Obtaining free and informed consent is a cornerstone of ethical research involving human participants. Consent ensures that individuals understand the nature, purpose, and potential risks of the study, and that their participation is voluntary. At Queen’s University, all research involving human participants must adhere to the principles outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) and institutional Research Ethics Board (REB) policies.
Researchers are encouraged to use the approved templates and guidance materials provided by the Queen’s Research Ethics Boards. These documents outline required components and standardized language to support the preparation of clear, compliant consent materials.
Guidelines
Researchers should review the informed consent guidelines when developing, revising, or submitting research protocols involving human participants. These guidelines explain when consent is required, outline key components of the consent process, and describe situations where alternative or modified consent procedures may be appropriate, including:
- Remote and E-consent
- Alterations to Standard Consenting Procedures
- Waiver of Consent
Review all Informed Consent Guidelines.
Form Templates
Following review of the guidelines, researchers are encouraged to use the following form templates to ensure their materials are clear, complete, and compliant with institutional and regulatory requirements.
Access the form templates folder
| Template Name | Applies To | Description / Use |
|---|---|---|
| Prospective Research with Human Participants (regulated with intervention) | Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB) | For research regulated by Health Canada or the FDA that evaluates one or more health-related interventions (e.g., drug administration, surgical procedures, devices, genetic therapies, preventive care). |
| Observational and Sampling Testing Prospective Research with Human Participants (non-regulated) | HSREB | For research not regulated by Health Canada or the FDA that evaluates health-related interventions (e.g., preventive care, manual therapies, surveys, focus groups, biological sample collection). |
| Observational Prospective Research with Human Participants (non-regulated with no interventions) | HSREB | For non-regulated studies evaluating health outcomes without interventions (e.g., interviews, surveys, focus groups, sharing circles). |
| Implied Informed Consent Form and Letter of Information (Survey Research) | HSREB and General Research Ethics Board (GREB) | For survey-based research using implied consent, where participation implies agreement (e.g., completion of a one-time questionnaire). |
| Observational Prospective Research with Human Participants | GREB | For behavioural or social science research involving human participants, exploring relationships between people, communities, and systems. Includes interviews, focus groups, and observational studies. |
| Informed Consent Form Components Checklist | HSREB and GREB | A checklist for verifying that all required consent form components are included, based on TCPS2 (2022) and Good Clinical Practice guidelines. |
| Verbal Consent Documentation Log Template | HSREB and GREB | For documenting verbal consent in studies where written consent is not practical. |