8:00-8:30am
8:00-8:30am
Registration & Breakfast
8:30-9:20am
Keynote: Working Toward a Cure in Hemophilia
Description to come
Barbara Konkle, MD
Medical Director, Special Hemotosis Laboratory
Associate Director, Hemophilia Treatment Center, Bloodworks Northwest
Interim Chief Scientific Officer, Bloodworks Northwest
Professor of Hematology and Medicine, University of Washington
A nationally and internationally recognized expert in laboratory evaluation, diagnosis, and treatment of bleeding and clotting disorders, Dr. Konkle continues to pursue research on hemostasis clinical test development and the use of such testing to support innovative clinical research. Dr. Konkle is especially interested in translational research—the bridge between scientific discovery and improved patient care. Her ultimate goal is to help bring new therapies to patients.
9:30-10:30am
The Human Research Protection Program: Cultivating a Partnership with your IRB
Institutional Review Boards (IRBs) have a federal mandate to facilitate research that protects the rights, safety, and well-being of research participants. By establishing a collaborative relationship with your IRB office, you can minimize misunderstandings, efficiently move your studies through the work flow, and together promote safe, ethical, high quality research.
Adrienne Meyer, MPA, CIP
Assistant Director for Research Support, Human Subjects Division
University of Washington
Adrienne Meyer, MPA, CIP, is the Assistant Director for Researcher Support in the Human Subjects Division at the University of Washington. Adrienne is a regulatory specialist and frequent lecturer on issues associated with regulatory compliance and research ethics in a broad spectrum of research disciplines.
Adrienne has been at the UW for nearly 20 years and has worked in many capacities with researchers from nearly every department and research discipline: from behavioral research with young children to first-in-human chemotherapy trials. She was recently a member of the Research on Medical Practices (ROMP) Ethics study team, which applied qualitative and quantitative methods to understand patient preferences for research consent.
10:40-11:40am
The Clinical Research Billing Cycle: Staff Role in Research Budget
The clinical research billing cycle is a complex process that involves multiple offices billing both clinical and study tests to the patient and the study budget. This session will provide an overview of a typical clinical research billing cycle, and highlight hand-offs between billing offices and members of the research team to prevent errors.
Will Dean
Revenue Cycle Manager
Clinical Trials Office, University of Washington
Eli Reis
Training and Communication Specialist, Clinical Trials Office
University of Washington
Laurel Weigler
Manager of Program Operations
Clinical Trials Office, University of Washington
11:40am-1:00pm
Lunch Break
1:00-2:00pm
Clinical Trial Management Systems: A One Stop Solution
Clinical Trials Management Systems (CTMS) integrate the multiple components of clinical research, such as billing, implementation timelines, and reporting guidelines. This session will describe the role of a CTMS and give a demonstration of the CTMS that will be rolled out at UW, SCCA, and Fred Hutch.
Oscar Cano
Product Manager, Clinical Trials Management System Program Office
Fred Hutchinson Cancer Research Center
Oscar Cano is the Product Manager for the CTMS Program Office, a tri-institutional group responsible for the implementation and ongoing operation of the Clinical Trial Management System (CTMS). Oscar has over ten years of experience in software implementation, training and support. He currently manages the OnCore CTMS shared across the University of Washington, Fred Hutch and Seattle Cancer Care Alliance.
2:00-2:15pm
Break
2:15-3:15pm
Accelerating Study Initiation: Institutional Resources to Catalyze Study Design
Learn sound methods to determine how best to approach implementing a new study, and apply elements of project management to organize the financial, timeline, institutional oversight, and research support resources to move your study through the start-up process.
Ashley Waldie, MA, CCRP
Operations Manager
Fred Hutchinson Cancer Research Center
Ashley Waldie, MA, CCRP, is the Start-up Operations Manager in Clinical Research Support (CRS). At CRS, Ashley manages a central team that provides comprehensive study start-up support on behalf of Cancer Consortium investigators to open clinical trials in 100 days.
Ashley is a seasoned oncology start-up project manager who has built systems to manage complex timelines for CRS and created tools to support study staff across the Consortium. She has developed communication and budget negotiation strategies that are effective and well-received by sponsors and CROs.
3:25-4:25pm
An Ethical Framework for Clinical Research: Rethinking and Going Beyond Informed Consent
In this session you will learn about eight ethical benchmarks for clinical research and apply them to cases to understand the trade-offs involved in ethical analysis.
Ben Wilfond, MD
Director, Treuman Katz Center for Pediatric Bioethics
Seattle Children’s
Benjamin S. Wilfond, MD, is the director of the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute and professor and chief of the Division of Bioethics in the Department of Pediatrics at the University of Washington School of Medicine. He is also adjunct professor in the UW Department of Bioethics and Humanities.
Dr. Wilfond is the chief of the Bioethics Consultation Service and an attending physician in the Division of Pulmonary Medicine at Seattle Children’s Hospital. He also coordinates Research Bioethics Consult Service for the Institute of Translational Health Sciences.
He attended New Jersey Medical School and completed his pediatric residency and his fellowship in pediatric pulmonology and medical ethics at the University of Wisconsin. Prior to moving to Seattle in 2006, he has held faculty appointments at the University of Arizona, National Institutes of Health, and Johns Hopkins University. He is the former chair of the intramural NHGRI IRB and has 25 years of experience on IRBs and DMCs.
He is currently working on ethical and policy issues related to the implementation of genetic testing for reproductive purposes, the role of disabilities in clinical decision‐making, the impact of research ethics consultation in clinical research, and the understanding of public attitudes about research on medical practices. He is the PAST president of the Association of Bioethics Program Directors and the chair for Pediatrics Working Group for the NHGRI Clinical Sequencing Exploratory Research Consortium.