The School of Medicine, along with Children’s and Fred Hutchinson Cancer Research Center, is sponsoring a day-long program on April 26 for clinical investigators.
Featuring several national experts, the program is structured as a UW Continuing Medical Education offering. Registration is required, with fees of $95 for faculty members and $75 for fellows. Faculty members from other health sciences schools are welcome to register. The sessions will be held in the HUB Auditorium on campus.
The title is “Clinical Research and Compliance: A Guide for Investigators.” For information and registration, see the Web site at http://www.dom.washington.edu/cme/mj0214/
Program segments include discussions of the roles and responsibilities of a principal investigator, the functions of an institutional review board (IRB), requirements for reporting “adverse events,” and several segments on current ethical and regulatory issues.
The course chair is Dr. Evan Kharasch, professor and vice-chair of anesthesiology and associate program director of the General Clinical Research Center.
“Recent events remind us of the compelling need to ensure patient safety in clinical research, which functions in an increasingly complex and time-consuming regulatory environment,” Kharasch said. “This program endeavors to educate clinical investigators in basic issues, to ease and maximize their regulatory compliance, and to present emerging issues and controversies which will affect clinical research in the future.”
Other UW faculty members participating are Dr. Albert Berger, associate dean for research and graduate education, and Helen McGough, director of the Human Subjects Division. Dr. Paul Ramsey, vice president for medical affairs and dean of the School of Medicine, will open the program.
Guest faculty members include Dr. David DeMets, chair of biostatistics and medical informatics at the University of Wisconsin; Dr. William Harlan of the Division of Services and Intervention Research at the National Institute of Mental Health; Julie Kaneshiro of the Office for Human Research Protections in the U.S. Department of Health and Human Services; and Dr. Robert Levine of the Yale Interdisciplinary Program in Bioethics.
Other guest faculty are Dr. Drummond Rennie, deputy editor of the Journal of the American Medical Association; Dr. Belinda Seto, deputy director of the Office of Extramural Research at the National Institutes of Health; Dr. Mark Sobel, executive officer of the American Society for Investigative Pathology; and Dr. Robert Temple of the U.S. Food and Drug Administration.
“This program,” said Associate Dean Berger, “is part of the School of Medicine’s commitment to the education and training of our clinical investigators. The School also has other training and education programs that include the Biomedical Integri†y Lecture Series, a National Institutes of Heal†h K-30 Clinical Research Training Program and a Robert Wood Johnson Foundation Physician Faculty Scholars Program.”