HSREB Application Forms and Events

Below you will find all HSREB applications available in fillable PDF format. These forms serve as tools to familiarize yourself with questions and requirements before submitting your project.

HSREB Application Forms

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, and database creation. Refer to SOP 101.

 View Application for Prospective Research with Human Participants (PDF 832 KB)

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 Office at  researchethics@queensu.ca to confirm which institutional REB to approach first. Refer to SOP 408.

 View Application for Multi-Jurisdictional Review (PDF 199 KB)

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. Refer to SOP 102.

 View Application for Secondary Data Use (PDF 528 KB)

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. Refer to SOP 102.

 View Application for Chart Review (PDF 491 KB)

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. Refer to SOP 102.

 View Application for Case Study/Series (PDF 136 KB)

Use this form for Quality Assurance/Quality Improvement/Program Evaluation (QA/QI/PE) 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. Refer to SOP 102.

 View Application for Quality Assurance/Quality Improvement/Program Evaluation (PDF 72.6 KB)

HSREB Event Forms

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 well-being. Refer to SOP 404.

 View Adverse Event and Serious Adverse Event Form (PDF 105 KB)

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. Refer to SOP 404.

 View Amendment Event Form (PDF 275 KB)

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. Team members needing access must be listed in the TRAQ study files.

 View Change to Project Team Event Form (PDF 70.3 KB)

Submit this form to report protocol deviations (PDs), which are unanticipated or unapproved changes to a study protocol. Refer to SOPs 102 and 404.

 View Protocol Deviation Event Form (PDF 93.6 KB)

Use this form to report privacy breaches, including unauthorized access, collection, use, or disclosure of personal information. Refer to SOP 404.

 View Privacy Breach Event Form (PDF 114 KB)

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. Refer to SOP 405.

 View Renewal Event Form (PDF 175 KB)

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)

Refer to SOPs 405 and 406.

 View Study Closure Event Form (PDF 121 KB)