Please submit your application to the WCH REB inbox at firstname.lastname@example.org. Hard copies and/or handwritten copies will not be accepted.
The PI, or local PI, must have a staff appointment at WCH. This does not include residents, students or volunteers. A person with a staff appointment can support a resident or student in their research.
You will require a WCH staff person to be responsible for the ethical conduct of the study at WCH.
- Are conducted for minimal risk, non-invasive studies (e.g. Retrospective chart reviews, questionnaires or surveys
- Are conducted on an ongoing basis
Full board reviews:
- Are conducted for research studies that are above minimal risk (Phase 1-IV studies, medical devices, research with high-risk populations)
If you are planning on submitting a study for full board review, please consult the REB submission dates for deadlines. The decision to designate a study as delegated or full board ultimately lies with the REB Chair.
CITI training is required for all WCH affiliated study team members that are listed on the REB application. In some rare cases, non WCH affiliated study team members may also be listed on the REB application, and TCPS2 will be accepted in lieu of CITI training for these individuals. You may learn more about these requirements here.
Please refer to the REB submission checklist for a complete list. Each new submission requires a completed checklist, a completed TAHSN form, protocol, recruitment documents (scripts, flyers, posters, brochures, consent forms, data collection forms, questionnaires/surveys).
If your study uses an informed consent form, please also utilize the Observational Study Informed Consent Form Template or Clinical Trials Informed Consent Form Template available on the REB forms page.
You may also contact Vanessa Ballin email@example.com for access to SCEPTR software for clinical trial protocol development.
The study PI must sign all forms.
In extenuating circumstances where the PI is unavailable (out of the country, on an extended leave from work) a study Co-I may sign the form. An explanation of why the PI cannot sign must be provided.
Only the study PI may sign an initial application.
If there are mitigating circumstances or your application is related to COVID research, please inform the REB assistant at firstname.lastname@example.org and your submission will be expedited as soon as possible. You may also choose to use the “high priority” Outlook feature to indicate that the email is urgent. Please note that not all requests for expedited review will be granted.
- If any funds or services are coming to or going from WCH
- If any information (e.g. Personal health information, data, video or audio recordings), biological specimens (e.g. Blood, saliva, tissues, etc.) will be sent to or received by WCH
- If any external researcher or third party will conduct research at WCH
Please contact the Research Contracts office for further information at email@example.com
There is a fee for industry-supported studies requiring REB review. Please consult the REB Office at firstname.lastname@example.org for more information.
A case report involves descriptive information about three or fewer patients only, and does not require REB review. All patients must consent to the use of their information in a case report.
A WCH REB approval only covers research conducted under its jurisdiction and does not cover any research activities conducted at other sites that are not under its jurisdiction.
Each centre/site should identify how it will provide oversight of research at its centre/site. Some will obtain REB approval from a private REB. Others will request all study-related material and provide their own review and approval. Please consult with each centre/site regarding their study oversight expectations.
Projects suitable for an APQIP review do not meet the TCPS 2 definition of research, “defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systemic investigation.” [TCPS 2 Chapter 1A]
To confirm if your study should undergo REB or APQIP review, please reach out to the REB office at email@example.com or the APQIP office at firstname.lastname@example.org. You may also use the following resource, the ARECCI screening tool, to determine if your study falls under research or quality improvement: https://arecci.albertainnovates.ca/.
The use of deception in research must be justified and defended to the REB. A debriefing document should be submitted to the REB office for all studies using deception. Please also note that after participants have been fully debriefed, they must reconsent to the use of their data, and informed that they can choose to withdraw if they so wish. You may also refer to the University of Waterloo’s Guidelines for the Use of Partial Disclosure and Deception in Research as a helpful tool for understanding the requirements associated with use of deception in research.
Minor amendment changes, also known as administrative changes, typically involve differences of wording, the extra addition of pre-approved study elements, or other changes that do not fundamentally change the study or impact of the study on participants. Major amendments involve larger changes, such as the addition of new study documents, a significant difference in recruitment or data collection methods, or other changes that fundamentally change the study or the impact of the study on participants.
All changes to the study or study documents require an amendment, although a minor amendment may be submitted for small alterations. Notes to file do not involve any changes to the study procedures or documentation.
PIs and trainees may contact Maya Strasser (email@example.com) for assistance with trainee onboarding and access to CITI training courses. In cases where trainees can not be given CITI access, TCPS2 is accepted in lieu of CITI course training. Please note that non-WCH institutionally affiliated study members should rarely be listed on WCH REB applications. Generally speaking, external study team members should seek REB approval and training oversight at their respective institutions, negating the need for their inclusion on the WCH REB application.
CTO has developed several applicant quick quides and video tutorials for users that are new to the platform. You can find these resources here.
The CTO review stream is best suited for multi-site studies with centres that are a part of CTO’s participating institutions, which you can find here.
Multisite studies will usually require REB approvals (or exemptions, where applicable) from all involved sites. If your study involves a site without an IRB/REB, the site should determine their level of required oversight. It must be communicated to the appropriate site representatives that a WCH REB approval can not provide oversight for study activities taking place outside of our jurisdiction. The site should determine if external (private) REB approval will be required, or if they have an alternate method of reviewing and approving research proposals within their organizational structure.