Conducting Human Research in public and private settings

Designation Number:
CAN/HRSO-300.01-2020
Standard Type:
National Standard of Canada - Domestic
Standard Development Activity:
New Standard
ICS code(s):
03.100.40
Status:
Proceeding to development
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. The necessity for a national standard for the conduct of human research is of paramount importance given the narrow focus of the current Canadian regulations. Canada’s Food and Drugs Act and applicable Regulations incorporate an internationally-accepted good clinical practice guideline. The guideline describes best practices for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials. There are two main deficiencies with this guideline: (i) it only applies to interventional (clinical) research, and (ii) its main focus is on the production of credible and accurate research data, and does not fully describe practices for the protection of human research participants. Verifying the quality of the research conducted at an investigative site requires harmonized procedures derived from a well-developed standard. Adherence to this standard will ensure that the investigative site has the requirements necessary to safeguard the rights and welfare of research participants, safely conduct the research, measure the investigative site’s efficiency and performance, and produce reliable, verifiable and credible data in an efficient and low-risk environment.

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.