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.
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
Faculty Contributor
Terri Butler
Assoc. Director of Outreach & Partnership