Directives: Resumption of research with human participants

There is an imperative to conduct research during a pandemic. As in normal times, researchers are required to demonstrate benefit and minimize harm. Researchers at McGill who work with human participants must abide by the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2018); the McGill Regulation on the Conduct of Research and the McGill Policy on the Ethical Conduct of Research Involving Human Participants.

The following is information to help with start-up of in-person research with human participants at McGill in the time of COVID-19. A core principle of this guide is that Research Ethics Boards will deliberate, as always, the risks and benefits intrinsic to the research itself. Research Ethics Boards will generally not be required to deliberate the risks associated with COVID-19 except in cases where there are required amendments to participant consent forms or changes to study protocols (see below).

The assessment of risks related to occupational health and safety and the protocols to mitigate them are guided by two University directives:

In general, researchers wishing to re-start research with human participants should begin by determining what type of research they will be conducting (remote participation, research respecting 2-metre physical distancing, or research where 2-metre physical distancing is not possible) and follow the Faculty and Ethics approval processes outlined below, as well as the environmental and researcher and human participant control procedures.

Remote participation

Any research that can be conducted remotely should be done using remote methods. A summary of McGill-supported remote platforms is a helpful start when thinking about moving research to remote participation.

Faculty approval:
None.

Ethics approval:
If researchers need to make changes to their research method to conduct data collection by phone or other virtual communication in order to eliminate risks related to COVID-19, then this change can be implemented by reporting to the REB Office using the COVID-19 Temporary Protocol Deviation Report, or using the COVID-19 Protocol Deviation Form (for the Faculty of Medicine IRB).

Environmental controls:
None.

Researcher and human participant controls:
None.

In-person research with human participants respecting 2-metre distancing

Faculty approval:
Required, as per the University Directive: Principles and Procedures for Research on Campus.

Ethics approval:
No REB amendment is required in the case where a study with a valid REB approval in place is authorized by the Faculty to restart. Principal investigators will be required to provide a letter to participants explaining the health and safety protocol in place for the study. Participants will be reminded in the letter that they are free to decline to participate or defer participation, and will be asked to acknowledge that they have been informed of the health and safety protocols in place and will follow them.

Environmental controls: As per the Directive: Preventing the Spread of COVID-19 on Campus. Additionally:

  • Ensure that all high-touch surfaces (e.g., doorknobs, washrooms) are disinfected daily and more frequently as needed (e.g., bathrooms) and that hand-washing (or hand sanitization) stations are available for all who enter (and leave) the research space. Verify that proper ventilation is provided (open windows if possible or increase the fresh air circulation in HVAC systems). Leave time for disinfection between participants.
  • If objects are touched or manipulated (e.g., microphones, computer keyboards, mice or other response boards, pens or pencils), they must be disinfected between users/participants. Keyboards and other similar surfaces may be covered with a plastic cover that is cleaned or replaced between users. Other equipment must be disinfected with 70% ethanol or other disinfectant after each use (see Appendix 1 below). Avoid liquid pooling on electronic devices. Never spray disinfectant directly on sensitive equipment. Be sure to wear gloves while disinfecting surfaces and safely dispose of them immediately thereafter (and wash your hands).

Researcher and human participant controls: As per the University Directive: Preventing the Spread of COVID-19 on Campus. Additionally:

  • All individuals must ensure they have proper training on preventing the spread of infection, including hand hygiene, and all McGill students and employees must respond each day to the self-assessment health questionnaire available in Minerva. Anyone accessing the premises (including a non-McGill research participant/visitor) must be screened with the same health questions prior to entry.
  • McGill researchers will be responsible for communicating to participants the protocol in place for preventing the spread of infection during the research encounter.
  • Ensure that circulation paths are clearly identified to maintain 2m physical distancing.
  • Do not use waiting rooms; instead ensure scheduling such that each participant may be met at the entry.

A note about vulnerable populations: Quebec directives currently advise persons 70 years of age and older, those who are immunocompromised and those with chronic disease to avoid all but essential outings in public places. It is especially important for research involving vulnerable populations to move to remote participation. In-person research with vulnerable populations is not allowed at this time in the absence of a strong clinical imperative.

A note about off-campus research: Travel for university business – including research – remains prohibited, but it may be reasonable for REB-approved in-person research to resume off-campus if, in addition to these guidelines for in-person research with human participants:
· No inter-jurisdictional travel on the part of the researcher or participant is required;
· The research would be considered culturally appropriate in the local setting during a pandemic;
· Local public health authority directives are known and followed;
· There is supervisor (in cases where a student is PI) and Faculty approval as per the Directive: Principles and Procedures for Research on Campus.

In-person research with human participants where 2-metre distancing is unlikely or not possible

The re-start of this type of research requires the most thought about procedure to ensure safety of both the participant and the researcher. What follows is necessarily quite detailed although unlikely exhaustive, attempting to anticipate issues arising for in-person research where distancing is unlikely to be possible.

Faculty approval:

Required, as per the University Directive: Principles and Procedures for Research on Campus.

Ethics approval:

Required. In-person research with human participants where 2m distancing is not possible will require a revised participant consent form outlining the health and safety protocols in place, what participants will encounter when they arrive and a renewed reminder that participants are free to decline or defer participation. Changes to informed consent and any changes to study protocol must be approved by the appropriate research ethics board.

Environmental controls: As per the Directive: Preventing the Spread of COVID-19 on Campus and the above Environmental Controls for In-Person Research with Human Participants Respecting 2-Metre Distancing. Additionally:

  • Research with children will often necessitate careful attention to environmental controls. For example, if you use toys or other shared objects in your research, ensure that all are made of materials that can be cleaned and disinfected easily (avoid plush toys, porous materials, books). Carpets or floors where young children may sit or crawl should be covered with a cleanable (non-porous) mat that is disinfected or replaced after each use.
  • Towels or other materials that may be required for use by participants (e.g., for EEG) must be placed into a closed plastic bag until they are laundered prior to next use. Sinks used for hair-washing must be disinfected after each use, along with any shared shampoo bottles (use single-use supplies preferentially).
  • Please note that brain imaging facilities have established their own guidelines for use and for disinfection that must be followed for research requiring such facilities.

Researcher and human participant controls: As per the Directive: Preventing the Spread of COVID-19 on Campus and the above Researcher and Human Participant Controls for In-Person Research with Human Participants Respecting 2m Distancing. Additionally:

  • As a first priority reorganization of research spaces to respect a 2-metre distance between all members of the research team and all participants should be considered. If not possible, physical separation with barriers such as Plexiglas or other partitions should be considered. Minimize the duration of live interaction as much as possible by prioritizing remote communication.
  • Ensure that all research staff, students and participants are provided with necessary PPE and proper training as to its use (procedure masks and protective eyewear, as currently indicated by the IRSST and the Ministère de la Santé et des Services Sociaux (MSSS)).
  • For research that entails physical contact with participants, PPE (procedure masks, protective eyewear or visors) is required. Gloves should only be used for short periods when touching mucous membranes or adjacent surfaces (e.g., lips) of participants. If gloves are required, hands must be washed immediately before donning and immediately after removal and safe disposal.
  • Wash your hands thoroughly with soap and water or with alcohol hand sanitizer for at least 20 seconds before commencing work and when you are finished working with a piece of equipment. This includes when going from one room to another when your touch-area changes, including the washroom (do not use air dryers; use paper towels). Keep a container of hand sanitizer with you for intermittent sanitization when soap and water are not available.
  • Before putting on a mask (and after its removal), wash your hands according to proper techniques (as noted above). The same is true for any PPE (e.g., gloves, safety glasses/visor). If gloves are required for your work, wear them only at the point of care and wash your hands immediately after removal. Be careful not to touch personal items (e.g., phone) while wearing them. If you do, you must clean your personal item.
  • Do not cross- contaminate surfaces and working areas – when you move from one area to another, wash your hands.
  • Don gloves only when you begin close interaction with a participant if the interaction requires touching of mucous membranes or adjacent surfaces (as noted above) and discard them immediately after use. Hands must be washed after removing gloves.

A note about vulnerable populations: Quebec directives currently advise persons 70 years of age and older, those who are immunocompromised and those with chronic disease to avoid all but essential outings in public places. It is especially important for research involving vulnerable populations to move to remote participation. In-person research with vulnerable populations is not allowed at this time in the absence of a strong clinical imperative.

A note about off-campus research: Travel for university business – including research – remains prohibited, but it may be reasonable for REB-approved in-person research to resume off-campus if, in addition to these guidelines for in-person research with human participants:

  • No inter-jurisdictional travel on the part of the researcher or participant is required;
  • The research would be considered culturally appropriate in the local setting during a pandemic;
  • Local public health authority directives are known and followed;
  • There is supervisor (in cases where a student is PI) and Faculty approval as per the Directive: Principles and Procedures for Research on Campus.
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