Island Health remains vigilant for new variants of COVID-19, annual epidemics of influenza, and outbreaks of other respiratory illnesses. Researchers are required to monitor guidance from the BC Public Health Office (PHO), Island Health, and other relevant authorities and comply with updated safety guidance to reduce the spread of infections.
The principles that guide ongoing infection control measures include:
- Protection for those who are immunocompromised, due to both underlying health conditions and/or effects of the research intervention;
- Acknowledgement that research has risk, which may require case-by-case mitigation;
- Ensuring equity and access to participation in research at all times and for all populations;
- Respect for, and compliance with, risk assessment and mitigation strategies in specific communities;
- Responsible monitoring of evolving infection rates and risks, as outbreaks can develop quickly;
- A reminder that masking and enhanced infection mitigation remain a personal choice for all researchers and research participants. Appropriate masks include N95, KN95, and 3-ply medical masks; cloth masks are not sufficient.
Island Health Research Ethics Reviews
Island Health REBs continue their concern for the safety of research participants and researchers but no longer require researchers to submit vaccine attestations.
Safe Research Plans for in-person research are also no longer required, except in the following circumstances:
- A. Research with immunocompromised individuals, including trials and therapies that may reduce immunity
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The risks of exposures for individuals who are already immunocompromised, and any increased risks of immune system compromise due to the trial or therapeutic agent, must be acknowledged and clearly explained to potential participants in the informed consent materials.
Age, underlying illnesses, concurrent treatments, and other factors that may compromise the immune system should be considered. For participants (or researchers) known or likely to be immunocompromised, enhanced infection control strategies are required.
If you are conducting research with immunologically compromised populations, you are required to submit a Safe Research Plan using the most recent template, attached to page 9 of your ethics application (on RISe) or under ‘Documents’ in the online Island Health Research Portal (ROMEO).
If you already have a COVID-19 safety plan attached to your application, you do not need to resubmit.
- B. Research taking place offsite or at external locations
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Offsite or external locations refer to places that are not Island Health affiliated. The REBs expect the safety of participants and researchers to be a consideration. We expect researchers to follow any applicable and required safety plans at these sites. You may use the Safe Research Site Plan Template if your study does not have an approved plan and the location does not have clear requirements.
Indigenous communities may set their own infection control strategies in excess of Island Health or PHO requirements. When research involves Indigenous communities, the REBs require evidence of engagement in the development of a site-specific Safety Plan and confirmation of community agreement to participate. Island Health REBs respect Indigenous sovereignty in these cases, and will defer to their requirements for their communities.
- C. Case-by-case high risk situations (researchers will be notified by the REBs)
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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 or other infections, and rates of hospitalizations due to respiratory infections.
In the event of a future significant outbreak of a COVID-19 variant or other respiratory illness, REBs may require research teams to update their safety strategies.
The REBs expect that all researchers, including students working within the health organization, will follow all Island Health and PHO orders and will take precautions against infectious diseases. This includes doing health checks for themselves and their participants before engaging in research activities. The REBs also expect that researchers will accommodate participant requests for increased infectious disease protections (see below, “Researcher Duty to Accommodate”). The REBs and Island Health continue to follow PHO orders around vaccination status for health care workers and, by extension, expect researchers who are health care workers to be in compliance.
For more information about current Island Health COVID-19 requirements please refer here.
Researchers may choose to maintain their Safe Research Plan within their REB applications. If you would like to remove or alter your Safe Research Plan from your REB application, you will need to submit a Post Approval Activity (PAA) – Amendment in the online application system. When doing so, include a statement in the PAA form indicating that you will follow Island Health’s COVID-19 and other infection control requirements, and all applicable PHO orders, and that you are, therefore, removing your Safe Research Plan.
Vaccination Requirements
The REBs will continue to define “Island Health researcher” broadly to include all affiliates and will require COVID-19 vaccines for researchers as directed by the PHO and Island Health.
Vaccination attestation for COVID-19 is no longer required. The research application will instead include the following attestation statement:
"I will monitor and abide by all provincial and institutional safety requirements in order to uphold the rights and welfare of research participants as COVID-19 circumstances evolve. I will ensure that additional safety requirements such as contact tracing, affirming vaccination status of participants, and other measures are performed if or when necessary."
All health care workers, including students, who engage in research are required to be in compliance with PHO and Island Health vaccine requirements for health care workers.
Researchers who are not required to be vaccinated (i.e., not health care workers) should disclose their vaccination status if asked by a participant. Those who are not vaccinated should take precautions to avoid increasing risk of infection for participants and colleagues.
Researchers should continue to consider ways they can reduce the risk of infection transmission among research team members and participants.
COVID-19 Health Check
If you would like to provide a health check for both participants and researchers prior to in-person contact, this link provides the most current self-assessment tool.
Before Submitting Your New Ethics Application or Amendment
Equity and Research Duty to Accommodate
The TCPS2’s principle of Justice requires that no one group or individual take on the burden of research or be unfairly excluded from research participation. The COVID-19 pandemic has increased the vulnerability of those who are immunocompromised and those who are in close contact with individuals who are immunocompromised. This has created a barrier to their participation in research. Researchers have a duty to accommodate reasonable requests from participants to increase their infectious disease safety protocols in order to allow them to participate in research. Accommodations may include ensuring that N95 or similar protective masks are worn by all research personnel, conducting interviews in well-ventilated or outdoor spaces, using remote video conferencing in place of in-person meetings, and ensuring that lab space and research equipment are cleaned between uses. The researcher should talk to each participant about the level of protection they want that will make their participation possible.
The REBs recommend including information in the Risk section of the consent form. Duty to Accommodate sample consent form wording:
Please let the researcher know if you require modifications to the research procedures to enable your participation. The researcher is obligated to accommodate reasonable requests and can discuss your situation with you. Examples of reasonable changes include increasing infectious disease protections by providing masks or improving ventilation, changing a meeting location to improve access and navigation, or providing the services of an interpreter.
Consultations
Consultations with the REBs may be required in some situations before you submit your amendment or new application. Please review the rest of this page before requesting a consultation.
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 for Clinical applications (CREB) or Victoria Philibert 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.
Provincial Health Orders Affecting REB Review
To view the PHO Orders published since the advent of COVID-19, view here.
- Additional resources include:
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- British Columbia Public Health Office
- BC Center for Disease Control
- WorkSafeBC
- Government of Canada pages
- Coronavirus (COVID-19) and Indigenous communities
- Island Health COVID-19 information
- Review the First Nation/Inuit/Métis community websites for the regions where you will be requesting permission to conduct research.
- Review other guidance specific to your profession or research field that could help with developing risk mitigation strategies.
- Ensure that you are aware of all relevant public health or other governmental or institutional policies, guidance, and regulations pertaining to the location where your research is being conducted.
Forms and Resources
Safe Research Site Plan Template
Notice of Respiratory Infection Risks During Research Template - Optional
COVID-19 Health Check - This tool should be used by researchers and participants to screen themselves before research interactions. Use of the tool, and a link to the tool, should be described in the consent form unless there is another assessment already occurring, e.g. Island Health Point of Care Risk Assessment. If this is the case, please indicate so in your application where appropriate.
Culturally Safe and Trauma-Informed Practices for Researchers during COVID-19
Prior Research Ethics & Compliance Information Regarding COVID-19
- November 4, 2022
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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
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 will continue to define "Island Health researcher" broadly to include all affiliates, and will require COVID-19 vaccines for researchers as directed by the PHO and Island Health. 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.
Before Submitting Your New Ethics Application or Amendment
- Research Safety and Vaccination Attestation
- Safe Research Plan
- COVID-19 Health Check
- Consultations
Research Safety and Vaccination Attestation Form
In all instances, all new research applications, submitted events, and post approval activities will need to fill out and attach a Research Safety and Vaccination Attestation form to their ethics application in the Study Documentation section or page. If your application has already submitted the form, it is not required again.
Safe Research Plan
For in-person research activities, researchers are to additionally use the Safe Research Guidelines and the Notice of COVID-related Risks During Research. All in-person research requires an up-to-date Safe Research Plan. The template was last updated January 2023.
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 PHO.
COVID-19 Health Check
Researchers are required to have participants and research team members complete a COVID-19 Health Check questionnaire at the onset of each in-person engagement: 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 the Research Services Portal or RISe. See the scenarios described below for instructions.
Consultations
Consultations with the REBs may 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 member of your research team is unvaccinated for any reason and/or does not wish to disclose their vaccination status.
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 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.
Regardless of the vaccination status of participants, researchers will still need to be vaccinated.
Provincial health orders affecting REB review of ethics applications
View the PHO Orders published since the advent of COVID-19.
Researcher Proof of Vaccination
All members of the research team must be vaccinated. If a researcher cannot be vaccinated for medical reasons, or does not wish to disclose their vaccination status, they will need to contact the REBs for consultation. Details regarding securing medical exemptions from the Ministry of Health are here and those from Island Health 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 (PI) is responsible for confirming that their research team members are vaccinated.
Participant Proof of Vaccination
The REBs will review whether vaccination should be be an inclusion or exclusion criteria for study participants on a case by case basis. 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.
- Forms and Resources
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Forms and Resources
Research Safety and Vaccination Attestation
Safe Research Plan Template (use this if you do not have an institutional plan)
BC COVID-19 Self-Assessment Tool (multiple languages are available from this link).
Island Health Notice of COVID-Related Risks During Research Version C
Culturally Safe and Trauma-Informed Practices for Researchers during COVID-19
- April 22, 2022
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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
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. 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.
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
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Masks and PPE:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Vaccinations
- 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.
- Vaccination status of researchers will be documented by attestation on the REDCap form.
- Beneficial interventions will not be denied to any participant due to their vaccination status.
- 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.
- Researchers should plan how they will document vaccine status of participants in the event that a general vaccine mandate is re-imposed.
- Pre-Screening
- 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.
- Contact Tracing
- 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.
- 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.
- Researchers should have a contact tracing plan in place for their research team members.
- 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.
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.
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.
- March 18, 2022
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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
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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.
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August 4, 2021
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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
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- 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
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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
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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
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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
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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)
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*“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
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Refer to your home institution’s guidance around travel advisories and any requirements around travel in place at that level.
- Forms and Resources
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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 ResearchCOVID-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
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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.
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February 25, 2021
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January 25, 2021
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December 1, 2020
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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 reviewInclude 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 reviewRequest to Resume or Initiate a Research Study at Island Health Form
Full Board review*
*An ad-hoc committee meeting will be convened for timely reviewInclude Covid-19 in the Amendment Title
Request to Resume or Initiate a Research Study at Island Health Form
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June 2, 2020
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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.
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May 29, 2020
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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.
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May 22, 2020
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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.
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April 27, 2020
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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.
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April 17, 2020
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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.
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March 30, 2020
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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
March 22, 2020
Please refer to this notice regarding clinical trials and research operations at Island Health in light of COVID-19.
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 Julita Traylen at researchoperations@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