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News Release
Noted Neurologist and Ethicist Joins EPA to Lead Agency
Review of Human Subject Research
Contact: Melissa Anley-Mills, 202-564-5179, or anley-mills.melissa@epa.gov
(Washington, D.C.— September 18, 2006) To continue to ensure that EPA’s research complies with all regulations that govern the protection of human research subjects, the EPA Administrator’s Science Advisor announces Warren E. Lux, Jr., M.D., has joined the Agency as the new Human Subjects Research Review Official (HSRRO). Dr. Lux’s appointment in the Office of the Science Advisor will provide high-level leadership and overall Agency direction regarding human research ethics and safety of those involved in EPA or EPA-funded research. Effective September 17th, Dr. Lux assumed the HSRRO duties from Dr. Peter Preuss who, for the past 10 years, provided exemplary leadership in assuring the highest of research ethics were observed and that study participants’ safety was always paramount.
“Dr. Lux will ensure that EPA’s research is conducted to the highest ethical standards and assure the safety of study subjects. EPA’s studies are used in the U.S. and throughout the world as the basis for policies that protect the health and well-being of people,” said EPA Assistant Administrator for Research and Development and EPA Science Advisor Dr. George Gray.
Dr. Lux was formerly medical director of the Defense and Veteran’s Brain Injury Center at Walter Reed Army Medical Center in Washington D.C. and Adjunct Associate Professor of Neurology at Washington University in St. Louis, MO. He is an Affiliated Scholar, Center for Clinical Bioethics, Georgetown University, Washington D.C.
As the principal Agency official to review and approve proposed research involving people, the HSRRO ensures that Agency studies comply with the Common Rule and all directives of 40 CFR 26, a federal regulation that provides guidance and principles to govern federal agency sponsored human subject research. Dr. Lux’s new duties include active participation in the Agency’s human subjects workgroups and federal oversight offices such as the Office of Human Research Protection. He will serve as the key liaison for EPA in interactions with Institutional Review Boards; develop, evaluate and oversee training and staff education regarding the ethical and safe conduct of human studies; and provide guidance to human research investigators in activities such as the preparation of study protocols, consent forms and questionnaires.
Dr. Lux graduated from New York University Medical School, has a Bachelor of Arts degree from Amherst College, is a Diplomate of the National Board of Medical Examiners, and holds a medical license for the District of Columbia as well as a certification in neurology from the American Board of Psychiatry and Neurology. He taught clinical ethics to medical, nursing and graduate students at the Georgetown University Medical Center and both ethics and cognitive and behavioral neurology to students, residents and others at the Walter Reed Army Medical Center. Dr. Lux twice received the Residents’ Award for Excellence in Teaching from the National Rehabilitation Hospital.
Dr. Lux has dealt extensively with human subjects research from the perspective of a clinical investigator and has valuable experience on hospital ethics committees and institutional review boards. These skills will enable Dr. Lux, as the HSRRO, to provide the necessary guidance, leadership and expertise on human research ethics and subject safety.
Office of Science Advisor: http://www.epa.gov/osa
Office of Research and Development: www.epa.gov/ord
Human Subjects of Research (the "Common Rule") http://www.epa.gov/oppfead1/guidance/cr-require.htm