Guidelines for research involving humans during COVID-19
The current pandemic has disrupted the lives of everyone across the University and across the world. Just as this affects our daily lives, so does it affect how research is and should be conducted. Safety considerations that were not needed before are now essential to conducting research safely.
This is reflected in Article 6.3 of the TCPS 2, as well as in the COVID-19 Interpretations provided by The Interagency Advisory Panel on Research Ethics, which address many aspects of the ethical review of research during the pandemic.
All new and ongoing projects that involve in-person research activities will need to follow the uOttawa Process for In-Person Research Activities, outlined below. This process applies to all projects, whether they are funded or not, and regardless of where the research is being conducted.
The Guidelines and Procedures for Conducting In-Person Research were developed in collaboration between the Office of Research Ethics and Integrity, the Office of Risk Management and the Office of the Vice-President, Research.
For projects that involve Individuals, groups or communities that are particularly vulnerable to the effects of COVID-19:
For those who were already vulnerable due to their particular health status, the risks are higher than ever before. Ongoing and new circumstances may exacerbate vulnerabilities even further. For more information, see https://www.canada.ca/en/public-health/services/publications/diseases-conditions/vulnerable-populations-covid-19.html
The University is not currently permitting in-person research activities with vulnerable groups on campus.
Activities with these groups may be permitted for off-campus research, if all public health requirements are met, the research conforms to the faculty remobilization plan, and once REB ethics approval is obtained.
Assessing Need and Urgency for In-Person Research with Human Participants
Determine The Need To Conduct In-Person Research Activity
- Data Collection: Is conducting in-person research the only viable option in order to meet the project’s objectives? Examples when it may be necessary to conduct in-person research:
- Physical testing and/or manipulation is required (e.g., specific infrastructure or equipment is necessary for data collection, data collection involves direct physical contact with participants).
- Suspension of the project may result in the loss of valuable services to participants (i.e., therapy-based research, intervention-based research).
- The loss of face-to-face interaction or observation would diminish the quality of the data.
- Design: Do all aspects of the protocol need to be conducted in-person (e.g., recruitment and/or consent process, specific phases within the design)?
- Participant Sample: Is the participant population only accessible in-person?
- Risks: Are there measures to mitigate COVID-19-related risks to participants when conducting in-person research, particularly in considering groups that may be more vulnerable to COVID-19?
- Benefits: Does the in-person data collection offer benefits to (a) individual participants, (b) participants sharing common characteristics, or (c) a community or society at-large.
Note: The Faculty and/or the REB may determine that the risk for participants outweighs the benefits of the research, and decide that the research should not proceed in its current state.
Determine The Urgency To Conduct In-Person Research Activity
- Consider if the research needs to be done now, due to special circumstances.
- Is the researcher a student who needs to complete the project to graduate?
- Is the project dependent on the academic school year?
- Is the project dependent on real-time pandemic experiences?
- Is the project dependent on scheduled events outside the researcher’s control?
- Is the researcher at risk of losing funding?
Considerations for moving from in-person to remote research activities
Research conducted by virtual means carries its own risks, including a possible increase in data privacy risks.
Things to consider
- Are any modifications to approved study procedures needed to responsibly carry out these activities?
- Is it possible to obtain consent in ways other than a signed consent form, e.g.,:
- verbal consent via telephone (required: verbal script and evidence of documented consent such as via audio-recording);
- written consent received via email attachment;
- online consent via Survey Monkey.
- Is the research sensitive?
- Are there potential risks to participants, particularly if there is a breach of confidentiality?
- Would modifications increase any risk to participants, researchers, the community at large or the institution?
- If ‘yes’, what steps will be implemented to minimize risk to all involved?
Technologies uOttawa makes available which may help facilitate social distancing
Below are some technologies uOttawa makes available which may help facilitate social distancing and minimize travel to campus and face-to-face interactions, while still allowing research teams to communicate with each other and with participants as needed.
- Videoconferencing options: MS Teams, Adobe Connect, Zoom
- Office 365 Suite: deemed secure for collection, transfer, storage of some sensitive information (e.g., de-identified research data)
- LiquidFiles – Secure emails allowing to send files up to 10GB
- Survey Monkey.
Process for in-person Research Activities at uOttawa
This process applies to new and ongoing projects, whereby in-person research activities with human participants will be conducted.
Step 1 - Assess the need for in-person research
Consult the section “Assessing Need and Urgency for In-Person Research with Human Participants” to determine:
- If in-person activities are absolutely necessary, or can remote methods be used?
- If there is an urgency of proceeding with in-person activities at this time?
*Based on the above assessment:
- If research protocol will not involve in-person activities, proceed with the submission of an ethics application (new projects) or request for modification (ongoing projects).
- If research protocol will involve in-person activities, proceed to Step 2.
Step 2 - Assess research site requirements
- If on uOttawa campus, determine if your research site (lab, office) is accessible to researchers and/or participants.
- If off campus, verify site requirements and feasibility of conducting the project at the site within the next six months, keeping in mind that if the project is taking place at a specific location (e.g., community centre, hospital, school) additional permissions may be required or the site may not allow you to conduct the research.
- If the project involves international travel, consult the “Faculty and Staff” section of the uOttawa COVID-19 website, as well as Travel Advisories to see if travel is permitted.
Step 3 - Complete the Safe Research Plan Form
- Consult your Faculty's “Research Remobilization Plan”, which ensures that research protocol adheres to provincial and local public health agencies’ directives and guidelines.
- Consult the “Guidelines for Creating a Safe Research Plan” to establish which safety measures are to be integrated into your research protocol.
- Consult with the Office of Risk Management (as needed) for guidance in determining the required measures for the safe conduct of research.
Step 4 - Submit the Safe Research Plan
- Send the plan to your Vice-Dean Research to ensure it aligns with the Faculty’s Research Remobilization Plan.
- Update the plan according to feedback and/or considerations brought forward by the Faculty.
- Submit a final version of the plan for an official sign-off by the Faculty.
Step 5 - Submit the ethics application or request for modification for REB review
- Complete an ethics application (new projects) or request for modification (ongoing projects).
- Answer ‘Yes’ to Question 2.6 and append the final version of the Safe Research Plan (with Faculty signatures).
- Consult the “COVID Consent Form Addendum” and append a copy of your Addendum in Section 7.
- Note that new projects supporting the COVID-19 effort will remain a priority (i.e., vaccine, treatment, mental health, epidemiology). If your project is COVID-19-urgent research, contact the OREI at ethics@uOttawa.ca prior to the submission of your ethics application.
Guidelines for Creating a Safe Research Plan
These guidelines are intended to assist researchers in developing a Safe Research Plan. Safety considerations differ from project to project, depending on the research methods and context, so the guidelines are not expected to act as a template. The Safe Research Plan you submit to your faculty is to ensure that your plan is aligned with the Faculty’s Research Remobilization Plan, in considering the risks to and impact on participants and researchers.
Step 1 - Review Safety Guidance and Consult
Be aware that community guidelines, restrictions and practices may differ from site to site and will need to be factored into your Safe Research Plan where applicable. Also, these can and do change with time so community guidelines are to be be monitored regularly.
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, for example:
- First Nation/Inuit/Métis community websites for the regions where you intend to conduct research to gain the latest information about community status.
- Guidance specific to your profession or research area that could help with developing risk mitigation strategies.
Consult with stakeholders, sponsors and participant communities (as appropriate) as you draft your plan.
Examples of guidance:
- Ottawa Public Health – Novel Coronavirus (COVID-19)
- Information for Ontario
- Public Health Ontario – Coronavirus Disease 2019 (COVID-19)
- Government of Ontario – COVID-19
- The Government of Canada pages
- Coronavirus (COVID-19) and Indigenous communities
- International SOS
Step 2 - Assess the risks of your research in the context of COVID-19
The virus that causes COVID-19 spreads in several ways: in droplets when a person coughs or sneezes; when someone touches a contaminated surface and then touches their face. The risk of person-to-person transmission increases the closer people are to one another, the more time spent near others, and the greater number of people are nearby. The risk of surface transmission increases the more people are in contact with the same surface and the more contacts happen over short periods of time.
Considering how, where and with whom your research will be conducted, what are the risks that COVID-19 may be transmitted either to participants or researchers? How can your research methods be modified to reduce risk? The guiding questions below will help you determine what kinds of risks might exist, based on the types of activities involved:
Contact Intensity | What is the contact intensity of activities with project participants – i.e. what is the type of contact (close/distant) and duration of contact (brief/prolonged)?
Number of contacts | What number of contacts will occur in the activity setting – i.e. how many people will be present in one setting at the same time? As a result of mass-gathering events public health orders, a large group may place the event in the high risk category.
Location and type of in-person interaction | What is the status of COVID-19 at the location of the research? What public health directives are in place? Please indicate if the status is unclear or incomplete and describe who has been consulted in the relevant jurisdiction. If confirmation is not available at the time of submission, the REB may decide to provide conditional approval only until confirmation can be received.
Travel and Accommodation | Does the research involve travel by participants or researchers?
Important: Consult the “Faculty and Staff” section of the University COVID-19 website to see if travel is permitted.
If the research team is travelling internationally, are they required to self-isolate on arrival? Have you obtained the appropriate institutional approvals for international travel?
Is travel to smaller or more remote communities required? If so, what health services are in place and would they have the capacity to handle a COVID occurrence? If you are unable to determine the health infrastructure, and are unable to find an alternate location for conducting the research, you are advised to delay submitting your ethics application until reliable information can be provided by the community.
Step 3 - Complete the Safe Research Plan Form
Considerations for completing the Safe Research Plan Form
- What limits have been placed on the number of people at a site or gathering at one time?
- What limits have been placed on the number and length of required in-person gatherings?
- Will gatherings be held outdoors or in a virtual format?
- What arrangements will be made in the space where gatherings are held to facilitate physical distancing requirements? For example: using furniture or other barriers; managing occupancy levels for bathrooms, COVID-related direction signage, sanitation, etc.
- What are the requirements for PPE, e.g., masks, face shields etc.?
2. Research Involving Indigenous Communities
Researchers will need confirmation from the community that it has the capacity to accept research activity (notwithstanding any agreements drafted pre-COVID). In addition to completing the Safe Research Plan, please also provide confirmation from an official community representative that the community agrees to this research moving forward during this time.
Before attempting to engage, verify whether the indigenous community has issued any guidance regarding their key contacts, capacity, and operations during COVID-19. These may be found on individual community websites, including on social media sites such as Facebook.
Coordinate with any other researchers known to be involved in the community to avoid duplicating outreach.
Use of Technology
To the extent that you are able to reach your contacts in indigenous communities, you should work with them to determine whether the indigenous community has the capacity to engage and their preferred method of engagement.
Although such engagement could be facilitated through video-conferencing and virtual town halls, communities or individuals within a community may not have the means (such as robust wifi) to connect. Familiarize yourself with any limitations in the community prior to engagement.
- Work with the local community to determine whether shared access to computer technology is available for those who may not have access in their homes, while ensuring that a protocol for maintaining public health guidelines (physical distancing and disinfecting for shared IT equipment) can be implemented.
- Discuss with the community, how to maintain regular yet respectful contact.
- Consider the extent to which you and your team may be able to support Indigenous (or remote) communities by providing surplus medical supplies, protective equipment, and other resources as part of a commitment to reciprocity.
3. Research Activities (e.g. interviews, testing)
Describe safety precautions being used if one-to-one sessions will be conducted in person:
- If interviews are held in public spaces, how will you maintain physical distancing while at the same time ensuring privacy of conversations?
- Will non-medical masks be used by the researcher and participant? If yes, consider how their use may alter the ability to understand one another, or muffle a recording. If using masks, the researcher should have a sufficient supply on hand and they should be provided by the researcher in cases where the participants don’t have their own.
- If recruitment is taking place in person, how will this be managed? Consider the perceptions of potential participants to being approached.
- How will interview schedules be maintained to ensure space between participants? Fewer interviews per time period may be necessary in order to allow time to disinfect surfaces between participants.
- The researcher should provide basics like hand sanitizer for participants.
- Washroom facilities must be available where interviews are held.
Example of good process
- an appropriate office space is available to conduct activities that allows for physical distancing of 2 metres;
- sessions will not involve more than X people at a time (indicate who is present);
- session times will be spaced at least 30 minutes apart to ensure that there is no overcrowding;
- Interviewers and participants will use hand sanitizer as they enter the room, and before leaving the room once the interview is complete;
- Consent form will be emailed to participants ahead of time, and verbal consent obtained at the time of the interview;
- gift card/cash will be sanitized and placed on the table, so the participant can pick it up at the end of the interview;
- surfaces will be sanitized between each participant;
- The PIs/Researchers will monitor with frequent check-ins that the research staff have not encountered any issues or reluctance from participants to adhere to COVID guidelines
- Information related to appropriate use of non-medical mask and facial covering.
4. Travel and Accommodation
Describe how required travel will be managed.
- Limit the amount and duration of required travel whenever feasible.
- Researchers who have travelled internationally must self-isolate upon return.
- Researchers may need to self-isolate when they arrive at the site
- Many remote and Indigenous communities also require that outsiders undergo self-isolation before engaging with the community population. Researchers should ensure that they have the resources to abide by community requirements.
- If explicit guidelines are not in place, voluntary self-isolation prior to entering a remote area for the protection of the community under study is recommended.
- Limit the number of people travelling together in vehicles, ideally having only one person per vehicle or two, if 2-meter physical distance can be maintained.
- Reduce or eliminate the need for utilizing public transit for participants and researchers.
- Provide for separate accommodation if overnight stays are required.
5. Surface Transmission and Personal Protective Equipment
Describe how the risk of COVID-19 transmission will be mitigated in your research setting
- Be aware of infection prevention and control protocols implemented for the location where the research is being conducted, e.g. washrooms, elevators, doorknobs, etc.
- Follow the cleaning protocol provided by the facility.
- Consider whether cleaning supplies will be available.
- Develop personal hygiene rules e.g. washing hands or utilizing hand sanitizer at frequent intervals.
- Limit as much as feasible, shared equipment, material, tool, and hard copy documents.
- Have disinfectant supplies and strategies in place for hard surfaces (equipment includes pens, computers, tablets)
Information regarding the use of masks
A mask should securely cover the nose, mouth and chin, and be in contact with the surrounding face without gapping and can filter respiratory droplets.
When buying or making a mask you should look for a mask that has:
- Two or three layers of tightly woven, but breathable, cloth such as cotton, flannel or quilting cotton
- A secure fitting to cover the nose, mouth, and chin. Should be in contact with the face without gapping
- No seams over the mouth and nose through which air may leak
- Horizontal pleats to help fit a variety of faces (pleats face downward when wearing)
- Re-usable fabric that can be washed after use or when damp and dirty
6. Research Team and Participant Safety
Confirm that research team members have completed the mandatory online training “Preventing COVID-19 Infection in the Workplace” (https://web47.uottawa.ca/en/lrs/node/36073) and describe how your research team will interact to ensure safety, including as appropriate:
- Team composition: e.g. using the concept of work teams to limit the number of people who will be interacting with one another.
- Steps that will be taken if a project team member or participant becomes sick or develops symptoms.
- Contingency plans for returning home or accessing care locally for research team members who experience worsening symptoms.
- Prepare a self-isolation plan in advance in case team members become symptomatic while travelling.
- Will other team members be available to cover illness or provide support to a team member needing to isolate?
- What regular check-ins with team members will occur for the duration of the project?
- Self-assessment questions asked of both participants and researchers prior to in-person contact. Some suggested questions are:
- Do you have any of the following new or worsening symptoms or signs?
- new or worsening cough
- shortness of breath, sore throat, runny nose or nasal congestion, hoarse voice, difficulty swallowing
- new smell or taste disorders
- nausea, vomiting, diarrhea, abdominal pain
- unexplained fatigue
- chills or headache
- Have you travelled outside Canada (or insert the country where research is being conducted) or had close contact with anyone who has travelled outside Canada (or insert country where research is being conducted) in the past 14 days?
- Do you have a fever?
- Have you had close contact with anyone with respiratory illness or a confirmed or probable case of COVID-19?
- Do you have any of the following new or worsening symptoms or signs?
Describe what communication plans are in place for posting or disseminating your Safe Research Plan requirements
- Note that contact information for participants must be retained for at least 14 days following each individual person-to-person meeting in the event that follow up is needed. (See Consent Form Addendum).
Disseminate, Monitor and Update your Safe Research Plan
- Distribute the Safe Research Plan to the research team.
- Make the plan available as a shared document. Team members can either provide a signature or email confirmation that they have read and understood the contents of the plan.
- Inform the REB of any required changes or protocol deviations.
Step 4 - Monitor and amend as needed
- Keep checking local requirements
- Have a plan in place to stop research if required by public health requirements at the site.
- Inform the faculty if there are major changes to your plan that they may need to be aware of.
- Submit adverse events to the REB if these relate directly to participation in the research.
Please note that a Word version of the Safe Research Plan and the uOttawa Consent Information Addendum forms can be requested to the Office of the Vice-Dean, Research of your faculty.