Researchers are required to submit applications to the General Research Ethics Board (GREB) or the Health Sciences Research Ethics Board (HSREB), as well as event forms for activities that occur throughout their research. To support you in this process, we have provided a collection of fillable templates for GREB and HSREB application and event forms, along with additional resources.
Before submitting your project, familiarize yourself with the requirements of the ethics application process. Applications and event forms are available in fillable PDF format.
HSREB Application Forms
To access the forms described below, visit the shared folder.
Use this form to initiate a new study involving human participants in prospective research. Prospective research evaluates the effects of health-related interventions on outcomes, including (but not limited to):
- drug administration
- surgical procedures
- radiologic procedures
- medical devices
- genetic therapies
- biological products
- radiopharmaceuticals
- natural health products
- preventive care
- manual therapies
- psychotherapies
- data/biological specimen collection
- interviews, surveys, focus groups
- database creation
Use this form if ethics approval has already been obtained from another Canadian institution (meeting Tri-Agency Funding requirements).
This form is applicable only if the local researcher’s role is limited to receiving funding, data, or samples for analysis (no local participant recruitment or interaction).
Before starting, consult the Research Ethics team to confirm which institutional REB to approach first.
Use this form for research that involves secondary use of data or biological samples initially collected for another purpose. This does not involve participant recruitment or interventions.
Review by the REB is required unless the information is publicly available.
To use this data, you must show that consent was obtained during initial collection or justify its use per TCPS 2 Articles 5.5A and/or 5.5B.
Use this form for studies solely involving chart reviews. If the study includes other methodologies alongside chart reviews, complete the appropriate alternative form.
Chart reviews analyze patient medical records, which are considered secondary use of identifiable information for research purposes.
Use this form for case reports or series documenting individual cases observed during practice.
These reports are not designed to be generalizable or initiated as formal research.
If the study has a research objective, HSREB approval is required. Teaching case series may qualify for exemption.
Use this form for projects assessing the performance of programs, organizations, or departments.
These projects are conducted internally for operational or administrative purposes and are exempt from REB approval under TCPS 2 Article 2.5.
GREB Application Forms
To access the forms described below, visit the shared folder.
Complete this form if you wish to start a new prospective research study involving human participants.
Use this form if the research study looks at the relationship between people and their surroundings, including how people interact with each other, their communities, and institutional systems.
They include psychological phenomena such as emotions, biases, and motivations. Psychological therapy and counselling studies fall under behavioural research.
Emergent design and community-based studies are considered social science and behavioural research unless a clinical intervention is involved.
Common methods include, but are not limited to:
- interviews, focus groups, surveys, questionnaires
- behavioural therapy workshops
- experimental coaching
- observations
Complete this form if ethics approval has already been obtained from another Canadian institution (adhering to the Tri-Agency Funding requirements).
Note: this form can only be used if the local researcher is responsible only for receiving funding and/or data and/or samples for analysis (i.e., without local active recruitment or participant interaction).
Please note that determining which institutional REB is the one that you must seek approval from first (it is not necessarily your home institution first) may need to be discussed. Before you begin preparing the multi-jurisdictional REB application, it is recommended that you reach out to the Research Ethics Office.
Complete this form if you are conducting research involving secondary use of data (i.e., data that have been initially collected for a different purpose) and that does not involve recruitment of participants or interventions.
Review by a research ethics board is required for all research that relies exclusively on secondary use of information unless the information is publicly available.
Note: to use this data, you will have to demonstrate that consent (i.e., broad consent) was obtained by the participants in the initial data collection study or describe how your proposed use of the data satisfies the TCPS 2 Article 5.5A and/or 5.5B.
Complete this form if you are conducting a study that solely involves Chart Review(s).
If your study involves any other methodologies alongside the chart reviews, you must use the appropriate alternative application form.
A chart review is an evaluation or analysis of an individual’s record. As the information contained in the records was originally collected for another purpose (e.g., court proceedings or probation orders), when used for research purposes, chart reviews are considered “secondary use of identifiable information for research purposes.”
Complete this form for case report study/series.
Case reports are unique accounts of individual cases noted during regular practice. These reports are not initiated as inquiry/investigation, nor are these cases meant to be generalizable.
If your case report study/series has a research objective, you will need to obtain approval by GREB before beginning your case report study/series.
If your case report study/series is a teaching series, you can obtain an exemption by GREB.
Complete this form if your research is a Quality Assurance (QA), Quality Improvement (QI) or Program Evaluation (PE) study. QA/QI/PE studies are projects undertaken to assess the performance of a program, organization, group, faculty, or department.
QA/QI/PE projects are conducted internally and for operational and/or administrative purposes per TCPS 2 Article 2.5.
QA/QI/PE projects will be granted a formal exemption by the REB.
Complete this form if you are an instructor and you wish to oversee the conduct of course-based student research assignments.
Review of course-based research is required due to participants encountering similar risks and experiences in these course assignments as they would in research studies, even if the assignments are primarily learning experiences for students.
This includes, for example, asking students to conduct interviews to collect data to be used in a course assignment, or to practice interviewing techniques. Participants in the activities may be exposed to risks (normally minimal risk) as a result of their participation and may not distinguish these activities from others that meet the definition of research in TCPS 2.
Complete this form for research where self-study is the only type of research being conducted.
Self-study research is an approach to understand one’s own practice and one’s self-concept, meaning that individuals look critically at their own professional values, work towards a better self-understanding, and have a moral purpose.
HSREB Event Forms
To access the forms described below, visit the shared folder.
Submit this form for adverse events or serious adverse events meeting reporting criteria. Researchers must report any events that could impact participant safety, rights, or wellbeing.
Use this form to propose changes to an REB-approved study. Changes can only be implemented after REB approval unless they are necessary to address an immediate hazard to participants. In such cases, notify the REB immediately and submit the amendment promptly.
Use this form to request changes (additions/removals) to study team members requiring TRAQ access.
Changes involving personnel who do not require TRAQ access do not need to be submitted.
eam members needing access must be listed in the TRAQ study files.
Submit this form to report protocol deviations (PDs), which are unanticipated or unapproved changes to a study protocol.
Use this form to report privacy breaches, including unauthorized access, collection, use, or disclosure of personal information.
Submit this form to renew a study that will continue beyond the approval expiry date. Renewal dates often align with the original approval anniversary but may vary, so check the approval letter. Researchers are responsible for timely submissions.
Use this form to close a study when:
- participant involvement is complete
- no new data will be collected
- databases are locked and resolved
- sponsor closeout activities are completed (if applicable)
GREB Event Forms
To access the forms described below, visit the shared folder.
Complete this form to submit adverse events which satisfy the requirements of submission criteria.
The Researcher is responsible for reporting to the REB any information about the conduct of the research that could affect the rights, safety, and wellbeing of research participants, including information about any serious or continuing noncompliance.
Complete this form to make any changes to the initial REB-approved research. Researchers may only implement changes to their study once the amendment has been reviewed and approved by the REB.
Complete this form to request changes (additions or removals) to the study team members who have or require TRAQ access.
Note: You do not need to submit this form for a study team member change involving personnel who do not require access in TRAQ.
If study team members require access to the files/correspondence in TRAQ, they must be listed as a study team member within the study files.
Complete this form to submit a protocol deviation (PD) report. PDs are changes to the study that have not undergone ethics review and received approval. These are normally unanticipated or unintentional changes.
Complete this form to submit a privacy breach report. Privacy breaches occur when there is unauthorized access to, or collection, use, or disclosure of, personal information.
Complete this form to submit a study renewal.
Renewals are required for research that will continue beyond the stated approval expiry date. Renewal dates are usually on the anniversary date of the initial REB approval, but not always, so please check the expiry date on the approval letter. It is the responsibility of the researcher to submit the renewal according to Queen’s SOPs.
Complete this form to submit a study closure. Study closures should be submitted when:
- There is no further participant involvement at the site
- There will be no new data collected from the study participants
- Databases are “locked” and queries have been resolved
- Sponsor closeout activities have been completed (if applicable)