Who is this for?
All individuals at the University of Toronto (U of T) who will conduct face-to-face research involving human participants.
What do I need before I can begin?
Please consult the COVID-19 Research & Innovation Updates
You also need the following.
- A protocol approved by, or to be submitted to the Research Ethics Board (REB)
- Completion of any other requirements or processes (e.g., departmental approval, biosafety, and safety abroad) for research
Last updated Wednesday, October 13, 2021 at 4:30 PM EDT
As the University continues to work towards research recovery, decisions regarding face-to-face (F2F) human participant research taking place on campus and in the field must be made with an emphasis on the safety of research participants, the research community and the public. Assessment of resuming F2F human research continues to be done in accordance with the University’s Approach for Research Recovery & Adaptation, in conjunction with the General Workplace Guidelines.
Research Ethics Board (REB) approval alone is not sufficient to resume F2F in-person research; other approvals or processes, including review and approval from the F2F COVID-19 Review Committee (F2FCRC) are required. Consult the Research and Innovation COVID-19 updates webpage and associated links to help with your planning for research recovery. It is the responsibility of the principal investigator to know what safety requirements are required (e.g. personal protective equipment (PPE), physical distancing) and to ensure that these measures are appropriately planned for and executed. Vaccination Guidance for Human Participant Face-to-face (F2F) Research should also be reviewed.
As per SGS’ Research Engagement/Re-engagement Planning webpage, the decision to return to on-campus or off-campus research activities must remain the right of the graduate student and trainee post-doctoral fellow. Please see this webpage for further information regarding the rights and responsibilities of students and post-doctoral fellows and their faculty supervisors with respect to on-campus and field research.
Below are research ethics principles and concerns researchers should consider in determining when and how to propose and conduct F2F human research. They should be used in developing/revising protocols and completing the Face-to-Face Human Participant COVID-19 Risk Assessment Form.
- Risk to Participants
Research Ethics Boards are responsible for the health and well-being of human participants. The overarching principle in considering the recovery of F2F research is risk to participants. Because the concept of minimal risk (i.e., the risk of “daily life”) has changed, this evolving situation should influence how researchers assesses the risk level if it involves having participants leaving their homes to participate in research. Specifically:
- Researchers should take into account the risks attributed to research methodology itself, the location of the research, risks of exposure for interactions that may occur during travel and at the research site, and how these risks escalate with vulnerabilities.
- Risks to third parties (e.g., other members of the household) should be considered.
- The risk-to-benefit ratio may be too high in some cases to conduct the research in the manner proposed. Researchers may need to adjust the research to lower risk or continue to postpone until the health and safety conditions permit.
- Privacy and Confidentiality
- All visitors to the University of Toronto are required to complete a UCheck paper screening form before coming to campus. For the purposes of contact tracing, the University contact must have up-to-date contact information before the visitor comes on site. This should be made clear to all participants.
- Maintaining two metres between researchers and participants, and/or speaking through masks, may increase the likelihood that conversations may be overheard. Researchers should not guarantee privacy in such circumstances.
- Research methods
Researchers are encouraged to use virtual (e.g. Microsoft Teams, Zoom), remote (e.g. phone, email) or online (e.g. MTurk, REDCap) research methods where possible.
Please see University-supported platforms and Centre for Research and Innovation Support resources for further information. Note that research conducted through virtual, remote or online methods may continue or commence in all phases of research recovery.
There may be circumstances where conducting the research virtually or remotely will not be possible or appropriate and therefore the researchers want to use F2F methods. These methods differ in the amount of physical contact between researchers and participants, and therefore should be assessed in accordance to safety, with respect to COVID-19 transmission:
|COVID-19 Research Risk||Research Method||Direct contact / close contact?|
|Level 1||Interaction / observation||None or minimal contact, physical distancing can be easily achieved (e.g., interviews, computer-based experiments, non-invasive methods)|
|Level 2||Intervention||Some physical contact (e.g., biospecimen collection, body measurements), physical distancing sometimes challenging to maintain|
|Level 3||Physical treatment / manipulation||Sustained physical contact, participant breathing heavily, physical distancing not possible|
- Vulnerability of human participants in context of COVID-19
“REBs and researchers should be aware that individuals, prospective participants, researchers, and institutions may not normally be considered vulnerable, but may become so by the very nature of public emergencies. Those already vulnerable may become acutely so (Article 4.7). The increased public risks and devastation that cause public emergencies to be declared can threaten autonomy and physical, emotional, institutional and social welfare or safety. They also bring inherent tensions and pressures that may impact deliberative decision making. Taking all of this into consideration, REBs and researchers should ensure that the risks and potential benefits posed by any proposed research are appropriately evaluated, including provisions for greater than normal attention to risk, where applicable.” TCPS, Article 6.23.
It is essential that researchers understand that COVID-19 raises the baseline of vulnerability for all people. However, for some individuals and communities, ongoing and new circumstances may exacerbate vulnerabilities even further. Researchers should assess participant vulnerability in terms of the following factors:
- Physical/physiological – attributes that put individuals at greater risk of morbidity and/or mortality from the disease (e.g., age, other diseases, immune system status).
- Psychological/emotional – attributes that may exacerbate mental health issues (e.g., obsessive-compulsive disorder, anxiety, depression) because of the pandemic, including pandemic directives and preventative measures (e.g., isolation, subjective fears).
- Social – attributes that put individuals at greater risk of exposure, of obtaining knowledge for prevention, taking preventative measures, obtaining treatment, and/or being able to maintain the health and life of others in their household or community (e.g., lack of space, food and water insecurity, unemployment, poverty, dependants).
A combination of these factors may contribute to a participant’s circumstances. Researchers should consider the highest level of vulnerability for their participant group when completing or amending their ethics protocol, obtaining informed consent and conducting the research.
It is important to consider that when researchers ask volunteers, who may not benefit from the research, to participate in F2F research the volunteers are not only taking additional risks during the encounter, but also during the act of travelling to the location or meeting the researchers at a specific location.
- Research environment
Considerations are dependent on where the research location will be, as risks to participants, the research team and to third parties may differ.
Researchers planning to conduct research in Indigenous communities should be aware of the current context of COVID-19 in the community.
- Participants must be screened in accordance to public health recommendations and University practices. Does the research team have the resources and capacity to conduct screening appropriately?
- What are the logistical considerations for physical distancing – elevators and staircases, hallways, lab and testing spaces?
- How will participants travel to campus – via car, public transportation, walking or cycling? Travel by public transportation carries additional risks
- Informed Consent
- Informed consent documents should include COVID-19-related screening and precautions, methods and the impact on the COVID-19 related risks, confidentiality, withdrawal and compensation. Suggested language is below.
- Resources to medical and public health services may need to be provided.
- Research site is located [insert], under the jurisdiction of [location] public health. We are taking all safety precautions to reduce the risk of spread of COVID-19 and expect you to follow public health directives as well.
- If you feel that you are from a vulnerable group with respect to COVID-19 effects (e.g., senior, immuno-compromised), please discuss your participation with the research team before consenting. You are under no obligation to participate and nothing bad will happen if you change your mind about participating in the research.
- Because you are coming onto campus, the following safety protocols must be followed, as per Occupational Health and Safety (see Vaccination Guidance for Human Participant Face-to-face (F2F) Research).
- We will be collecting personal contact information that we must retain in order to follow up with you and/or conduct contact tracing if you may have been exposed to COVID-19 in coming to the research site.
- Contact information will be kept separate from data collected through the research study to allow for de-identification of the research data (if applicable, as detailed in the protocol).
- You maintain your right to withdraw from the study at any time, including research data (if applicable). If you do withdraw, we will continue to maintain your contact information and will only give it to Occupational Health if required for contact tracing.
- We cannot guarantee anonymity as the personal contact information identifies you as a participant.
- Coordinate and administer U of T’s Research Ethics Boards
- Provide policy and procedural advice and guidance to researchers in the planning and execution of their research to ensure compliance with all of the relevant regulations and policies