dates.  15 copies
 10 copies
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

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
 Stapled

 10 copies
 Stapled

Pre-Screening and Screening Form(s)   /Questionnaires (Including Phone Screening Forms)

 5 copies

 5 copies

Participant Information and Consent Form(s) - (if applicable)  15 copies
 Stapled
 10 copies
 Stapled
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
Questionnaires and Other Material(s) to be given to participants - (if applicable)  5 copies
 Stapled
 5 copies
 Stapled
Advertisements and other recruitment material - (if applicable)  5 copies
 Stapled
 5 copies
 Stapled
Study Budget
 5 copies
 5 copies
Any Supporting Documents  5 copies
 Stapled
 5 copies
 Stapled

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
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)
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)
 
**All documents must be dated.  (Protocol, Informed Consents, Investigator's Brochures, Advertisements, Questionnaires, etc.)
  

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
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

Participant Information and Consent Form(s) - (if applicable)  3 copies
 Stapled
 3 copies
 Stapled
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
Questionnaires and Other Material(s) to be given to participants - (if applicable)  3 copies
 Stapled
 3 copies
 Stapled
Data Collection Form (for retrospective chart review studies only)  3 copies
 Stapled
 3 copies
 Stapled
Advertisements and other recruitment material - (if applicable)  3 copies
 Stapled
 3 copies
 Stapled
Study Budget  3 copies
 3 copies
Any Supporting Documents  3 copies
 Stapled
 3 copies
 Stapled

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

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

 

 2 copies
 

Stapled

On CD or

Memory Stick


Required Documents for Review of Amendments and Other Changes to the Study
 (Please ensure all revised documents are provided with a new version date)
  

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

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
Amendment Summary  5 copies
 Stapled
 5 copies
 Stapled
Amended and/or new Participant Information and Consent Form(s) - (if applicable)  15 copies
 Stapled
 10 copies
 Stapled
Amended Protocol  5 copies
 5 copies
Amended and/or new Questionnaires and Other Material(s) to be given to participants -  (if applicable)  5 copies
 Stapled
 5 copies
 Stapled
Amended and/or new Advertisements and other recruitment material - (if applicable)  5 copies
 Stapled
 5 copies
 Stapled
Any Supporting Documents  5 copies
 Stapled
 5 copies
 Stapled

Principal Investigator's Curriculum Vitae Templaterequired 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
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

**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.  

Documents for AMENDMENTS qualifying for DELEGATED REVIEW.  (Please ensure you have reviewed the amendment guidelines prior to preparing your submission)
 BREB  HREB

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
Amendment Summary  1 copy
 Stapled
 1 copy
 Stapled
Amended and/or new Participant Information and Consent Form(s) -  (if applicable)  1 copy
 Stapled
 1 copy
 Stapled
Amended Protocol  1 copy
 1 copy
Amended and/or new Questionnaires and Other Material(s) to be given to participants - (if applicable)  1 copy
 Stapled
 1 copy
 Stapled
Amended and/or new Advertisements and other recruitment material - (if applicable)  1 copy
 Stapled
 1 copy
 Stapled
Any Supporting Documents  1 copy
 Stapled
 1 copy
 Stapled

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
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

Required Documents for Annual Review of a Study Previously Approved by the BREB or HREB


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

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
Participant Information and Consent Form(s) - (if applicable and only if recruiting is ongoing)  15 copies
 Stapled
 10 copies
 Stapled
Protocol **see note below for electronic submissions  3 copies
 3 copies
Latest Data Safety Monitoring Board - (if applicable)  3 copies
 3 copies
Minor Protocol Deviation Log - (if applicable)  3 copies  3 copies

Principal Investigators' Curriculum Vitae Template.  New CV Templates for 2013 required.

One per year.

 1 copy  1 copy

**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.  


Documents for ANNUAL REVIEW that qualify for DELEGATED REVIEW

 BREB  HREB
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

Participant Information and Consent Form(s) - (if applicable and only if recruitment is ongoing)

 1 copy
 Stapled

 1 copy
 Stapled

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.