Topic

U of T Guidance for the Recovery of Human Research During the COVID-19 Pandemic

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 Tuesday, August 4, 2020 at 10:30 AM EDT

Preamble

As the University works toward research recovery, decisions regarding face-to-face human participant research taking place on campus and in the field must be made with an emphasis on the safety of research participants, researchers and the general public. Assessment of resuming face-to-face human research will 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 begin research; other approvals or processes, including departmental approval, biosafety, and safety abroad may be required. Consult COVID-19 Research & Innovation Updates and associated links to help with your planning for research recovery. It is the responsibility of the Principal Investigator (PI) 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.

As per the School of Graduate Studies’ (SGS’) Research Engagement/Re-engagement Planning guidelines , the decision to return to on-campus or off-campus research activities must remain the right of the graduate student. Please refer to these SGS Planning Guidelines 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.

Research Ethics Considerations

  1. Risk to Participants

    The overarching principle in considering the recovery of face-to-face 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, keep the following in mind.

    • 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
  2. Privacy and Confidentiality
    • Personal health information may be collected through COVID-19 screening protocols, as required for visitors to the University of Toronto (U of T).
    • Contact information for all participants will be collected should a participant or researcher test positive to COVID-19 to facilitate prompt contact tracing by Occupational Health and Safety and/or other public health officials. Guarantees of anonymity cannot be made for this reason. Moreover, researchers and REBs should consider the potential consequences that providing names to public health could potentially have, with respect to risk, if disclosed. This should be made clear to all participants.
    • Researchers should store contact information separately from de-identified data and maintain confidentiality to the extent otherwise described in the protocol. Please see Data Security Standards for Personally Identifiable & Other Confidential Data in Research
    • 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.
  3. Research methods

    Human research that can be done through virtual (e.g. Microsoft Teams) or remote (e.g. phone, email) or online (e.g. MTurk, REDCap) methods should be conducted through these methods. Please see University-supported platforms and Centre for Research & 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.

    Time-sensitive COVID-19 clinical research that has been approved by the University may be conducted without waiting for later phases.

    There may be circumstances where conducting the research virtually or remotely will not be possible and therefore the researchers want to use face-to-face 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 Examples Direct Contact
Level 1 Interaction/observation Interviews, focus groups, surveys, computer-based experiments and data collection, non-invasive neuro-imaging (on campus) None or minimal contact, physical distancing can be easily achieved
Level 2 Intervention Introducing dietary or exercise regime, drug, or natural health product testing Some physical contact (e.g. biospecimen collection, body measurements, participant sweating, breathing heavily et al), physical distancing sometimes challenging to maintain
Level 3 Physical treatment / manipulation Physical therapy, dental procedure, biopsy Sustained physical contact, physical distancing not possible
  1. Level of risk of the research method will be considered in addition to other risks and weighed against direct benefits to participants.

    Ethical considerations for face-to-face methods include the following.

    • If conducting interviews, focus groups, or experiments, why can’t virtual methods be used? There must be a compelling reason for needing to meet face-to-face during research recovery.
    • If face-to-face research will take place off-campus, where, and how will the research team ensure that cleaning protocols are being followed and that physical distancing measures can be maintained between participant and researcher and/or between participants? If physical distancing cannot be maintained, is enough PPE available?
    • It is common for research participants to suggest the location for conducting interviews; however, this may pose unknown risks to researchers and participants and should therefore be discouraged unless a valid justification is presented
    • If the research requires physical interaction or intervention (e.g., touching to collect biometric data, physical manipulation, or collection of biological materials);
      • Is there appropriate and adequate PPE available for both researcher and participant?
      • What is the extent of the physical interaction and the associated risks (e.g., attaching biometric equipment to the participant vs. conducting dental exam)?  
      • Have you exhausted all physically distanced / contactless approaches to the task?
  1. 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 the COVID-19 public emergency 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 face-to-face 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.
     

  2. 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.

    Research may not be conducted in Indigenous communities or in areas where vulnerable populations live (e.g., long-term health care facilities) until public health officials deem such activities safe.
     

    On campus

    • 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

    In the field

    • What is the infection rate in the respective community, city, province or country? These details are important in terms of risk and consent.
    • Are researchers allowed to enter the country/region and conduct research? Is there a mandatory quarantine period open entering?
    • What are the legal and public health requirements for the area and participant population?
    • How will the researcher travel to the area, and what risks will mode of travel carry for the researcher and participants?
    • Does the region have appropriate and adequate PPE in addition to other infection prevention and control precautions in place?
    • What are the reporting requirements, and the implications of having contact information of participants on the risk to them?
    • Upon returning home, is there a mandatory quarantine period?
  3. 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.

The information below should be embedded, as relevant, in the various sections of consent documents or should be provided as a stand-alone section.

  • 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:
    • Screening – as per requirements for persons coming onto campus.
    • Take appropriate precautions (e.g. face covering / cloth mask) if taking public transportation and entering public indoor spaces.
    • Wash your hands upon coming onto campus / entrance to building. Hand sanitizer will be made available to you.
    • Physical distancing will be maintained, at all times, and if not possible wear a face covering / cloth mask. Otherwise we will provide you with PPE.
  • 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.

Process

Previously Approved Protocols (Approved prior to July 24, 2020)

  • Protocols approved prior to July 24, 2020 that involve face-to-face interaction or intervention with human participants must submit an amendment to the REB for review and approval.
  • The amendment must include a completed Face-to-Face Human Research Checklist.
  • Amendments should include updates to the following sections.
    • Consent – consent documents should include language as written above in the section Consent Documents: COVID-19 Wording
    • Project details – include COVID-19 screening process, precautions, collection of personal contact information, as required by public health and the University
    • Risks and benefits – changes to risk from coming to campus or research site, including commuting; collection of identifiable information and risk of breach of their personal information
    • Privacy and confidentiality – limits to confidentiality because of duty to report positive COVID-19 cases, may need to provide personal information for contact tracing.
    • Participant withdrawal – personal information cannot be withdrawn or destroyed, as may be needed to re-contact ex-participants
    • Risk level – vulnerability of participants, impact of COVID-19 and changes to level of risk.
  • Once REB approval of the amendment is obtained, the research recovery plan for each PI must be approved by the Chair and Dean (multi-department Faculties) or Dean (single-department Faculties) prior to commencement or continuation of the research activity.
  • In addition to REB approval and research recovery approval, researchers must abide by other applicable approvals and requirements (e.g., biosafety permit)
  • Safety protocols must be implemented for human participants coming onto campus, or the research site. These include updated COVID-19 information for participants, screening questions, necessary PPE for the research site (and, if necessary, for travel to the site), and collection of personal information in case of outbreak and need for contact tracing.

New Protocols (Approved after July 24, 2020)

  • After July 24, 2020, human ethics protocols for research that involves face-to-face interaction or intervention must include a completed Face-to-Face Human Research Checklist
  • The protocol should include ethical considerations regarding COVID-19 in the following sections.
    • Consent – consent documents should include language as written above in the section Consent Documents: COVID-19 Wording
    • Project details – include COVID-19 screening process, precautions, collection of personal contact information, as required by public health and the University.
    • Risks and benefits – changes to risk from coming to campus or research site, including commuting; collection of identifiable information and risk of breach of their personal information.
    • Privacy and confidentiality – limits to confidentiality because of duty to report positive COVID-19 cases, may need to provide personal information for contact tracing.
    • Participant withdrawal – personal information cannot be withdrawn or destroyed, as may be needed to re-contact ex-participants.
    • Risk level – vulnerability of participants, impact of COVID-19 and changes to level of risk.
  • Once REB approval for the ethics protocol is obtained, research recovery must be approved by the Chair and/or Dean prior to commencement or continuation of the research activity.
  • In addition to REB approval and research recovery approval, researchers must abide by other applicable approvals and requirements (e.g. Biosafety permit).
  • Safety protocols must be implemented for human participants coming onto campus, or the research site. These include updated COVID-19 information for participants, screening questions, necessary PPE for the research site (and, if necessary, for travel to the site), and collection of personal information in case of outbreak and need for contact tracing.

Forms & Downloads

VPRI Role

  • 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

VPRI Contact

Staff

General Inquiries: Human Research & Ethics Unit (HREU)

Research Oversight & Compliance Office (ROCO)
(416) 946-3273
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