News and Overview - Research Involving Human Participants

  (November 25, 2020) Suspension of In-Person Research

Due to the second wave of the COVID-19 pandemic, the Research Ethics Board and the COVID-19 Advisory Review Committee (C19ARC) has suspended the application process for all requests for in-person (face-to-face) research and/or activities under the purview of the Office of the Vice-President, Research & Innovation.  The REB will continue to review new applications, renewals, and amendments involving research which can be conducted remotely.  Currently approved in-person research studies and activities have been assessed on a case by case basis, and researchers have been notified of the changing status of their protocols.

The REB and the C19ARC will revisit the decision to suspend in-person research on a frequent basis and the University community will be informed of any status changes.


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(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:

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It must be noted that due to the nature of the COVID-19 pandemic, this information may be modified, replaced or superseded by other plans or provincial directives as necessary.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

Research Partnerships:
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.


Approval Process:

Approval Process for In-Person Research

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.
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(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.

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(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. 

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(August 15, 2019) The Panel on Research Ethics releases TCPS2 (2018)
To assist with the transition to TCPS2 (2018), please see the Highlights of Changes and download your copy of the TCPS2 (2018).

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(December 20, 2017)  Panel on Research Ethics launches participant resources.

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(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.

 

Research Involving Human Participants

Lakehead University requires that all research conducted by faculty, staff, and students conform to the highest ethical standards in the use of human participants. Any research or study conducted within University facilities or undertaken by persons connected to the University, which involves human participants, must be reviewed and approved by the Lakehead University Research Ethics Board (REB).

Lakehead University is covered under Human Subjects Assurance Number FWA00012950 which is on file with the U.S. Office for Human Research Protections (OHRP).

The Research Ethics Board

The Lakehead University Research Ethics Board was established to fulfill the ethical responsibilities surrounding research involving human participants in accordance with the standards developed by the Tri-Councils [Canadian Institute of Health Research (CIHR)], Natural Sciences and Engineering Research Council (NSERC) and Social Sciences and Humanities Research Council (SSHRC) and contained in the TCPS2 (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans).

The REB is built upon the guiding core ethical principles as discussed by the TCPS2, of: respect for persons, concern for welfare, and justice. The application of these core principles is intended to maintain balance between the necessary protection of participants and the legitimate requirements of research.

REB APPLICATIONS, Renewals, Amendments, and Final Reports

You can submit an application, renewal, amendment, or final report by logging into the Romeo Research Portal through MyInfo. For LU faculty, staff, and students, use your myInfo username and password.  Login here for those external to Lakehead University.

If you have any questions regarding the Romeo Research Portal, please contact Bonnie Knott from the Office of Research Services at bknott@lakeheadu.ca or 807-343-8934.