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PROCEDURE: In-person Research with Human Participants

In-person/face-to-face research involving human participants has resumed with exceptions, subject to approved health and safety plans, current ethics and/or permit approval and applicable physical distancing requirements. However, it is advisable continue to conduct your research remotely if you are able to do so.

If your previously approved or new/proposed research involves face-to-face contact with human participants, please review the following. 

If your previously approved research (i.e. pre-COVID) involved face-to-face contact with participants and you suspended/moved to remote options previously, you will be required to apply for an amendment and provide a reason for the need to resume in person, non-invasive research involving low-risk participants. If you can continue to conduct your research remotely, we advise you to keep doing so.

NOTE: Resumption of face-to-face research involving vulnerable persons data collection methods is not permitted at this time. Invasive data collection procedures are reviewed on a case-by-case basis. Please contact ORE (ore@yorku.ca) for further information regarding the re-establishment or update of your ethics protocol.


Documents to be Submitted to Resume in Person Research:

  1. AMENDMENT FORM

The amendment application 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  • Participant withdrawal – personal information cannot be withdrawn or destroyed, as may be needed to re-contact ex-participants.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.
  1. ADDENDUM CHECKLIST: In Person Research with Human Participants
  2. A Revised INFORMED CONSENT FORM that includes COVID-19-specific consent language (see Template - COVID-19 consent language).
  3. HEALTH AND SAFETY PLAN for review by the BSO/HS Advisor

 

New research that involves face-to-face contact must provide a clear rationale for the need to conduct in person, non-invasive research involving low-risk participants.  If you can continue to conduct your research remotely, we advise you to keep doing so.

NOTE: Resumption of face-to-face research involving vulnerable persons data collection methods is not permitted at this time. Invasive data collection procedures are reviewed on a case-by-case basis. Please contact ORE (ore@yorku.ca) for further information regarding the re-establishment or update of your ethics protocol.


Documents to be Submitted to start New In-Person Research:

  1. HPRC PROTOCOL FORM

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 (see Template - COVID-19 consent language).
  • 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.

2. ADDENDUM CHECKLIST: In Person Research with Human Participants

3. HEALTH AND SAFETY PLAN for review by the BSO/HS Advisor


Please ensure that the following documents are appended to your research ethics application, for any research study involving in-person research with human participants:

  1. Protocol or Amendment Application Form
  2. Addendum Checklist: In Person Research with Human Participants
  3. An informed consent form that includes COVID-19-specific consent language (see Template - COVID-19 consent language).
  4. Health and Safety Plan

Please note approval of new or previously approved in person research is based on your confirmation that you will abide by the measures and procedures listed in your approved Health and Safety Plan for in person research. Please ensure all research team members and participants complete the YU Screen daily for COVID-19 symptoms before they conduct/participate in person research. If they answer YES to any of the questions on the questionnaire, no in person research should be conducted. Screening verification records need to be kept for 30 days.

Please also note for on campus research, in addition to the precautions above, all researchers/personnel and participants should be fully vaccinated, unless they are medically exempted, as per York U’s vaccine policy. Proof of vaccination for York community members (Staff/students/faculty) must be uploaded to the YU Screen to continue accessing York’s campuses. Guests will also be required to confirm that they have been vaccinated and be prepared to show proof while on York’s campus if requested.   

Should you have any other questions regarding resuming in person research, please email ore@yorku.ca.