COVID-19 and Research Ethics & Compliance

Please note: 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.

Current Research Ethics & Compliance Information Regarding COVID-19

December 1, 2020

Updated orders from the Provincial Health Officer and Island Health requirements have resulted in additional considerations from the Island Health Research Ethics & Compliance office and REBs. Please refer to this notice for further information.

As before, the following information regarding Amendments continues to apply:

While TCPS 2 (2018) typically requires review and approval of modifications prior to implementation, an exception can be made where the change is necessary to eliminate an immediate risk to participant(s) (Article 6.15). Such changes may be implemented but must be reported to the REB at the earliest opportunity. This could be reported as (a) a formal Sponsor-driven amendment, (b) protocol deviation reports, or (c) a protocol waiver request (a request to temporarily modify the protocol to alter the procedures for site visits, etc.)

Similarly, studies that must comply with the US federal regulations require that the REB review any revision to the protocol before they are implemented except in cases, “where necessary to eliminate apparent immediate hazards to the human subjects.” 21 CFR 56.108(a)(4).

The below table is helpful for quick reference regarding what is required of applications for submitted for initial or ongoing ethical review. 

Conducting In-Person Research - Requirements at a Glance
Research Phase    New Application Renewals or Suspended/Amended during COVID
Research Type In person COVID-related In person NOT COVID-related In Person COVID-related In person NOT COVID-related
Forms Required

Safety Plan

Request to Resume or Initiate A Research Study at Island Health form

Safety Plan

Request to Resume or Initiate A Research Study at Island Health form

Safety Plan

Request to Resume or Initiate A Research Study at Island Health form

Safety Plan

Request to Resume or Initiate A Research Study at Island Health form

CREB Application

Include COVID-19 in the Project Title

Consider what flexibility in study procedures you may require (e.g., virtual visits, shipping medications, remote monitoring, etc.) and build them into your proposal.

Full Board review* 
(If above minimal risk; this may be harmonized with other sites in BC.)
*Ad hoc meetings can scheduled as needed.                                                            

Consider what flexibility in study procedures you may require (e.g., virtual visits, shipping medications, remote monitoring, etc.) and build them into your proposal.

Full Board review if above minimal risk                                                                                                                                                         

 

 

 

Include COVID-19 in the Project Title

Submit an amendment to change study procedures, or a waiver to request a temporary halt of certain procedures for a period of time.

Consent forms can either be modified (e.g., COVID-related risks added, changes in study visits, adding remote monitoring, etc.) or an addendum can be added to explain what has changed.

Delegated review *Subject to change if risks are significantly increased 

Submit an amendment to change study procedures, or a waiver to request a temporary halt of certain procedures for a period of time.

Consent forms can either be modified (e.g., COVID-related risks added, changes in study visits, adding remote monitoring, etc.) or an addendum can be added to explain what has changed.

Delegated review*Subject to change if risks are significantly increased                   
 

 

HREB Application

Full Board review* 
*An ad-hoc committee meeting will be convened for timely review

Include Covid-19 in the Project Title

Request to Resume or Initiate a Research Study at Island Health Form
 

Full Board review*
*An ad-hoc committee meeting will be convened for timely review

Request to Resume or Initiate a Research Study at Island Health Form

Full Board review* 
*An ad-hoc committee meeting will be convened for timely review

Include  Covid-19 in the Amendment Title

Request to Resume or Initiate a Research Study at Island Health Form

Full Board review* 
*An ad-hoc committee meeting will be convened for timely review

Request to Resume or Initiate a Research Study at Island Health Form

 

June 2, 2020

We are now starting the gradual resumption of non-COVID-19 research at Island Health. Please refer to this notice for further information. To assist researchers with their applications, refer to this update about research ethics review, and resumption of research at Island Health

For a direct link to the Resumption or Initiation of Research at Island Health Form click here.

May 29, 2020

Health Canada issued an interim order regarding the conduct of COVID-19 clinical trials on May 23, 2020. Please review the following PDF for more details.

Information on Health Canada’s Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

May 22, 2020

The gradual resumption of research including non-COVID-19 is now beginning. Additional guidance, policies and processes will be developed over the coming weeks. Please refer to the initial notice from Research Ethics & Compliance regarding conducting research at Island Health at this time.

Changes will be made given the circumstances of the pandemic.

More details will be posted at Research & Capacity Building

It is the responsibility of researchers to be familiar and act within the guidelines posted. To help researchers with their applications please refer to this update about research ethics review, approvals, and resumption of research at Island Health.

Use of virtual tools in research

Island Health’s Research Ethics & Compliance, together with our Research Privacy Specialist, has created a guidance for the use of virtual tools in research specific to Island Health requirements.

May 21

Clinical Research Training Requirements during COVID-19

April 27, 2020

Notification of Intent to Conduct COVID-19 Related Clinical Research at Island Health

Please refer to the memo Island Health – COVID-19 Clinical Research – Notice of Intent for a current notice regarding clinical research at Island Health.

April 17, 2020

Research Ethics BC (REBC) has announced a Rapid Ethical Review Process for Provincial Clinical Research Pertaining to COVID-19. This process has received agreement from all REBs in BC. You can find the details including guidance, FAQs, and a review flowsheet on their website.

March 30, 2020

Please refer to the most recent general Research Ethics Guidance from our office. The REBs have provided their own guidance and directions for researchers. Please review PRIOR to submitting your research ethics documents and applications.

Island Health Research Ethics Guidance, March 25, 2020

SOP 525 REB Review During Publicly Declared Emergencies, V 1.0

Operational Review of Research at Island Health

March 30, 2020

In light of the COVID-19 pandemic, Research & Capacity Building is focused on reducing risks for research participants and the public, and on proactively ensuring that health system resources are prioritized and available to fully respond to this public health emergency as it develops.

Therefore, until further notice, our department:

  • is suspending the initiation of new clinical trials and clinical/health research projects, with the exception of those related to COVID-19
  • is suspending recruitment into existing trials with the exception of those related to COVID-19
  • may delay the issuing of Institutional Approval due to limited resources at this time

Initiation of and enrollment into clinical trials, and research as well as health research studies that are a part of essential care or that have significant cost or time-related implications or other specific circumstances will be assessed on a case-by-case basis, in cooperation with the Sponsor (if applicable) where Island Health resources permit.

If you have questions or concerns about your research study and its operational review, please contact Kim Horie at Kimberly.Horie@viha.ca. If you have questions specific to research ethics and compliance, please contact E. Sarah Bennett at Elizabeth.Bennett@viha.ca

Clinical Research Ethics Board (CREB) and Health Research Ethics Board (HREB) Guidances

CREB

March 30, 2020

Island Health CREB Guidance During COVID-19 - March 27, 2020

COVID-19 ICF Addendum - March 26, 2020

HREB

March 30, 2020

HREB Guidance (HREB) Co-Chairs’ Bulletin 1 - March 27, 2020

HREB Review Process During COVID-19 - March 26, 2020

March 22, 2020

Please refer to this notice regarding clinical trials and research operations at Island Health in light of COVID-19.