| UHN/CTO Integrated consent form template with guidance | - For studies that involve more than minimal risk to participants, i.e. interventional research that requires review at a full board meeting.
- Most appropriate for studies involving investigational and/or approved drugs or procedures, devices, biologics, randomization, blinding, or invasive procedures beyond standard clinical care.
- The template integrates Clinical Trials Ontario (CTO) requirements with UHN-specific language to ensure regulatory and ethics compliance.
- Includes detailed guidance and sample language for sections on study procedures, foreseeable risks, potential benefits, alternatives to participation, confidentiality, injury during the study, and withdrawal.
*Please note: if you are submitting to CTO Stream directly you must use the template and process outlined on CTOs Website |
| UHN/CTO Minimal risk integrated consent form template with guidance | - For studies that pose no more than minimal risk, meaning the probability and magnitude of harm are no greater than those encountered in everyday life.
- Appropriate for qualitative studies involving surveys, interviews, focus groups and chart reviews that require participant consent. Note: Most, but not all, observational research studies will fall under this category.
- Guidance and sample language is streamlined and avoids unnecessary clinical-trial terminology while still meeting TCPS 2 requirements. Key elements include a simplified explanation of risks and benefits, and clear descriptions of data use and confidentiality.
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| UHN/CTO Integrated Optional Consent Form template with guidance | - For studies that include study components that are not required for participation in the main study.
- Common examples include optional bio-specimen collection, permission for future use of samples or data, re-contact for future research, or participation in sub-studies (e.g. optional lumbar puncture, optional genetic research or optional MRI).
- This template can minimize the burden of the consent process by not combining all required and optional study components into one lengthy main consent form.
- Guidance and sample language ensures that consent for optional elements is clearly separate and voluntary while highlighting that declining optional components will not affect participation in the main study.
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| Continued Participation Consent Form Template | - For studies that involve re-consenting of participants where there is a significant change that alters the nature, duration, or scope of their involvement and may affect their willingness to continue.
- Most appropriate for when a study transitions into a new phase, such as a roll-over/extension phase, continued access to a study intervention after the main study ends (e.g. treatment beyond progression), or long-term follow-up beyond the original commitments.
- Rather than restating the entire original consent form contents, this form focuses on what has changed and asks participants whether they agree to continue participating beyond what they originally consented to.
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| - For use when a participant becomes pregnant during a study and the protocol specifies collection of pregnancy or infant outcome data. This typically includes plans for sharing with the study sponsor.
- Addresses ethically distinct considerations related to pregnancy and the handling of sensitive health information about the pregnancy outcome.
- Can be adapted for a standalone consent version for pregnant partners of a participant.
- Focuses on observational follow-up rather than study intervention and clearly outlines what information will be collected, how it will be used, and the voluntary nature of participation.
(note: you must be on UHN's network to access this link) |
| Sample Addendum to Consent Form | - For updating an already approved consent form when new or revised information emerges during an ongoing study and the study’s overall structure and scope remains unchanged.
- Most appropriate for when participants must be informed of significant new findings—such as new or increased risks, safety or late-term side effects, changes to procedures, visits, dosing or administration, or substantive changes to costs or reimbursements that may affect their willingness to continue. The addendum template is not designed for substantive study changes involving participants entering a new study phase or a fundamentally different participation context.
- Allows participants who are actively receiving the study intervention or in follow-up to reassess their willingness to continue participation within the same study framework, with participant signature obtained when re-consent is required.
- Guidance and sample language demonstrates how to present only the new/updated information during an ongoing study that could influence a participant’s decision to continue. The addendum clearly references the original consent form, and supplements rather than replaces it.
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