Safeguarding Research Participants: How Human Research Protection Programs (HRPPs) Promote Patient Safety

Patient safety is a critical issue in healthcare today, as the growing complexity of medical systems has led to an alarming rise in patient harm. Each year, 134 million adverse events occur in low- and middle-income countries alone, resulting in 2.6 million deaths. Even in high-income countries, one in ten patients is harmed during hospital care.

To address this global challenge, World Patient Safety Day was established in 2019 by the World Health Organization (WHO) , urging international action to improve safety in healthcare. On September 17, landmarks around the world are lit in orange, symbolizing a collective commitment to safer care.

While the focus is often on hospitals, patient safety also extends to human research. Protecting the rights and welfare of research participants is essential, and one of the most effective ways to do this is through a Human Research Protection Program (HRPP)—a system that ensures ethical standards are upheld throughout research studies.

Let’s explore why an HRPP is crucial and how it plays a vital role in promoting ethical research and participant safety.

What Exactly is an HRPP?

An HRPP (Human Research Protection Program) is not just a set of rules but an organization-wide program where everyone plays a crucial role in protecting research participants. From the institution’s leadership to researchers and their staff, and the research ethics board, all parts of the organization are interconnected, sharing responsibility to safeguard participants.

The institution’s leadership ensures that adequate resources and support are in place, promoting a culture of integrity and accountability. Researchers and their staff follow standard operating procedures, ensuring research participant safety and data accuracy, while the research ethics board (REB) oversees the review and approval of research, ensuring compliance with regulations, policies and standards.

An HRPP is a network of interdependent entities that operate within a system designed to promote research quality, efficiency, and accountability, while ensuring that evidence-based practices are followed. This protective framework ensures that participants’ rights, welfare, and dignity are prioritized throughout every phase of the research process.

An HRPP can exist in any type of organization—whether for-profit, not-for-profit, public, or private—where human research is conducted or overseen. By fostering collaboration across the entire organization, the HRPP upholds the highest standards of ethical research, ensuring both research participant protection and compliance with regulatory requirements.

Why Should Organizations Invest in an HRPP?

You might be wondering, why is an HRPP so important? What does it offer beyond regulatory compliance?

Here are five reasons why a Human Research Protection Program is essential:

1. Protecting Research Participant Rights: HRPPs ensure that research participants are treated with dignity and respect. Institutional procedures guiding research activities like informed consent ensure research participants fully understand the research and their role in it.
2. Meeting Regulatory Requirements: Regulations for human research are complex and vary depending on its nature, its location and its funding. An HRPP helps organizations stay compliant with local, national, and international normative requirements, avoiding legal pitfalls.
3. Ensuring Research Integrity: Accurate data is critical. HRPPs establish standards for how data is collected, managed, and analyzed, ensuring results are reliable and unbiased.
4. Continuous Improvement: HRPPs aren’t static. Regular audits and feedback help identify areas for improvement, making the program more effective over time.
5. Building Public Trust: When research participants and the public see that an organization is committed to ethical research, it builds credibility. This trust encourages participation and strengthens the organization's reputation.

Case in Point:

Imagine a study where research participants were unclear about their rights or unsure about the research's purpose. This could lead to mistrust or even withdrawal from the study. But with an HRPP in place, participants feel informed, protected, and respected—leading to higher retention levels and stronger research outcomes.

Accreditation: The Next Step Toward Excellence

Developing an HRPP is a significant step, but accreditation can take your organization’s commitment to the next level.

Accreditation is a voluntary process that signals to the world that your organization holds itself to the highest ethical standards. It demonstrates a commitment to continuous improvement and accountability for all human research activities. Organizations that achieve accreditation demonstrate they have rigorous processes to safeguard research participants and produce reliable, credible data.

Veritas IRB Inc. made history by becoming the first Canadian IRB/REB to achieve accreditation in 2006, and it has maintained this accreditation ever since. In addition, Veritas IRB became the first research organization in the world to achieve accreditation with three different research accreditation bodies, including Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) and HRA Canada . This level of commitment shows not only compliance but leadership in the field of ethical research oversight.

Here’s why accreditation matters:

• Rigorous Standards: Accreditation confirms that your HRPP meets and even exceeds basic regulatory requirements, ensuring research participants are well-protected.
• Efficiency Gains: Accredited organizations tend to operate more efficiently, with streamlined procedures that minimize delays or shutdowns due to non-compliance.
• Trust and Credibility: Accreditation builds confidence among sponsors, regulatory bodies, and research participants, showing that your organization is dedicated to maintaining ethical and professional standards.

By pursuing accreditation, organizations reinforce their role as leaders in ethical research. It’s not just about compliance—it’s about being the gold standard in research integrity and research participant protection.

Conclusion: Protecting People, Enhancing Research

At its core, a Human Research Protection Program (HRPP) isn’t just a legal necessity—it’s a way to build trust, ensure ethical practices, and protect the people who make research possible.

Veritas IRB has long recognized this, becoming a leader in accredited ethical research oversight. Since its inception in 1996, Veritas IRB has been dedicated to ensuring that its processes not only respect research participants’ rights but also deliver services according to the highest standards of ethical and clinical practice.

Whether your organization is just starting to develop an HRPP or looking to achieve accreditation, the focus should always be on creating an environment where research participants feel safe, respected, and valued. By doing so, your research will not only meet regulatory requirements but also foster public trust, attract more research participants, and produce more reliable data.

Ready to take the next step?

Investing in an HRPP or pursuing accreditation can set your organization apart and ensure you're at the forefront of ethical research. It’s time to prioritize research participant safety and elevate your research practices to new heights.

REFERENCES:

Slawomirski, L.,?A. Auraaen?and?N. Klazinga (2017), "The economics of patient safety:?Strengthening a value-based approach to reducing patient harm at national level", OECD Health Working Papers, No. 96, OECD Publishing, Paris, https://doi.org/10.1787/5a9858cd-en.

Human Research Standards Organization (HRSO) (2020), "Development of a Human Research Protection Program (HRPP)", CAN/HRSO – 100.01 – 2020, available online: Published Standards - HRSO (hrso-onrh.org)

Association for the Accreditation of Human Research Protection Programs (AAHRPP), www.aahrpp.org

Human Research Accreditation Canada, www.hracanada.org