Interim Staffing: Reinvigorating Your Human Research Protections Program

Evolving regulations, technological advancements, changing societal norms, and new research methodologies can cause an organization to pause and think, “Does our human research protection program (HRPP) have the proper expertise, policies, and procedures in place? Are we ready for increasing new single IRB (sIRB) mandates? Should we pursue accreditation?”

Maybe your organization has a vision for modernizing the HRPP. This may include implementing electronic management systems, creating new positions, or conducting intensive trainings to address identified gaps or new requirements. However, it’s hard to implement such changes or trainings without seriously impacting day-to-day operations. It’s difficult to know where to begin.

How Interim Staffing Can Help Evolve Your HRPP

External interim staff can help assess and revise an HRPP’s structure, policies, and procedures, ensuring they reflect the latest standards and best practices. Outside perspectives and experience are invaluable in identifying areas for improvement and ensuring policies and processes are both compliant and conducive to efficient operations. Benefits of external interim staff include:

• Specialized expertise and experience: Interim staff bring targeted expertise and skills not necessarily available in-house. This option also provides access to experts with knowledge of and expertise in specific regulatory frameworks, emerging research technologies, specific therapeutic areas, or in nuances of regulatory processes or roles. They come with a wealth of experience garnered from working across different organizations and environments.
• Objective evaluation and fresh perspectives: External interim staff can bring new eyes when evaluating an HRPP’s policies, procedures, and practices. It’s helpful they are removed from any internal dynamics, history, and implicit biases potentially existing within an institution. Because of this, they can identify gaps and previously unnoticed issues and offer unbiased assessments and fresh perspectives to the program.
• Accelerated learning and knowledge transfer: Through targeted training and development initiatives, interim staff can quickly inform internal staff on the latest regulations, ethical considerations, and industry best practices. They can also provide training for staff with evolving roles or roles new to the HRPP. This direct infusion of knowledge and dedicated training can enhance research protection and compliance, as well as accelerate training and integrating new roles within the HRPP.
• Filling the gaps: Special projects and big changes can be resource- and time-intensive. Even if the expertise needed is available in-house, the time needed might not be. Interim staffing can supply the necessary personnel for maintaining operations, and allow project completion without disrupting the HRPP’s ongoing, core responsibilities. In addition, if a recent change has resulted in accumulating reviews or “to dos,” interim staff can help your HRPP clear any backlogs.
• Facilitating change and cultural shifts: At the institutional level, facilitating change requires a strategic approach to change management. Interim staff can serve as agents of change, guiding the institution through necessary transformations by leveraging proven strategies to minimize resistance and helping to ensure buy-in from key stakeholders. Their external status can also lend credibility to the change process, making it easier to implement new policies and practices.

When Accreditation is the Catalyst for Change

Of all the major changes an HRPP can make, the accreditation process is one of the more formidable and with high stakes consequences. It’s a lot to take on, especially for a team with little prior accreditation experience, and the process can place significant strain on current staff due to the time investment required. Interim staff can contribute to the accreditation process in several ways:

• Streamlining the accreditation process: Professionals experienced with accreditation can demystify the process, serving as project managers, facilitating training and staff preparation as well as coordinating efforts across departments and ensuring milestones are met on time. Their experience can help the institutional team avoid common pitfalls and streamline efforts, making the path to accreditation smoother and more efficient.
• Gap analysis and preparatory work: One of the first steps towards accreditation is conducting a thorough gap analysis to identify areas where the HRPP might not meet the standards established by the accreditation body. External interim staff, with their fresh perspectives and breadth of experience, can identify these gaps more efficiently and propose innovative solutions to address them. Their expertise is especially valuable in navigating the complex documentation requirements of the accreditation process.
• Policy and procedure enhancement: Accreditation typically requires a comprehensive review, revision, and (often) policy and procedure creation to ensure they align with accreditation standards. Interim staff, particularly those with experience in accreditation processes, can lead these revisions and draft needed policies. With experience implementing new policies resulting from the accreditation process, they can ensure policies are compliant, meet the required standards, and are practical.
• Addressing specific accreditation feedback: Following an accreditation review, HRPPs can receive specific feedback or directives about larger changes needed to meet accreditation standards, requiring additional resources and support to address. Interim staff can be engaged to help address various areas directly. Their targeted expertise allows for a focused approach to resolving these issues efficiently, ensuring the HRPP meets the expectations for accreditation.
• Sustaining accreditation standards: Beyond achieving accreditation, maintaining those standards requires ongoing effort and vigilance. Interim staff can establish frameworks and continuous improvement processes to ensure the HRPP remains in compliance with accreditation standards. They can also help implement and/or staff a robust post-approval monitoring and quality improvement program that identifies potential issues before they become compliance risks, ensuring accreditation is both achieved and sustained.

By bringing objective evaluation, specialized expertise, and effective change management skills, interim staff can significantly improve an institution’s ability to identify issues and implement necessary changes.

External support can propel the institution towards accreditation success, facilitate a large project without impacting basic operations, or simply help build a stronger, more compliant HRPP designed to adapt to future challenges and changes in the research landscape. Engaging professionals from outside the institution is an important strategy for ensuring the ethical and responsible conduct of research involving human subjects.

Back to Resources