Participant Protection Framework for Human Research

The Digital Governance Standards Institute (DGSI) and the Human Research Standards Organization (HRSO) are proud to announce the revision of a collaborative standard: CAN/DGSI 129 / HRSO 100.01 (Rev. 1 2024) – Development of a Human Research Protection Program (HRPP). This revision marks a significant milestone in the standardization of human research.

 

Comprehensive Scope and Impact

This revised standard applies to all individuals and organizations involved in the conduct or oversight of human research, including for-profit, not-for-profit, public, and private entities. By providing clear guidelines for establishing HRPPs, this standard aims to:

  1. Reduce variability in the interpretation of regulations, policies, and guidelines
  2. Establish unambiguous documented procedures adhering to Canadian and international normative references
  3. Create a culture of shared responsibility for safeguarding research participants’ rights, safety, and welfare

The standard applies to various types of human research (qualitative and quantitative methods), disciplines (health, social sciences and humanities, arts, engineering), and approaches (interventional, observational) conducted in a variety of domains (biomedical, social, legal, behavioral).

 

Key Features of the Standard

CAN/DGSI 129 / HRSO 100.01 provides comprehensive guidance on aspects of Human Research Protection Programs, including:

– HRPP mandate and leadership
– Human research determination
– Approval processes within the HRPP
– Qualification and training of individuals involved in the HRPP
– Compliance and quality improvement measures
– Privacy and data governance
– Management of conflicts of interest and undue influence
– Dissemination of research results
– Community and research participant engagement

 

Collaborative Effort

The revision of this standard is the result of a strong collaboration between DGSI and HRSO, bringing together expertise in digital governance and human research standards.

 

Darryl Kingston, Executive Director of DGSI, commented on the collaboration: “The partnership between DGSI and HRSO in developing this standard exemplifies the power of cross-disciplinary collaboration. By combining our expertise in digital governance with HRSO’s deep understanding of human research, we’ve created a robust framework that will significantly enhance the ethical conduct and oversight of human research in Canada and beyond.”

 

Janice E. Parente, PhD, President of HRSO, adds: “Human research conducted in conformity with our NSCs ensures that the data derived from it were produced ethically and can be trusted to be valid and reproducible. HRSO is grateful for the support and collaboration of DGSI, whose expertise and experience in data governance is essential for the development and maintenance of NSCs that successfully and effectively meet these objectives.”

 

Looking Ahead

The release of CAN/DGSI 129 / HRSO 100.01 is expected to have a far-reaching impact on the human research landscape in Canada. By providing a clear and comprehensive framework for HRPPs, this standard will promote consistency, efficiency, and ethical conduct across various research disciplines and organizations.

For more information about the standard and its implementation, please visit the DGSI website and HRSO website.

 

Get Involved

As an organization, we highly prioritize collaboration and openness in our standards development process. We firmly believe that the best standards are created through the collective effort of diverse stakeholders. Therefore, we extend a warm invitation to all interested parties to actively contribute to our ongoing work. If you are interested in contributing to the work to assist in the development of standards, please get in touch through the contact below.

Get in touch with Darryl Kingston, Executive Director of Standards for more information or to get directly involved.

 

For media inquiries:

Shyra Wells
Communications and Knowledge Mobilization Lead
Digital Governance Council
Shyra.craig@dgc-cgn.org

 

About the Digital Governance Standards Institute

The Digital Governance Standards Institute develops digital technology governance standards fit for global use. The Institute works with experts, as well as national and global partners and the public to develop national standards that reduce risk to Canadians and Canadian organizations adopting and using innovative digital technologies in today’s digital economy. The Institute is an independent division of the Digital Governance Council. To learn more about the organization and its initiatives, visit www.dgc-cgn.org or contact info@dgc-cgn.org .

 

About HRSO

Human Research Standards Organization is a Canadian, not-for-profit, standards development organization that develops standards of relevance to those individuals conducting, overseeing, and participating in human research.  Adherence to human research standards ensures that the rights and welfare of research participants are safeguarded, and that human research is conducted in an environment that promotes efficiencies, mitigates risks, and produces reliable, verifiable, and credible data.

HRSO adheres to the World Trade Organization (WTO) Agreement on Technical Barriers to Trade: Code of Good Practice for the Preparation, Adoption, and Application of Standards.

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