Lawrence S. Bloomberg Faculty of Nursing

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COVID – Research Restart

Lawrence S. Bloomberg Faculty of Nursing (LSBFON) Guidelines for Research Restart and Recovery


Update: Implication of the Ontario Provincial Roadmap to Reopen Plan on Research Activities (July 19, 2021)

Update: Coronavirus FAQs 1.1, 1.2, 1.3, 4.1 were updated July 5, 2021

Update: Research Services has updated the Approach for Research Recovery and Adaptation (July 5, 2021)

New: COVID-19 General Workplace Guideline (released June 30, 2021)

As of June 11, 2021, the University REBs are reviewing research proposals of all risk levels for face-to-face human participant research. 


Introduction

The University of Toronto is beginning the process of research restart and recovery. All researchers should become familiar with:

The LBSFON will follow the University of Toronto’s Approach for Research Recovery and Adaptation (updated July 5, 2021). This plan reflects the Province of Ontario’s Roadmap to Reopen Ontario (now in stage 3). This approach places the health, safety and security of all at the centre of decisions about restarting research. The timeline and guidelines for implementation of each stage will be coordinated by the LSBFON following Provincial and University direction. The LSBFON and the University may make faculty or institutional decisions if necessary to address public health concerns or institutional directions. This may result in revisions or update to this document.


Research requiring face-to-face contact with human participants (updated March 25, 2021)

The University of Toronto recognizes that the concept of minimal risk has changed due to the COVID-19 pandemic. New research and previously approved research that involves face-to-face contact with human participants may begin with approval from the REB and the researcher’s primary department. 

All research work that can be conducted remotely must be done remotely, and researchers may only work on campus if the nature of the work requires them to be on-site.

Face-to-face (F2F) human participant research where the University’s Research Ethics Boards (REBs) were the Board of Record was previously suspended on November 23, 2020. Given the lifting of the provincial State of Emergency, as of March 22, 2021 the University’s REBs have begun accepting limited submissions of F2F human research as one of two separate review processes. The REB review process focuses on human research ethics issues. The second review process is conducted by the Face-to-Face COVID-19 Review Committee (F2FCRC) and focuses specifically on the COVID-19 health and safety risks of the research being proposed, through the review of the principal investigator’s submission of the Face-to-Face and Off-Campus (F2FOC) COVID-19 Review Form. Approvals from both review processes will be required before F2F research activities can commence.

Acceptance of submissions for F2F research will occur in a stepwise progression based on COVID-19 research risk, beginning with Level 1 research and following prioritization criteria determined by the Research Restart Steering Committee. Information regarding which studies are currently accepted into the process can be found on the Face-to-Face Research Review Status page.


COVID-19 research or F2F research where the participant is receiving a service that would be delivered/received regardless of the research may be submitted for REB review at any time. Researchers should contact ethics.review@utoronto.ca if they have questions regarding whether their study qualifies. Researchers currently in other regions or countries where public health directives may allow for F2F research to commence may submit their protocols for REB review at any time.

Amendments to pivot to online or virtual methodologies will continue to be reviewed, and all renewals and protocol completion reports will continue to be reviewed to ensure that protocols remain in good standing.


Faculty of Nursing Approval Process.

Step 1. New protocols and amendments to previously approved research. Ethical considerations around face to face research may have changed. Researchers should consult the U of T Guidance for the Recovery of Human Research During the COVID-19 Pandemic , including informed consent language that should be added to informed consent documents and processes.

Step 2. Researchers must complete the Face-to-Face Human Research Checklist and attach it to the Document Summary (Section #13) of their University of Toronto REB to confirm that University policies and procedures will be followed. Researchers proposing F2F human participant research will also complete the Face-to-Face and Off-Campus (F2FOC) Covid-19Review Form, and upload the provided PDF copy of the completed form to the Documents Summer (Section #13) of their My Research Human Protocols (MRHP) new submission or amendment. 

Step 3. Once REB approval is received, researchers should submit their full REB protocol, REB approval and the  Face-to-Face and Off-Campus (F2FOC) Covid-19Review Form and either the Bloomberg Nursing On-campus research restart request form or the Bloomberg Nursing Off-campus research restart request form to research.nursing@utoroto.ca. Doctoral students or post-doctoral fellows must use the Bloomberg Nursing PhD and PDF declaration form.

Please see COVID-19 FAQs 3.1 and 3.2 for more information about restarting human research or initiating new studies.

The University has provided context for COVID-19 wording on consent documents.

Researchers should evaluate risk of their subject populations, particularly vulnerable populations, using the University’s Guidance for the Recovery of Human Research During the COVID-19 Pandemic.

The Waakebiness Bryce Institute for Indigenous Health at the Dalla Lana School of Public Health is developing guidelines for conducting research specifically in Indigenous populations.


Research at TAHSN Hospitals

Researchers should follow the direction of TASN hospitals for research conducted under their auspices (see FAQ 3.1). 


Off-Campus Research

Researchers conducting off-campus research (including at hospitals, clinics) where REB was obtained will be bound by the REB directives and regulations of those sites. The public health directives of these sites or facilities must be followed and if permission from the site is required, it must be granted and provided to the Associate Dean, Research & External Relations before proceeding with research. In order to resume research at a third party site, REB approval from the off-campus site must be obtained and provided to the Associate Dean, Research & External Relations.


Oversight

Faculty and institutional oversight of adherence to the guidelines will be in place and deficiencies may lead to suspension of the permit to perform in person activities.

Safety concerns can be reported to the LSBFON research office at research.nursing@utoronto.ca.


Access Request Forms

Bloomberg Nursing On-campus research restart request form

Bloomberg Nursing Off-campus research restart request form

Bloomberg Nursing PhD and PDF declaration form


Resources

 

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