In this episode of PHRP Perspectives, Joe Smith talks with Andrea Dragan, Director of Quality Assurance and Evaluation at Rutgers University, about the evolving role of quality assurance in human research. They discuss how Human Research Protection Programs can balance compliance and innovation, build stronger partnerships with investigators, and use education and transparency to support ethical research and participant protections. 

Show Notes:

Joe Smith and Andrea Dragan explain quality assurance in human research isn't just about compliance—it's about building trust. Their key points include:

Andrea Dragan: Quality assurance is about partnership, not punishment.
Effective audits and compliance reviews should focus on education, accountability, and continuous improvement. By approaching oversight as a collaborative process, HRPP professionals can help researchers succeed while maintaining participant protections.

• Andrea Dragan: Routine reviews help identify problems before they become compliance issues. Proactive monitoring allows institutions to spot trends, uncover gaps, and provide guidance early. These reviews create opportunities to strengthen research practices across an organization before concerns escalate.
• Andrea Dragan: The goal should be to ”get to yes” responsibly. Regulations provide important guardrails, but they should not become barriers to research. Understanding the intent behind the rules helps compliance professionals work with investigators to find solutions that support both ethical requirements and scientific innovation.
• Joe Smith: Strong relationships make compliance programs more effective. Researchers are more likely to engage positively with oversight when compliance offices provide practical resources, education, and ongoing support. Building trust creates a more efficient and productive research environment for everyone involved.
• Andrea Dragan: The future of human research protections requires flexibility and simplification. As AI, big data, decentralized trials, and other emerging research methods continue to evolve, oversight programs must adapt. However, Dragan argues that complex research does not require increasingly complex regulatory approaches—simplification should remain a key principle for effective compliance.

PHRP Online Training helps ensure ethical, safe research practices with human participants through accessible, up-to-date courses. Designed to meet HHS standards, the training includes realistic scenarios, exam-based certification, and two course options tailored to biomedical or social, behavioral, and educational (SBE) research. Individuals and institutions receive one-year access and a downloadable certificate upon completion. Institutional partners enjoy custom portals with branded URLs and messaging. Courses are offered in English, Spanish, and French, with CE credits available. Learn more at PHRPTraining.com.