NED 2025

In this session, attendees will learn about ethical benchmarks for clinical research and practice applying them to real-life case examples, with a focus on the role of researcher-participant interactions

Learning Objectives:

• Describe eight benchmarks for ethical clinical research
• Discuss how empirical data illustrate challenges with informed consent
• Describe the role of researcher-participant interactions in the ethical conduct of research

Presenter:

Kate MacDuffie, PhD, MA
Associate Research Director, Treuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle Children’s Research Institute
Assistant Professor, Department of Pediatrics, UW School of Medicine

Dr. MacDuffie’s research is focused on understanding the ethical and social impacts of advances in neuroscience on children and adults affected by psychiatric, neurological, and neurodevelopmental disorders. In her approach, she seeks to draw in and learn from the voices of those who are most likely to be impacted by cutting-edge science, but who are not often included in the design, conduct and dissemination of such research. She uses a combination of qualitative, quantitative, and conceptual methods with the overarching goal of embedding the perspectives of research participants and other impacted stakeholders into the practice and process of research.

This session will be part informational/presentation of the topics listed in the bullets below and then we’ll open it up for any/all REDCap questions. We will demonstrate the new/updated features and attendees can ask questions about what we demonstrate. Time will be set aside for general REDCap questions and/or concerns.

We have recently upgraded REDCap with many new features they may not be aware of including:

Updated features:

• New eConsent framework
• Updates to randomization
• Updated codebook display
• Mobile technology options

New features:

• New field navigator
• Multiple field editing
• Draft preview mode
• Descriptive popups
• New survey settings and options
• List of upcoming calendar events
• New smart variables
• Mosio texting option
• Also: new online training opportunities

Receiving an overview of the updated features will be informational and applicable to those using those features, but the new features topics should be applicable to all REDCap users and will generally make using REDCap easier and/or introduce new features that have been asked for such as the descriptive popups and new field editing options.

Learning Objectives:

• Attendees will learn about and be able to make better use of new features recently added to REDCap for creating and editing project instruments and automating surveys
• Attendees will learn to use new features available within REDCap that provide tools for the full lifecycle of research projects from eConsent and subject randomization to mobile technology data collection options and sending alerts to participants using SMS text messaging

Presenters:

Ann M. Gleason, Ed.D.
Research Applications Training Analyst
Research IT
UW Medicine IT Services | ITHS

Ann Gleason provides education and training materials for users of the research tools provided by UW Medicine Research IT including: REDCap, Epic research, and Leaf, as well as serving as administrator of the ITHS TREE learning management system.

Courtney Howell
Manager, RedCap Application
UW School of Medicine – RIT

Courtney Howell is originally from Anchorage, Alaska and ventured to the lower 48 to attend Seattle University and received their BS in Psychology. They previously worked as a housing case manager, research coordinator, and are currently the REDCap manager for the University of Washington. They have been using REDCap for over 8 years, and will happily talk to you about it any day of the week.

Gretchen Kuhn
REDCap Administrator
Research IT
UW Medicine IT Services | ITHS

Gretchen Kuhn is a REDCap administrator with the University of Washington. Prior to moving into REDCap, they worked as a research coordinator for two years with Washington State University. Gretchen is from Virginia so they don’t understand the UW/WSU rivalry but would love to hear your opinions.

Adam Mahama
Lead REDCap Administrator
Research IT
UW Medicine

Adam Mahama is a REDCap administrator with nearly 6 years of experience. His background is in IT Systems Administration.

Project management is a vital skill for research coordinators at any stage of their career. Research coordinators are asked to wear a variety of hats and must juggle near-constant demands on their time from multiple PIs, regulatory organizations, study participants, and more. Understanding project lifecycles, how to manage limited resources, and using available tools to keep track of your tasks and work will help you coordinate research more effectively. This will be an interactive session and discussion to share best practices.

Learning Objectives:

• Understand the “triple constraint”, “scope creep”, and strategies for “pushing back” when overwhelmed
• Identify tools that can help stay organized

Presenter:

Caitie Hawley, MSPH
Project Manager
Center for Pediatric Bioethics
Seattle Children’s Research Institute

Caitie (she/hers) has a decade of experience managing a variety of clinical research studies ranging from behavioral interventions, drug and vaccine trials, ancillary studies on topics such as HIV, cardiovascular health, and most recently, pediatric bioethics and palliative care. Her passions include health equity, reproductive justice, and vaccines. She has an MSPH in Global Disease Epidemiology and Control from Johns Hopkins Bloomberg School of Public Health and is working on a Certificate in Biomedical Regulatory Affairs from UW. She lives in Shoreline with her husband, dog, and 2-year-old son. In her spare time, she enjoys reading and rock climbing.

This session will explore the foundational principles of community-based participatory research (CBPR) and highlight practical approaches for engagement in research. Drawing from experiences working with people with traumatic brain injury (TBI) and care partners, the discussion will emphasize ethical considerations, trust-building strategies, and ways to foster meaningful collaborations. Participants will gain insights into the challenges and benefits of CBPR in research and leave with actionable strategies to enhance community engagement in their own work.

A key focus will be addressing the unique challenges of engaging individuals with TBI in research, including cognitive impairments, communication barriers, and issues of accessibility. Strategies for overcoming these barriers—such as adapting research materials, incorporating flexible participation methods, and prioritizing inclusive research design—will be discussed.

Learning Objectives:

• As a result of attending this session, participants will be able to identify two key principles of community-based participatory research (CBPR)
• Participants will be able to describe at least two strategies for effectively engaging individuals in research
• Participants will understand common barriers to research participation for people with TBI and explore solutions to enhance engagement and accessibility

Presenter:

Leslie Kempthorne, BS
Research Manager
University of Washington School of Social Work

Leslie Kempthorne has over two decades of experience in research focused on traumatic brain injury (TBI) and health equity. She joined the University of Washington (UW) in the Dept of Rehabilitation Medicine in 2000, where she contributed to numerous studies, including the TBI Model System. In 2024, Leslie transitioned to the UW School of Social Work (SSW), where she collaborates with Dr. Megan Moore at the Harborview Injury Prevention & Research Center (HIPRC). Her work has centered on patient-engaged research, with a strong emphasis on the perspectives of people with TBI. Leslie will begin her Master of Social Work (MSW) program at the UW SSW in Fall 2025.

Artificial intelligence (AI) is revolutionizing clinical research, reshaping how trials are designed, conducted, and analyzed. This presentation will explore innovations AI brings to clinical research, from streamlining data collection to optimizing patient recruitment and trial efficiency. We will examine real-world applications, critically assess data from recent studies, and discuss the challenges AI present, including ethical concerns, biases, and regulatory hurdles. Looking ahead, we will explore who is driving AI development in the field, where the technology is headed, and what steps are needed to fully harness AI’s potential while ensuring its responsible and effective integration into clinical research.

Learning Objectives:

• Understand AI Fundamentals:Gain a clear introduction to artificial intelligence and generative AI, and learn how these technologies are being applied within clinical research
• Critically Evaluate Research:Examine key studies and data on AI implementations, discussing both successes and limitations, and learning how to assess evidence critically

Presenter:

Patrick N. Panlasigui, MS
Senior Manager, Clinical Operations, Clinical Research Support
Fred Hutch Cancer Center

Patrick Panlasigui, is a Washington state native and an accomplished leader in the field of clinical trials and healthcare. With a master’s education in pharmacological and genomic research from George Washington University and a background in biology from the University of Washington, Patrick is a dedicated research professional with a wealth of experience. Currently serving as the Senior Manager of Clinical Research at Fred Hutchinson Cancer Center, he oversees a team of 20 research employees managing 60 genitourinary medical oncology clinical trials for twelve principal investigators, showcasing his effective leadership and project management skills. Patrick’s comprehensive training in clinical research study operations, coupled with his roles as a clinical research manager at UC San Diego, the University of Washington and the Fred Hutch Cancer Center, reflects his commitment to ensuring regulatory compliance and advancing the field of oncology research. Beyond his exceptional contributions to the clinical trials realm, Patrick serves as the General Director on the Board of Directors at Resounding Joy, Inc., demonstrating his commitment to integrating healthcare expertise into the mission of providing music therapy. He now resides in Lynnwood, WA with his wife Amoreth where, in his spare time, not only does he enjoy playing tennis but also performs as talented guitarist and musician.

This will be a Q&A discussion among a panel of research professionals, sharing their experiences with regulatory inspections/assessments. In addition, there will be a brief introduction explaining the differences among different types of regulatory assessments (sponsor audits, FDA inspections, NIH audits, etc.) as well as concluding remarks, highlighting regulatory preparedness strategies to instill into everyday research activities to ensure success during future regulatory assessments.

Learning Objectives:

• Participants will know the difference among sponsor audits, FDA inspections, NIH audits and organizational compliance inspections
• Participants will be able to identify at least three strategies on how to prepare for each of these regulatory assessments

Moderator & Panelists:

Joanna Yuan, MPH (Moderator)
Program Manager, Office for Training Regulatory Affairs and Quality Support (TRAQS), Seattle Children’s Research Institute

Kira A Spencer, PhD (Panelist)
Regulatory Affairs Specialist II, Office for Training Regulatory Affairs and Quality Support (TRAQS), Seattle Children’s Research Institute

Zoe MacDougall, BS (Panelist)
Clinical Research Coordinator I, Center for Child Health, Behavior and Development, Seattle Children’s Research Institute

Mason Nuding, BS (Panelist)
Clinical Research Coordinator III, Lead, Gastroenterology and Hepatology, Center for Clinical & Translational Research, Seattle Children’s Research Institute

Deb Bergevin, BS (Panelist)
Quality Assurance Specialist III, Ben Towne Center for Childhood Cancer and Blood Disorders Research, Seattle Children’s Research Institute

Nicole Groves, PhD (Panelist)
Acting Assistant Professor, University of Washington School of Medicine, Department of Psychiatry & Behavioral Sciences; Attending Psychologist, Seattle Children’s Hospital, Division of Psychiatry & Behavioral Medicine

Biographies:

Joanna Yuan: Out of undergrad, I was looking for a public health related “big girl” job, somehow, I ended up as a research assistant for an NIH behavioral health clinical trial. I never thought I would end up working in clinical trial research, but here I am! During my time as a research coordinator I was fortunate to work on a wide variety clinical trials funded by the NIH, CDC, and other industry sponsors. These days, I work as a program manager, strategizing and building lasting systems to produce top tier research. It is my hope that investing in these systems, would lead to an increase of public trust and knowledge, ultimately leading to a more equitable society. In this session, I’m honored to serve as your host! Come along with me as we explore important questions from our amazing panelists to understand the whys behind all the “busy work” we do as research study team members.

Kira A Spencer: I am a Regulatory Affairs Specialist with passion for ensuring research professionals have the knowledge, skills and resources they need to collect high quality, integrous data. My work is informed by experience in both animal and clinical research studying topics spanning developmental neuroscience, anesthesiology and psychology. I have experience with sponsor-audits, internal/organizational audits and for-cause FDA inspections.

Zoe MacDougall: I am a Clinical Research Coordinator with experience in NIH-funded clinical trials focused on child and adolescent mental health. My interest is in improving the participant experience while maintaining proper research conduct. I have experience in internal/organizational audits and a for-cause FDA inspection.

Mason Nuding: I am a clinical research coordinator in gastroenterology and hepatology.  I have experience with investigator-initiated studies and industry sponsored research.  My role in clinical trials is to make sure that the participant is the focus of the research and to support quality research outcomes.

Deb Bergevin: I started my career as a clinical coordinator in 1989 and knew I found my calling in research. As a Quality Assurance Specialist III, leading teams to understand how quality assurance and regulatory issues matter in clinical research is a rewarding endeavor. I’ve had manager and director titles, but my favorite research role is that of QA Specialist – mainly because I have a passion for training whyit matters. I have experience with internal/organizational audits, sponsor audits, NCI cooperative group audits, and both routine and for cause FDA inspections.

Nicole Groves: I am a clinical psychologist who works with individuals with ADHD across the lifespan in both clinical and research settings. My research experience spans multiple federally funded clinical trials focused on efficacy of novel interventions and effectiveness/implementation of extant interventions. I primarily have experience in internal/organizational audits as well as supervising junior colleagues in understanding and adhering to Good Clinical Practice when engaged in human subjects research.

This session provides a behind-the-scenes look at coordinating the WWAMI Region Practice and Research Network (WPRN), offering research coordinators insights into how studies are managed, partnerships are built, and research is implemented in primary care settings.

Learning Objectives:

• Describe how the WWAMI Region Practice and Research Network (WPRN) connects research teams with primary care clinics, including the key steps and decision points in the project-matching process.
• Identify at least two common challenges that research teams face in coordinating clinic-academic partnerships and potential solutions.
• Apply WPRN tools and strategies to better facilitate clinic engagement, support study implementation, and help research teams navigate primary care collaborations.

Presenter:

Dillon van Rensburg, MPH, MCHES
Research Scientist
Institute of Translational Health Sciences

Dillon van Rensburg, MPH, MCHES, is a Research Scientist at the University of Washington’s Institute of Translational Health Sciences. He is a part of the Community Engagement division. At ITHS, Dillon co-manages the WWAMI region Practice and Research Network, which builds partnerships between primary care clinics and academic researchers. In addition, he supports community-engaged research and implementation studies through conceptualization, data collection and analysis, and dissemination. He also provides training on the science of community engagement to enhance research rigor, credibility, and trustworthiness.

Dillon serves on the board of directors for the Washington Rural Health Association. He holds a Master of Public Health in Health Services from the University of Washington and is a Master Certified Health Education Specialist. With a focus on rural and underserved populations, Dillon is committed to advancing research that directly addresses community needs and contributes to lasting improvements in health outcomes.

This session will discuss health inequities faced by participants with limited English proficiency, and how the research coordinator can confidently enroll individuals from all backgrounds. This session will also address practical approaches to difficult conversations with PI’s about unequal enrollment strategies. The research coordinator plays a pivotal role in developing a culture of competency, and creating an environment that benefits all participants.

Learning Objectives:

1. Understand the benefits of translating written materials for those who have limited English proficiency
2. Understand approaches to access translation services at one’s institution for study recruitment and enrollment

Presenter:

Alexandra Quinn, BA
CRC-1
Laguna Lab, McGarry Lab
Center for Respiratory Biology and Therapeutics (CRBT)
Pulmonary and Sleep Medicine Division
Seattle Children’s Research Institute & Seattle Children’s Hospital

Ali graduated from the University of Colorado Boulder in 2020 with a BA in Psychology. After graduating, Ali worked in a locked facility with male youth offenders serving sentences for committing violent crimes. In December 2021, Ali moved to Seattle to work 1 on 1 with high needs Special Education students in WA state schools using the Emotion Focused Therapy model. In 2022, Ali transitioned into a CRC role at a private research site in Bellevue, conducting phase 3 pharmaceutical trials for patients with psychiatric and neurologic conditions. Ali has worked at Seattle Children’s Hospital for a year and a half in Dr. Terri Laguna and Dr. Meghan McGarry’s labs as the primary CRC for both investigators. The Laguna and McGarry Labs study pediatric Cystic Fibrosis from a microbiological standpoint, as well as health inequities faced by individuals with Cystic Fibrosis. Ali is an active member of the Science Insights Committee, the SCRI Women’s Council, and The Pulmonary and Sleep Medicine Division EDI Task Force and the Pulm Wellness Committee. Outside of work, Ali is a volunteer on the City of Seattle Victim Support Team in the Crime Survivor Services Department, assisting survivors of domestic violence.

Emotional intelligence (EI) is crucial for effective leadership. Emotional intelligence has been associated with higher productivity, performance and job satisfaction in numerous fields. Leaders with high EI are more capable and confident and are able to relate more positively with others on the team. We will ask participants to complete an EI assessment prior to the session. During the session, we will discuss your strengths, areas for improvement, and strategies for boosting your EI. Competencies and characteristics of EI include self-awareness, self-management, social awareness, relationship management, empathy, and motivation. High EI correlates to crucial workplace skills including conflict management, communication and teamwork.

Learning Objectives:

• Utilize a self-assessment survey to understand your strengths and areas for improvement related to EI competencies.
• Understand the basic competencies of emotional intelligence and how these competencies impact leadership.
• Identify one to two actions that you take to strengthen your emotional intelligence.

Presenter:

Jennifer Sprecher, MS
Director of Strategy Development and Deployment
University of Washington School of Nursing

Jennifer Sprecher is Director of Strategy Development and Deployment with the School of Nursing.  Ms. Sprecher works with organizations to achieve excellence through Strategy development, Lean Project Management*, balanced scorecards, change management, benchmarking, team problem solving, team and leadership coaching and facilitation.

Ms. Sprecher is a strong team facilitator, called upon to facilitate high-level teams where interaction to reach objectives is critical. Her facilitation ranges from groups of 6-200+ individuals working in person and virtually, from central to internationally diverse team locations.  She has worked extensively in the team science arena providing both research, workshop development and delivery, and facilitation to health science research teams.

Ms. Sprecher has a bachelor’s degree in Industrial Engineering, a Master’s of Science in Management Systems, is a certified Lean Six Sigma Black Belt and a certified Leadership Coach.

Before the UW School of Nursing, Ms. Sprecher focused exclusively on health research in the Institute of Translational Science, also within the University of WA.   Prior to the UW, Ms. Sprecher spent 7 years as Executive Director of the Washington State Quality Award (WSQA), a Baldrige-based non-profit organization. With a background in Industrial Engineering, Ms. Sprecher has been working with process improvement for over 25 years using continuous process improvement methods including Lean, Lean-Sigma, Plan Do Check Act and 6S (5S workplace organization combined with Safety) and Total Quality Management.  Her coaching is focused on working with leaders and up and coming leaders within the technical and scientific community.

Jesse Gelsinger’s death in a gene transfer clinical trial, and its widespread ramifications had a profound effect on the conduct of research, particularly at academic medical centers, and it almost killed the field of gene therapy clinical research. It greatly impacted the institution at which the clinical trial was conducted (UPenn) – but also other research institutions, as they looked at their own policies (or lack thereof). Hearing this story is a learning experience for academic investigators and people in regulatory positions. There are lessons on clinical trial design and conduct, conflict of interest, GCPs, informed consent, and human subjects protection.

Learning Objectives

1.  Attendees will learn the importance of following Good Clinical Practice regulations and guidelines, and will understand the gravity of not complying with regulations for the conduct of clinical research
2. Attendees will learn what steps the FDA and other governmental entities take to enforce regulatory requirements for the conduct of clinical research

Presenter

Erica C. Jonlin, PhD
University of Washington

Erica Jonlin is the regulatory manager for clinical research activities in the UW Institute for Stem Cell and Regenerative Medicine (ISCRM) and the UW Department of Laboratory Medicine and Pathology, where she is responsible for educating and assisting investigators in complying with FDA and IRB regulations. Erica regularly lectures and publishes on ethical conundrums in Human Subjects research and stem cell research, and for over 13 years she was an instructor for the UW Certificate in Clinical Trials and UW Biomedical Regulatory Affairs Masters of Science programs. For five years, Jonlin was a human subjects review administrator for one of the University of Washington’s Institutional Review Boards, serving as a member and facilitator of the committee, and documenting committee reviews and decisions. Erica has a Ph.D. in Biochemistry which she earned at the University of California, Los Angeles.