COVID-19 and Research Ethics & Compliance

Please note: The Research Ethics & Compliance Office remains open during the COVID-19 outbreak, with a hybrid model of on-site and remote work. 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

April 22, 2022

Future waves of COVID-19 due to new variants and/or reduced immunity are expected over time. Updated legislation, orders from the Public Health Officer (PHO) and related directives may impose binding requirements beyond the control of the REBs. For research studies that unfold over months or years, re-imposition of infection control requirements may create confusion and disrupt approved protocols. 

Guiding Principles 

  1. The core responsibility of Research Ethics Boards is the protection of participants, researchers and the wider community as research is undertaken. In the context of epidemic illness, reducing risk of disease transmission is a relevant priority. Individuals who may not normally be considered vulnerable may become so by the very nature of the epidemic, while those already vulnerable may become acutely so. 
  2. REBs seek to protect researchers and approved research studies from disruption. Proactive measures to anticipate outbreaks and prepare back-up plans will better enable researchers to proceed under evolving circumstances.
  3. The REBs and Research Ethics & Compliance Office have limited capacity to monitor studies and process amendments. Default positions for a high standard of infection control will be adopted by the REBs and remain in force for an extended period to protect resources, reduce confusion and prevent delays for researchers. These default measures may on occasion be in excess of PHO requirements.  Exceptions to these requirements will require persuasive reasons. Consultation should be reserved for substantive questions and persuasive concerns. 
  4. All Island Health-affiliated researchers (broadly understood) represent the health care authority as they undertake their work. Researchers should therefore emphasize best practices for patient protection, vaccination, etc. regardless of current PHO orders for the general public. 

Summary of policy update: The REBs will continue to define “Island Health researcher” broadly to include all affiliates, will require Covid-19 vaccines for researchers as directed by the PHO and Island Health, and will require researchers to wear masks in most face-to-face interactions. The REDCap form will serve as attestation of researcher vaccine status, and will prompt for site safety plans and protocol adjustment plans in the event of a significant surge. Researchers will not be required to submit safety plans or protocol adjustment plans to the REBs for review. 

Policy Details
  1. The REBs will continue to define “Island Health researcher” broadly to include all students, contractors, and other affiliates for all risk assessment and safety plan purposes. Monitors, company representatives and other occasional visitors are included in this definition.  
  2. Infection control safety plans are required for all locations in which in-person research takes place. Site safety plans may be Island Health site plans, site safety plans for universities or other health care facilities, and/or plans developed by the researcher. Researchers should confirm that site safety plans are in place, but are not required to submit them to the REBs. For research taking place in a location without a site safety plan, a template can be provided by the Research Ethics and Compliance Office. 
  3. All new applications and amendments submitted to the REBs must include the current REDCap form, Research Safety and Vaccination Attestation April 2022, (unless previously submitted for the same study) that documents their safety plans and adherence to applicable PHO and Island Health policies.
  4. Researchers are responsible for ensuring their compliance with updated PHO orders, WorksafeBC requirements and Island Health policies. We recommend that researchers monitor local case counts and evolving conditions. Researchers may contact RECO for assistance.
  5. It is recommended that researchers anticipate future surges and possible re-imposition of stay-at-home orders or other directives from the PHO, and consider how the protocol may need to be adjusted if conditions change. A protocol adjustment plan does not have to be submitted to the REB in advance for an application to be approved, but a later amendment to the protocol &/or the Informed Consent Form will require time for approval.  
  6. REBs will require a 1-page information sheet that outlines for participants the general risks of Covid-19 exposure and safety measures to be taken during the study.  This should be a separate document from the Informed Consent Form, so that it may be updated without having to submit a protocol amendment to the REB in the event of new restrictions. This one-page sheet replaces prior documents related to risks of contact, travel, etc. A sample document is available here.
    1. Informed consent forms should continue to include details of significant protocol adjustments that would affect participants if conditions worsen (e.g., risks of self-administering injections, remote monitoring). Later amendments to the protocol and/or ICF will require submitting an amendment to the REB for approval.
  7. Masks and PPE:
    1. The default position is that researchers will always wear medical grade masks when interacting in person with participants in any setting.  Exceptions may be made for circumstances in which mask-wearing is inappropriate (e.g., a participant with hearing loss needs to read lips for comprehension). Reasons for any exceptions to the mask requirement must be explained on the REDCap form, and the REB should be consulted for alternatives.
    2. Masks are required in all patient care settings, as per PHO and Island Health policies. “Patient care setting” may include a patient’s home or other facility outside of direct Island Health management. Additional PPE may be required depending upon the location and nature of the interaction.
    3. Visitors to all Island Health sites must wear medical grade masks, as per Island Health policy. Workers in public areas of Island Health facilities must also continue to wear masks. 
    4. When there is no general public mask mandate in place, and when researchers are not interacting with participants, mask wearing may be optional for researchers working in sites that do not require masking, such as administrative offices and private work areas. Researchers are responsible for returning to mask-wearing if directed to do so by PHO orders or Island Health directives.
    5. Participants who are not subject to visitor requirements are encouraged to wear masks in other locations, but this is not required unless a general mask mandate is issued by the PHO.
    6. It is the responsibility of researchers to ensure that medical grade and well-fitting masks, hand sanitizer, and other appropriate PPE are provided for all research team members and participants.
  8. Vaccinations
    1. All Island Health researchers (broadly defined) will continue to be required to have Covid-19 vaccinations as required by PHO orders and/or Island Health requirements for employees.  
    2. Vaccination status of researchers will be documented by attestation on the REDCap form.
    3. Beneficial interventions will not be denied to any participant due to their vaccination status.
    4. Participants in research that does not provide direct benefit to them should continue to be encouraged to have vaccinations, but these are not required unless a PHO order re-imposes a vaccine requirement for the general public.  
    5. Researchers should plan how they will document vaccine status of participants in the event that a general vaccine mandate is re-imposed.
  9. Pre-Screening
    1. All visitors to Island Health facilities must be pre-screened for symptoms of respiratory infections, as per Island Health policies.  Researchers in other locations should consider how they will pre-screen participants for symptoms of Covid-19 and recent contact with people known to be infected.
  10. Contact Tracing
    1. Researchers must collect participant contact information and store it securely – but separately from research data – to share with public health authorities in the event that contact tracing becomes necessary. 
    2. Contact information must be retained for 30 days after the last in-person interaction with the individual, even if the participant leaves the study early.
    3. Researchers should have a contact tracing plan in place for their research team members.
  11. Researchers are responsible for ensuring that the capacity exists to undertake procedures or lab work for research purposes at Island Health facilities. In the event that future outbreaks overwhelm health care facilities or limit access to them, researchers should be prepared to adjust their protocol.

Island Health Research Ethics Reviews

Island Health REBs require that all researchers be vaccinated in order to conduct research in conjunction with Island Health. The REBs promote vaccination of participants where feasible, and remote rather than in-person studies where feasible. COVID-19 safety plans that address vaccination must be submitted for all in-person contact including research teams working in-person and participant activities.

The REBs will continue to review ethics applications with consideration of conditions in the research region including: vaccination rates and availability of vaccination services; rates of COVID-19 infection, and rates of hospitalizations due to COVID-19.

Researchers should continue to consider ways they can reduce the risk of COVID-19 transmission among research team members and participants. The Safe Research Guidelines, the Safe Research Plan template and the Notice of COVID-related Risks During Research have been updated (November 2021). In all instances, researchers will need to attach an up-to-date Research Safety and Vaccination Attestation to their ethics application in the Study Documentation section or page. This should happen with a new application or next submitted event or post approval activity.

Institutional safety protocols that do not address the safety of research participants (in addition to staff safety considerations and requirements) will not be sufficient. The REBs will not approve activities that do not adhere to the requirements imposed by the public health order. The REBs will not review research proposals from unvaccinated researchers until further notice. 

Before Submitting Your New Ethics Application or Amendment/Annual Renewal

Consultations

Consultations with the REBs will be required in some situations before you submit your amendment or new application. Please review the rest of this page before requesting a consultation. 

Please contact the Research Ethics & Compliance office to schedule a consultation if any of the following applies:

  1. Any member of your research team is unvaccinated for any reason and/or does not wish to disclose their vaccination status.
  2. You will not require participants to be vaccinated. 

REB staff and members will review the details of your research before the meeting, so you may be asked to provide additional details or other supporting materials in advance. To schedule a consultation, please email Karen.Medler@islandhealth.ca for Clinical applications (CREB) or Victoria.Philibert@islandhealth.ca for Health or Behavioural applications (HREB). 

The following sections provide more detail about the information researchers will be required to include when submitting new or resuming ethics applications. If you still have questions, please contact REB staff

Principles for the Resumption of In-Person Research

  • All researchers must be vaccinated to conduct research at Island Health.
  • 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 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 require researchers to be vaccinated. In addition to reviewing the details in this section, you will need to follow the guidance for the scenario that most closely matches your research. 

Researcher Proof of Vaccination

All members of the research team must be vaccinated. If a researcher cannot be vaccinated for medical reasons, they will need to contact the REBs for consultation. Details regarding securing medical exemptions are here. During consultation, the REBs will look at the benefits to participants among other factors. Please see the Consultations section above for details. 

The principal investigator is responsible for confirming that their research team members are vaccinated. 

Participant Proof of Vaccination

The REBs will review the requirement for participant vaccination based on the nature of the study. This will include considering the participant population, the study risk-benefit to participants, and availability of the vaccine along with the existence of safety protocols in the geographical area. 

Regardless of the vaccination status of participants, researchers will still need to be vaccinated.

STUDY RISK-BENEFIT TO PARTICIPANTS

If the study DOES NOT offer substantial benefit to participants:

Proof of vaccination will be required in most cases. Allowable exceptions to participant vaccines include studies involving children under the age for whom vaccines have been approved, or populations that cannot be vaccinated for health reasons. These exceptions must be clearly outlined in the Safe Research Plan. Any other proposed exceptions must be discussed with the REBs before submission. See the Consultation section above for details. 

Where the exclusion of unvaccinated populations may affect research results, this limitation should be disclosed in publications. 

If the study DOES offer substantial benefit to participants:

The REBs may ease the requirement when the benefits to participants outweigh the risks of contracting COVID-19 AND provided the requirements of the PHO Order regarding mandatory vaccination for Island Health researchers can be met. In addition, other appropriate risk mitigation procedures should be in place. See the Consultation section above for details. 

You are beginning or resuming in-person research

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 (including researcher response times). Full board meeting dates and deadlines through 2022 are listed online. Amendment turnaround times will vary depending on volume of requests and complexity of the changes.

All researchers intending to resume in-person research will need to submit an amendment that includes a Research Safety and Vaccination Attestation (attached in Study Documentation for the Portal and Box 9.7 in RISe). The most recent PHO Order must be reflected in your Safe Research Plan, including how vaccination and mask-wearing protocols will be managed. See the Vaccination section for details. 

1. 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
  • The most recent BC PHO orders will need to be reflected in your Safe Research Plan, including how vaccination and mask-wearing protocols will be managed. See the vaccination section above for details.
  • For research being conducted outside Island Health facilities, attach the facility’s safety protocol, if available:
    • Research Services Portal:  Attachments
    • RISe: Box 9.7 (Behavioural Form) or 9.8 (Clinical Form)

2. 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
       
  • Attach your Safe Research Plan.
    • 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
    • The most recent BC PHO orders will need to be reflected in your Safe Research Plan, including how vaccination and mask-wearing protocols will be managed. See the vaccination section above for details.

3. You are beginning or resuming in-person research outside Canada

Contact REB staff if your research falls into this category. Before submitting your ethics application, please contact the Research Ethics & Compliance office to schedule a consultation; this will ensure that your study can be considered for review. See the Consultation section above for details.

 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 or Island Health sites will need to include a Safe Research Plan. The REBs will consider current circumstances in the region where the research is being undertaken. Provide 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.

  • Specify the locations where your research will be conducted in Section 4.2. Institutions and Sites for Study. Indicate if you are travelling to multiple sites within a country.
  • Include a note in Box 5.6 that a COVID Health Check will be used for all participants at the start of each interaction.
  • Complete a Safe Research Plan and attach to Box 9.7.
  • The most recent health orders from the region where you are conducting the research will need to be reflected in your Safe Research Plan, including how vaccination and mask-wearing protocols will be managed. See the vaccination section above for details.
You have already received full approval for in-person research with a Safe Research Plan and you need to update your safety protocols

The most recent BC PHO orders will need to be reflected in your Safe Research Plan, including how vaccination and mask-wearing protocols will be managed. See the vaccination section above for details. Add a dated sub-heading at the bottom of any boxes that need to be amended, e.g. “September 2021 resumption of research amendment.” Do not overwrite previously approved content in the ethics application. Describe any procedural changes being proposed in Box 5.6 and attach your updated Safe Research Plan to Box 9.7. Note that the template has been updated.

  • 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

Attach updated consent forms and/or letters of invitation if amendments are needed. Do not remove earlier versions if they were put into use.

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.
The most recent BC PHO Orders, where applicable, will need to be reflected in your Safe Research Plan, including how vaccination and mask-wearing protocols will be managed. See the vaccination section above for details. 

Research in non-Indigenous communities

Research will be 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: Attachments
    • 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

Provincial health orders affecting REB review of ethics applications

To view the PHO Orders published since the advent of COVID-19, view here

Forms and Resources

Research Safety and Vaccination Attestation

Safe Research Guidelines

Safe Research Plan Template (use this if you do not have an institutional plan)

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.

Island Health Notice of COVID-Related Risks During Research Version C

Culturally Safe and Trauma-Informed Practices for Researchers during COVID-19

Zoom Guidance for Research

Safe Research Site Plan Template

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 give updated consent. 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.

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.

Prior Research Ethics & Compliance Information Regarding COVID-19 

March 18, 2022

Research conditions remain in flux due to the COVID-19 pandemic. As Covid-19 restrictions are being eased for the general public, the Research Ethics and Compliance Office is reviewing the vaccination and infection control policies for research at Island Health.  Updated guidance will seek to balance easing restrictions with the likelihood that new variants and surges will continue challenging health care facilities and disrupting ongoing research.

Until further notice, the guidance from November 19, 2021 (below) remains in effect with few changes.  All researchers connected with Island Health – including contractors, students, and others - must continue to meet Island Health’s vaccination requirements, and masks or other appropriate PPE must continue to be worn in all health care sites (including patient homes and facilities that are not part of Island Health), as per PHO orders.  Where researchers are subject to inconsistent requirements from multiple jurisdictions, such as universities or Indigenous band councils as well as Island Health, researchers are advised to employ the strictest applicable infection control standards. Local arms of multi-site studies must follow local requirements.

One restriction may be eased at this time: if you work in a non-clinical setting (e.g., analyzing results in an office) and believe that you can safely work without wearing a mask, then you may now do so if this is consistent with that site’s policy. Remote rather than in-person contact continues to be encouraged where feasible, as are social distancing and masking in indoor settings, for the ongoing protection of participants, researchers, and members of the general public who may be vulnerable.

We remain available for consultation if you have concerns or questions related to your study. Thank you for your patience as we continue to adjust to evolving conditions.

November 19, 2021

The Research Ethics & Compliance Office and Research Ethics Boards (REBs) at Island Health have updated their requirements regarding vaccination status. 

All researchers affiliated with Island Health or using Island Health care sites (as defined in the PHO Order) for research purposes must be vaccinated.  Vaccination status is an inclusion/exclusion criterion for participants in in-person studies that do not have direct benefit to the participant.   Participants in in-person studies who may receive direct benefit in excess of the risks of exposure to Covid-19 do not have to be vaccinated, although vaccines are to be encouraged.   All researchers and participants must adhere to updated vaccination requirements regarding visitors to Island Health sites, and also any updated PHO and/or Island Health directives (e.g., vaccinations for children, boosters, or new vaccines for emergent variants).

See below for detailed information about vaccination requirements and where exceptions may apply.

You are asked to review the latest guidance before finalizing and submitting any new human research ethics applications, amendments or annual renewals and other ongoing review activities.

If your research requires the use of other sites, or institutional review, its policies will also need to be followed. Where there is inconsistency between policies at various jurisdictions, the most stringent protections are to be followed.  If there are concerns, please contact these other sites or institutions. Guidance on this page is for research covered under the auspices and jurisdiction of Island Health’s Clinical and Health REBs. 

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

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.

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.

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.

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.