Research Ethics & Compliance Office

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Announcements

Health Canada updated their recent Notice: Period reduced for keeping clinical trial records for drugs and natural health products. The notice previously stated that the change in record retention applied only to trials authorized in the last 15 years. It now states that it is for any trials previously approved that still had on-going record retention requirements.

Updated Memo: April 5, 2022 – Retention Period Reduced for Keeping Clinical Trial Records for Drugs and Natural Health Products

Important COVID-19 Notice: Clinical Trials and Health Research Operations at Island Health 

Island Health research is focused on reducing risks for research participants and the public, and on proactively ensuring that resources are prioritized and available to support the COVID-19 response.

For information regarding Research at Island Health and COVID-19, please go to Conduct Research with Island Health.

For current information regarding COVID-19, Research Ethics, Operational Review, and Compliance please go to COVID-19 and Research Ethics & Compliance.

Researchers submitting a COVID-19 clinical research ethics application that includes or intends to include Island Health must notify the Manager of Clinical Research by email to sheilah.frost@islandhealth.ca at the time of submission to support coordination and planning. Please read this notice for further details. 

COVID-19 Operations Update 

The Research Ethics & Compliance Office remains open during the COVID-19 outbreak. We have, however, moved to full-time telework to protect our staff and their families. Therefore, all communication should be conducted through email. During this time we will do our best to respond to your communication and provide our normal level of service as efficiently as possible. Contact the Research Ethics & Compliance Office.

Approval to Conduct Research

In order to conduct research at Island Health, Principal Investigators must obtain:

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)

The TCPS 2 (2018) is a joint policy of Canada’s three federal research agencies – the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), or "the Agencies."

The Secretariat on Responsible Conduct of Research has launched the third revision of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). The TCPS 2 (2018) replaces the TCPS 2014 as the official human research ethics policy of the Agencies. 

Read more about the TCPS 2 (2018), see a summary of changes, and learn about guidance on how to address material incidental findings.  

NEW – TCPS 2: CORE-2022

Since, April 2020, Island Health has required the completion of TCPS 2 (2018) online tutorial “Course on Research Ethics” (CORE) for all researchers and study team members conducting research at Island Health.

The TCPS 2 (2018): CORE-2022 is a new tutorial designed as an introduction to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans TCPS 2 (2018), which was originally released in June 2019. It consists of nine (9) modules and is applicable to all research involving humans, regardless of discipline or methodology. 

Requirement

The CORE-2022 tutorial will be required for all researchers and study team members conducting research involving humans.

Deadline for completion: July 01, 2023

Single Jurisdiction - Submitting through Island Health’s Research Services Portal only

If submitting a research ethics application through Island Health’s Research Services Portal, attestation by the Principal Investigator (PI) to the completion of the CORE tutorial for all research team members, including the PI, can be found within the research ethics application.

Multi-Jurisdiction – Submitting through UBC’s RISe 

If submitting a multi-jurisdictional (harmonized) research ethics application through the Provincial Research Ethics Platform (PREP) on UBC’s RISe, further information on TCPS 2 (2018) training requirements can be found on UBC’s Office of Research Ethics ‘Online Tutorials + Training’ page.

Registration for CORE: 2022 Tutorial

When registering, please affiliate with ‘Vancouver Island Health Authority’, if not affiliated with another institution already.

Training Documentation

CORE: 2022 completion certificates for all research team members will be held within the Investigator’s training documentation. Review of certificates may be requested by the Research Ethics Boards or Research Compliance.

Resources

TCPS2 2018 Policy Statement
CORE 2022 tutorial
Memo: March 11, 2022 – RE: TCPS: CORE-2022 Training 
Memo: December 17, 2021 - RE: New TCPS 2 Course On Research Ethics (CORE) Tutorial Launching January 2022
Visit the Training & Compliance page to review the Guidance for Research Training Requirements

Research Ethics Harmonization for Multi-Jurisdictional Studies at Island Health

Researchers who must obtain multiple ethical approvals from separate BC research ethics Boards (such as UVic, UBC, BC Cancer, or another BC health authority) must now do so using the Provincial Research Ethics Platform (PREP). All new research projects that involves both UVic and Island Health must be completed in PREP.

UBC Family Practice Resident Research, UBC Dietetic students, UBC Pharmacy Residents and UBC Faculty of Medicine Summer Student Research Program (FoM SSRP) must also use PREP to submit their ethics application. Refer to the UBC Guidance document.

Please visit here for instructions on how to get started.

Further Considerations for Clinical Trials:

  1. Clinical Trial Agreement between Island Health, Principal Investigator, and Sponsor
  2. Health Canada Letter of No Objection (NOL)
  3. Clinical Trial Registration number with a non-profit clinical trials registry, e.g. http://www.clinicaltrials.gov/
  4. CIHR Policy Guide for CIHR-funded clinical trials – Requirements for Registration and Disclosure of Results from Clinical Trials

QI/QA and Program Evaluation Projects

Although Quality Improvement (QI) and Quality Assurance (QA) projects do not undergo a formal review by a research ethics board (REB), they still require appropriate organizational oversight. As per TCPS 2 (2018), Article 2.5, they fall outside the scope of research ethics review but they may still have ethical considerations. Institutions may implement review processes in order to address these and indicate the project has been exempted from REB review. Island Health offers the QI Ethics consult process.

If you are unsure if your project would be considered QI or Research, please consider completing the Quality Improvement (QI) Ethics Decision Making Tool and Registry created by Island Health.

Additional approvals for grant-funded studies:

  1. Grant Contribution Agreement

Additional approvals for external affiliated researchers:

  1. Research Affiliation/Collaboration Agreement (inter-institutional)
  2. Study Specific Researcher Affiliation Agreement

Contacts

Research Ethics & Compliance Office 
Queen Alexandra Centre
Main Building, Room 205
2400 Arbutus Rd
Victoria, B.C.
V8N 1V7

250-519-6726
researchethics@islandhealth.ca 

Manager

E. Sarah Bennett
250-519-6706 ext. 36706
elizabeth.bennett@islandhealth.ca 

Health Research 

Victoria Philibert, Research Ethics Coordinator (Health Research Ethics Board)
250-519-5300 x 36212
victoria.philibert@islandhealth.ca

Julita Traylen, Administrative Assistant, Research Ethics (HREB, General Inquiries) 
250-519-5300 ext. 36216
julita.traylen@islandhealth.ca

Kimberly Horie, Research Administrative Coordinator
250-519-6726 ext. 36726
kimberly.horie@islandhealth.ca

Clinical Research 

Karen Medler, Research Ethics Coordinator
250-519-5300 ext. 36207
karen.medler@islandhealth.ca

Joey Pearson, Administrative Assistant, Research Ethics (CREB, General Inquiries)
250-519-5300 ext. 36210
joy.pearson@islandhealth.ca

Operational or Institutional Approval

Kimberly Horie, Research Administrative Coordinator
250-519-6726 ext. 36726
kimberly.horie@islandhealth.ca

Research Compliance

Tracy Wong, Research Quality Assurance Specialist
250-519-5300 ext. 36220
tracy.wong@islandhealth.ca  


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