Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate
If there’s one constant in clinical research, it’s change. With continual innovations and transformations, establishing a human research protection program (HRPP) can help many research institutions adapt to these changes while upholding the highest ethical standards.
A significant change currently taking place in the industry is the shift to single institutional review board (sIRB) review for multisite research. The shift is designed to encourage collaboration, efficiency, and expertise as we continue to move science forward.
This blog explores the significance of HRPP staffing despite an sIRB mandate, where IRB resources are outsourced. Additionally, it explains how adequate HRPP staffing maintains ethical research practices throughout a study’s lifespan.
Ethics in Research
Ethical considerations shape how research is conducted, the conclusions we derive, and, most importantly, how we communicate and apply findings in the real world. Increased access to data, rapid technological advancements, and the globalization of research means today’s research professionals are under greater scrutiny. Research misconduct or unethical behavior can devastate public trust, and more importantly, profoundly impact lives and societies.
Key Roles in HRPP Staffing
HRPP staff are all integral to ensuring the protection of the rights and welfare of human subjects in research. For research institutions, understanding the importance of filling key HRPP resources is a critical step to transitioning to a centralized IRB review process. Let’s examine some key HRPP roles and the critical work they do to ensure research is conducted compliantly and ethically.
Institutional Review Board Members
Members of the IRB are responsible for reviewing and approving research protocols involving human participants. This committee is made up of a diverse group of experts: researchers, ethicists, community representatives, and legal professionals. Collectively, they work to ensure the research study under review aligns with ethical guidelines and legal regulations.
HRPP administrators facilitate communication between researchers, IRB members, and participants. Day-to-day communication management tasks are typically funneled through the HRPP administrator.
Researchers often look to HRPP administrators to help guide them through the IRB submission and review process. They work collaboratively to ensure all necessary documentation is provided and ethical concerns are addressed.
Education and Training Specialists
Every HRPP requires education and training to help stakeholders understand how their research plan fits into ethical principles and regulatory requirements. Education and training specialists work to design and implement training programs so research staff can recognize how to implement these ethical research practices and raise awareness.
Quality Improvement Personnel
There may be various research staff working toward quality improvement on their HRPP. Their roles may include identifying areas for improvement, addressing discrepancies, and ensuring the HRPP operates efficiently while maintaining ethical standards.
The sIRB Mandate
It’s becoming more commonplace for governing bodies to require sIRB review. In an effort to streamline the review process, new mandates currently being circulated by the FDA recommend a centralized or sIRB of record to oversee multisite research studies.
Historically, institutions participating in multisite research studies each had their own IRBs, which led to duplicative efforts, delays, and inconsistencies throughout the review process. Consistency is an ongoing challenge with this methodology and with separate IRB reviews, this leaves room for confusion and error. Per the recommended sIRB mandate requirements, these challenges are overcome by using an sIRB for all participating sites.
Benefits of sIRB Mandates
Utilizing an sIRB can help both sponsors and sites. Each organization can take advantage of different aspects of an sIRB, such as:
- Efficiency: Eliminating redundancy, sIRB mandates reduces administrative burdens and accelerates the research timeline
- Consistency: Ethical standards and regulatory requirements are applied consistently across all sites through an sIRB, ensuring participants are consistently informed of risks
- Resource allocation: Through collaboration with an sIRB, institutions can optimize their resources by reallocating personnel and funding toward other aspects of research
Having access to experienced HRPP resources can assist institutions implement and sustain compliance with the sIRB mandate. Ensures ethical considerations are upheld, while simultaneously revolutionizing multisite research review.