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Controlled Human Inhalation-Exposure Studies at EPA (2017)

Chapter: Appendix A: Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants

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Suggested Citation:"Appendix A: Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants." National Academies of Sciences, Engineering, and Medicine. 2017. Controlled Human Inhalation-Exposure Studies at EPA. Washington, DC: The National Academies Press. doi: 10.17226/24618.
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Appendix A

Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants

Robert A. Hiatt (chair) is professor and chair of the Department of Epidemiology and Biostatistics at the University of California, San Francisco (UCSF). He also is the associate director of the UCSF Helen Diller Family Comprehensive Cancer Center. In addition, Dr. Hiatt holds adjunct appointments as professor in the Division of Epidemiology at the University of California, Berkeley School of Public Health and as an adjunct investigator at the Division of Research at Kaiser Permanente Northern California in Oakland. From 1998 to early 2003, he was the first deputy director of the Division of Cancer Control and Population Sciences at the National Cancer Institute, where he oversaw cancer research in epidemiology and genetics, surveillance, and health services research. Dr. Hiatt has been the principal investigator of the Bay Area Breast Cancer and the Environment Research Center that is studying the influence of environmental factors on pubertal maturation as a window to understanding the causes of breast cancer. He is a past president of the American College of Epidemiology and the American Society for Preventive Oncology. He has served on several past Institute of Medicine (IOM) committees including the Committee on Breast Cancer and the Environment: The Scientific Evidence, Research Methodology, and Future Directions. Currently, Dr. Hiatt serves as a member of the National Academy of Medicine (NAM) Committee on the State of the Science in Ovarian Cancer Research and the National Research Council’s Board on Environmental Studies and Toxicology. He received an M.D. from the University of Michigan and a Ph.D. in epidemiology from the University of California, Berkeley.

A. John Bailer is university distinguished professor and chair in the Department of Statistics, Scripps Research Fellow in the Scripps Gerontology Center, faculty affiliate of the Statistical Consulting Center, affiliate member of the Department of Biology, and affiliate member of the Department of Sociology and Gerontology at Miami University in Oxford, Ohio. His research interests include the design and analysis of environmental and occupational health studies and quantitative risk estimation. Dr. Bailer is a fellow of the American Statistical Association (ASA), a fellow of the Society for Risk Analysis, and a recipient of the ASA Statistics and the Environment Distinguished Achievement Medal. He has served on several National Research Council committees, including the Committee on Improving Risk Analysis Approaches Used by the U.S. EPA, the Committee on Spacecraft Exposure Guidelines, the Committee to Review the OMB Risk Assessment Bulletin, and the Committee on Toxicologic Assessment of Low-Level Exposures to Chemical Warfare Agents. He also has served as a member of the Report on Carcinogens Subcommittee and the Technical Reports Review Subcommittee of the Board of Scientific Counselors of the National Toxicology Program. Dr. Bailer received a Ph.D. in biostatistics from the University of North Carolina at Chapel Hill.

Rebecca Bascom is a professor of medicine at the Milton S. Hershey Medical Center at Pennsylvania State University. As a specialist in pulmonary medicine, her primary clinical focus is caring for patients with serious diseases of the lung. Dr. Bascom has conducted research on lung diseases and inhalation toxicology, including a team analysis to evaluate the cardiorespiratory health effects on New York City police officers exposed during the 9/11 terrorist attack. She is committed to multidisciplinary translational

Suggested Citation:"Appendix A: Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants." National Academies of Sciences, Engineering, and Medicine. 2017. Controlled Human Inhalation-Exposure Studies at EPA. Washington, DC: The National Academies Press. doi: 10.17226/24618.
×

research, connecting basic scientists to her lung disease patients, and ensuring consistency with Penn State University research policies and procedures. She has enrolled patients with tobacco-related lung diseases in clinical trials for the past 10 years. Previously, she performed controlled human exposure studies using sidestream tobacco smoke and evaluated mechanisms of injury. She has served on several National Research Council committees, including the Committee on the Evaluation of the Department of Defense Comprehensive Clinical Evaluation Protocol, the Committee on Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants, and the Committee on Health Effects of Indoor Allergens. In addition, Dr. Bascom served on the Institute of Medicine Committee on Scientific Standards for Studies on Modified Risk Tobacco Products. She trained in internal medicine, as well as pulmonary and critical care medicine at the Johns Hopkins Hospital. Dr. Bascom earned an M.D. from the University of Oregon Health Sciences Center and an M.P.H. in occupational medicine from the Johns Hopkins Bloomberg School of Public Health.

Larry R. Churchill (NAM) is the Ann Geddes Stahlman Professor of Medical Ethics at Vanderbilt University, with a primary appointment in the Department of Medicine, and secondary appointments in Philosophy and the Graduate Department of Religion. Prior to Vanderbilt, Churchill was at the University of North Carolina at Chapel Hill (UNC), where he served as Department Chair of Social Medicine, 1988-1998. He has played a major role in developing medical ethics and humanities programs at both UNC and Vanderbilt. Dr. Churchill’s major research projects have been focused on justice and health policy, care of the dying, research with human subjects, and, most recently, the ethical features of routine medical care. Dr. Churchill has served on numerous Institutional Review Boards (IRBs) and Data Safety Monitoring Committees and has published widely on the ethics of human-subjects research. He served on the Institute of Medicine committee issuing the report on Complementary and Alternative Medicine in the United States in 2005 and was the principal author for the ethics chapter in that study. In 1991 Churchill was elected to membership in the NAM, and has been a Fellow of The Hastings Center since 2000. His most recent books are Healers: Extraordinary Clinicians at Work (2012), and What Patients Teach: The Everyday Ethics of Health Care (2013), both from Oxford University Press. He received a Ph.D. in religion from Duke University.

Kenny S. Crump is an independent consultant. Previously, he was a principal with Environ Corporation. He has over 35 years of experience in assessing risks related to exposure to toxic materials. He has served on science advisory boards of the Environmental Protection Agency, the National Center for Toxicological Research, the Mickey Leland National Urban Air Toxics Research Center, and the National Institute of Environmental Health Sciences. His research interests are in the areas of biostatistics, health risk assessment, and analysis of epidemiologic data. Statistical models for assessing risk developed by Dr. Crump have been widely used by regulatory agencies and private groups. These include the Linearized Multistage Model and the benchmark methodology. Dr. Crump has participated in risk assessments of many substances, including asbestos, benzene, manganese, and mercury. He was previously a member of the National Research Council’s Diesel Impacts Study Committee, the Committee on Risk Analysis Issues and Reviews, the Committee on Risk Assessment Methodology, and the Committee on Institutional Means for Assessment of Risks to Public Health. He recently served on the Institute of Medicine’s Committee to Evaluate Potential Exposure to Agent Orange/TCDD Residue and Level of Risk of Adverse Health Effects for Aircrew of Post-Vietnam C-123 Aircraft. Dr. Crump received a Ph.D. in mathematics from Montana State University.

Daniela B. Friedman is professor and chair in the Department of Health Promotion, Education, and Behavior at the Arnold School of Public Health of the University of South Carolina. She is also a core faculty member of the university’s Statewide Cancer Prevention and Control Program. Dr. Friedman uses both qualitative and quantitative methods to evaluate how people access, understand, and use information on disease risk and prevention. Her research examines individual and social influences on health comprehension, and she studies a variety of innovative strategies for the development and delivery of accurate, lan-

Suggested Citation:"Appendix A: Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants." National Academies of Sciences, Engineering, and Medicine. 2017. Controlled Human Inhalation-Exposure Studies at EPA. Washington, DC: The National Academies Press. doi: 10.17226/24618.
×

guage-appropriate, and culturally sensitive health information. She received a Ph.D. in health studies and gerontology from the University of Waterloo in Canada.

Diane R. Gold is a professor in the Department of Environmental Health in the School of Public Health at Harvard University, professor of medicine at Harvard Medical School, and associate physician at Brigham and Women’s Hospital. Dr. Gold’s research focuses on the relationships between environmental exposures and the incidence or severity of respiratory diseases, including asthma. The environmental exposures considered include indoor allergens, such as fungi, smoking, and outdoor ozone and particles. She investigates the environmental exposures that may explain socioeconomic, cultural, and gender differences which have been observed in asthma severity. These include perinatal exposures and family stress as well as exposure to the allergens and pollutants mentioned above. She is also interested in the cardiopulmonary effects of particles on the elderly and she has collaborated in research involving controlled human exposures. Dr. Gold served on the Institute of Medicine’s Committee on an Assessment of Asthma and Indoor Air Quality. She received an M.D. from the University of Connecticut School of Medicine.

Lewis R. Goldfrank (NAM) is Herbert W. Adams Professor of the Department of Emergency Medicine at New York University, and medical director of the New York City Health Department’s Poison Center. Dr. Goldfrank has worked at the Bellevue Hospital Center and New York University’s Medical Center for more than 30 years. He has served on multiple IOM committees, including the Committee on Personal Protective Equipment for Healthcare Workers in the Workplace Against Novel H1N1 Influenza A. Dr. Goldfrank also served on the NAM Board on Health Sciences Policy. He is a long-standing member of NAM’s Forum on Medical and Public Health Preparedness for Catastrophic Events. He received an M.D. from the University of Brussels Medical School. Dr. Goldfrank was elected to NAM in 1996.

Nancy E. Lane (NAM) is an Endowed Professor of Medicine and Rheumatology at the University of California at Davis. She is also director of the Center for Musculoskeletal Health and Aging Research and director of the K12 National Institutes of Health (NIH) Building Interdisciplinary Research Careers in Women’s Health program. She is principal investigator of the NIH-funded Program on Sex Differences in Musculoskeletal Diseases Across the Lifespan at the University of California at Davis School of Medicine. Dr. Lane was president of the board of the United States Bone and Joint Decade and she co-led the International Bone and Joint Decade Conference in Washington, DC. She received an M.D. from the University of California at San Francisco School of Medicine. Dr. Lane was elected to the National Academy of Medicine in 2013.

Morton Lippmann is a research professor in the Department of Environmental Medicine at New York University’s School of Medicine. Dr. Lippmann’s research has involved a series of studies that seek to identify the physical and chemical components of airborne particles responsible for observed health effects, including subchronic exposures to concentrated fine particles in a mouse model of atherosclerosis, and observational studies of human populations for association of acute and cumulative responses to exposures in the general atmospheric environment. Dr. Lippmann has served on several National Research Council committees, including the Committee on Air Quality in Passenger Cabins of Commercial Aircraft, the Committee on Toxicology, and the Committee on Research and Peer Review in the U.S. Environmental Protection Agency (EPA). He received a Ph.D. in environmental health science from New York University.

Murray A. Mittleman is an associate professor in the Department of Epidemiology at the Harvard School of Public Health and an associate professor of medicine at the Harvard Medical School. He is the director of the Cardiovascular Epidemiology Research Unit at the Beth Israel Deaconess Medical Center; vice-chair of the Committee on Clinical Investigations, which serves as the Institutional Review Board, at the Beth Israel

Suggested Citation:"Appendix A: Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants." National Academies of Sciences, Engineering, and Medicine. 2017. Controlled Human Inhalation-Exposure Studies at EPA. Washington, DC: The National Academies Press. doi: 10.17226/24618.
×

Deaconess Medical Center; and chair of the Master of Public Health program at the Harvard School of Public Health. Dr. Mittleman’s applied research focuses on behavioral and environmental determinants of acute cardiovascular events and their prognosis. He received an M.D. from McGill University and an M.P.H. and Dr.P.H. in epidemiology from the School of Public Health at Harvard University.

Philip Needleman (NAS/NAM) was elected to the National Academy of Sciences in 1987 and to the Institute of Medicine in 1993. He was a professor and chair of the Department of Pharmacology at Washington University Medical School (1976-1989) and Chief Scientist and head of R&D for Monsanto/Searle/Pharmacia (1989-2003). He was interim president of the Donald Danforth Plant Science Center (2009-2010) and interim president and CEO of the St. Louis Science Center (2010-2011). He has served on the NAS council, chaired NAS Section 23, and served on the NAS Division of Earth and Life Studies. Dr. Needleman received a Ph.D. in pharmacology from the University of Maryland at College Park.

Robert F. Phalen is co-director of the Air Pollution Health Effects Laboratory, professor in the Department of Medicine, and professor in the Center for Occupational and Environmental Health at the University of California, Irvine (UCI) School of Medicine. In 1972, Dr. Phalen joined the College of Medicine at UCI to establish the Air Pollution Health Effects Laboratory, which conducts studies relating to the toxicology of air pollutants. His research areas include lung modeling for predicting doses from inhaled particles, lung morphometry for growing mammals, health effects of inhaled air pollutants, and applied aerosol physics. He chaired the IRB at UCI for 7 years. He served on the National Research Council’s Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents. Dr. Phalen received a Ph.D. in biophysics, with specialization in inhalation toxicology, from the University of Rochester.

Margaret Foster Riley is a professor of law in the School of Law, professor of public health sciences in the School of Medicine, and professor of public policy in the Batten School of Leadership and Public Policy at the University of Virginia. Her research focuses on human-subjects research law and ethics, biotechnology, health care regulation, and food and drug law. She serves as chair of the university’s Embryonic Stem Cell Research Oversight Committee and as legal advisor to the Health Sciences Institutional Review Board, and is a member of the executive committee of the Center for Health Policy. Prior to joining the University of Virginia, Ms. Riley was an associate with Pepper Hamilton & Scheetz in Philadelphia, where she worked primarily in complex securities, commercial, and mass tort litigation. Prior to that position, she was a litigation associate with Rogers & Wells in New York. She served on the National Research Council’s Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, and has advised numerous committees of the Institute of Medicine and the Virginia Bar. Ms. Riley received a J.D. from Columbia University.

Hwashin H. Shin is a research scientist in the Environmental Health Science and Research Bureau of Health Canada. She is also an adjunct professor in the Department of Mathematics and Statistics of Queen’s University in Ontario, Canada. Previously, she was a research associate at the Institute of Population Health at the University of Ottawa. Her research areas include environmental public health risk models, epidemiology, and experimental optimal design. Dr. Shin’s recent research topics include bias correction in estimation of public health risk attributable to short-term air pollution exposure, and the systematic review and meta-analysis of outdoor fine particles and strokes. Dr. Shin is a member of the Outdoor Air Pollution Committee of Global Burden Disease. She received a Ph.D. in statistics from Queen’s University.

Suggested Citation:"Appendix A: Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants." National Academies of Sciences, Engineering, and Medicine. 2017. Controlled Human Inhalation-Exposure Studies at EPA. Washington, DC: The National Academies Press. doi: 10.17226/24618.
×
Page 106
Suggested Citation:"Appendix A: Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants." National Academies of Sciences, Engineering, and Medicine. 2017. Controlled Human Inhalation-Exposure Studies at EPA. Washington, DC: The National Academies Press. doi: 10.17226/24618.
×
Page 107
Suggested Citation:"Appendix A: Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants." National Academies of Sciences, Engineering, and Medicine. 2017. Controlled Human Inhalation-Exposure Studies at EPA. Washington, DC: The National Academies Press. doi: 10.17226/24618.
×
Page 108
Suggested Citation:"Appendix A: Biographical Information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants." National Academies of Sciences, Engineering, and Medicine. 2017. Controlled Human Inhalation-Exposure Studies at EPA. Washington, DC: The National Academies Press. doi: 10.17226/24618.
×
Page 109
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The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA’s pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality.

Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA’s clinical research facility.

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