Research Ethics Review Forms
The REB has transitioned to virtual operations as part of the University’s response to the COVID-19 pandemic. The REB will continue to provide research ethics related support to faculty, students and staff, including review and clearance of research applications. All forms and related documents should be submitted to the Research Ethics Officer via email at email@example.com.
Please keep in mind that members of the REB, the REB Vice Chair, REB Co-Chairs, and Research Ethics Officer are all working at home during a pandemic. Some of us are working in circumstances that are challenging. It may take up to 10 business days to respond to emails.
Normally, researchers who submit a Form 1 application to the REB receive word from the REB chair 6-8 weeks after the application is submitted.
If you are a researcher with a time-sensitive COVID-19 application, then please contact Ms. Orshy Torok at firstname.lastname@example.org and indicate why your application merits expedited review. Research ethics review during the COVID-19 pandemic demands greater attention and consideration because volunteers, researchers and even the members of the REB may be in a position of greater vulnerability.
We will endeavour to process time-sensitive COVID-19 applications within 10 business days. Although we cannot guarantee this turn around time, we will work hard to accomplish this goal. Please note that in some circumstances, the review process may exceed this time frame.
We thank you for your patience.
Important information for researchers who create and submit their proposal for initial research ethics review:
Keep in mind that members of the Research Ethics Board (REB) review your Form 1 application. Please make sure your application is complete and that you explain your proposed research in detail and in non-technical language. The process is much like a peer –review process for grant applications and manuscripts, etc. If your application is incomplete or lacks sufficient detail, it will need to be returned to the research team, the ethics review process for your proposal will be delayed until materials and information are received. REB reviewers can only be sent complete proposals.
Complete applications receive an initial acknowledgment of receipt from the Research Ethics Officer, followed by a note from the REB Chair within 6-8 weeks after submission, sometimes within a shorter time-frame. Usually the REB Chair will have questions for you. A prompt and thorough response from you to the REB Chair enables the review process to continue. Please submit all materials in PDF format without the use of compressed folders. This ensures proper accessibilty and visibiliy, as the materials would appear to research participants, and avoid delay in the review process.
Student research: If the proposed research involves a student research (e.g., thesis, directed study), the faculty supervisor must submit the application (and subsequent continuing review requests) to the REB. The REB Chair will communicate directly with the faculty supervisor (students can be copied on all communication). All subsequent communication must also arrive to the REB directly from the faculty supervisor.
The REB Office can walk you through this process and help you with your application. The REB Office can also review your draft application to identify potential difficulties that could be easily fixed before it is submitted to the REB (saving you time!).
Please contact the Research Ethics Officer to book a consultation at email@example.com, office hours are Tuesdays/Thursdays 10 am to 12 pm.
Applications are sent to firstname.lastname@example.org.
Please ensure that the most up-to-date versions of the request forms are submitted for research ethics review from the below options:
Request for Exempt Review
The general categories of research that require REB review (Form 1) in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans are defined in TCPS2, 2018, Chapter A. Article 2.1.
"A determination that research is the intended purpose of the undertaking is key for differentiating activities that require research ethics review by an REB." Non-research activities do not require REB review (Form 1) even if they employ methods and techniques similar to those in research. The TCPS2 suggests that when in doubt about the applicability of the Policy to a particular project, the researcher shall seek the opinion of their home REB.
Simply, in technical terms, the exempt review process counts as a "review" to determine whether the undertaking is considered "research" per the federal policy. This process is not mandatory. To assist the SMU research community, the REB has developed the below form to help with working together to understand next steps researchers need to take moving forward with their plans. This means, whether researchers will continue with a further review, via the submission of a Form 1 or whether they will be formally considered exempt from needing to submit a Form 1.
Initial research ethics review request forms:
- FORM 1- Application for Ethics Review of Research Involving Humans
- Form 1 C- Application for Ethics Review of Research Involving Humans Cleared at Another Canadian REB
Continuing research ethics review request forms:
- Unanticipated Issues- Adverse Event Report Form
- Form 2 - Request for Changes to Cleared Research
- Guidelines for Continuing Research Ethics Review during COVID-19 Pandemic- Form 2: Request for Changed to Cleared Research
- Form 3: Annual Renewal Request Form
- Form 5: Completion of Research Request Form
Language for Informed Consent Forms/Scripts and Feedback letters for your preparation:
- How to draft an Informed Consent Form- Sample Informed Consent Form
- Sample Participant Feedback Letter
Review Process- Instruction, Tips and Common Mistakes
Initial Research Ethics Review (New application):
- Form 1 (holds no previous research ethics clearance from another Canadian REB):
Applications are considered complete when they contain:
a) a fully completed (applicants are asked to please write N/A when a question does not relate their research proposal) and signed Form 1;
b) an Informed Consent Form/Script;
c) all supporting documentation as relevant to the research.
- Form 1C (already holds research ethics clearance from another Canadian REB):
a) 1 original package is required. Be sure to review what set of documents make up a submisison package and how it is considered to be complete for research ethics review. Details are provided on top of Form 1C. It is a common mistake that applicants only submit the research ethics clearance letter/certificate from the other Canadian REB who has already granted a research ethics clearance. Please note it is necessary that the application package also include all communication that has taken place between the Principal Investigator and the other Canadian institution's REB Chair and that omitting these documents would result in an incomplete application package causing unfortunate delay. This communication or set of communication qualifies as evidence/material of the other Canadian REB's "review" that applicants are asking their home SMU REB to review at this time via the Form 1C process. If you have any questions or need additional guidance, please don't hesitate to contact the Research Ethics Officer at email@example.com to book a time to go through your draft work. Office hours are Tuesdays/Thursdays 10 am to 12 pm. Feel free to bring the details of your circumstance to our attention!
- Supporting Documents
Supporting documents refer to all research material applicants are asking the REB for research ethics review and clearance. Generally, supporting documents are items such as recruitment scripts/posters, interview protocols, surveys, questionnaires, scales, scripts, draft interview questions, invitation letters, letters of support, feedback forms, debriefing forms, advertisements, other research tools as relevant to the research, letters of support, other REB or government clearances, safety reports involving devices or materials used in the research evidencing compliance to Canadian standards, etc. Form 1 lists options for documents that must be included in the submission and provides a custom field to enter any other additional documents applicants wish to detail they are submitting. As a tip, at the minimum; a Form 1, a consent form/script, recruitment material and questions to partipants in some form (full paper versions or copies of an online survey, a word document listing of open or close ended questions, a word document detailing the interview plan) are submitted. Research proposal vary and each research will normally consist of different set of materials. As a rule of thumb, applicants submit all documents that participants would be exposed to for research ethics review and clearance.
- The REB request forms are routinely updated. Be sure to download the most current version of the application form directly from this web page.
Continuing Research Ethics Review Requests
Reporting of Unanticipated Issues, Changes to Previously Cleared Research (Form 2), Annual Status Report (Form 3) and End of Research Report (Form 5) requests:
- Submission via email (firstname.lastname@example.org) is accepted as well as the preferred method for both applicants and the Office of Research Ethics due to the time-sensitive nature of these requests. Only one copy of the request form (Adverse Event, Form 2, 3, 5) is required to be attached. Requests are accepted from the Principal Investigator of the protocol or, in case of student research, from the faculty supervisor, only. Student researchers must ask their faculty supervisors to forward the request. Submission of manual forms is also accepted and routinely submitted. Applicants are welcome to practice either option most convenient to them.
Working with Request Forms - Technical Instructions and Tips
Forms are Adobe fillable, savable, PDF forms; work can be saved and returned to at a later time. When working with the forms: 1) Ensure your Adobe Reader is updated, 2) Open the forms using Adobe Reader (otherwise users may experience issues and the recipient is unable to view the content of the form.)
The REB advises against opening the forms using Mac Preview. The Software and Application Support Centre (SAS) advises that if Mac Preview is used, after the PDF form is completed in Preview, applicants are to choose Print from the File menu and then use the dialog box's PDF option to save it to PDF. The Centre assist SMU users with tresolving their station related technical problems.
Additional blank space is available on Form 1. If applicants have further additional information to convey, additional supporting documents are welcome.
For technical assistance while working with the forms please contact the Software and Application Support Centre (SAS) at email@example.com, (902) 496-8168. The SAS Centre reports any technical issues to the Office of Research Ethics.