Protocol Amendments or Changes to Study
Change in Study Personnel and Contact Information
Adverse Event Reporting
Study Closure and Termination
Request for Preliminary Access (RPA) to Grant Funding
2. Review Submission Deadline Dates
3. Determine appropriate Research Ethics Board for review:
Biomedical Research Ethics Board (BREB) - Research proposals involving clinical trials and other biomedical research interventions.
Health Research Ethics Board (HREB) - research involving behavioral sciences, databases, surveys, registries, specimen collection/banking and examination of medical records.
4. Review Categories and Procedures for Review of New Research Protocols to determine Level of Review (i.e. Full Board or Delegated) required for your protocol.
5. Review the Bannatyne Campus Research Training Manual and Common REB Submission Pitfalls - Tips for making a Good REB Submission and Avoiding Delays in Approval. Review of these documents will assist you in understanding the issues that need to be addressed in the ethics submission.
6. Prepare submission to Bannatyne Campus Research Ethics Board by using appropriate checklist
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
Checklist for Single Case Report (pdf)
7. Institutional Approval independent of the Bannatyne Campus Research Ethics Board review and 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.
8. 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. Please visit the link provided above for more information.
1. Review “Submission and Review Procedures for Amendment/Changes to Previously Approved Study” to determine Level of Review required (i.e. Delegated or Full Board )
2. Review Submission Deadline Dates if Full Board Review is required. Changes/Amendments that meet the criteria for delegated review can be submitted at any time.
3. Prepare submission using the appropriate checklist:
1. 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.
2.Complete Change in Study Personnel Amendment Form (pdf)
3.A checklist of required documents is outlined on the form.
1. Review Annual Procedures to determine Level of Review required (i.e. Delegated and Full Board)
2. Review Submission Deadline Dates if Full Board Review is required. Annual review that meet the criteria for delegated review can be submitted at any time.
3. Prepare submission using the appropriate checklist:
1. Review Study Closure and Termination Guidance to assist in determining when a study should be closed.
2. All studies must have a Final Study Status Report (pdf) sent to the REB at the time of study closure as outlined in the guidelines.
1. Please contact the University of Manitoba Office of Research Service (ORS) to assist you in determining whether these forms are appropriate to complete.
2. If it is determined by het ORS an RPA is required please review the documents listed below
PROBLEMS USING PDF FILLABLE FORMS ONLINE?
Questions or problems contact:
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.
MANDATORY CLINICAL TRIAL REGISTRATION
TCPS 2 requires registration of certain clinical trials. The international committee of medical journal editors also requires certain clinical trials be registered as a condition of publication
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.
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 6-12 months of study completion.