Development of a Human Research Protection Program (HRPP)

Designation Number:
CAN/DGSI 129 / HRSO 100.01
Standard Type:
National Standard of Canada - Domestic
Standard Development Activity:
Amendment Revision
ICS code(s):
03.100.30
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Scope

This standard applies to all individuals, as well as all for-profit and not-for-profit, public and private organizations engaged in the conduct and/or oversight of human research. By reducing the variability of interpretation of regulations, policies, and guidelines, this standard provides a basis for the establishment of unambiguous documented procedures that adhere to Canadian and international normative references.

 

Human research incorporates various types of qualitative and quantitative methods, disciplines (e.g. health, social sciences and humanities, arts, engineering), and approaches (e.g. interventional, observational) conducted in a variety of domains (e.g. biomedical, social, legal, behavioural). Human research may involve the use of existing or prospectively collected data or specimens.

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 of 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 assures the organization's collaborators that their investment _ will produce reliable and verifiable results in an efficient and low-risk environment.

 

The NSC is being revised to continue to support the nationally recognized HRPP certification program. The HRPP is composed of individuals or entities within an organization whose actions directly or indirectly affect research data integrity and/or the health, welfare, interests, or rights of Research Participants, such as the Leader or Leadership, Investigators/ Researchers, research personnel, REB members, and administrative and ancillary personnel.  Human research incorporates various types of qualitative and quantitative methods, disciplines such as health, social sciences and humanities, arts, engineering, and approaches such as interventional and observational that are conducted in a variety of domains (e.g. biomedical, social, legal, behavioural) who support the ongoing maintenance of the NSC. 

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.