Development of a Human Research Protection Program

Designation Number:
CAN/HRSO-100.01-2020
Standard Type:
National Standard of Canada - Domestic
Standard Development Activity:
New Standard
ICS code(s):
03.100.30
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Scope

Note: The scope was updated by the responsible SDO on June 30, 2020.

 

This standard applies to all individuals, as well as all public or private organizations, engaged in the conduct and/or oversight of human research.

 

Human research is defined as a systematic, scientific investigation involving human beings.

 

Human research includes, but is not limited to, the following disciplines: health research, social sciences and humanities research, creative and arts-based research, and engineering research.

 

Human research includes, but is not limited to, the following methodologies: interventional research, observational research, qualitative research, social and behavioural research, health services research, public health research, educational research, research involving existing human data, research with deceased individuals, and research involving human biological materials and their derivatives.

Project need:

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. A Human Research Protection Program (HRPP) is an organizational-wide program composed of all entities responsible for protecting the rights and welfare of participants in human research . An HRPP is composed functional units responsible for funding , resources (human and other), procedures, training and quality assurance. Together, these functionalities form an overall program of research participant protection wherein responsibilities are shared among all entities of the HRPP In the absence of Canadian regulations governing human research , the necessity for national standards governing the conduct and oversight of research in humans is paramount. Adherence to this standard ensures that an organization has the necessary structure and oversight capabilities to ensure that it meets a rigorous set of standards focused on research participant protection, evidenced-based practices, efficiency, quality, integrity and accountability. It also provides assurance to the organization's collaborators that their investment _ will produce reliable and verifiable results 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.