Regulatory Knowledge & Support
The ITHS Regulatory Knowledge & Support (RKS) team supports quality clinical research and innovation at the University of Washington, Seattle Children’s, Fred Hutch and beyond.
What We Do
At the Institute of Translational Health Sciences (ITHS), RKS plays a critical role in advancing biomedical research while ensuring compliance with ethical standards and federal regulations. ITHS provides expert guidance to researchers navigating complex regulatory landscapes, including Institutional Review Board submissions, FDA approvals, and adherence to Good Clinical Practice guidelines. By offering tailored consultations, training programs, and resources through RKS, ITHS helps streamline the approval processes for clinical trials and other research projects, empowering investigators to focus on scientific innovation while maintaining rigorous regulatory standards.
RKS leverages a Clinical Trials Office (CTO) Collaborative spanning University of Washington, Seattle Children’s, and Fred Hutchinson Cancer Center to streamline study startup and research coordinator training. We developed and implemented two types of clinical research training curriculum for research coordinators: a Competency-Based All-Level Training (COBALT) focused on Good Clinical Practice (GCP) guidance and clinical research regulations; and a Modular Institutional Training (MINT) focusing on organization-specific policies and processes.
Through the Technology Development Center (TDC), we have consolidated and coordinated training, funding support, and services for academic innovators. The intent of this consolidation was to make it easier for translational researchers to find and connect with others who can help advance their scientific and technological developments beyond their laboratory “comfort zone” and through regulatory path definition, early clinical study, and preparation for commercialization. This consolidation has also facilitated the establishment of a regional presence through partnerships with innovation hubs and CTSAs and attracted a broader field of WWAMI innovators to apply for ITHS Pilot Awards.
Regulatory Knowledge & Support Services
Research Coordination Center
The Research Coordination Center is a multidisciplinary team of research coordinators, regulatory specialists, and study monitors who can support the design and conduct of clinical and translational research.
Research Bioethics Consultation Service
Our research bioethics consultants offer advice to researchers, research staff, personnel involved in protection of human subjects, and research participants who have questions about any aspect of a research study.
Technology Development Center
The ITHS Technology Development Center is staffed with clinical, regulatory, and commercialization experts to assist innovators through all the steps of building a startup from translation to market entry.
RKS Team
Laura Baker
Seattle Children’s Senior Director of Clinical Research Integration
Kristi Stiffler
Fred Hutch VP of Clinical Research
Lynn Rose
RKS Faculty Contributor
Terri Butler
ITHS Assoc. Director of Outreach & Partnership