Health Research Ethics Authority Guidance Regarding COVID-19

Apr 23rd, 2020

BY OFFICE OF THE VICE-PRESIDENT (RESEARCH)

Health Research Ethics Authority Guidance Regarding COVID-19

The Health Research Ethics Authority (HREA) has been closely monitoring the developments related to COVID-19. This communication is to inform researchers about the current priorities for review of submission by the Health Research Ethics Boards (HREBs), instructions for how to address ongoing research studies, and instructions regarding the review of new research studies.

The public health emergency was declared in this province on March 18, 2020. The Chief Medical Officer of Health has made a number of Special Measures Orders in accordance with the Public Health Protection and Promotion Act, which may impact the conduct of research. For example, gatherings of more than five people are prohibited and most private health care clinics have been ordered to close except for urgent or emergent services. For more information see the Government of Newfoundland and Labrador’s COVID-19 website.

Our Priorities

  1. The review of any new research related to COVID-19.
  2. The review of changes related to COVID-19 to ongoing research.
  3. The review of studies that may have a clinical benefit. 

Ongoing Research

As of March 23, and following forward, all research protocols must be modified or delayed to avoid face-to-face personal interactions with research participants, in the interests of participant safety. Specifically, research protocols for continuing research will need to be amended to replace face-to-face interactions with remote communication. With the exception of research under the auspices of Memorial University, face-to-face interactions may continue where necessary for safety and health of the participant. For more information, see the following communication here.

With respect to research under the auspices of Memorial University, on March 19 Memorial suspended on-campus research and scholarly activities in research spaces across its campuses. Additionally, all Memorial fieldwork was suspended and all activities that would involve face-to-face (in-person) interactions (e.g., surveys or focus groups with research participants) were to be deferred or carried out remotely using a technology solution that allows researchers and participants to be involved from their homes. The suspension of face-to-face interactions remains in effect. Please see the following statement on research at Memorial from Dr. Neil Bose, vice-president (research), [VPR] here.

New Research

Until the public health crisis related to COVID-19 has abated, no new studies involving face-to-face contact may be initiated at this time. Once the public health emergency order has been lifted, HREA will reassess, and in line with orders from the Chief Medical Officer of Health, researchers will receive a communication from the HREA permitting them to begin new research. Researchers must not begin any recruitment, consent processes, or study interventions until they have received this communication. Exceptions will be made for research-related to COVID-19. Exceptions may also be made for clinical trials under exceptional circumstances, and for research that involves no participant contact. Exemptions will be considered at the request of the researcher and decisions will be made by the relevant HREB on a case-by-case basis.

At Memorial University, the suspension of on-campus research and scholarly activities and of in-person interaction with research participants remains in effect.

On March 27, the university announced a process whereby it would consider exemptions for some on-campus research spaces for specific types of critical research activities falling under the auspices of Memorial. Exemptions were granted by the Office of the Vice-President (Research) (VPR). Approvals for exemptions were made at vice-president level and involve both the vice-president (research) and the applicable vice-president of the Grenfell Campus or the Marine Institute (or their delegate).

Memorial’s exemption process is outlined here. Please note, at Memorial no on-campus research or scholarly activity is permitted to be undertaken at any campus before receipt of a letter from the Office of the VPR granting an exemption and outlining any conditions associated with the exemption.

Under Health Research Ethics Board’s (HREB) regulations, while new research cannot begin, applications will be reviewed and approved as usual. Researchers will receive a deferred approval so that they can begin their research as soon as possible, once the public health crisis related to COVID-19 has abated. It is important to note that, HREB approval for new research and/or amendments does not override any restrictions that may be in place from the researchers institution or organization. 

If you have any questions, please contact the Ethics Officer at ethicsofficer@hrea.ca. Thank you for your patience.

Contact

Research

230 Elizabeth Ave, St. John's, NL, CANADA, A1B 3X9

Postal Address: P.O. Box 4200, St. John's, NL, CANADA, A1C 5S7

Tel: (709) 864-8000