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

August 4, 2021

Guidance for Resuming In-Person Research After COVID-19 Restrictions

The Research Ethics & Compliance Office (RECO) and the Research Ethics Boards (REBs) at Island Health have updated their guidance in anticipation that authorization to resume in-person research of all types (e.g. health, socio-behavioural) will be fully implemented over the next few months.

Although the safety of research participants continues to be a factor in how research ethics applications are reviewed, the REBs have eased their requirements in alignment with updates issued by the British Columbia Public Health Officer (PHO) updated July 7th, 2021.

The REBs will be reviewing ethics applications taking into consideration the conditions in the research region including:

  • Vaccination rates
  • Rates of COVID-19 infection including variants
  • Rates of hospitalizations due to COVID-19

While restrictions are easing, researchers should continue to consider ways they can reduce the risk of COVID-19 transmission within research teams and with participants. We are introducing Safe Research Guidelines and the Safe Research Plan template (August 2021) captured in an updated form in REDCap. This replaces the Request to Resume or Initiate a Research Study at Island Health form. 

The Request to Initiate or Resume In-Person Research at Island Health form is only required for the initiation or resumption of in-person research. If you have completed the initial Request to Resume form, and there are no substantial changes to the current study related to in-person research, you do not need to complete the new form. 
 
In instances where a Safe Research Plan is not required, researchers will still need to describe their safe research protocols for both new and resuming research. The REBs will not approve activities that do not adhere to the minimum standards imposed by the public health order for the community where the research is taking place.

To learn how your research may be affected, please find the sections below that most closely match your research scenario. If you are unsure of which description applies to your research, please contact REB staff. We continue to work remotely, but can be reached by email under ‘Contacts’. 

If your research takes place at a health authority site, specific policies and practices continue to apply. This includes considerations around operational approvals, if applicable. These are described in the most recent Research Notice. Where research is led by an academic institution or another health authority, their requirements will also apply when that research happens at or with Island Health. Guidance on this page is for Island Health researchers or those community research groups submitting to the Island Health REBs. 

Principles For The Resumption Of In-Person Research

  • All in-person research that can be conducted safely may proceed.
  • Researchers may not undertake research activities that will unnecessarily increase the risk to participants of contracting COVID-19.
  • Researchers will provide details of their safe research plan to the degree required (see the scenarios below) based on the study’s risk status in the context of where in-person research is proposed and the nature of the research methods being employed.
  • Please note that an amendment is required to resume all previously approved in-person research that has been on hold or to convert online studies to in-person research. Please see below for details.
Vaccination Status

The REBs endorse the BC provincial COVID-19 vaccination program and recommend that all researchers be vaccinated as a layer of protection for themselves and the participants with whom they interact. The relationship between researchers and participants is not the same as an employer-employee relationship; it is both legal and ethical. The ethics of trust articulated in the Tri-Council Policy Statement TCPS 2 (2018) – e.g. respect for persons, concern for welfare, and justice – applies to the researcher-participant relationship. Researchers also have a fiduciary duty to their participants, in much the same way that a physician has to their patients, which requires them to act in the best interests of participants.

While immunization is not mandatory, researchers do have a duty to disclose their vaccination status to research participants if asked. Further, the REBs may require that researchers disclose their vaccination status in their safety protocols and to their proposed participants in instances where:

  • Research activities increase the number of in-person contacts experienced by participants;
  • Research interactions need to take place over an extended period of time;
  • There are challenges to mitigating the risk to participants.

In other instances, researchers who are not required to do so, may elect to disclose their vaccination status in their ethics application (as part of their safety protocols). Since research participants are not required to disclose their vaccination status, researchers should base their safety protocols on the premise that research participants have not been vaccinated.

Research Context

The REBs will review ethics applications and related safety protocols in view of the specific research context and the risks entailed for both research participants and researchers. The following sections provide more detail about the information researchers will be required to provide and instructions for submitting new or resuming ethics applications. If you don’t find the information you are looking for, please contact REB staff for a consultation. 

Please be aware that, as the current situation is fluid, these interim policies may well change, and we will update you as necessary in future bulletins. Should you have any questions about these policies or other issues, please do not hesitate to contact E. Sarah Bennett, Manager, Research Ethics & Compliance | elizabeth.bennett@islandhealth.ca

You Are Submitting A New Application

All new ethics applications must be submitted through the Research Services Portal or RISe (when multijurisdictional or harmonized) following usual procedures. Researchers should be aware of and follow the guidance at EACH SITE in which they plan to conduct research. For example, different hospitals may have different specific guidance as COVID-19 hospitalization rates may vary, etc. In general, the guidance should be similar. If submitting an application using RISe, please be mindful of this when describing how the study will be conducted at different sites.

Turnaround times for ethical review have returned to pre-COVID levels and, unless requested to do so, the REBs are no longer prioritizing COVID-19 related research. Turnaround time for minimal risk applications is 4-6 weeks and for full board applications is around 6-8 weeks (depending on researcher response times). Full board meeting dates and deadlines through 2022 are listed online.

For specific details that apply to your research program, please review the requirements below.

You are conducting new in-person research at an Island Health facility or site

This guidance applies if you are conducting your research in a regulated facility or site under Island Health’s jurisdiction where COVID-19 safety protocols are in place:

  • Follow the facility and/or institutional requirements.
  • Ensure that your ethics application specifies the locations where your research will be conducted. 
    • Research Services Portal: Where applicable 
    • RISe: 4.2
  • Institutions and Sites for Study:
    • Research Services Portal: Where applicable
    • RISe: Outline in Box 5.6 or 5.7 which safe research protocols you are following and confirm that a COVID health check will be used for all participants at the start of each interaction.
  • Confirm that the Notice of COVID-related Risk will be included in the consent form package.
    • Research Services Portal: 8.3
    • RISe: Box 6.6
  • For research being conducted outside Island Health facilities, attach any relevant safety protocol, if available:
    • Research Services Portal:  Attachments
    • RISe: Box 9.7 (Behavioural Form) or 9.8 (Clinical Form)

You are conducting new in-person research in a public setting that is at a non-Island Health facility or site but within Canada

This guidance applies if you are conducting research that involves meeting participants in locations where safety protocols are unknown, such as a café, participant’s home or office.

  • Ensure that your ethics application specifies the locations where your research will be conducted
    • Research Services Portal: Where applicable
    • RISe: 4.2
  • Provide details of your safe research protocols and include a note that a COVID-19 health check will be used for all participants at the start of each interaction. You may alternatively use the Safe In-Person Research Plan Template to describe your safe research protocols and attach when you submit.
    • Research Services Portal: 8.3
    • RISe: In Box 5.6 and include the Safe Research Plan Template in Box 9.7 (Behavioural Form) 9.7 or 9.8 (Clinical Form), if applicable
  • Confirm that the Notice of COVID-19 related Risk will be included in the consent form package.
    • Research Services Portal: 8.3
    • RISe:  6.6.
Resuming Previously Approved or On-Hold Research

All researchers intending to resume in-person research will need to submit an amendment. Learn more: Resuming Previously Approved or On-Hold Research

You Are Beginning or Resuming Research In-Community* (Includes Rural and Indigenous Research)

*“In community” in this context refers to sustained in-person engagement with research populations over a period of time, beginning prior to the onset of formal data collection. In all cases, the REBs will be looking for demonstrated community support for the researchers being present and carrying out in-person research activity.

Research in non-Indigenous communities

If you are conducting research within Canada:

  • Allowed at the discretion of the community
  • Submit a Safe Research Plan co-created with the community
    • Research Services Portal: Attachments
    • RISe: Box 9.7.
  • Include a note that a COVID health check will be used for all participants at the start of each interaction.
    • Research Services Portal: 8.3
    • RISe: Box 5.6

If you are conducting research outside Canada:

  • Allowed at the discretion of the community.
  • Contact REB staff if your research falls into this category. Complete a Safe Research Plan and attach to Box 9.7 in RISe or with study documents in the Research Services Portal. All research conducted outside Canada of Island Health sites will need to include a Safe Research Plan. The REBs will consider current circumstances in the region in the non-local area where the research is being undertaken, so please ensure that your Plan includes as much detail as possible about current public health directives, vaccination rates, rates of COVID-19 infection, and rates of hospitalizations due to COVID-19 in the region/s non-local area where you will be conducting research.

Research in Indigenous communities

The guidance provided here was drafted for the Canadian context. However, there may be relevant content for research conducted in other Indigenous communities. If you are conducting research in communities outside Canada and are needing assistance, please feel free to contact the Research Ethics & Compliance office.

You are advised to review the guidance, Culturally Safe and Trauma-Informed Practices for Researchers during COVID-19 before finalizing your research logistics. You should also review Section 4 “Research Involving Indigenous Communities” in the Safe Research Guidelines.

Research will be reviewed once there is agreement from the community, as demonstrated through an attached research agreement, MOU or other proof of approval. If you have a previously existing MOU with a community, this agreement should be re-affirmed.

  • Attach your Safe Research Plan co-created with the community
  • Include a note that a COVID-19 health check will be used for all participants at the start of each interaction.
    • Research Services Portal: 8.3
    • RISe: Box 5.6
  • Confirm that the Notice of COVID-related risk will be included in the consent form package.
    • Research Services Portal: 8.3
    • RISe: Box 6.6
You Are a Student Conducting Research Outside Canada

Refer to your home institution’s guidance around travel advisories and any requirements around travel in place at that level. 

Forms and Resources

Request to Initiate or Resume In-Person Research at Island Health
Safe In-Person Research Guidelines
Safe In-Person Research Plan Template
Notice of COVID-Related Risks During Research
Culturally Safe and Trauma-Informed Practices for Researchers during COVID-19
Zoom Guidance for Research

COVID-19 Health Check: Researchers are required to have participants and research team members complete a questionnaire at the onset of each in-person engagement. We provide a link to the latest BC COVID-19 Self-Assessment Tool (multiple languages are available from this link). This tool or a similar set of questions must be used. The questionnaire does not need to be attached to the ethics application, but confirmation of its use needs to be provided in the application in either Research Services Portal or RISe. See the scenarios described above for instructions.

Detailed Documentation Guidelines for COVID-Related Research

The following applies both to new studies and amendments to previously approved ethics applications. In order to mitigate risks associated with the inclusion of COVID-related topics, please follow this guidance.

Recruitment materials (including ads, posters, letters of invitation, information sheets)

Clearly state that the research involves discussion/consideration of topics related to the COVID-19 pandemic.

If questions about the pandemic are not optional, make this clear in recruitment materials so invitees can choose to opt out.

Consent forms/scripts

Clearly disclose that the researcher will be asking COVID-related questions and provide the research justification in lay terms for including the topic.

Provide examples of COVID-related questions you will be asking. 

Indicate whether COVID-related questions can be skipped. If answering the COVID-related questions is a condition of eligibility, (i.e. if not answering would disqualify a participant), make this clear so invitees don't waste their time.

If COVID-related questions are being added to a study in progress, all participants still active in the study will need to be reconsented. This could be done either through a supplementary script or email explaining the nature of the additions and options available to them (e.g. withdraw from further participation without penalty, skip the COVID-related questions, proceed to answer all questions). Attach the consent renewal materials to Box 9.2.

If COVID-related samples are being collected as part of the research, explain:
a) If it is optional;
b) Why it is being collected, and;
c) Who the information is being shared with.

Questionnaires/surveys

Provide a warning at the point where COVID-related questions begin, e.g. “The next 5 questions are asking about your experience with the COVID-19 pandemic. You can skip these questions if you prefer not to answer them."

Ensure that the survey tool allows participants to skip questions, either by providing a “prefer not to answer” response or by allowing users to bypass the question set. E.g. “I would like to skip this section.” The BREB prefers that both options are provided, since some people may not even want to read the questions or may change their mind partway through.

Interview script

During the interview introductions, explain how you will handle the COVID-19 related questions and what options are available to participants.

If answering questions about COVID are essential to participating in the research, we recommend that you seek verbal confirmation from the participant at the beginning of the interview to ensure that they understand, but also remind them that they can decide at any point to discontinue the interview. E.g. “I am asking for your agreement to answer questions about the COVID-19 pandemic during this interview. But even if you say “yes” now, you can still change your mind later.”

If the questions are optional, explain how participants can signal to you that they do not want to answer COVID-related questions.

Focus-group script

Because individual participants will have less control over a focus group discussion than in a one-to-one interview scenario, special care should be taken. Before the discussion begins:

Remind participants that COVID-19 will be discussed.

Include a warning that participants may find the topic upsetting and they should feel free to leave at any time. 

Advise participants that information disclosed in the session should not be shared outside the group, but remind participants that the researcher cannot guarantee confidentiality.

List of support services & resources

Attach a list of resources to your application and ensure the services are continuing to function during the pandemic restrictions.

Provide the list of resources to participants at the outset of their engagement and how it will be done.

Prior Research Ethics & Compliance Information Regarding COVID-19 

February 25, 2021

Guidance for Public Health Surveillance

January 25, 2021

Guidance for Remote Monitoring requests

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

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, 2020

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@islandhealth.ca. If you have questions specific to research ethics and compliance, please contact E. Sarah Bennett at elizabeth.bennett@islandhealth.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.