Research ethics review during the COVID-19 publicly declared emergency

In these exceptional times, the Secretariat on the Responsible Conduct of Research acknowledges the efforts of research ethics boards (REBs) and research ethics administration in prioritizing and streamlining the ethics review process, and of researchers in their commitment to conducting research that will address urgent and important questions. We recognize that considerations and pressures around the ethical conduct of research involving humans under these circumstances are complex and continually evolving. We encourage you to continue to refer to guidance in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans TCPS 2 (2018).

This message responds to questions that the Secretariat has received in recent weeks with respect to requirements for REB review and informed consent processes during publicly declared emergencies.

The mere fact that a public emergency has been declared is not a sufficient justification for allowing research to proceed without REB review or for waiving requirements for informed consent. Researchers and REBs must continue to rely on all guidance in the Policy during the COVID-19 pandemic.

Exceptions to TCPS 2 (2018) guidance during a publicly declared emergency may be permitted by the REB, based on strong justification by the researcher. The REB makes the final decision on the need for an exception.

We refer you to a dedicated section in TCPS 2 (2018) related to research ethics review policy and procedures during publicly declared emergencies – Chapter 6, Section D, Articles 6.21, 6.22, and 6.23.

Article 6.23 indicates the following: REBs should give special care to requests for exceptions to the principles and procedures outlined in this Policy during publicly declared emergencies.

Key excerpts from the Application to Article 6.23 include:

…Especially during times of emergency, researchers, REBs and institutions need to be vigilant and exercise due diligence in respecting ethical principles, procedures and the law in effect during the emergency to preserve the values, purpose and protection that the principles of this Policy advance…

…To guide fair and reasonable implementation of these principles in emergency circumstances, any exception to, or infringement of, ethics principles and REB procedures must be demonstrably justified by those urging the exception or infringement…

…Where exceptions to or infringements of ethics principles and REB procedures are justified, they should be narrowly tailored to address the necessities occasioned by the publicly declared emergency, such that they rely on the most restrictive or least intrusive means necessary to achieve the Policy goal: the promotion and guidance of ethical conduct in research.

We encourage REBs and researchers who will conduct research on publicly declared emergencies to continue to work collaboratively. We appreciate your efforts in making the ethics review of research on COVID-19 a priority. This is one way you contribute to keeping Canadians safe and healthy, and to enhancing Canada’s position in attracting and maintaining research and innovation.

TCPS 2 (2018) applies to all research undertaken by its faculty, staff or students under the auspices of any institution that is eligible to receive and administer research funds from any of the three federal Agencies (CIHR, NSERC and SSHRC). The Policy applies to Agency and non-Agency-funded research, as well as non-funded research that takes place under the auspices of the eligible institution and its affiliates regardless of where the research is conducted.

As Secretariat staff are now working remotely, all requests for interpretations of the guidance in TCPS 2 (2018) should be directed to secretariat@srcr-scrr.gc.ca.

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