Submitting a research ethics application is a key step in conducting ethically sound, meaningful human‑participant research. It helps ensure that studies are designed to minimize harm and respect the rights, dignity and welfare of participants. The following tips outline helpful strategies for preparing your ethics application and supporting an efficient review process.
Be mindful of timelines
In general, studies that are categorized as minimal risk will be reviewed within 15 business days. If revisions are required, you will be notified by e-mail. Once you address the feedback and resubmit the application, you can expect the revisions to be reviewed within 5 to 10 business days. For additional details regarding timelines and other helpful information, please review the Research Ethics frequently asked questions page.
Complete the TCPS 2 (CORE) tutorial
As of December 31, 2023, all University of Waterloo researchers named on a research ethics application are required to complete the 2022 version of the TCPS 2 Course on Research Ethics (CORE) before submitting the application for review. If you have completed an earlier version of the tutorial (2021 or earlier), you will need to update your training. Researchers will be prompted to upload their certificates to the ‘People’ section of the application each time they submit a new application or are added to an existing one via an amendment. If you submit ethics applications frequently, consider saving a copy of your certificate somewhere it can be conveniently accessed.
Choose the correct application type
When a new application is initiated, you will be prompted to select the type of application that best suits your research study (e.g., Standard Application, Secondary Use of Information for Research Purposes Application, Clinical Trial, etc.). It is important to confirm that you have selected the correct application type before entering any study details, as changing the application type later may erase information you have already entered. If you are unsure which application to fill out, please contact Research Ethics, and we will be happy to assist you.
If your research study involves investigators from another Canadian institution that is eligible to receive and administer Tri-Agency funds (i.e., NSERC, SSHRC, CIHR), learn more about Waterloo’s multi-jurisdictional single review model for minimal risk research.
If you have never completed a Waterloo ethics application or you would like a refresher, consider reviewing our step-by-step video.
Submitting a new research ethics protocol (step-by-step video)
Upload all study materials and documentation
Ensure that all required study materials are uploaded to their corresponding sections of the application. For example, if you are submitting a Secondary Use of Information application, include your list of variables to help reviewers understand the types of information you plan to access for your analysis. If you are submitting a standard application, you will be prompted to upload study materials such as:
- Recruitment materials (e.g., poster, e-mail, etc.)
- Data collection materials (e.g., question guides, surveys, etc.)
- Information letter(s) and consent form(s)
- De-briefing materials if deception is used
- Letter(s) of appreciation
For samples of these documents, please see our samples and other supporting materials web page. Depending on the nature of your study, you may also need to upload supporting documentation such as:
- SOPs or user manuals, if your study involves equipment or devices
- Delegation of a controlled act and medical directive form
- Conflict of interest disclosure form (PDF)
- Safety Office review forms
- Ethics clearance certificate(s) if the study has already received clearance elsewhere
To help you upload the correct materials, the application will guide you to relevant web pages that provide samples and additional information. When writing participant-facing materials (e.g., recruitment messages, information letters), ensure that study details are communicated in language appropriate for your participant group. In general, avoid acronyms and academic terminology. Informed consent is an ongoing process that begins with how the study is communicated to prospective participants. In other words, how you explain your study matters, and care must be taken to ensure the information you provide is understandable and accurate. Participants have a right to know what they’ll be asked to do, how it might impact them, and how the use of their time and data contributes to the research. See the Using Plain Language in Participant Materials guideline for helpful tips.
Include a detailed description
To assist reviewers with assessing the ethical considerations for your study, ensure the application clearly describes:
- Your research questions and study objectives.
- The significance of the research.
- Any potential risks to participants and the measures you will take to mitigate them.
Reviewers also need to understand what participants will experience if they take part in the study, which is why it is important to outline each interaction you anticipate having with participants. Ensure you provide a detailed and sequential description of all study procedures, such as:
- How participants will be recruited.
- Step-by-step overview of the informed consent process.
- What participants will be asked to do and how information will be collected from them (e.g., answer a survey, take part in an interview, perform movement tasks, etc.)
- How study data will be stored securely, and the minimum period for which data will be retained.
- If the dataset will be shared, with whom (e.g., industry partner), and for what purposes (e.g., reproducibility, future research, etc.)
- How study findings will be shared with participants.
It is essential that the proposed study procedures clearly align with the research objectives. All information collected from participants should have a defined purpose and directly contribute to addressing the research questions. This ensures that participants’ time and contributions are respected and used meaningfully within the scope of the study. Additionally, the information reviewers consider during the ethics review process differs from what is typically included in a grant proposal. For this reason, copying and pasting sections from other proposals into the ethics application is discouraged. Focus on answering the specific prompts within the application to provide a clear picture of study objectives and procedures.
Review the application
As you fill out the various sections of the application, you will notice that a green check mark appears on the left-hand side menu once a section is completed. This helps flag sections that are incomplete. Once you have filled out all sections, review the application thoroughly to ensure consistency — the application, study materials and supporting documents should all reflect the same information. Additionally, ensure that the characterization of the data being collected is accurate. For instance, have the correct terms been used throughout (e.g., anonymous vs. anonymized vs. de-identified/coded)? Have all applicable statutory regulations been met (e.g., for use or collection of personal health information and regulations associated with PHIPA)?
Before clicking ‘Submit’, look for the green check marks and make sure you have reviewed the application for completeness. Keep in mind that only the person named as the principal investigator can click the ‘Submit’ button once the 'Attestation' section at the bottom of the application has been checked. For student-level projects, the faculty supervisor is considered the PI, and students are to be listed as student investigators.
After the submission
If you are asked to revise your application, don’t worry — revisions are a normal part of the ethics review process, and reviewer feedback is meant to strengthen and improve research projects.
Revisions
Revision comments appear as ‘action items’ next to the section or uploaded document they pertain to. Read through the requested revisions and/or requests for additional information. Research ethics staff view the ethics review as a collaborative process and are available to discuss any questions or concerns you may have about the revisions or the review process in general. After thoroughly reviewing the feedback, should you wish to connect with your research ethics advisor, contact the ORE to schedule an in-person or online meeting.
Expedite the review process
When addressing action items, enter important procedural details directly into the designated fields of the application rather than replying within the comment thread only. This helps organize information in a comprehensive manner and ensures important study details are readily visible within the application. If there is no text field available to respond to an action item, you may respond directly to the comment. Direct replies to action items may also help provide reviewers with additional context if needed, or as a note to self or other members of the research team to indicate when a comment has been addressed.
When revising the body of the application, you do not need to indicate where changes were made. Once the application is resubmitted, reviewers will see any new text highlighted in green and any deletions highlighted in red. However, for study materials (e.g., recruitment messages, information letters and consent forms, etc.), please highlight or use track changes to show reviewers what has been added or deleted within the documents.
When an application receives ethics clearance, only the most recently approved versions of your study materials are covered under that clearance. It is therefore important to keep track of document versions. Using version numbers and dates in document titles is a helpful strategy for keeping track of attachments and when they have been revised (e.g., RecruitmentPoster_version1_year/month/date). If you ever need to reference the initial submission, you will find the option to go back to past versions of the application at the top, under ‘Selected Version’. Remember to switch back to the ‘Revisions in Progress’ version when you want to make changes.