Conducting Human Research During Publicly-Declared Emergencies

HRSO Inc.
Standards Development Organisation:
Human Research Standards Organization (HRSO)
Designation Number:
CAN/HRSO-300.02-2020
Standard Type:
National Standard of Canada - Domestic
Standard Development Activity:
New Standard
ICS code(s):
03.100.40
Status:
Development Cancelled
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This standard applies to all organizations, public and private, engaged in the conduct of human research, including hospitals, universities, academic health centres, and clinics. Human research is defined as a systematic, scientific investigation involving human beings as research participants. Human research can be interventional (eg clinical research involving a test article), observational (eg behavioural studies that do not involve a test article), or an analysis of existing human research data or human specimens. Human researchers are commonly referred to as investigators and include physicians, dentists, psychologists, engineers, scientists, and all other individuals involved in the research process.

Project need:

One of the primary ethical justifications for conducting human research is to benefit society. Because human research seeks to understand something not yet known, participation in human research is not without risks. Given the fundamental importance of human research, society must ensure that research is conducted ethically, scientifically, safely, and in a manner that safeguards the rights and welfare of research participants. Publicly-declared emergencies are extraordinary events that arise suddenly or unexpectedly, pose an enormous risk to the population, and require an urgent response in order to minimize harm. Declaration of the emergency is done by authorized public officials in accordance with legislation and/or public policy. Publicly-declared emergencies include natural disasters, outbreaks of communicable diseases, humanitarian emergencies, and environmental disasters. Publicly-declared emergencies have the potential to present significant risks to research participants in ongoing research. Additionally, new research may emerge as a direct result of a publicly-declared emergency that may require a temporary modification of normal practices and procedures. The existence of an emergency does not override established norms regarding research participant protection, data integrity, the preservation of biological specimens, as well as the preservation, availability, and administration of interventional products. A national standard is required to guide researchers in the development of procedures for publicly-declared emergencies that are proportionate to the complexity and urgency of the emergency, and the risks posed by the ongoing research.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.