Submit a new application
- Log in to the Research Services Portal.
- Click APPLY NEW.
- Select the correct application. If you are unsure which application to fill out, please review the information under: Determine your REB.
- Please fill in all the tabs. Be sure to press the save button often as the Portal does not auto-save and will time out after two hours.
- Upload attachments. Ensure each has a version date in the footer.
- When the application is ready for submission to the REB, the PI must fill out the Attestation Tab (tab 11) and then may click the submit button.
Please note that the “submit” button acts as a form of electronic signature for the PI. Any team member can draft a new application, but only the PI can submit it to the Research Services Portal. Once the study has been approved, any team member can submit post-approval applications, such as amendments and renewals.
Frequently Asked Questions (FAQs)
- Why can I not submit a new application on behalf of my Principal Investigator (PI)?
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The “submit” button acts as a form of electronic signature for the PI. Any team member can draft a new application, but only the PI can submit it to the Research Services Portal. Once the study has been approved, any team member can submit post-approval applications, such as amendments and renewals.
- Does the Research Services Portal auto-save my work?
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No, the Portal does not auto-save and will time out after two hours. Please press the save button often, as there is no way for our team to recover lost work.
- I need to add someone to my study team, but they are not listed in the Investigator Registry. What do I do?
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Please email ResearchEthics@islandhealth.ca with the name and contact information of the person you wish to have added and we will create a profile for them in the Portal. If a team member does not need to access the Portal or wish to receive any email notifications regarding the application, please just list their name and affiliation in the application form on question 3.1.
- Why can't I edit my file after I press 'submit'? If I need to make changes, what do I do?
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You will not be able to make any changes to your application while it is under review. If you pressed submit in error or need to make a change, please call 250-519-6726 or email ResearchEthics@islandhealth.ca, and we will be happy to assist you.
- How do I know when my application has been reviewed?
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When your project has been reviewed, you will receive provisos in an emailed Notice of Review. You can then log in to the Portal, and will find the application under Applications: Requiring Attention. Please submit all revisions to the application and attach updated documents through the Portal. Please note: any updated document must have a new version date in the footer.
Submit Post Approval Activities
Post Approval Activities (PAA) are all submissions made to the REB after initial ethical review and Institutional Approval is issued.
There may be fees for ethical review of amendments and annual renewals for 'for-profit' studies, such as sponsored clinical trials.
Please refer to REB Administration Fee for Industry-Sponsored Studies for clarification.
Please contact us if you are unsure if your study is required to pay fees.
- Amendments
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Changes in approved research studies may not be initiated without prior REB review and approval. The only exception to this rule is when a change is necessary to eliminate apparent immediate hazards to human participants. Such a change must subsequently be reported to the REB.
Researchers must submit an Amendment Application Form through the Research Services Portal for both major and minor amendments.
Please note if no changes have been made to the study, but you have documents which must be submitted to the REB for review and acknowledgement, an Unanticipated Event Report should be used. Please see the information below about acknowledgement.
- Acknowledgements
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Major Audit and Inspection Observations or Enforcement Actions
All major audit and inspection observations must be reported to the REB by the PI. This includes enforcement actions taken against the local PI or research site.
Reports to the REB should be submitted within 10 working days. However, where there are observations that immediately impact the safety of participants or significantly impact data integrity, notification should be made to the REB office as soon as the PI becomes aware of the situation.
The Unanticipated Problem Report form should be used in both cases.
How to report events occurring external to the local research site
Please submit the following information to the REB as a Non-Local Safety Event using the Unanticipated Problem Report form in the Research Services Portal:
- Summary or Listings of External SAE Reports (CIOMS, MedWatch, IND Safety reports, etc.)
- Reports, publications, or interim results or findings (DSMB notifications, 'Dear Healthcare Professional' Letter, etc.)
- New or updated study product safety information (Revised label/ Package Inserts, Device manuals, etc.). Note: Investigator’s Brochures must be submitted using an amendment application.
- Recalls / Withdrawals (Regulatory Agency or Sponsor Marketing withdrawal, etc.)
See Safety Information and Unanticipated Problems Reporting Guidelines.
- Annual Renewals
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Ongoing studies must be reviewed at least annually to ensure they continue to be conducted as described in the initial approval. The annual renewal process can be completed within the Research Services Portal and are submitted by the Principal Investigator or their delegate.
The Principal Investigator or other identified study main contact will receive a reminder approximately six (6) weeks before the study date.
If the study is not renewed prior to the expiry of the current Research Ethics Approval, it will be considered as lapsed and you will be unable to conduct research activities until such time as the renewal is in place. In addition, the lapse will be reported to the department head(s) where the research is taking place. If access to funding is contingent on active research ethics approval, Finance will also be notified. We may also be required to notify the funding agency, study sponsor, and/or regulatory authorities of the lapse of approval.
- Notification of Study Closure
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The Principal Investigator is required to notify the REB when the study is ready to be closed (i.e. when there are no active study activities with participants, and the study can be archived for the requisite period of time indicated in the application). Please submit the Study Closure form in the Research Services Portal.