Speakers:
Michele Russell-Einhorn, JD
Chief Compliance Officer and Institutional Official
Advarra
Stephanie Malia Fullerton, Ph.D.
Professor, Bioethics & Humanities
University of Washington School of Medicine
Topic: Privacy and Human Subjects Research
Session Time: 11.30am
Session Objectives:
• Understand the importance of Privacy.
• Understand the challenge to Privacy as data sets grow,
• Consider ways of rethinking this challenge and how an IRB committee should respond to this issue.
Speaker Bio:
Michele Russell-Einhorn, JD, is the chief compliance officer and institutional official for Advarra, an independent IRB. Her expertise is in the areas of the protection of human subjects in research, scientific review of cancer research, and research administration generally. Previously, she served for 11 years as the senior director of the Office for Human Research Studies at the Dana-Farber Cancer Institute, where she was responsible for the management of scientific review and IRB review, involving all cancer relevant research involving human subjects conducted at the five Harvard University clinical institutions. She has over 30 years of professional experience, including service as the conflicts of interest attorney for the NIH; director of regulatory affairs for the HHS Office for the Protection from Research Risks and its successor office, OHRP; director in the Global Pharmaceuticals Practice at PWC; and associate general counsel for the J. Craig Venter Institute. Ms. Russell-Einhorn is a co-chair of the Secretary’s Advisory Committee on Human Research Protections, Subcommittee on Subpart A, and a founder and leader of the IRB Directors Group of the National Comprehensive Cancer Center. She served as co-chair of the AER Core Conference Planning Committee for three years, and as a member for five years. She is a speaker at numerous conferences on various topics relating to research involving human subjects protections, biorepositories, and FDA regulations.
Speaker Bio:
Stephanie Malia Fullerton, DPhil, is Professor of Bioethics and Humanities at the University of Washington School of Medicine. She is also Adjunct Professor in the UW Departments of Epidemiology, Genome Sciences, and Medicine (Medical Genetics), as well as an affiliate investigator with the Public Health Sciences division of the Fred Hutchinson Cancer Research Center. She received a PhD in Human Population Genetics from the University of Oxford and later re-trained in Ethical, Legal, and Social Implications (ELSI) research with a fellowship from the NIH National Human Genome Research Institute.
Dr. Fullerton’s work focuses on the ethical and social implications of genomic research and its equitable and safe translation for clinical and public health benefit. She serves as the ELSI lead for the Clinical Sequencing Evidence-Generating Research (CSER2) Consortium coordinating center, co-chairs the TOPMed Consortium ELSI Committee, and chairs the Bioethics Advisory Board of the Kaiser Permanente national Research Bank. She contributes to a range of empirical projects focused on clinical genomics translation and precision medicine approaches to the treatment and prevention of cancer and kidney disease in diverse patient populations.
Speaker Contact Details:
michele.russell-einhorn@advarra.com
(513) 619-7760
6940 Columbia Gateway Drive, Suite 110
Columbia, MD 21046
Speaker Contact Details:
(206) 616-1864
Box 357120
Department of Bioethics & Humanities
UW School of Medicine
Seattle, WA, 98195