Main Application Forms must be submitted by 4pm on Monday in order to be considered for review in the following two weeks. Late submissions will be put over to the next review cycle. An application cannot be formally reviewed until it is complete, and if necessary, all Pre-Screening Review requirements are met.
- All applications require the submission of a TCPS2 certificate for all members of the research application.
- Once an application is accepted for review the REB has up to four weeks to review the application and provide feedback.
The University of Windsor has a proportional review process where a protocol is assigned a level of review based on assessment of risk or designation by the Chair.
The delegated committee meet weekly, usually on Tuesday, to review proposals which qualify for the expedited process. Generally, these include applications that:
- Have been previously cleared but require minor revisions;
- Do not contain more than minimal risk
- Do not involve deception and/or
- Do not include biomedical elements
If the board believes that more than minimal risk is involved then the proposal will go through the full review process.
Research, which involves greater than minimal risk, notable deception, and/or biomedical procedures, is reviewed by the full REB. They usually meet once a month.
Minimal risk occurs when potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participants in the research to be no greater than those encountered by the participant in those aspects of his or her everyday life that relate to the research.
Protocols involving the use of deception would normally be referred to full REB for consideration. Any use of deception requires a rationale as to why alternatives to deception cannot be used, including an argument showing that the benefits of the use of deception outweigh the risks.
Biomedical research is defined as studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures and/or invasive procedures, and studies concerning human health-related behaviour and/or experiences in a variety of circumstances and environments.
Most protocols undergo one or more rounds of revisions prior to being cleared. Within a week after reviewing the application, the REB contacts the researcher by email with the questions and comments raised by the reviewers. If revisions are minor, these can be carried out quite quickly in an expedited fashion. Researchers should allow at least 4 weeks for the review process for minimal risk research to be completed. The timeliness of review of an application is highly dependent on the submission of a complete application and that the information in the application is clearly described in terms that an educated person from outside of the field of the research can understand.
Revisions are submitted by email to the Office of Research Ethics, unless otherwise noted. Researchers respond to the comments in one document, and edit the original application using track changes. Both documents (the responses to the comments and the revised application) must be submitted to the office before the responses will be reviewed.
When the final clearance has been obtained, researchers are notified by email by the Chair of the REB (student supervisors are copied on this correspondence). This is followed by a formal letter listing the terms of the clearance. For research funding awarded 'pending ethics approval', an email is sent to the Office of Research and Innovation Services indicating ethics clearance, whereupon they authorize the opening of research accounts. Ethics clearances are issued for a maximum period of 12 months only.
In some cases, "outstanding materials" is given where a document, such as the approval letter from a school board or hospital, has not been received by the researcher prior to submission to the REB. Final clearance is given once the document has been received by the Office of Research Ethics.
At least once a year, all researchers must submit a progress report to the Office of Research Ethics in order to have their clearance extended past the initial twelve-month period. If the project ends prior to one year from the date of the clearance letter, a final report must be submitted. Researchers may be notified by email in advance of their twelve month clearance expiring, and provided with a Progress/Final Report form which they must complete, prior to the expiry of their initial clearance. A progress report must be submitted for each funded project prior to the release of any additional funds associated with that project. This process is repeated each year until the project is finished.
Any changes made to either the research protocol (including changes to the study design recruitment method, study population, surveys, questionnaires, or interview formats), or the consent form must be submitted for REB review prior to their implementation.
Researchers seeking an amendment should submit one signed copy of the Request to Revise form along with:
- A memo briefly describing the changes that the researcher wish to make, and why they wish to make them. The memo should describe what is the impact of the change on the study objectives, methodology, and data analysis.
- Any changed documents associated with the study (e.g. recruitment materials, consent forms, study instruments), with the modification highlighted for comparison with the original versions on file.
Amendments can be very minor (in which case the Chair of the REB can authorize their clearance), or more fundamental (in which case they are sent to the expedited reviewers). If the proposed amendment requires revision, or further information is needed, the researcher will be notified by email. Once the Request to Revise is cleared, the Chair of the REB will notify the researcher by email of this clearance.
All researchers must complete and submit a final report once their data collection is completed. Should a research project be finished prior to the twelve month renewal date, the researcher must notify the Office of Research Ethics as soon as possible and complete and submit a final report using the Progress/Final Report form.
Cleared protocols with no other changes can be extended by submitting any progress reports that are due. The progress report form provides a space for requesting very minor changes to applications. Extending dates can be submitted on the Progress Report, or in a separate Request to Revise. After an application has been open for 3 years, the REB may request the submission of a new application.
Protocols will be closed: on the receipt of a final report; three months following the final clearance date; or once a file has been open for three years unless other arrangements have been made. Incomplete/pending files will be closed at the discretion of the board after a period of no longer than 12 months.
The board will consider re-opening a protocol that has been closed within the past 12 months. Such requests are submitted on the Request to Revise form. Files that have been closed for more than 12 months must be submitted as a new application.