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Hello McMaster Researchers,

This FAQ contains important information about MREB research ethics review procedures and requirements during the disruption caused by COVID-19. The first set of questions refer to the ethics review process, while the second set of questions provide direction on ethical considerations for conducting research remotely during COVID-19. This FAQ provides some guidance on the use of online video conferencing for data collection, and additional guidance, in conjunction with IT Security and the Office of the VP Research, is available at https://research.mcmaster.ca/videoconferencing/.

For updated information on McMaster University’s response to COVID-19 visit https://covid19.mcmaster.ca/. Please contact the MREB Secretariat (Ethics Office) with any questions about ethics review during this disruption: ethicsoffice@mcmaster.ca.

Questions

Ethics Review Process

Ethical Considerations for Remote Research

Ethics Review Process

Q. Is MREB operating as usual?

A. The MREB Ethics Office on campus is closed and in-person support will not be provided. The ethics office staff are working remotely and will continue to respond to your questions by email and are able to meet with you by phone. Review of new applications and other forms will continue as usual.

Q. What are the MREB requirements for approving Phase 2 on-campus research with human participants?

A. The first step is to ensure you are familiar with the University guidelines for Phase 2 of on-campus research activity, especially the safety requirements for human participant research. Once you have read and understood the guidelines, follow the instructions below for MREB approval.

  1. Approval for the on-campus research from your Associate Dean (Research) is required before you can submit a new application or amendment to MREB. To seek approval, your Research Activity Plan should be submitted through this portal. This approval is required both for new studies and for the resumption of in-person research that was paused due to the COVID-19 restrictions. Please add a statement to the new application (in Q. 11.1) or the amendment (in Q. 1.12) confirming that you have received approval from your Associate Dean (Research) for your Research Activity Plan to include human participants.
  1. Both new applications and amendments should include the standard COVID-19 Letter of Information for on-campus research, which will accompany the regular Letter of Information for your study. Most of the language is standard, but there are a few places, highlighted in grey, that you will need to revise based on your study information. For most studies, you will not need to include COVID-19 specific information in your regular Letter of Information as it should be covered in the COVID-19 specific letter. Participants should have access to the Letters of Information as early as possible in the recruitment process (e.g. attached to recruitment email, via link in social media posting).
  1. When submitting a new application or amendment for on-campus research, you will need to account for some COVID-19 specific procedures within your application form. See the FAQs below for specific guidance on including COVID-19 details in a new application or amendment.
  1. An amendment should be submitted for a study that is;
    1. Adding in-person procedures to an approved protocol that currently only has remote participation.
    2. Activating in-person procedures that were approved by MREB with the condition that they would not begin until University restrictions on human participant research were lifted.
    3. Resuming in-person procedures that were suspended due to the University restrictions on human participant research.

Q. What COVID-19 specific details need to be included in a new application for on-campus research with human participants?

The following items are generally required for new applications (numbering refers to specific questions in the standard MREB application form).

  • 9.2 – a statement that the participant exclusion criteria listed in the COVID-19 Letter of Information (LOI) will apply to the study while COVID-19 procedures remain in place.
  • 11.1 – if certain procedures will need to be temporarily adjusted due to COVID-19 precautions, then this adjustment should be outlined (e.g. a certain procedure will not run during COVID-19, less trials of a certain procedure to minimize time in the lab during COVID-19, one researcher assisting with the procedure instead of the usual two, etc.). This assumes the standard, “non COVID-19”, procedures are being outlined, along with the temporary adjustments, and is more likely for long-term studies expected to continue after COVID-19 precautions are lifted. Note: it is not necessary to outline standard COVID-19 safety precautions that are included in the COVID-19 LOI (e.g. wearing masks, taking COVID-19 assessment, etc.).
  • 14.1 – this should be checked “yes” and the risk of COVID-19 discussed in Q. 14.2, as the Panel on Research Ethics has issued an interpretation that increased chance of contracting COVID-19 through research participation is a research attributable risk. For most studies, discussion of the mitigation of the risk can simply refer to the COVID-19 LOI, which lists the COVID-19 risks and safety measures. Studies where social distancing is not possible (Category 4), should include a discussion of additional precautions related to mitigating risk from direct/closer contact with participants.
  • 15.1 – this should be checked “yes” and sub-questions should include the details on keeping participant contact information for COVID-19 contact tracing purposes, per the COVID-19 LOI. This section may be covering other administrative purposes for collecting personal information and should be clear on any differences in storing the personal information. Q. 15.4 should state that contact information kept for contact tracing will be destroyed as soon as permitted by public health, per the COVID-19 LOI.
  • 16.1 – along with the consent process for the study itself, the consent process using the COVID-19 LOI should be covered. This should include the participants receiving the COVID-19 LOI prior to coming on-campus. The COVID-19 LOI should be uploaded to the application in Section 16 (there are a few parts of the COVID-19 LOI, highlighted in grey, that need to be tailored to your study). If participants are children then the COVID-19 LOI can be modified to include a signature section for the parent/guardian (generally, participants age 16 and 17 can provide their own consent for the COVID-19 LOI). Note: For most studies, the regular LOI will not need to cover COVID-19 specific information as those details are in the COVID-19 LOI.

Q. What COVID-19 specific details need to be included in an Amendment to an approved application to (re)start on-campus research with human participants?

The following items are generally required for amendments to existing applications to start on-campus research with COVID-19 precautions (numbering refers to specific questions in the Amendment form). The guidance below is for COVID-19 specific changes. If you are also changing the study from remote data collection to on-campus, then other changes related to that transition would need to be covered in the amendment as well.

  • 3.3 – a statement that the participant exclusion criteria listed in your COVID-19 Letter of Information (LOI) will apply to the study while COVID-19 procedures remain in place. To access 3.3, select “yes” to 1.8 and select “participants” in 3.1.
  • 3.7 – if certain procedures approved in the original application will need to be temporarily adjusted due to COVID-19 precautions, then this adjustment should be outlined (e.g. a certain procedure will not run during COVID-19, less trials of a certain procedure to minimize time in the lab during COVID-19, one researcher assisting with the procedure instead of the usual two, etc.). Note: it is not necessary to outline standard COVID-19 safety precautions that are included in the COVID-19 LOI (e.g. wearing masks, taking COVID-19 assessment, etc.). To access 3.7, select “yes” to 1.8 and select “methods to collect data” in 3.1.
  • 4.2 – the risk of contracting COVID-19 should be discussed, as the Panel on Research Ethics has issued an interpretation that increased chance of contracting COVID-19 through research participation is a research attributable risk. For most studies, discussion of the mitigation of the risk can simply refer to the COVID-19 LOI, which lists the COVID-19 risks and safety measures. Studies where social distancing is not possible (Category 4), should include a discussion of additional precautions related to mitigating risk from direct/closer contact with participants. To access 4.2, select “yes’ to 1.9 and select “physical risks” in 4.1.
  • 5.2 – this should include the details on keeping participant contact information for COVID-19 contact tracing purposes, per the COVID-19 LOI. If the original application did not collect any personal information for administrative purposes, then information on storage and security of contact information will need to be covered in detail in the amendment. If information kept for contact tracing will be handled differently than other information kept for administration of the study (e.g. for scheduling), then those details should be covered in 5.2. To access 5.2, select “yes” to 1.11 and select the first option in 5.1.
  • 6.2 – the additional consent process using the COVID-19 LOI should be discussed. This should include the participants receiving the COVID-19 LOI prior to coming on-campus. To access 6.1, select “yes” to 1.10 and select “informed consent process” in 6.1. Note: The COVID-19 LOI should be uploaded to the Amendment in Section 6, select “yes” to 6.6 (there are a few parts of the COVID-19 LOI, highlighted in grey, that need to be tailored to your study COVID-19). If participants are children then the COVID-19 LOI can be modified to include a signature section for the parent/guardian (generally, participants age 16 and 17 can provide their own consent for the COVID-19 LOI).
  • For most studies, the regular LOI will not need to cover COVID-19 specific information as those details are in the COVID-19 LOI. However, if the addition of COVID-19 precautions requires a change to the originally approved LOI, then a revised LOI can be uploaded to the Amendment form as well. For example, changing the data collection procedures to reduce COVID-19 risk (e.g. removing a procedure) results in the description of procedures in the originally approved LOI being inaccurate. Additionally, if the amendment is to transition from a remote study to an in-person study on-campus, or add an in-person option, then substantial changes to the original LOI or an additional LOI for in-person would be required.

Q. Is in-person research in the community/off-campus allowed in Phase 2?

A. The extraordinary ranges of the nature of fieldwork –  the environmental and societal conditions under which fieldwork takes place, and the temporal and spatial variance in COVID-infection rates or lack of information on such rates – make it extremely difficult to provide overarching guidance that ensures the safety of research personnel and human participants. Because of this, Phase 1 did not allow for “face-to-face” interactions with human participants.

Recognizing that some fieldwork involving human participants may be of direct and immediate importance to society as the pandemic continues, Phase 2 will allow for some exemptions. The VPR will consider special requests for fieldwork that clearly demonstrate the benefits to human health and well-being. See the University guidelines for Phase 2 of fieldwork activity for further details. Please add a statement to your new ethics application (in Q. 11.1) or your amendment (in Q. 1.12) confirming that you have received approval from the Vice-President (Research) for an exemption to conduct fieldwork involving in-person contact with human research participant.

Q. What if I need to change in-person study procedures to remote procedures due to COVID-19 and/or social distancing requirements?

A. Even with the University phasing in some in-person research, most human participant research that can be conducted remotely will be required to use remote data collection. Adjusting your study to remote procedures may also affect other parts of your approved protocol, such as how team members are accessing study data. Should you need to change your recruitment, data collection, informed consent, data security, or other study procedures, please submit an Amendment form for review. The change must be reviewed by MREB before implementation (TCPS2, Art. 6.16). The MREB Chairs will prioritize review of amendments for studies requiring changes due to COVID-19.

Examples of changes that could require an Amendment include:

  • Poster or in-person recruitment to email/social media recruitment
  • In-person interviews to telephone or online interviews
  • In-person/lab-based studies to online studies
  • Focus groups held in person to an online or teleconference format
  • Written Consent to Oral Consent documented on an Oral Consent Log
  • Changes to incentives or how they will be given to participants

If you need to make changes to a recently submitted application that is still in the review process, please send an email to ethicsoffice@mcmaster.ca and we can advise you on how to proceed depending on where it is in the process.

Q. What if I am only changing the study dates due to COVID-19 or making a similar minor administrative change?

A. If you are only delaying your study or making another minor change that does not substantively change the protocol or documents, then you could submit a For Information Only form instead of an Amendment form. This form is used to update the file with new information that does not require REB review. If you are unsure if your change can be submitted via a For Information Only form, please contact the Ethics Office at ethicsoffice@mcmaster.ca.

Q. What if I need to modify the study procedures immediately in order to protect participants from COVID-19 transmission?

A. The TCPS2 does allow an exception where a change is necessary to eliminate an immediate risk to participants and there is no time for an amendment review (TCPS2, Art. 6.15). Such changes may be implemented but must be reported to the REB at the earliest opportunity (ideally within 5 business days). To report this type of protocol deviation to MREB, use the Reportable Event form (a sub-form within MacREM, accessed the same way as an Amendment or Annual Report).

Q. What if I have COVID-19 related research that is time sensitive and requires MREB approval?

A. Please contact ethicsoffice@mcmaster.ca at the time of submission to inform us of the need for a prioritized review. The Ethics Office staff will make every effort to find reviewers who can do a timely review of the protocol and the MREB Chairs will prioritize the application when providing MREB feedback.

Q. Are there any other actions I should take due to COVID-19 and the social distancing guidelines?

A. Please continue to monitor the University’s COVID-19 site, McMaster’s Daily News and the University’s Research & Innovation site for the most current directives.

Ethical Considerations for Remote Research

Q. How should I handle recruitment of participants during the COVID-19 restrictions?

A. Use forms of recruitment that can be accessed from a distance, e.g. online posters, social media, email and telephone. In the ethics application, be prepared to describe how you will gain access to email addresses and phone numbers.

Q. I was planning on giving participants their incentive in person, what should I do now?

A. As giving incentives in person is not an option for research conducted remotely, consider other ways to provide incentives while trying to minimize the amount of identifiable information being collected. The best options are sending electronic gift cards or e-transfer of money. Mail is another option but requires the collection and storage of full mailing address and in some studies with high social risk would not be recommended (e.g. the incentive arriving in the mail could alert someone else in the household that the participant was in the study).

Q. If I cannot get in-person written consent, how should consent be obtained and documented?

A. Written consent is not recommended for conducting research remotely. Asking participants to print, sign, scan and email back signed consent forms is not only not possible for all participants but adds to participant burden. If signed consent is essential for your project then there could be alternatives such as using mail, e-signatures, or having the participant take a photo of the signed consent form (if printer, but no scanner). However, the recommended alternative is an oral consent process, which is easier for both participants and the researcher.

For oral consent, whenever possible, send a Letter of Information (signature lines removed) ahead of the interview or focus group, and follow up to obtain consent using an Oral Consent Script and document consent on an Oral Consent Log. Use of an Oral Consent Script assumes the participant has had the opportunity to read through the Letter of Information. It allows the researcher to cover the key ethics information at the time of oral consent without having to read the full Letter of Information aloud. In some study contexts or with specific participant groups, working through the full Letter of Information as part of the oral consent process may be preferable to ensure informed consent.

Online surveys or experiments, where the participant follows a link to the Letter of Information/Consent Preamble and the survey/experiment, should continue to obtain consent as before, with participants selecting a “yes” consent button to continue to the data collection or a “no” button to leave the study.

Q. What are the recommended practices for recording online interviews and focus groups?

A. Moving from in-person interviews and focus groups to phone or online may seem like an easy transition, however, there are several things to consider when completing the ethics application.

  • Making the Recording: The most secure way to audio record interviews/focus groups is to record to your computer or device using a recording application that directly records the audio to your hard drive. Another option is to record through the online meeting platform (e.g. Zoom) directly to your computer. For the latter option, you will need to confirm that the platform you are using can record directly to your computer as opposed to the platform’s server or to a cloud service.  As soon as the interview/focus group is finished, the audio file should be saved to a password protected storage device, e.g. computer, external hard drive, and encrypted.  This data security information should be included in the Letter of Information.  A clear consent statement needs to be included on the Oral Consent Script if audio recording.
  • Video Recording: Online platforms make it easy to video record a meeting. Video recording should not be used unless it is essential for your research methodology and clearly justified. If you do need a video recording, then this needs to be stated in the Letter of Information and a clear consent statement needs to be included on the Oral Consent Script. Most interviews will not need video recording and in those cases both the Letter of Information and the Oral Consent Script should reassure participants that the interview/focus group will be audio recorded only and not video recorded.
  • Attendance: Consider whether participants can choose to join the interview/focus group by audio only, given not all participants may have access to video and there may be limitations to the location from which a participant can join during this time of social distancing. Additionally, in a focus group setting, audio only increases the confidentiality of participation. If audio only is not an option, this should be clear in the Recruitment and the Consent materials.

Q. What steps do I need to take to protect participant confidentiality and data when conducting phone and online interviews/focus groups?

A. The following should be considered and addressed in your ethics application if applicable.

  • High-Risk Studies: If you will be collecting highly sensitive data and/or there is a significant social risk for participants if their data was disclosed or it was known they participated in your study, please contact ethicsoffice@mcmaster.ca for advice on how to proceed. Most of the available online services or a standard phone connection are appropriate for low- to moderate-risk studies, but higher risk studies may need a more secure option.
  • Participant Recording of Focus Groups: Any participant could covertly record an in-person focus group if they were so inclined. However, it is even easier to make a good recording of an online focus group without other participants or the researcher knowing, and it could include video. In the section of the Focus Group Guide where you discuss confidentiality with participants, include a statement requesting participants not record the session. Additionally, this risk to participant privacy should be clearly stated in the Letter of Information along with a reminder that researchers cannot guarantee that all participants will refrain from recording the session. For more sensitive data, one-on-one interviews may be preferable to a focus group.
  • Recording and Storing Interviews: See the “Making the Recording” section in the answer to the question on recording online interviews (above).
  • Privacy Risks from Using Online Meeting/Voice Calling Platforms: No online platform is 100% secure, so participants should be given enough information to make their own decisions about participation on the selected platform. The Letter of Information should include language that makes it clear what platform(s) is being used, and that no guarantee of privacy of data can be made, so the risks of participation are clear. Here is some sample wording, “This study will use the X platform to collect data, which is an externally hosted cloud-based service. A link to their privacy policy is available here (LINK). Please note that whilst this service is approved for collecting data in this study by the McMaster Research Ethics Board, there is a small risk with any platform such as this of data that is collected on external servers falling outside the control of the research team. If you are concerned about this, we would be happy to make alternative arrangements for you to participate, perhaps via telephone. Please talk to the researcher if you have any concerns.” Note: Including the link to the privacy policy is not necessary when using one of the McMaster licensed videoconferencing platforms (Webex, MS Teams, or Zoom) for low risk research. Additionally, only include the sentence on alternative arrangements if they are possible in your study.
  • Keeping Focus Group and Interview Sessions Private: Before using online platforms for interviews or focus groups, researchers should become familiar with the settings and invitation options and take steps to prevent unauthorized persons from accessing the session (e.g. “Zoom bombing”). Most of the time, unauthorized access is due to the meeting link being made public, which should be less of an issue for research as the link should only be shared privately with participants. But participants could accidentally disclose the link, and therefore researchers should be aware of other options to prevent access (e.g. two-factor authentication) and to address the situation if someone gains access to a focus group (e.g. have screen sharing turned off, know how to remove someone, etc.). For those using Zoom, there is a guide to preventing unauthorized access posted by the company.

Additional guidance is available at https://research.mcmaster.ca/videoconferencing/.

Q. Does McMaster University have any official guidance on the use of online meeting/voice calling platforms?

A. Currently, Information Technology has posted a guide to best practices for privacy and security when using Zoom video conferencing. There is also a guide to creating a secure work-from-home environment, which could be useful for researchers having to switch to handling data at home that they would normally only work with on campus. Additional MREB guidance, in conjunction with IT Security and the Office of the VP Research, is available at https://research.mcmaster.ca/videoconferencing/.

Please contact the MREB Ethics Office if you have any questions about the above or have a question not covered in this FAQ – ethicsoffice@mcmaster.ca.