Karen Moe

We are delighted to submit our enthusiastic nomination of Karen Moe, Director of the Human Subjects Division (HSD) for the past fifteen years, for a David Thorud Leadership Award.

Karen has exemplified stellar leadership since she took on the Director’s position. In 2004, then Vice Provost for Research, Craig Hogan, described the state of UW’s administrative infrastructure for human subjects research as needing immediate attention and significant change to address delays in research protocol approvals. Karen was faced with an extensive list of improvements to prioritize, coordinate, resource, and champion in what would become her legacy to the University. Rewriting policies and streamlining processes to increase capacity and implementing a web-based solution for processing protocol review were among the initiatives undertaken – and often refreshed — during Karen’s tenure. With perennial attention to improving service to the UW research community and frequent, clear communication with HSD staff, protocol reviewers, researchers and their staff, the promised improvements began almost immediately and have been ongoing ever since.

Leadership

From the first day Karen took over the Directorship, her leadership qualities shone through. She had an extraordinarily difficult task ahead—taking over from a long-time Director an understaffed and overburdened office, with high expectations from campus. But Karen had a strong vision for HSD, and she knew how to rally her team, build their trust, focus them on tangible, ambitious goals, and help them succeed. It was hard going for a while, but Karen never wavered in her belief in her team or in her vision, facing every challenge with optimism and a commitment to success. In the process, she became a leader more broadly in the Office of Research, as the unit focused on campus-facing service and continuous process improvement. Time after time when the OR leadership grappled with a difficult problem, it was Karen who showed everyone the way to a solution. She has been incredibly creative and thoughtful in this leadership role, always supporting the other Directors and always focused on the overall goals rather than her own achievements. At every level of Karen’s involvement: within HSD, within the Office of Research, within the University, and in a national context, she has embraced new ideas and approaches. As her track record for achieving success against high odds expanded, she was turned to more and more often to lead, create vision, and achieve success implementing that vision.

Modernizing UW IRB

An important example is HSD’s adoption of an on-line automated system (Zipline) for managing the submission, review and approval of research protocols. Everyone recognized the need to convert a largely paper-based administrative information management system to a fully electronic format, but the inertia of years’ worth of paper documents, policies and procedures made the change a particularly heavy lift.

Karen approached the task in a holistic fashion. She engaged stakeholders in the process of aligning operational, policy and organizational structures with the implementation of the electronic system. HSD staff were tasked with recommending policy and procedural changes that would take advantage of and accommodate the purchased system. As policy was rewritten, the organizational structure of HSD itself evolved – as a team effort – to reflect the changes.

Finally, training was developed for all types of users, including HSD staff, protocol reviewers (the Institutional Review Board), researchers and their support staff. Communications about all impending changes were published in manageable portions over time. The phased rollout of the system resulted in a nearly seamless transition from the paper-based system to Zipline for new applications over a period of less than 12 months.

Zipline is fully operational, there are no residual paper processes, and reporting to inform management and operational metrics is robust. The result is an operation that is transparent and accessible to all stakeholders. In 2020, the system supported processing of over 7,250 applications and problem reports, representing a 22% increase over 2019 despite the setbacks of COVID-19.

DEI Efforts

Within the Office of Research, Karen led HSD in becoming an early adopter of Diversity, Equity and Inclusion (DEI) initiatives and influenced OR more broadly. She established a DEI Committee within HSD and formulated a charter that is providing a framework for developing the charter of the larger OR DEI Committee. She started implementing best practices in hiring (e.g., standardized interview questions), which serve as a model for other OR units. She supported efforts to provide DEI educational opportunities for staff and require DEI training for her management team. DEI principles are also incorporated into HSD’s mission statement. In addition to her work on DEI internal to HSD, Karen has been a leader in OR efforts to consider equity and inclusion principles in researcher-facing policies, documents, and training. For example, HSD website content is being revised to use gender-neutral language and make forms that are accessible to persons with disabilities (e.g., individuals with visual impairments).

Legislative Advocacy

Karen worked on behalf of individuals who participate as subjects in research and for the teams that conduct the research when she successfully advocated for a change to the Washington State law (RCW 42.48) that required handwritten confidentiality agreements from researchers, redundant of existing privacy protections. Partnering with UW’s State Government Relations Office, Washington State University, the Washington State Council of Presidents, and the Fred Hutchinson Cancer Research Center, Karen ultimately testified before the Washington State Senate in support of the proposed legislation to change the law.

By eliminating this requirement, considerable unnecessary administrative burden on researchers and HSD staff was relieved, enabling all involved to devote more attention to research quality, productivity and subject protections.

At the federal level, in November of 2011, Karen provided testimony to the Presidential Commission for the Study of Biomedical Issues in Washington, DC regarding the UW’s unique compensation for injury program, the Human Subjects Assistance Program. She explained to experts on the Commission how the program was an ethical and responsible model for improving the risk-benefit ratio of research involving human participants. By expanding financial protections for potential research participants, a larger volume and variety of individuals may be recruited to research protocols benefitting society at large.

COVID-19 Response

As COVID-19 infection rates climbed in 2020, state and University precautions were established to prevent the spread of the virus among the general population. Those precautions evolved over the weeks and months, requiring decisions regarding what human subjects research could and could not be conducted.

Thousands of human research protocols are active at UW at any given time. While it would have been easier to simply curtail all human subjects research that involved close contact between and among research subjects, researchers and clinicians, Karen recognized the importance of allowing as much research activity as could safely be done as possible. In addition to preserving the scientific progress of ongoing research protocols and supporting UW’s research workforce, many new protocols were being developed to specificly address the pandemic and its effects on society.

Karen’s approach was to develop a Risk Assessment Tool — a score sheet researchers could use to assess the level of risk of each of their human subjects protocols. The tool was easy to understand and use, leveraging responses to a list of criteria to provide a risk score, which is compared to a specified threshold for determining whether the protocol is safe enough to proceed. By describing the risk criteria in the Tool, researchers could adjust their protocols to make them safer, resulting in lower risk scores. As the effects of the pandemic wax and wane, the threshold for acceptable risk could be adjusted accordingly. Finally, the Tool aligns with the more general Office of Research guidelines for allowable research at UW to provide specific guidance for human subjects research.

In addition, Karen was instrumental in helping the research team responsible for the Seattle Flu Study (SFS) and the Husky Coronavirus Testing Program (powered by the SFS) (HCT) navigate the complex federal regulations governing human subjects research. Each of these initiatives has research components as well as public health components, with overlapping regulatory frameworks. Finding a way for the SFS to pivot from a research initiative to a public health initiative was essential to the rapid and early (March, 2020) start of large scale testing of individuals for SARS-CoV-9 in the Seattle area. The HCT was structured so that data collected from testing could be used for research purposes, which will provide invaluable insights to this and potential future pandemics.

Conclusion

Karen is retiring in 2022. She is leaving HSD having had a transformational impact on the operations, positively impacting researchers across campus and the subjects that they work with, as well as the morale of HSD staff. While she will be greatly missed, her mentoring of staff leaves HSD with a strong management team to continue the tradition of service that she has established. We hope the UW will take advantage of this final opportunity to recognize a leader who has had such broad impact on the UW community.

Mari Ostendorf & Mary Lidstrom, Current/Former Vice Provost for Research
Joe Giffels, Senior Associate Vice Provost, Research