NOTE: Effective May 12, 2022, the V/ADR approval process is no longer required for in-person human participant research. The COVID LOI is still required, but an updated version has been released. Please see the update from the Vice-President, Research for full details.

 

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/home/support-for-researchers/ethics/mcmaster-research-ethics-board-mreb/video-conferencing/.

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

Answers

Ethics Review Process

Is MREB operating as usual?

The Research Office (ROADS), which includes the MREB support staff, is providing service as usual and has in-person support available 10 am to 3:30 pm, Monday through Thursday. Normally, one of the ethics staff will be in the office during these times, but it is best to make an appointment if you require an in-person meeting. The ethics office staff continue to work remotely as well and will respond to your questions by email and are able to meet with you via videoconference or phone. MREB review of new applications and other forms will continue as usual.

What are the University and MREB requirements for approving in-person research with human participants?

The first step is to ensure you are familiar with the COVID-19 related University requirements for on-campus or fieldwork/off-campus in-person research with human participants. Once you have read and understood the requirements, follow the instructions below for MREB approval. Here are the links for on-campus research requirements and fieldwork/off-campus research requirements.

1. For on-campus research, study procedures must include the EOHSS recommended precautions for COVID-19. These precautions are already included in the standard language of the COVID-19 LOI (see #2 below). For fieldwork/off-campus research, the study procedures must follow any COVID-19 precautions required or recommended by the local health authority and should include the EOHSS recommended precautions as well. For both study settings, it is understood that some study procedures may require (momentarily) suspension of a precaution (e.g., not keeping physical distance while affixing sensors to a participant). These exceptions should be covered in the COVID-19 LOI. Researchers should consult EOHSS for advice on precautions for unique situations related to COVID-19 (e.g., procedures that may increase risk of transmission, a participant population more vulnerable to COVID-19, etc.). MREB may also consult EOHSS during the ethics review if additional advice on reducing COVID-19 risks is required.
2. Both new applications and amendments should include the standard COVID-19 Letter of Information (the updated on-campus version or the fieldwork/off-campus version), 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 details. For most studies, you will not need to include COVID-19 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) and at least prior to attending the in-person session.
3. When submitting a new application or amendment form that includes in-person 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. For fieldwork research, you may need to make some adjustments to account for the specific study context, based on the current COVID-19 situation at the study location and local health authority requirements.
4. 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 the researcher was waiting until restrictions were lifted and/or there was no longer the additional University approval process. This applies to studies where the original clearance does not already include COVID-19 precautions or the COVID-19 LOI.
   3. Resuming in-person procedures that were suspended due to the University restrictions and/or researcher/participant concerns about COVID-19. This applies to studies where the original clearance does not already include COVID-19 precautions or the COVID-19 LOI.

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

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

• 11.1 – Most studies will not need to include details on COVID-19 precautions here, as COVID precautions will be covered in other sections. However, 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.
• 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 with higher risks of transmission, the involvement of COVID-19 vulnerable populations, or taking place in jurisdictions with unique COVID-19 restrictions/requirements, should include additional discussion of the risks and mitigations.
• 15.1 – If the local health authority where you are conducting the study requires collecting participant contact information for COVID-19 contact tracing, then 15.1 should be checked “yes” and sub-questions should include the details on keeping participant information for contact tracing purposes. This section may be covering other administrative purposes for collecting personal information (e.g., booking appointments) and should be clear on any differences in storing the personal information for these purposes versus storing for contact tracing. Q. 15.4 should state that contact information kept for contact tracing will be destroyed as soon as permitted by the local health authority. If contact tracing is required, then the section on collecting personal information in the COVID LOI should be kept and revised per the specific study details.Note: For on-campus research, there is currently no requirement to collect participant information for contact tracing. So, the above details do not need to be included for on-campus studies.
• 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 attending the study sessions (where logistically possible). 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). Please ensure that you use the correct COVID-19 LOI, there is one for on-campus studies, and one for off-campus/fieldwork studies. 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.

What COVID-19 specific details need to be included in an amendment to an approved application to (re)start in-person research with human participants?

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

• 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 with higher risks of transmission, the involvement of COVID-19 vulnerable populations, or taking place in jurisdictions with unique COVID-19 restrictions/requirements, should include additional discussion of the risks and mitigations. To access 4.2, select “yes’ to 1.9 and select “physical risks” in 4.1.
• 5.2 – If the local health authority where you are conducting the study requires collecting participant contact information for COVID-19 contact tracing, then 5.2 should include the details on keeping participant information for contact tracing purposes. This section may be covering other changes with regard to collecting personal information for administrative purposes (e.g., booking study appointments) and should be clear on any differences in storing the personal information for these purposes versus storing for contact tracing. The description should state that contact information kept for contact tracing will be destroyed as soon as permitted by the local health authority. If contact tracing is required, then the section on collecting personal information in the COVID LOI should be kept and revised per the specific study details. To access 5.2, select “yes” to 1.11 and select the first option in 5.1. Note: For on-campus research, there is currently no requirement to collect participant information for contact tracing. So, the above details do not need to be included for on-campus studies.
• 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 attending the study session (where logistically possible). 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). Please ensure that you use the correct COVID-19 LOI, there is one for on-campus studies, and one for off-campus/fieldwork studies.
• 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, or add an in-person option, then substantial changes to the original LOI would be required to cover the in-person procedures.

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

Even with the University allowing in-person research, there may be specific study contexts and/or locations where it will be necessary to switch to remote data collection due to a COVID-19 outbreak, a participant population vulnerable to COVID-19, or local restrictions on in-person interaction. 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.

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

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.

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

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).

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

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.

Are there any other actions I should take due to COVID-19 and the University requirements and recommendations?

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.

Do I need to do anything in response to the May 12, 2022 VP-Research announcement about human participant research?

The VPR announced that there is no longer an Associate Dean – Research (ADR) approval process for in-person research. There is also a revised COVID LOI that matches the current COVID precautions at McMaster (e.g., details on the vaccine mandate have been removed). The new COVID LOI is also shorter and no longer requires participants to sign. See the VPR announcement for full details.

Below are several in-person research scenarios, please find the one that fits the current status of your project, or plans for your project, and follow the required actions. Please contact ethicsoffice@mcmaster.ca if you have any questions or require assistance in submitting a new application, an Amendment, or a For Information Only form.

1. A project with ARD approval that is currently collecting data from participants.
   • Submit the updated COVID LOI, edited for your study, via a For Information Only form (use either the on-campus or fieldwork version, as applicable). The ethics office will be working to approve the FIO submissions of the revised COVID LOI as quickly as possible.
   • Collection of participants’ contact information for COVID contact tracing is no longer being done for on-campus research. The on-campus COVID LOI no longer has this requirement. For fieldwork, whether you need to collect contact information is still dependent on the requirements of the local health authority at the study location.
   • If you want to propose to change the ADR approved COVID precautions in your procedures (given the new recommendations from EOHSS, listed in the new COVID LOI), then submit an Amendment to MREB for review. Otherwise, continue to follow the ADR approved precautions for your study. With the current pause of the vaccine mandate and MacCheck, it is understood that participants will not follow these procedures, as covered in the old COVID LOI, at this time.
   • If you have any participants scheduled for an appointment in the next few days and they received the old COVID LOI, and you do not have the updated COVID LOI completed, approved and sent to the participant by the time of the appointment, please contact the participant and let them know of the changes to their requirements for attending the study regarding MacCheck and the vaccine mandate
2. A project with ADR approval that has completed data collection.
   • If you have completed data collection from participants then there is no need to revise your application or COVID LOI
   • If you decide to recruit another cohort of participants then you will need to follow the actions required in #1 above.
3. A project that received ethics clearance before COVID, did not obtain ADR approval, and has put the in-person research on hold while waiting for COVID conditions and/or University requirements to change.
   • If you now want to resume the in-person research, follow the directions in the MREB COVID FAQ for submitting an Amendment to add the COVID related details.
   • Also read the section in the FAQ on the general COVID related requirements for in-person research.
4. A project that received ethics clearance during COVID, did not obtain ADR approval, but included an in-person component that was being put on hold while waiting for University requirements to change (or for another COVID related reason).
   • If you now want to start the in-person research option/component, follow the directions in the MREB COVID FAQ for submitting an Amendment to add the COVID related details.
   • Also read the section in the FAQ on the general COVID related requirements for in-person research.
5. A project that currently only has a remote data collection procedure, but there are plans to add an in-person data collection option (or switch entirely to in-person).
   • You will need to submit an Amendment to MREB containing all the changes required to add (or switch to) in-person data collection. Such as changes to the study LOI, data security details, data collection procedures, recruitment documents, etc.
   • The Amendment will also need to include the COVID related details as covered in the MREB COVID FAQ.
   • Also read the section in the FAQ on the general COVID related requirements for in-person research.
6. An in-person project with ADR approval that is currently in the ethics review process.
   • The MREB Chair sending the review feedback will include instructions to replace the old COVID LOI with the new version and to revise other COVID related details as applicable. So, it will be addressed as part of the review and approval.
7. Plans for a new in-person research project, but no ethics application has been submitted yet.
   • Read the section in the MREB COVID FAQ on the COVID related requirements for in-person research. Including the links to the summaries of requirements for on-campus or fieldwork in-person human participant research.
   • Read the section in the MREB COVID FAQ on what COVID details need to be included in a new application.

Please do not hesitate to contact us at ethicsoffice@mcmaster.ca if you have any questions or to arrange a consultation meeting.

Ethical Considerations for Remote Research

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

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.

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).

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

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).

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

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.

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

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.

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

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.

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

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.

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.