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The Institutional Review Board (IRB) action plan for continuous quality improvement has five priority areas.

Priority Area 1: Operational Metrics Data and Reporting

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Impact Goal:

Using newly developed operational metrics and data, reporting will increase transparency among the research community. The project team will establish an operational metrics portfolio for internal and external reporting by July 2024. 

Overview

Research Compliance Services (RCS) to run routine reports in the priority metric areas. These priority areas include building base queries, active studies, submissions received, submissions approved, volume, turnaround time and more. The project team will create visuals for internal and external use.

Once the baseline portfolio is built, RCS will increase transparency by reporting data on unit activity, including volume and turnaround times, as well as use data to explore opportunities for education, outreach, and training. 

RCS Satisfaction and Accessibility Survey

RCS hosts an online survey continuously, and it will continue to gather and evaluate survey results. The survey collects data from elective responders regarding all responsibility areas of RCS and includes questions about barriers, experience, tools, and resources; these data are reviewed bi-monthly by RCS leadership and the Human Subjects Research (HSR) Advisory Committee. The data will be used to evaluate the success of the action plan. 

Priority Area 2: Research Compliance Service’s Internal Quality Assurance

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Impact Goal:

RCS will maintain a continuous quality improvement (CQI) initiative using a multi-phased approach throughout 2024 that will include data-informed strategic priorities for training, education, outreach, and enhancement of resources to build rapport; increase knowledge and understanding; and facilitate expedient, compliant, and ethical HSR review among the UO research community.

Overview

RCS will triage submissions and whenever possible, accommodate “rush” designations. RCS will also review routinely a sampling of protocol revisions requested to assess the quality of revisions and ensure congruency with policy, procedures, regulations, guidance, and best practices. This monitoring will allow for targeted feedback and training amongst RCS staff.

Below is a visual of the CQI multi-phased continuum. Work often occurs in multiple phases at once. RCS will build upon, enhance, and revise training, monitor for backlog and implement corrections, focus on process, guidance and internal resource development, use newly developed operational metrics to explore data for themes for improvement, identify process improvement opportunities, and further training and outreach activities. Staff will have opportunities for continuing education to remain current with regulations and best practices. 

Continuous Quality Improvement Continuum

Priority Area 3: Process and Procedures

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Impact Goal:

RCS will continue to review and improve processes and procedures to facilitate expedient, ethical, and compliant review of HSR. 

Overview

RCS will review and improve processes and procedures to ensure regulatory compliance and ethical best practices in HSR. CQI work includes exploring processes to ensure consistency and development or enhancement of internal resources to assist staff and the research community. Further, education and training will work in tandem with established processes to promote consistency and accuracy in reviews by RCS staff and IRB, as well as solicit better submissions from researchers who will have a clearer understanding of regulatory requirements. RCS will:

• Enhance outreach efforts to build rapport with researchers and offer transparency for the research community on processes and procedures.
• Use metrics to explore efficiencies in processes and procedures as part of CQI in conjunction with feedback received from the research community (e.g., survey results, liaison input) to allow RCS leadership to identify areas for refinement, simplification, or further clarification.
• Develop tools based on the reporting from priority area 1 (operational metrics data and reporting) to assess review procedures more fully for expediency, compliance, quality and clarity. Communications and outreach efforts will be evaluated to ensure they are helpful, clear, timely, and provide excellent customer service.
• Continue to oversee operations to support IRB review (RAP administration, documentation, facilitating reviews, and communications), including operationalizing two fully convened IRB meetings per month and working with IRB members who conduct IRB reviews outside of these two meetings to ensure effective review of human subject research.

Priority Area 4: Communication and Outreach

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Impact Goal:

RCS will enhance communication and outreach with the UO research community to positively impact awareness and understanding of human research protections and facilitate compliant and ethical review of HSR. 

HSR Advisory Committee

The HSR Advisory Committee (HRAC) will serve as a collaborative committee to human subject research and facilitate constructive feedback. Members will include an OVPRI faculty associate vice president, the RCS director, and four to six faculty representatives from the HSR research community. The HRAC will:

• Obtain and share stakeholder feedback, provide guidance and counsel on cross-cutting HSR issues, make recommendations and generate ideas for innovative approaches, and serve as a conduit for knowledge and constructive feedback from the research community to RCS.
• Develop and administer an annual human subject research survey. The HRAC will evaluate survey results and use results to inform priority areas for exploration and action planning.
• Explore the regulatory understanding of minimal risk research to broaden and enhance understanding amongst the research community. This will include, for example, what research qualifies for exemption, what research qualifies for expedited review, and how minimal risk is determined.
• Evaluate best practices and examples from external institutions, professional human research protection organizations such as the Public Responsibility in Medicine and Research (PRIM&R), and human research protection accrediting bodies such as AAHARP.

Liaison Group

RCS will identify the primary research departments and solicit interest to identify unit staff liaisons who will connect RCS and researchers in the department. This individual can be a research coordinator, DGA, or a research assistant. Liaisons will:

• Share resources, educational opportunities, and serve as a first point of contact to assist researchers within their department, connecting researchers with available RCS trainings, pertinent new materials, and other offerings.
• Become knowledgeable about key resources available through RCS and assist researchers with navigating complexities within human research protections.
• Attend quarterly meeting hosted by RCS.
• Identify additional compliance offerings.

The Liaison Group will provide RCS feedback about training and communication needs. RCS staff will remain available to answer specific review questions prior to protocol submission and for any requested clarifications.

Priority areas for outreach and training include IRB approval criteria, research with multiple sub-studies, expectations of the fully convened IRB review process, expectations of the expedited IRB review process, expectations of the exempt review process, advertisement of available and/or new resources, and more. Addressing the priority areas will require resources as noted in the resource column on the action plan table, including technology, experienced communications professionals, and staff time for resource development and dissemination.

RCS Website Update

Working with the OVPRI Research Communications team, RCS will redesign its webpages to include more user-friendly tools and materials and increase outreach efforts about available offerings.

RCS Virtual Office Hours

To enhance availability, RCS established twice weekly virtual office hours hosted via Microsoft Teams. Research compliance administrators are available during office hours to answer questions or discuss HSR protocols, processes, ethics, and more. RCS will also continue to regularly meet with researchers during any requested hours.

General Outreach and Advertisement

Further, RCS will partner with the Research Communications to identify opportunities to enhance awareness when resources are newly available or to highlight existing tools useful for the research community. RCS will further partner with SPS to increase information shared with DGAs using existing SPS/DGA systems (e.g., meetings and list servs). Information is and will be routinely included in The Frontline newsletter and other outreach mechanisms identified through feedback from researchers. 

Priority Area 5: Training and Education

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Impact Goal:

RCS will add, enhance, and/or advertise available resources, supports, and increase training and educational supports for research community to facilitate learning community on human research protections. This improved training and education will increase HSR knowledge and improve protocol submission and review.

Overview

Additional training and education are available and/or will be developed to support the research community and address consistency and regulatory compliance within the review process. Training and education will target the following specific audiences. Some training and educational offering examples are listed below.

• IRB members:  Incoming member orientation and online training, continuing education sessions, and annual “refresher” session including policy and practice review.
• RCS staff: Webinars, virtual and live conference attendance, self-study, group review, review of revisions requested, and special topic lectures and luminary series; most offered through PRIM&R, the US Office for Human Research Protections, and National Institutes of Health; occasional the US Food and Drug Administration.
• Researchers: Short video clips to walk researchers through various submission processes in the RAP database system; federal guidance, resources, and educational offerings available through RCS About Us webpage; RAP system (integrated) resources, FAQs, topical guidance documents, targeted outreach to key departments, special topic trainings, small group discussions, and office hours.

Training will be developed specific to minimal risk research to broaden and enhance understanding amongst the research community and to provide greater tools and support to facilitate the review of minimal risk research. This will include which research qualifies for exemption expedited review, as well as how minimal risk is determined.

Action Plan Table

The action plan table outlines each priority area along with action steps, person(s) responsible, start and end dates, and any potential resources needed. As noted, some action items were already initiated prior to the development of this plan and are in the process of being implemented.

Download the action plan table.