(September 1, 2020) Phase 3 Resumption of In-Person Research with Human Participants:
*Note – all in-person research must be reviewed and approved by the Research Ethics Board through the Romeo Portal.
All in-person research activity with human participants was previously restricted to remote research due to COVID-19 public health directives. Remote practices are still required whenever possible; however, as the Province of Ontario enters into Phase 3, some research may be allowed to proceed with appropriate justification and health and safety plans in place.
Research that is allowed in-person is research that:
- cannot be done remotely
- follows provincial government regulations
- meets the requirements set out below
All in-person research must follow all public health guidelines for safety due to COVID-19 for both researchers and participants.
It must be noted that due to the nature of the COVID-19 pandemic, this information may be modified, replaced or superseded by other plans or provincial directives as necessary.
Re-starting Human Participant Research
The re-start process is two-fold. First, researcher(s) must provide justification as to why the study cannot proceed remotely and should be done in-person, and second, researchers must provide a Human Participant Safety Plan. The Human Participant Safety Plan details how procedures will be modified to take researcher(s) and participant(s) safety into account. These processes are included in the REB application form (for new protocols) and the REB amendment form (for existing protocols) through the Romeo Portal.
1) Justification for in-person research – a minimum of one of the following criteria must be met for in-person research to be justified:
- The research is time sensitive
- There is a pressing need for the research
- An alternative is not available or appropriate
- The research relates to COVID-19
2) A Human Participant Safety Plan for both research team members and research participants must be provided. The following items must be included:
- Daily COVID-19 screening
- Creation of a contact tracing log
- Appropriate personal protective equipment available and physical distancing measures in place
- Safe travel is available for research participants
- Advisory to research participants that additional risk due to COVID-19 may be present
- Plan for immediate cessation of research should a COVID-19 case be declared
- Plan for immediate cessation of research should the regulations of the University, District Health Unit or Province change
Any research that involves partner organizations must have approval from the partner organization. Evidence of written approval from the appropriate institutional authority must be provided to the Research Ethics Board.
Research with Indigenous Communities:
Researchers working with Indigenous Communities should seek direction from those communities about acceptable modes of contact, as well as the feasibility of in-person research at this time. The Research Ethics Board requires information about the community’s public health guidelines, and evidence of community approval through an up-to-date letter of support confirming ongoing commitment and consent to participate in the in-person research activity at this time.
Research at the Undergraduate Level:
Currently all research at the undergraduate level is reviewed by Undergraduate Research Ethics Committees (RECs) established at the Departmental level. At this time, undergraduate research is limited to remote and online human-based research, and RECs should continue to review all of these protocols. If remote/online research is not possible and MUST be carried out in person, applications for in-person research at the undergraduate level will require review by Lakehead University’s Research Ethics Board. Applications will be submitted through the Romeo Portal. The same standards of review related to COVID-19 will apply to all in-person undergraduate research projects, including the need for justification of in-person research and the provision of a Human Participant Safety Plan.
Researchers must apply first to the REB for approval through either the COVID-19 Tab in Romeo for new REB applications or the COVID-19 Tab in the Romeo Amendment Form for existing projects. Once a decision has been made, researchers will be notified by via email.
Once the research activity with human participants is approved by the Research Ethics Board, the researchers will need to obtain separately the approval of their Dean and the Vice-President, Research & Innovation for access to on-campus research laboratories/spaces and/or for domestic travel and fieldwork. The process described in the approval process below outlines steps for obtaining approvals from the REB and the University to resume research on-campus and in the field. The Dean and VPRI approval relates to, for example, the use of space, ability to travel to field site, etc.
(March 18, 2020) COVID-19 and REB Operations: The Standard Operating Procedure (SOP) for REB Review During Publicly Emergencies has been implemented in this unprecedented time. The REB has deemed the current level of impact as "moderate" and will be proceeding with new reviews, renewals, and modifications as per usual. Section 5.5 regarding expedited review of research related to COVID-19 will be enacted.
(December 9, 2019) HOLIDAY CLOSURE: The Research Ethics Board will be closed from December 24, 2019 to January 2, 2020 to coincide with the University closure for the holidays.
(May 18, 2018) Lakehead University Revised Research Integrity Policy
(December 20, 2017) Panel on Research Ethics launches participant resources.
(December 18, 2014) Launch of the revised version of the TCPS 2 (2014).
The Office of Research Services upholds the highest standards in the ethical conduct of research involving the use of humans, animals, biohazards and the environment in research, teaching, and testing services. We support the efforts of researchers through the ethics review process from the preparation of a protocol submission to continuing review of ongoing research.