SFU's common COVID-19 impact scale is currently rated HIGH (H2).
At the HIGH (H2) rating, researchers are expected to work remotely where possible. However, at this phase, “minimal intervention” Human Participants Research (HPR) may now resume. Examples of minimal intervention HPR permitted at H2 include: 1:1 interviews in an appropriate space, or small focus groups that can maintain required distancing.
All in-person human participants research, on or off campus, requires an HPR Safety Plan submitted to the Office of Research Ethics (ORE) for review and approval, along with the standard ethics applications prior to proceeding. Further information is detailed in the "Guidelines for Creating and Submitting HPR Safety Plans" section below.
If your HPR research is on an SFU campus, a Site Safety Plan must be developed and approved in accordance with your faculty processes and submitted with the HPR Safety Plan to the ORE. Please connect with your Associate Dean, Research for further information on site safety plan processes.
Research that involves human participants has been partially curtailed by the university in response to the COVID-19 pandemic. REB approval of research that already utilizes remote surveys or questionnaires remains unaffected. Methodologies that can easily pivot to online methods, such as many interview or focus group studies, may simply modify their protocol, seek approval of the amendment, and then carry on. This is not to say that the research itself is unaffected. Data gathered during a unique, often stressful period may be less useful than it would be otherwise. In-person methods are often preferable for a wide variety of reasons, and studies that are partially complete may encounter issues comparing in-person and remotely gathered data.
The concept of minimal risk research has changed as a result of the COVID-19 pandemic. The TCPS2 defines minimal risk as “research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research”. During this pandemic, the risks potentially encountered in everyday life have changed significantly. Individual perception of those risks is also far more variable than before.
Fundamentally, the risk/benefit balance of in-person research has now shifted. In order to justify in-person research, the risk level must be reduced to an acceptable ‘everyday life’ level or the research must be brought to a full board review to assess or reassess the risk/benefit balance. Research with external communities, including Indigenous communities, and organizations may need to be reconsidered in light of potential constraints or changes in focus as a result of the pandemic.
Both WorkSafeBC and SFU have done significant work over recent weeks to clearly document risk reduction methods for labs and offices on campus. Whether on-campus or off, in-person research is an extension of a university ‘lab’, and those contemplating in-person research will be required to develop and submit an HPR Safety Plan that extends the other on-campus requirements.
Guidelines for Creating and Submitting HPR Safety Plans
The information included in the HPR Safety Plan must be reflected in the study documents (Study Detail, Consent Form, etc) so that all activities noted in the HPR Safety Plan are also noted in the study documents.
Please note: you will be asked to submit an amendment to revise your study documents if there is information included in the HPR Safety Plan which is not included in the study documents. For example, text referring to the provision of PPE, any safety processes that will be followed, any alterations to the consent process, the provision of study documents, etc.
A safety plan for human participants research (HPR) will vary from project to project, so the guidelines presented below are not expected to act as a template. You may already have submitted site-specific safety plans through your Faculty for approval by Chair and Dean, or you may be operating under a plan that covers your Faculty or a specific building. The safety plan you develop for HPR activities provides reviewers with details specific to the conduct of the research and its impact on participants. Off-campus activities may require that you develop both, or adapt to the plan that is active in the third-party site.
In-person HPR Safety Plan Workflow Process:
- Review guidance documents and other resources to assist in the preparation of your HPR Safety Plan.
- WorkSafe BC specifies the minimum content of COVID-19 safety plans for a generic workplace environment.
- This Government of Canada site has general guidance.
- Additional GoC pages regarding Indigenous Communities
- SFU's SRS resource pages
- If you are working in a remote or Indigenous community, contact them to determine the local status (many remain essentially closed)
- Review public health policies, existing Site Safety Plans, or other regulations that pertain to your research site.
- Assess the risks of transmitting COVID-19 while conducting your research. Factors to consider include:
- Number of people present in the setting
- The contact intensity - type and duration of contact
- The status at the research location - plans in place, PHO directives, etc.
- Is PPE required/in place?
- Multiple sites - consider risks of transmitting between the sites.
- Travel - is self isolation required? What health services are in place?
- Equipment - sharing equipment, cleaning protocols.
- Consider modifications such as:
- Providing participants with information related to the pandemic and reducing their risk of infection, preferably before the visit.
- Remote screening of participants prior to contact, using the BC COVID-19 Self Assessment Tool or a phone/email script such as this.
- Additional training of research personnel to address screening, masking protocols and triage procedures should a participant be identified as at risk during a screening
- Maximizing remote interaction by, for example, administering consent forms and questionnaires by phone or video.
- Eliminating wet signatures on forms.
- Protocols to follow if a participant is identified as infected before, during or after the interaction.
- Minimizing risks associated with travel to the laboratory e.g. free parking or providing appropriate PPE for participants using transit.
- If the activity is on-campus, a Site Safety Plan must be developed in consultation with your faculty processes. The approved Site Safety Plan accompanies the submission of the HPR Safety Plan to the ORE.
- Most faculties have developed a localized template based on the WorkSafeBC Safety Plan requirements.
- Contact your Associate Dean, Research for information.
- Refer to the SFU COVID-19 Guidance on Safe Work on Campus document for more detailed information.
- If the HPR and site ;plans are separate documents (i.e. for off campus HPR research), the two must be in close alignment and submitted as a package for review.
- The HPR Safety Plan must include sufficient documentation to assure ORE that the space being utilized is covered by an approved Site Safety Plan and research is permitted under current conditions, whether on or off campus.
- All Site Safety Plans contain lists of individuals (and contact info) who are authorized to enter the space in order to facilitate contact tracing if required. The HPR Safety Plan should specify how participants will be logged and how the log may be accessed should the need for contact tracing occur.
- The HPR Safety Plan, outlining the safety and risk protocols for HPR, is submitted to ORE (email@example.com) for ORE/REB review and approval. Include as appropriate:
- Approved Site Safety Plan
- If the activity involves a protocol modification submit an ORE amendment form.
- If the protocol is new, submit a new application form with the overall package.
- If a new or modified protocol has already been tentatively approved (under COVID-19 restrictions), then the Site Safety Plan is submitted on its own.
- Other supporting documents
- The ORE/REB review may require clarifications regarding safety and the normal TCPS requirements. ORE will reach out to SRS, VPRI, Faculty or others as required.
- The ORE will inform PIs when the activity is cleared to commence.
- Ongoing compliance and monitoring (guidelines forthcoming).
For new protocols, consult the guide below before submitting to the ORE. Protocols may be approved but put on hold subject to reduced hazard levels.
Just as before the pandemic, modifications to an approved research protocol require that the changes be documented and approved via the amendment process. The level of review is proportionate to the risks associated with the proposed changes.
The following guide illustrates the type of activities permitted at each level.
At any hazard level the ORE/REB will accept requests to initiate or continue research related to COVID-19 or the pandemic.
|Type of activity||Requirement|
Temporary shift to remote - Submit an Amendment Request Form, noting that the changes are related to COVID-19 restrictions on in-person research. When restrictions on in-person research are lifted studies with the appropriate approvals may transition to approved in-person research activities.
Permanent shift to remote - Submit an Amendment Request Form
These activities may operate during ALL hazard levels
|Minimal intervention procedures: i.e. no physical contact and/or low intensity contact. (e.g. 1:1 interviews, in-person small focus groups in appropriate space)||
HPR Safety Plan approved by the ORE utilizing appropriate PPE.
May operate during High hazard levels (H1, H2) (or below) subject to approval
|Medium intervention procedures: i.e. some physical contact, low-intensity contact (e.g., research on wearable devices, collection of some biological samples)||HPR Safety Plan approved by the ORE utilizing increased level of PPE.
May operate during Moderate 1 hazard level (or below) subject to approval
|High intervention procedures: i.e. sustained physical contact, high intensity, or high risk of aerosol generation (e.g. exercise testing or respiratory function testing)||HPR Safety Plan approved by the ORE utilizing significant level of PPE and other precautions.
May operate during Moderate 2 hazard level (or below) subject to approval.
|Impractical research: i.e impacted by travel bans or closures of facilities||On hold. Amendments not required unless the delay affects the research significantly.|