Institutional Review Board (IRB) submission process and effective change management are critical to maintaining the integrity and efficiency of research programs within hospitals. During our Connect Conference in 2023, IRB Coordinators Amanda Hong and Rayna Potkonjak shared their professional experience with change management at Mount Sinai Hospital in Chicago and Logan Health in Montana, respectively.
In this post, we’ll share key takeaways from their presentation on IRB submission best practices, challenges, and solutions.
About Logan Health and Mount Sinai Hospital
Logan Health is a nonprofit 590-bed health system based in Kalispell, Montana. They cover an extensive area across 20 Montana counties (nearly 50,000 square miles), operating six hospitals and 68 provider clinics.
Mount Sinai Hospital is located on Chicago’s west side. As a safety net level 1 trauma center with 350 beds, Mount Sinai treats low-income and underserved communities.
In their presentation, both Rayna and Amanda emphasized the importance of IRB processes at their respective hospitals.
Training protocols for committee members and investigators
Effective training for IRB members and research staff is a cornerstone of both institutions. Logan Health employs the Collaborative Institutional Training Initiative (CITI) for board members and research staff, alongside additional in-house orientation and training materials. Each of Logan Health’s nine board members has their own alternate who can attend meetings if they aren’t able to make it themselves.
Board members don’t need to renew their training, with the exception of the chairperson, and investigators (PIs, sub-PIs, and research coordinators) must renew their training every three years.
Because CITI is connected to Cayuse, it’s easy to see if the research team is up to date on all their training each time they submit. Rayna doesn’t have to log into CITI for visibility; it’s easy to check within their submission. Study-specific training is also included in each submission to the IRB.
Within the CITI training, Rayna highlighted two elements:
- Belmont Report: Ethics in healthcare research; protects all subjects and participants
- Conflict of Interest: What classifies a COI, ethical concerns, and types of COI
Logan Health also supplies step-by-step documents outlining the basics of Cayuse Human Ethics.
Mount Sinai Hospital also goes through human ethics protection training. They allow the ACRP or CITI training and accept them from other universities, as many of their investigators are medical students, alumni, or external investigators with certifications from their own institutions.
Human ethics training is supplemented by institutional HIPAA training and annual IRB training for all committee members as a refresher. Finally, Mount Sinai also conducts Cayuse-specific IRB training, either one-on-one with Amanda or with the committee chairman. Investigators receive a Cayuse IRB user manual, which shows the step-by-step process for completing submissions.
Staff turnover
Turnover within a hospital setting is inevitable, particularly when the organization goes through transitional periods. At Logan Health, turnover within the research department impacts access to studies within Cayuse because the research coordinators had originally granted access just to a specific coordinator involved in the study, which created difficulties for the IRB office.
Rayna addressed this challenge by creating an IRB Office Administrative account that gets added as a research coordinator to each study. She then has access and can assist whenever needed. Logan Health also has a specific personnel modification form. Whenever a new research coordinator or PI comes in without any other change to a study, this form helps them avoid completing an entire modification form. This approach ensures continuity and compliance despite organizational changes.
Mount Sinai hasn’t had as much personnel transition, but they did have an organizational approval change. Amanda contacted the new department chairman, explaining the roles and responsibilities of Cayuse and why they use the system rather than paper forms. They then sent the chairman the org approval user manual and provided one-on-one training.
One key learning Amanda emphasized from this process was the importance of removing the original organizational approver only after pending applications are complete, to avoid process disruptions.
Central and local IRBs
Central and local IRB reviews can be complex, so Rayna defined both for clarity. A central IRB conducts reviews on behalf of all study sites that agree to participate in the centralized review process, while the local IRB is typically at the hospital level to conduct and review their studies and trials.
At Logan Health, the majority of studies engage in an oversight waiver that they rely on the central IRB to review. However, they still require studies to be reviewed by their local IRB. Those that don’t rely on a central IRB are usually specific to their location, but these are rare.
The policies and procedures at Mount Sinai are very similar, with most studies relying on local IRBs. Most of their central IRBs are through clinical trial-sponsored studies. If they need to go through a central IRB, they go through Mount Sinai first as a local IRB for approval, then submit a modification to go to a central IRB.
Internal and external audits
Logan Health conducts internal audits, including termination and quarterly audits, to ensure compliance and document integrity. These audits are crucial for maintaining the trustworthiness of research activities and for meeting regulatory requirements.
This has been a source of some contention; before Rayna’s arrival at Logan Health, it had been decided that these internal audits would be conducted by compliance after they audited their IRB. But when she met with their compliance officer, she found that wasn’t happening, because they’d had a new compliance officer every year for the past four years, disrupting communication and compliance workflows.
In the end, the audits were passed back to Rayna, who now conducts a termination audit on every study closure. One study per quarter is also selected at random for an audit.
The workflow for internal audits is simple:
- Notification: First, they send a letter to the research team and PI notifying them of the audit. This letter supplies a range of five work days about two weeks out when they can choose a time for the audit. The research department is generally flexible on scheduling and will suggest alternate days and times if needed.
- Execution: The next step is to conduct the audit, which takes about 30 minutes to an hour, depending on how long the study has been going. Primarily, Rayna ensures that they have all of their papers online, including CVs, licenses, CITI training, and study-specific training for everyone involved.
- Evaluation: Rayna then evaluates her findings. If anything is out of compliance, she sends an audit report and a completion of audit letter to the research team, PI, IRB chairman, and the attorney on her findings. This gives the research team time to come back with any responses or corrections.
The objective for these audits is to ensure that all documents are up to date and match what they most recently submitted to the local IRB.
FDA inspections are also done virtually through Cayuse rather than on paper. Logan Health downloads all requested files on a flash drive and provides that to the FDA, alongside any documents that need to be printed. They also provided the FDA with a demonstration of Cayuse to familiarize them with the workflow.
Lessons learned
The experiences of Logan Health and Mount Sinai Hospital highlight some key lessons for managing IRB submissions and change within hospital settings:
- Comprehensive training: Continuous and comprehensive training for all IRB and research staff is essential for maintaining high standards of research integrity and compliance.
- Adaptability in staff turnover: Developing strategies to manage workflows after turnover ensures that research oversight remains consistent and effective.
- Effective change management: Clear communication and careful planning are essential when managing organizational change, such as changes in approvals or adapting to new systems.
- Audit preparedness: Regular internal and external audits are crucial for compliance and for identifying areas for improvement in research processes.
The IRB submission process and change management in hospital settings demand a proactive, well-organized approach to ensure compliance, efficiency, and integrity in research. The experiences shared above provide valuable insights and best practices that can guide other institutions in navigating these complex processes.
