Decision Making FAQ
Review Period Questions:
- What should I do after I submitted my application package for review?
- When will I hear a response from the REB?
- What are possible responses I could hear from the REB?
- What happens if my proposal involves no more than minimal risk?
- How will I be notified of the Board's decision?
- What happens after my initial response from the REB Chair?
- What tips can you provide to an applicant who is in the process of answering the REB?
- How long can I expect the review to take from the the time I submit my revisions?
- When can I expect to start my research?
- When/how will I be notified that my research has the status of ethical clearance from the REB?
- How will I receive my Certificate of Research Ethics Clearance?
- How long does my research ethics clearance last?
1. What should I do after I submitted my application package for review?
Once you submitted your application, you will receive an email receipt from the Office of Research Ethics (email@example.com) detailing your SMU REB registration number. Researchers place their SMU REB registration number on their research documents before they are disseminated to research participants. This is so when research participants have questions, they can reference the research to researchers and to the REB.
2. When will I hear a response from the REB?
Applications are reviewed shortly after they are received. All reviews are processed as expeditiously as possible and allocated reviewers. It is important that application packages are fully complete to avoid delays. If the proposal cannot be sent to reviewers because answers or materials are missing, investigators will be notified and asked to course correct and resubmit the proposal.
It is also possible that the REB may seek expert in-house or off-site advice about an application. Generally, the review process, from initial submission to final approval, takes 6-8 weeks, faster during slower periods. The Board often completes the process in a shorter period but this cannot be guaranteed and the turn around time is entirely based on the work that has been submitted. The process may take longer during busier times of the academic year, typically November to March. The REB Chair will contact applicants in writing by email. It is common for the REB Chair to seek clarification from applicants on various issues; a prompt and thorough response from applicants to the REB Chair's questions facilitates the review and clearance process. Instructions about the proper way to respond will be detailed by the REB Chair. Please do not hesitate to ask questions and for help during this process. We are happy to assist and clarify issues during the response stage.
3. What are possible responses I could hear from the REB?
First, the level of risk of the proposal will be assessed and receive either of the following decision:
- Minimal risk: The REB Chair will communicate the questions from the committee members and request information in writing via email
- Exceeds minimal risk: The REB Chair will notify the research team that a full meeting of the REB will be scheduled to discuss the study.
Secondly, the recommendation from committee members will be communicated by the REB Chair. Possible recommendations involving the proposal include:
- Clarifications are requested
- Resubmission is required
The REB Chair and the Research Ethics Officer will work together with you to explain the process, answer any questions you may have and provide guidance throughout the review process. It is important to remember that each proposal is unique and will receive proposal-specific question as well as that the REB will also serve as a contact to research participants and needs to be fluent in discussing the study. This means that the proposal needs to detail what is known about the intentions to date and the consent process needs to be participant-centered (meaningful to participant audiences) and transparent about the intentions.
4. What happens if my proposal involves no more than minimal risk?
The application is reviewed by two committee members and the REB Chair. The REB Chair will communicate the questions from the committee members and request information in writing via email.
5. How will I be notified of the Board's decision?
The REB Chair will notify all members of the research team in writing via email. The communication includes the level of risk and itemizes the questions that have been raised by REB committee members. Keep in mind, just as the investigators, the REB is a point of contact to participants and must be able to clearly communicate with participants about the research.
6. What happens after the initial response from the REB Chair?
The initial response from the REB Chair includes requests for information. This process may include revising some of the research materials. The REB Chair will ask you to revise any relating research materials but to not submit Form 1 or Form 1C again. There is no need to revise the application form during the review process. This means, Form 1 is only filled out once. Keep in mind, Form 1 is a very important document for the research team and for the REB to maintain in the master file. It details the intensions of the research and proper documentation of a protocol of a study is needed, and must be on record in order to obtain REB clearance.
What is important during this stage is that you follow the instructions of the REB Chair. This involves answering all questions that are being raised, thereby submitting a fully completed response, with no missing points, and sending the response directly to the REB Chair (their direct email address will be provided). Investigators are assigned one of three REB Chairs. The REB Chair will ask that you "reply all" to the REB Chair's request. Replying all means that the REB Chair and the Research Ethics Officer (firstname.lastname@example.org) are copied. Incorrect approaches will cause delays. The REB asks that applicants check who the response is being sent "to" in reply and simply chose "reply all". Responses must be submitted by the Faculty Supervisor for student research and by the Principal Investigator for faculty and staff research. This means that simply "copying" the Faculty Supervisor does not suffice and applicants would experience delays until the REB Chair receives the response in the requested manner. The direction of the REB Chair and the criteria of the REB needs to be followed. Investigators can double check instructions by reading the instructions on the top of the request forms, the directions from the REB Chair or review the standard operating procedures of the REB listed on the REB website.
Again, take note that you are not being asked to resubmit Form 1 or Form 1C. This means that you do not have to fill out the application form again and attach it with your response package. The REB Chair asks that applicants document your responses in the body of the response email.
7. What tips can you provide to an applicant who is in the process of answering the REB?
- For student applicants, ensure that your supervisor sends all communication to the REB. Neither the REB Chair nor the Research Ethics Officer is in a position to be able to accept requests for review from students only.
- Contact the Office of Research Ethics with questions and concerns at any point without hesitation. Help is always available. Office hours for the Research Ethics Officer are Tuesdays and Thursdays 10 am to 12 pm. To book a slot, please contact email@example.com.
- Feel free to seek clarification from the REB Chair if you are uncertain as to what is being asked. Ensure that questions are answered fully. Ensure that documents are revised, highlighted and that the documents are fully visible and free of error.
- It is in the applicant’s best interest to respond to the REB in a timely manner so the research can be cleared and recruitment of research participants may begin.
9. How long can I expect the review to take from the time that I submit my revisions?
The response time from the REB to revisions is normally done during the week it is received. It is a common mistake that either responses are not received from the faculty supervisor in case of student research or that the REB Chair is not copied on the response at all. The REB asks that in cases of student research the faculty supervisor submit the response to the REB by "replying all" to the REB Chair's email requesting clarifications and address each question that the REB Chair has summarized on behalf of the REB committee members.
10. When can I expect to start my research?
Recruitment may only begin once the project has received SMU REB clearance. The REB Chair will communicate when recruitment can start by the means of an email. In addition to the REB Chair's communicating that the proposal has received research ethics clearance, you will be provided with a signed Certificate of Research Ethics Clearance electronically. A copy of this certificate is also stored in your master file with the REB. Please do not hesitate to reach out with questions whenever in doubt.
11. When/how will I be notified that my research has the status of ethical acceptability from the REB?
The REB Chair will email all investigators that the project has REB clearance. Investigators may recruit participants into the research study at that time. Please do not hesitate to reach out with questions whenever in doubt.
12. How will I receive my Certificate of Research Ethics Clearance?
Certificates of Research Ethics Clearance are received via email.
Ensure that you fully review your Certificate of Research Ethics Clearance as it stipulates the conditions of the clearance and details the continuing review reporting requirements that pertain to the life cycle of the research.
Contact the Research Ethics Officer if you need additional explanation and guidance involving the continuing review responsibilities.
13. How long does my research ethics clearance last?
Normally, REB approval is valid for the period of one year (365 days) unless the SMU REB conditions otherwise. There exist several scenarios in which it might be a shorter time frame. This would involve a scenario in which the investigators are not yet aware of some aspects of the research yet at the time of the initial review or some aspects of the research is expected to emerge. Both researchers and the REB agree that a later review is expected to occur prior to the standard minimum annual review. For example, the REB may need to issue a 3 or 6 month clearance period, as relevant. The start and end dates are specified on the Certificate of Research Ethics Clearance. When investigators need to extend the research, it is renewable upon submission of an Annual Status Report (Form 3).