Researchers’ FAQs

Research Ethics Submissions – Research Involving Human Participants

Note: ALL other research ethics applications, please contact Alison Collins-Mrakas at acollins@yorku.ca for information.

IMPORTANT UPDATE – FACE TO FACE RESEARCH – MEMO November 30th, 2020

Dear York Researchers: 

As indicated in the President’s November 22nd communication, anyone approved to be on campus for research, continues to be approved until further notice for any time-sensitive activities that cannot be postponed. Several researchers have asked for clarification as to whether research involving human participants can also continue. Please note the following: 

By order of the Government of Ontario, the City of Toronto and Peel Region entered the Grey Zone (lockdown) as of 12:01 am November 23, 2020.  This order is in effect for a minimum of 28 days. This announcement impacts research in the following ways:  

1. Face to Face/In-Person Research with Human Participants: 

a) Face to Face/In-Person Research with Human Participants when York’s Research Ethics Board (i.e., York University Human Participants Review Committee (HPRC)) is the primary Ethics Board of Record: 

Face to Face Research 

All face-to-face (in-person) research involving human participants in the City of Toronto and Peel Region, that is not COVID-19-related,must stop, until further notice. This includes all in-person recruitment of human participants; in-person data collection involving human participants for all on-going approved research both on campus and off campus; as well as studies involving human participants that have recently received HPRC approval.  

Online and Virtual Research  

Online and Virtual Research may continue as usual.   

Researchers currently in other regions or countries conducting already approved field research, may continue if the approved research cannot be delayed, as long as the regions are not under a pandemic advisory that disallows face to face/in-person research and they follow all applicable local public health directives and safety measures. Should the situation in other regions/countries change and local public health directives no longer permit or allow face to face research, you must suspend your research and notify ORE immediately. 

If you have any questions/concerns regarding safety while conducting research, please contact Alison Collins-Mrakas, Sr. Policy Advisor ORE at: acollins@yorku.ca. 

b)  Face to Face/In-Person Research with Human Participants when York’s Research Ethics Board is not the primary Ethics Board of Record:   

In the scenario of Face to Face/In-Person Research with Human Participants where York’s Research Ethics Board (i.e., York University Human Participants Review Committee (HPRC)) is not the primary ethics board of record (such as a hospital Board of Record) and research is already approved: Researchers may continue so long as they follow all applicable local public health directives (e.g., regional pandemic restrictions) and all prescribed safety measures.   

In addition, they must have provided Alison Collins-Mrakas, Sr. Policy Advisor ORE at: acollins@yorku.ca. with a confirmation from the primary research ethics board of record that their research can continue at this time in the pandemic.   

It is highly recommended that research and associated research staff from provincially designated Grey Zone regions (currently City of Toronto and Peel Region) should not travel at this time to other regions or countries to conduct field research activities without a risk assessment being conducted by researchers prior to travel.  Please note that Health, Safety and Employee Well-Being (HSEWB) should be involved in this risk assessment.  

Please contactJay Majithia (Health and Safety Advisor / Biosafety Officer; jmajithi@yorku.ca) and Steve Matterson (Director, Risk Management Services; stevem1@yorku.ca) for further information and guidance.  

c)  Starting New Face to Face/In-Person Research with Human Participants when York’s Research Ethics Board is the primary Ethics Board of Record:   

Due to the current pandemic lockdown of City of Toronto and Peel Region, no new face to face/in-person research with human participants where York University Human Participants Review Committee is the primary ethics board of record will be approved. Should you have any questions, please contact Alison Collins-Mrakas, Sr. Policy Advisor ORE at: acollins@yorku.ca 

2. Research that does not involve human participants: 

For all approved on-campus research that does not involve human participants, researchers may continue for any time-sensitive activities that cannot be postponed. They must continue to follow their approved health and safety plan and all public health measures already in place and the processes currently in effect, such as scheduling of time and people in the research spaces.  As before, if researchers can work remotely, they should continue to do so. 

For those approved to be on campus, please continue to follow the University’s screening and health and safety protocols and: 

• Complete the COVID-19 screening checklist each time before you come to campus 
• Wear a face covering in shared spaces and within buildings. 
• Practice physical distancing and frequent handwashing. 
• Use hand sanitizer when handwashing is not available. 
• Avoid touching your face. 
• Disinfect high-touch surfaces. 
• Self-monitor for COVID-19 symptoms; and 
• Stay home and self-isolate if you are sick (use the self-assessment tool); are in close contact with a confirmed COVID-19 case; are COVID-19 positive; or have travelled internationally recently. 

Should you have any questions, please contact Alison Collins-Mrakas, Sr. Policy Advisor ORE at: acollins@yorku.ca 

Amir Asif, Vice-President Research & Innovation

UPDATE:  Research involving face-to-face contact with human participants

Further to the June 10, 2020 memo from the Vice-President Research & Innovation, Amir Asif. As researchers are aware, the COVID-19 pandemic has affected the standard related to minimal risk. As a consequence, research involving face-to-face contact with human participants requires additional considerations.

Previously Approved Studies

If your previously approved research (i.e. pre-COVID) involves face-to-face contact with participants, you will be required to re-apply to HPRC and provide a compelling reason for the need to resume in person, non-invasive research involving low-risk participants. (Non-invasive data collection procedures include studies where participants are asked to do simple tasks with or without instrument monitoring as per an approved HPRC protocol.) If you can continue to conduct your research remotely, we advise you to keep doing so. Changes to such research will only be considered on an exceptional case-by-case basis.

NOTE: Resumption of face-to-face research involving vulnerable persons and/or invasive data collection methods is not permitted at this time. Please contact ORE (ore@yorku.ca) for further information regarding the re-establishment or update of your ethics protocol.

If your research involves face-to-face contact with low-risk human participants using non-invasive procedures for which there are no other options, and you are seeking to renew your protocol, researchers must submit the following for review and approval:

1. Amendment form: The amendment application and revised project protocol should provide details as follows:
   • 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.
2. An informed consent form that includes COVID-19-specific consent language (see Template – COVID-19 consent language).
3. Health and Safety Plan, which includes:

• Review of Health and Safety Guidelines for Returning to Campus during the COVID-19 Pandemic
• Completion of COVID-19 Health and Safety Risk Assessment Form – Planning for Returning to Campus
• Completion Return to Campus Checklist for Labs, Research and Machine Shops
• Confirmation that all personnel have completed the Return to Campus COVID-19 Training
• Infection control SOP, which outlines:
  1. PPE requirements
  2. Precautions prior to coming onto campus/entering research location
  3. Lab/research location entry protocol
  4. Precautions specific to the study
  5. Lab/research location exit protocol
  6. Cleaning and disinfection protocols

These documents can be found on the YU Better Together website.

New Studies

New research that involves face-to-face contact must provide a compelling reason as to why there are no other options. You will be required to provide a clear rationale for the need to conduct in person, non-invasive research involving low-risk participants.  Such research will only be considered on an exceptional case-by-case basis.

NOTE: Resumption of face-to-face research involving vulnerable persons and/or invasive data collection methods is not permitted at this time. Please contact ORE (ore@yorku.ca) for further information regarding the re-establishment or update of your ethics protocol.

The new Protocol submission must include consideration of the following ethical considerations regarding COVID-19 in the following sections:

• Consent – consent documents should include language as per the template. Link to forms.
• 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.

Researchers must also append a Health and Safety Plan for review by the BSO/HS Advisor.

Health and Safety Plan, should include where applicable:

• Review of Health and Safety Guidelines for Returning to Campus during the COVID-19 Pandemic
• Completion of COVID-19 Health and Safety Risk Assessment Form – Planning for Returning to Campus
• Completion Return to Campus Checklist for Labs, Research and Machine Shops
• Confirmation that all personnel have completed the Return to Campus COVID-19 Training
• Infection control SOP, which outlines:
  1. PPE requirements
  2. Precautions prior to coming onto campus/ entering research location
  3. Lab/research location entry protocol
  4. Precautions specific to the study
  5. Lab/research location exit protocol
  6. Cleaning and disinfection protocols

These documents can be found on the YU Better Together website.

Q: Is the Office of Research Ethics and Research Ethics Board (HPRC) operational?

The Office of Research Ethics and the Research Ethics Board (HPRC) are fully operational, although working remotely. Ethics reviews are conducted virtually. Should a meeting be required to discuss an urgent matter, meetings will be held remotely via Zoom. All ORE email addresses continue to be monitored with the same frequency. However, while ORE staff will do its best to respond to all inquiries as quickly as possible, responses to inquiries and applications may be delayed somewhat.

Contacts:

• For general questions: Wendy Jokhoo ore@yorku.ca or wjokhoo@yorku.ca
• For substantive questions: Alison Collins-Mrakas acollins@yorku.ca

Both email addresses will continue to be frequently monitored throughout each work day.

Q: What has changed?

• Phones: As the office is now remote, phones will no longer be answered. To reach ORE staff, please use the contact emails noted above.
• Submit any paper-based items via email instead of campus mail or in-person drop-off. Send paper-based submissions to: ore@yorku.ca.
• Highest priority will be given to research that is time sensitive (such as COVID-19).
• Presentations – as all in-class instruction has been moved online, scheduled presentations will be postponed until further notice.
• Meeting requests: Please contact Alison Collins-Mrakas, Sr. Policy Advisor, ORE at: acollins@yorku.ca. Note if preferred or required, meetings may be conducted via zoom or telephone.

For Current or Proposed Research involving Human Participants, see the memo from the Vice-President Research & Innovation, Amir Asif, dated June 10, 2020.

Q: How do I submit my ethics protocol?

For Faculty:

Faculty members are encouraged to use the ORE online ethics review system for the submission of new protocols. The online system will continue to be monitored, and protocols processed as per usual – albeit with a moderately slower response time.

The online system may be accessed here.

Effective immediately, any paper-based application (for new protocols, renewals to and/or amendments to existing protocols) must be sent as electronic documents to ore@yorku.ca OR acollins@yorku.ca. Approvals will be issued and returned via email.

If your previously approved research (i.e. pre-COVID) involves face to face contact with participants, you will be required to re-apply to HPRC and provide a compelling reason for the need to resume in person, non-invasive research involving low risk participants. (Non-invasive data collection procedures include studies where participants are asked to do simple tasks with or without instrument monitoring as per an approved HPRC protocol.) If you can continue to conduct your research remotely, we advise you to keep doing so. Changes to such research will only be considered on an exceptional case by case basis.

NOTE: Resumption of face-to-face research involving vulnerable persons and/or invasive data collection methods is not permitted at this time. Please contact ORE (ore@yorku.ca) for further information regarding the re-establishment or update of your ethics protocol.

As additional documentation (including revised consent forms) are required, please contact the ORE (ore@yorku.ca) for further information.

For Graduate Students (Thesis- and dissertation-related research ONLY):

Students are advised to follow the direction of the Faculty of Graduate Studies (FGS) regarding the submission of research proposals and ethics protocol documents (where applicable). Information can be found at the Grad Studies website here.

Student protocols will be processed as per usual process once received in ORE.

Do NOT email your TD1, TD2 or TD4 directly to ORE. It must be processed by FGS first. Please contact gsthesis@yorku.ca for any questions.

For All Other Student Research (course related, MRPs, etc.):

Please contact your program office for submission procedures regarding research related to MRPs, Individualized research (such as undergraduate theses).

STUDENTS ARE REMINDED THAT UNSUPERVISED RESEARCH MAY NOT BE CONDUCTED and WILL NOT BE REVIEWED BY ANY ETHICS COMMITTEE.

Q: What changes to a current or ongoing study require an amendment application and approval?

August 2020

If your previously approved research (i.e. pre-COVID) involves face-to-face contact with participants, you will be required to re-apply to HPRC and provide a compelling reason for the need to resume in person, non-invasive research involving low-risk participants. (Non-invasive data collection procedures include studies where participants are asked to do simple tasks with or without instrument monitoring as per an approved HPRC protocol.) If you can continue to conduct your research remotely, we advise you to keep doing so. Changes to such research will only be considered on an exceptional case-by-case basis.

NOTE: Resumption of face-to face-research involving vulnerable persons and/or invasive data collection methods is not permitted at this time. Please contact ORE (ore@yorku.ca) for further information regarding the re-establishment or update of your ethics protocol.

As additional documentation (including revised consent form and Health and Safety Plan) are required, pleases contact the ORE (ore@yorku.ca) for further information.

Procedures

Amendment applications are NOT REQUIRED if you are halting, rescheduling or delaying research activities UNLESS those actions are at the request of the funding agency, study sponsor or other body. Researchers are required to document when studies have been halted.

Amendment applications are REQUIRED and HPRC approval must be obtained before you change study procedures (including consenting processes) for new or existing participants.

Example: You want to administer new and follow-up study questionnaires over the phone instead of in-person, or you want to change the location of in-person interviews instead of having participants come into the lab at the University.

There are some limited exceptions to the requirement for an Amendment: For all approved applications that do not specify whether a procedure is remote versus in-person, you do not need to submit an amendment.

The amendment application form is available on the ORE website here.

Please contact Alison Collins-Mrakas at acollins@yorku.ca if you have any questions.

Q: Temporary halt to participant recruitment… what do I do?

This does not need to be reported to the Office of Research Ethics unless the study hold is initiated at the request of an external funding agency if applicable or relevant.

Graduate Students are asked to inform FGS of any delay or hiatus in research. Please visit this website for more information.

Q: When participants cannot come to study locations, what should I do?

As of March 20, 2020, due to the current COVID-19 outbreak and the possible risk of exposure for in-person contact associated with research activities, study participants may not  be able to come to campus labs, offices, clinics or other study locations. Study teams should plan for this possibility and submit an amendment application for any alternatives. These might include (but are not limited to):

• Phone calls;
• Use of digital technology to interact with participants for the purposes of recording data (e.g., cell phone photos, zoom, etc); and
• Alternate study locations.

Q: Can I still interact with my research subjects?

August 2020

If your previously approved research (i.e. pre-COVID) involves face-to-face contact with participants, you will be required to re-apply to HPRC and provide a compelling reason for the need to resume in person, non-invasive research involving low-risk participants. (Non-invasive data collection procedures include studies where participants are asked to do simple tasks with or without instrument monitoring as per an approved HPRC protocol.) If you can continue to conduct your research remotely, we advise you to keep doing so. Changes to such research will only be considered on an exceptional case-by-case basis.

NOTE: Resumption of face-to-face research involving vulnerable persons and/or invasive data collection methods is not permitted at this time. Please contact ORE (ore@yorku.ca) for further information regarding the re-establishment or update of your ethics protocol.

As additional documentation (including revised consent forms and Health and Safety Plans) are required, please contact the ORE (ore@yorku.ca) for further information

June 2020

For Current or Proposed Research involving Human Participants, see the memo from the Vice-President Research & Innovation, Amir Asif, dated June 10, 2020.

March 2020

As of 11:59 pm March 27, 2020, the University campus is closed to non-essential/required/permitted personnel. Research with human participants can continue, however, due to the current COVID-19 outbreak and the possible risk of exposure for in-person contact associated with research activities, researchers should have a compelling reason why in-person interactions with participants need to occur or continue. One example might be studies where there are literally no options other than in-person interactions.

For studies where there are no options to in-person interactions, researchers are advised that they must follow current public health guidelines including but not limited to appropriate physical distancing of at least 2 metres and nose and mouth coverings, and, where necessary, full PPE during all interactions.

Q: What studies involving human participants can continue without requiring an amendment?

Approved research studies that limit participant interactions to online or remote communication, telephone contact, remote monitoring, remote data collection or secondary data analysis may continue.

Wherever possible, rather than suspending research, investigators are encouraged to modify their procedures to replace in-person study visits with remote options for questionnaires, survey, screening and consent procedures.