> **March 1, 2006**
>
> **Invitation for Comments on the "Short List" Candidates for the**
>
> **EPA Human Studies Review Board**

**EPA Office of the Science Advisor**

On January 3, 2006, the EPA, Office of the Science Advisor (OSA)
announced a request for nominations of qualified individuals to serve on
the EPA Human Studies Review Board (HSRB) (*Federal Register* 71 116).
Information on the HSRB, including the nomination process, appears in
the above-referenced *Federal Register* notice and on the HSRB Web site
at: <http://www.epa.gov/osa/hsrb/> As stated in the *Federal Register*
notice, the OSA requested nominees who are nationally-recognized experts
in one or more of the following disciplines:

\(a\) Biostatistics. Expertise in statistical design and analysis of
human subjects research studies.

\(b\) Human toxicology. Expertise in pharmacokinetic and toxicokinetic
studies, clinical trials, and toxicology of cholinesterase inhibitors
and other classes of environmental substances.

\(c\) Bioethics. Expertise in the ethics of research on human subjects;
research ethics.

\(d\) Human health risk assessment.

**The OSA has reviewed the nominations and identified 20 candidates to
serve on the HSRB**. Brief biographical sketches ("biosketches") on
these candidates are provided below. The OSA hereby invites comments
from members of the public for relevant information or other
documentation that the OSA should consider in the selection of HSRB
members.

Any information furnished by the public in response to this Web site
posting will be combined with information already provided by the
candidates, and gathered independently by the OSA. Prior to final
selection of HSRB members, the combined information will be reviewed and
evaluated for any possible financial conflict of interest or a possible
appearance of a lack of impartiality. The information will also be used
to ensure appropriate balance and breadth of expertise needed to address
the charge to the Board. The EPA Science Advisor will make the final
decision concerning who will serve on the HSRB.

Please e-mail your comments no later than no later than noon, eastern
time, March 14, 2006 to Paul Lewis, OSA, at: lewis.paul@epa.gov

**[HSRB Candidate Biosketches]{.smallcaps}**

**Dr. David Bellinger**

Dr. David C. Bellinger is Professor of Neurology, Harvard Medical
School, Professor in the Department of Environmental Health, Harvard
School of Public Health (HSPH), and Senior Research Associate in
Neurology and Psychiatry, Children's Hospital Boston. He received a
Ph.D. in Psychology from Cornell University in 1977 and completed
post-doctoral fellowship training at the University of Rochester School
of Medicine and Boston University. In 1987, he received a M.Sc. in
Epidemiology from the HSPH. He received a Research Career Development
Award from the NIEHS (1985-1990). He currently directs an NIH-funded T32
Interdisciplinary Training Program in Neurodevelopmental Toxicology at
the HSPH. He has served on several committees of the National
Academies/National Research Council/ Institute of Medicine, including
Measuring Lead Exposure in Infants, Children, and Other Sensitive
Populations; Toxicological Effects of Methylmercury; Submarine Escape
Action Levels; and Nutrient Relationships in Seafood: Balancing the
Benefits and Risks. He has participated in World Health Organization
(WHO) consultations involving lead, mercury, and principles of risk
assessment. On several occasions, he has been a Technical Advisor to the
FAO/WHO Joint Expert Committee on Food Additives and Contaminants
(JECFA), as well as serving as a member of JECFA. From 2001-2004, he was
a member of the Federal Advisory Committee of the National Children's
Study. He participated in the EPA Science Advisory Board review of the
Agency's Mercury Report to Congress. He has served as Epidemiology
Section Editor of Neurotoxicology and Teratology and is the editor of a
forthcoming volume on *Human Developmental Neurotoxicology*. His major
research interests are the developmental impact of early metabolic and
chemical insults to the nervous system and neuropsychological
toxicology. Much of his research has focused on the neurotoxicity of
metals in children, particularly lead, mercury, arsenic, and manganese.
His research has been funded primarily by the NIH (NICHD, NIEHS, NINDS,
NIDCR, NHLBI), and by EPA, the Agency for Toxic Substances and Disease
Registry, and Harvard University.

**Dr. Stephen Brimijoin**

Dr. Stephen Brimijoin is Clement Professor and past Chair (1993-2003) of
Pharmacology at Mayo Medical School and Distinguished Investigator at
Mayo Clinic, which he joined in 1971 after two years at the National
Institutes of Health. For over thirty years he has investigated the
neurobiology, pharmacology, and toxicology of cholinesterase enzymes,
including studies on the pathophysiology of their axonal transport in
human peripheral nerve. He contributed substantially to knowledge of the
cellular distribution and fate of the molecular forms of these enzymes
in brain. He discovered that anti-esterase antibodies destroy central
sympathetic neurons in a selective manner that provides insights into
the pathophysiology of the autonomic nervous system. He used genetically
engineered neuronal cell lines to show that this acetylcholinesterase
may promote nerve growth and maturation, in addition to regulating
cholinergic transmission. More recently, his research team modified
human plasma cholinesterase to produce a cocaine-metabolizing enzyme
that blocks physiological responses to this drug and may pave the way
for a gene therapy of addiction. In cholinergic toxicology, Dr.
Brimijoin helped generate more potent oxime reactivators to rescue
individuals from pesticide overdose, and he devised a new method to
detect cholinesterase inhibition that yields more precise benchmark
doses for carbamate pesticides. He is now investigating the
developmental neurotoxicity of organophosphates, on which he provided
invited testimony to the NAS Committee on the Use of Third Party
Toxicity Research with Human Research Participants. Dr. Brimijoin has
served on the editorial boards of several journals (currently, Molecular
and Cellular Neurobiology) and on the Mayo Human Studies Committee
(IRB). For over ten years he has been an ad hoc member of multiple
sessions of the EPA FIFRA Scientific Advisory Panel (FIFRA SAP). In
recognition for research accomplishments, he received a Javits
Neuroscience Investigator Award (1987-94) a Humboldt Foundation Senior
Distinguished U.S. Scientist Award (1987-88) and an annual Distinguished
Investigator Award from Mayo Clinic (1992-present). He completed his
undergraduate and graduate training at Harvard (B.A., 1964; Ph.D.,
1969).

**Dr. Alicia Carriquiry**

Dr. Alicia Carriquiry is professor of statistics and director of
graduate education at Iowa State University. Between January of 2000 and
July of 2004 she was Associate Provost at Iowa State University. Her
research interests are in Bayesian statistics and general methods. Her
recent work focuses on nutrition and dietary assessment, as well as on
problems in genomics, forensic sciences and traffic safety. She
currently teaches the graduate-level course on Bayesian data analysis at
Iowa State University and has five doctoral students working under her
supervision at this time. She is an elected member of the International
Statistical Institute and a Fellow of the American Statistical
Association. Dr. Carriquiry served on the Executive Committee of the
Institute of Mathematical Statistics between 1999 and 2005 and has been
a member of the Board of Trustees of the National Institute of
Statistical Sciences since 1997. She is also a past president of the
International Society for Bayesian Analysis (ISBA) and a past member of
the Board of the Plant Sciences Institute at Iowa State University. Dr.
Carriquiry is Editor of *Statistical Sciences* and of *Bayesian
Analysis*, Associate Editor of *Statistical Surveys* and serves on the
editorial boards of several Latin American journals of statistics and
mathematics. She has served on three National Academy of Sciences
committees: the Subcommittee on Interpretation and Uses of Dietary
Reference Intakes; the Committee on Evaluation of USDA\'s Methodology
for Estimating Eligibility and Participation for the WIC Program and the
Committee on Third Party Toxicity Research with Human Research
Participants. Currently, she is a member of the standing Committee on
Applied and Theoretical Statistics of the National Research Council, the
Committee on Assessing the Feasibility, Accuracy and Technical
Capability of a Ballistics National Database of the National Research
Council and of the Committee on Gender Differences in the Careers in
Science, Mathematics and Engineering Faculty of the National Academy of
Sciences. She is a member of the Federal Steering Committee Future
Directions for the CSFII/NHANES Diet/Nutrition Survey: What we Eat in
America and also a member of the NIH Kidney, Nutrition, Obesity and
Diabetes Study Section. Carriquiry received a MSc in animal science from
the University of Illinois, and an MSc in statistics and a PhD in
statistics and animal genetics from Iowa State University.

**Dr. Janice Chambers**

Dr. Chambers is the William L. Giles Distinguished Professor and
Director, Center for Environmental Health Sciences Professor, Department
of Basic Sciences at Mississippi State University. Dr. Chambers directs
several research projects that deal with the effects of pesticides in
mammalian systems to determine the potential human health effects of
pesticide exposures. Specifically, there are projects related to the
neurochemical and behavioral effects of pesticides in developing
organisms as well as the metabolism of pesticides in developing
organisms to yield predictions about potential effects of pesticides in
infants and children. Other projects are involved in developing
mathematical predictions of the effects of mixtures of pesticides on the
nervous system so that predictive models can be generated to potentially
describe the effects of future uncharacterized mixtures. Dr. Chambers
has been the Principal Investigator for numerous federally funded
competitive grants in the field of toxicology. Because of her expertise,
she has been asked to serve on a number of advisory boards and
prestigious committees. Dr. Chambers is board certified as a
toxicologist by the American Board of Toxicology and the Academy of
Toxicological Sciences. As Director of the Center for Environmental
Health Sciences, she has developed an interdisciplinary research center
specializing in pesticide toxicology and funded primarily by NIH. The
center comprises the areas of neurotoxicology, biochemical toxicology,
analytical chemistry, biostatistics, epidemiology, computational
chemistry, computational simulation, biochemistry, and endocrinology.
Dr. Chamber is a member of the EPA FIFRA Scientific Advisory Panel.

**Dr. Gary Chadwick**

Dr. Gary Chadwick is the Associate Provost and Director of the Office
for Human Subject Protection at the University of Rochester (UR). Dr.
Chadwick holds faculty appointments in the School of Medicine and
Dentistry (SMD) as Clinical Professor of Community and Preventive Health
(Health Policy and Ethics) and Clinical Professor of Medical Humanities
(Research Ethics). Since arriving at the University, Dr. Chadwick has
been active in teaching research ethics to graduate and medical
students, serving on institutional committees for Ethics (Clinical),
Conflict of Interest (both for SMD as well University-wide), and
Compliance (UR). Dr. Chadwick's former research interests were in
suicidology, alcoholism, drug abuse and health services administration,
however, his current research activity is serving as an ethics
consultant (unpaid) on some federal grants.

Before joining the University of Rochester, Dr. Chadwick was a
commissioned officer in the U.S. Public Health Service for over 26
years. He served in the Food and Drug Administration (FDA) where he was
the Associate Director for Human Subject Protection in the Office of the
Commissioner and was a Senior Scientific Reviewer in the Division of
Scientific Investigations of the FDA\'s Center for Drug Evaluation and
Research. Dr. Chadwick has also worked in the Office for Protection from
Research Risks at the National Institutes of Health. He is a Past
President of Applied Research Ethics National Association (ARENA). He
was the founding Chair of the ARENA Council for Certification of IRB
Professionals. He is the co-author of the widely used investigator
training book, "Protecting Study Volunteers in Research." Dr. Chadwick
is a subcommittee member (Subpart A) of the DHHS Secretary's Advisory
Committee for Human Research Protection. He earned his BS in Pharmacy
from the Ohio State University, his PharmD from the University of
Tennessee, and his MPH from the Uniformed Services University.

**Dr. James Chen**

## Dr. James Chen is Senior Biomedical Research Service -- Senior Mathematical Statistician- in the Division of Biometry and Risk Assessment at the National Center for Toxicological Research, U.S. Food and Drug Administration. He is also an Adjunct Professor in the Department of Biostatistics, University of Arkansas for Medical Sciences. He received his B.S. degree from Taiwan Tsing-Hua University, M.A. degree from the University of Pittsburgh, and his Ph.D. from Iowa State University. Dr. Chen is an elected Fellow of the American Statistical Association. He has over 100 scientific publications in peer-reviewed journals and numerous invited subject review articles. Dr. Chen has served on the FDA, EPA, and interagency committees and workshops that directed at developing scientific and regulatory issues and guidelines, and has provided consultations to FDA and EPA scientists on the statistical analysis of toxicological data and risk assessment procedures. Dr. Chen is an associate editor of Communication in Statistics, and the Journal of Biopharmaceutical Statistics. 

## Dr. George Corcoran

Dr. Corcoran is Professor and Chairman of the Department Pharmaceutical
Sciences, College of Pharmacy & Health Sciences, Wayne State University,
and Adjunct Professor of Pediatrics, Wayne State University School of
Medicine. He earned his B.A. in Chemistry (Ithaca College - 1970), M.S.
in Chemistry (Bucknell University - 1973), and Ph.D. in Pharmacology and
Toxicology (George Washington University -1980), before completing
Post-Doctoral training in Toxicology (Baylor College of Medicine, The
Methodist Hospital - 1981). Prior to his Wayne State appointment, Dr.
Corcoran served as Assistant Professor of Pharmaceutics at the State
University of New York at Buffalo, followed by 9 years at the University
of New Mexico in Albuquerque, NM as Associate Professor and later
Professor, and Director of the Toxicology Graduate Program.

Dr. Corcoran has published over 170 original research papers, abstracts
and other reports, and has received nearly \$4 million in grants and
contracts as Principle Investigator, Co-Principal Investigator, and
Co-Investigator. He has chaired grant review panels for NIH, the
National Academies, and the Howard Hughes Medical Institute, and has
reviewed papers for more than 50 national and international scientific
journals. He has contributed to the training of over 150 MS and PhD
graduates, 2500 pharmacists, and many hundreds of undergraduate
students.

## At the University of New Mexico, he served under Vice President for Health Sciences Jane Henney (FDA Director 1998-2000) as a member of her Health Sciences Leadership Council. He is now Vice-President Elect of the Society of Toxicology, a 5500-member organization of academic, industry and government scientists practicing in the USA and 45 foreign countries. He will become Vice President in 2006-2007, and President in 2007-2008. He has contributed to Society positions having national and international impact, ranging from the best science for rational safety legislation, to organizational ethics and governance.

## 

## Dr. Joseph DeGeorge

Dr. Joseph DeGeorge received his Ph.D. in Pharmacology at the New York
State Medical Center, Syracuse, NY in 1980 investigating the role of
cell surface glucocongugates in axonal regeneration. Dr. DeGeorge was a
Postdoctoral Fellow at the University of North Carolina, Chapel Hill, in
the Department of Childrens Health (1980-83) investigating glial
transmembrane signal transduction and second messenger responses. He
followed up on this research interest as a Senior Staff Fellow in
Laboratory Neurochemistry, National Institute on Aging, NIH, Bethesda,
MD, investigating the use and development of unsaturated fatty acids for
*in vivo* imaging of brain function in response to neuroactive
challenges.

He joined the Center for Drug Evaluation and Research, FDA, as a
pharmacology reviewer in the Division of Neuropharmacological Drug
Products in 1989, then served as a supervisor for Pharmacology and
Toxicology in the divisions Oncology and Pulmonary Drug Products, and
eventually served as Associate Director for Pharmacology and Toxicology
until 2002. In these roles he was responsible for developing and
implementing national and international preclinical drug development
guidance and functioned as the CDER/FDA Lead Safety Expert for
carcinogenicity, safety pharmacology and chronic toxicity test
guidelines within the International Conference of Harmonization.

In 2002 Dr. DeGeorge joined Novartis Pharmaceuticals Corporation where
he served as Vice President, Preclinical Safety Evaluation; Global Head,
Research and Development Safety Assessment. In 2004 Dr. DeGeorge joined
Merck & Co. as Vice President, and currently serves as Worldwide Head of
Safety Assessment.

**Dr. Richard Fenske**

Dr. Richard A. Fenske is Professor of Environmental and Occupational
Health Sciences at the University of Washington (UW) and director of the
NIOSH-supported Pacific Northwest Agricultural Safety and Health Center
since its establishment in 1996. He is a core faculty member of the
NIEHS-supported Center for Ecogenetics and Environmental Health. He also
served as Deputy Director of the EPA/NIEHS-supported UW Center for Child
Environmental Health Risks Research from 1998-2003, and Director of the
UW Field Research and Consultation Group from 1992-1996. Dr. Fenske has
focused his research on the assessment and mitigation of chemical
hazards through workplace and community studies. He has developed new
procedures for the assessment of skin exposure through the use of
fluorescent tracers. He has also contributed to the elucidation of
pesticide exposure pathways for children living in agricultural
communities and in residential settings. His current research includes
studies of pesticide spray drift, novel biomonitoring techniques, and
para-occupational exposures of children in rural communities. He
currently receives research support from the NIOSH Agricultural Centers
Program, the EPA/NIEHS Children's Environmental Health Centers Program,
and an EPA STAR grant.

Dr. Fenske currently serves on the U.S. Environmental Protection
Agency's Science Advisory Board (Integrated Human Exposure Committee),
and is also a member of the National Academy of Sciences/Institute of
Medicine Committee to Review the Health Effects in Vietnam Veterans of
Exposure to Herbicides.

From 1984-1990 Dr. Fenske was Assistant Professor and then Associate
Professor of Environmental Sciences at Rutgers University. Prior to this
position, he received his doctoral degree and master\'s in public health
from UC Berkeley in Environmental Health Sciences. He was also awarded a
master\'s degree in geography from UC Berkeley and a master\'s degree in
comparative religion from Columbia University in New York. His
bachelor\'s degree was in history from Stanford University.

**Dr. Susan Fish**

Dr. Susan Fish is Associate Professor of Biostatistics and Epidemiology
at the Boston University School of Public Health. She is also the
co-director of the MA in Clinical Research program at Boston University
School of Medicine. Dr. Fish received her Doctor of Pharmacy degree from
the University of Minnesota and her Masters of Public Health from Boston
University, as well as a Bachelor\'s Degree in pharmacy from
Massachusetts College of Pharmacy and Allied Health Sciences and a
Bachelor\'s Degree in chemistry and education from the University of
Massachusetts.

Dr. Fish previously held positions as Director of Human Subjects
Protection and Associate Director of the Office of Clinical Research at
Boston University Medical Center (BUMC), Director of the BUMC
Institutional Review Board and Director of Research Participant Safety
at the General Clinical Research Center at Boston University School of
Medicine. She has also served as Director of Regulatory Affairs at
CareStat, Inc, (a contract research organization) and as Vice Chair for
Research in the Department of Emergency Medicine at Boston City
Hospital/Boston Medical Center and Associate Professor of Emergency
Medicine at Boston University School of Medicine. Prior to that, she was
Associate Director of the Massachusetts Poison Control System and
Associate Professor at Massachusetts College of Pharmacy and Allied
Health Sciences. Dr. Fish has been a medical researcher for more than 20
years. She was a member of the Human Studies Committee at Boston City
Hospital/Boston Medical Center from 1989-99 and served for five years as
Associate Chair of the Committee. On the national level, Dr. Fish is an
active member of many organizations, including the Society for Academic
Emergency Medicine and PRIM&R (Public Responsibility in Medicine and
Research) where she serves on the Board of Directors. In a variety of
forums, Dr. Fish lectures on the design, conduct, and management of
clinical trials, as well as research ethics and protection of human
research subjects. She teaches courses at the Boston University Schools
of Public Health and Medicine, and is frequently an invited speaker
nationally. Although she has a long history of research in the areas of
clinical toxicology and emergency medicine, Dr. Fish has most recently
focused on research ethics in general, and application of the federal
regulations for waiver of informed consent in certain emergency research
circumstances. Her sabbatical project was consistent with this focus,
working as Project Director for PRIM&R's Accreditation Project to
develop a national accreditation system for human research protection
programs.

**Dr. Celia Fisher**

Dr. Celia B. Fisher is the Marie Ward Doty Professor of Psychology and
Director of the Fordham University Center for Ethics Education. Dr.
Fisher is a member of the DHHS Secretary's Advisory Committee on Human
Research Protections (SACHRP), Co-Chair of the SACHRP Subcommittee on
Research Involving Children, and founding editor of the journal *Applied
Developmental Science*. She chaired the American Psychological
Association's (APA) Ethics Code Task Force, the New York State Board for
Psychology, the Ethics Committee of the Society for Research in Child
Development, and the National Task Force on Applied Developmental
Science*;* and is past member of the Ethics Working Group of the
National Children's Study, the NIMH Data Safety and Monitoring Board,
and the Institute of Medicine s Committee on Clinical Research Involving
Children. Dr Fisher is author of *Decoding the Ethics Code: A Practical
Guide for Psychologists* (Sage Publications), co-editor of 5 books
including *Ethical Issues in Mental Health Research with Children and
Adolescents* (Erlbaum Associates) and *The Handbook of Ethical Research
with Ethnocultural Populations and Communities* (Sage Publications),
author of over 100 publications in the areas of ethics and life-span
development and of commissioned papers for the President's National
Bioethics Advisory Commission on relational ethics and vulnerable
populations and on the ethics of suicide research for NIMH. With support
from NICHD she has studied how to assess and enhance research consent
capacity of adults with developmental disabilities. With funding from
NSF and NIH she has developed research ethics instructional materials
for undergraduates, graduate students, senior scientists, and IRBs and
examined parent-child perspectives on the ethics of adolescent risk
research. Her current federally funded projects include Mentoring the
Responsible Conduct of Research (ORI/NIAID), Participant Perspectives on
Drug Use and Related HIV Research (NIDA) and the Fordham Alcohol
Prevention Program (NIAAA). In July 2001 she co-chaired the APA, NIMH,
and Fordham Ethics Center sponsored national conference on Research
Ethics for Mental Health Science Involving Ethnic Minority Children and
Youth (*American Psychologist, December 2002)*. In 2005 she chaired the
APA meeting on Minimal Risk in Social Behavioral Research and co-chaired
the Fordham Summit on Biopharmaceuticals for the 21^st^ Century:
Responsibility, Sustainability & Public Trust. She has developed
assessment instruments to evaluate how teenagers and parents from
different racial/ethnic backgrounds prepare for and react to racial
discrimination, examined the validity of child abuse assessment
techniques in institutional and forensic settings, and family attitudes
toward involvement of adolescents in decisions to participate in
pediatric cancer research.

**Dr. Suzanne Fitzpatrick**

Dr. Suzanne Fitzpatrick is a Senior Science Policy Analyst in the Office
of the Commissioner, Office of Science and Health Coordination, at the
US Food and Drug Administration. She is the Human Protection
Administrator for the FDA Institutional Review Board. In this position,
she drafted the Standard Operating Procedures for the FDA IRB and
oversees its daily activities. She is also working on the oversight
program for quality assurance of all FDA sponsored research. She is a
member of the FDA Human Protection Steering Committee, the FDA Human
Subjection Protection/Biomonitoring Steering Committee, and the 21 CFR
50.24 consultative review committee. Dr. Fitzpatrick is also a
co-investigator on an FDA grant entitled "Pediatric Assent in Adolescent
Research Participants" in collaboration with NCI/NIH and Walter Reed
Army Medical Center. Dr. Fitzpatrick is the FDA National Environmental
Protection Act (NEPA) liaison to the Council for Environmental Quality
at the White House. She represents FDA on several Office of Science and
Technology Policy Committees (OSTP) including the CNER Subcommittee on
Toxics and Risk, the OSTP Subcommittee on Health and the Environment,
and the CNER Subcommittee on Endocrine Disruptors. She chairs, with EPA
and USGS, the OSTP Interagency Working Group on Human and Veterinary
Pharmaceutical in the Environment, whose charge is to leverage research
strategies in this area across the different federal agencies. Dr.
Fitzpatrick is also a member of the Interagency Committee on Validation
of Alternative Animal Models. Dr. Fitzpatrick is a board certified
toxicologist. She is the past president of the American College of
Toxicology and also a past member of its board of councilors. Currently
Dr, Fitzpatrick is the President Elect of the Nation's Capital Chapter
of the Society of Toxicology (SOT), a Councilor for the Regulatory and
Safety Specialty Section of and a member of the K-12 SOT Education
Committee. She is also an adjunct professor at Johns Hopkins University,
Zanvyl Krieger School of Arts and Science. Dr. Fitzpatrick received her
BA from the University of California at San Diego and her PhD from
Georgetown University.

**Dr. Kannan Krishnan**

Dr. Kannan Krishnan received his Ph.D. in Public Health from Université
de Montréal, Canada and postdoctoral training from the Chemical Industry
Institute of Toxicology (CIIT), Research Triangle Park, North Carolina.
He is currently Professor of Occupational and Environmental Health and
Director of the Human Toxicology research group (TOXHUM) at Université
de Montréal. He has been the leader of the risk assessment methodologies
theme team of the Canadian Network of Toxicology Centers (1994 -- 2001),
and Vice President of the Biological Modeling Specialty Section of the
Society of Toxicology (2001-02). A member of the U.S. National Academy
of Sciences (NAS) Sub-committee on Acute Exposure Guideline Levels
(2001-2004), Dr. Krishnan is currently the president of the Risk
Assessment Specialty Section of the Society of Toxicology and a
temporary advisor for the World Health Organization. His expertise is in
the areas of general toxicology, pharmacokinetics, physiologically-based
modeling, chemical mixtures and health risk assessment methods. He has
been a peer reviewer of several risk assessments, mixture risk
assessment supplemental guidance and efforts on interactions for U.S.
EPA. He has also been involved as a reviewer of toxicological profiles
of chemicals and interaction profiles for chemical mixtures produced by
ATSDR. An author of a text book on environmental pollution, Dr. Krishnan
has authored or co-authored over 100 full-length publications in the
areas of human health risk assessment, pharmacokinetics and its
determinants in humans, chemical interactions in rodents and humans as
well as computational toxicology. He has served on the editorial boards
of *Toxicological Sciences*, *International Journal of Toxicology*,
*Journal of Applied Toxicology* and *Journal of Child Health*. In the
year 2000, he received the *Veylian Henderson Award* from the Society of
Toxicology of Canada for significant contributions to the field of
toxicology in Canada and was co-recipient of the *Best paper award
(2003)* from the Board of Publications of the Society of Toxicology.

Dr. Krishnan's current research projects are funded by the Natural
Sciences and Engineering Research Council of Canada. Past funding
sources include Quebec Health Research Council, Canadian Network of
Toxicology Centers, Health Canada and Ethylbenzene Panel of American
Chemistry Council.

**Dr. Kyung Mann Kim**

Dr. Kim is Professor of Biostatistics and Statistics and Associate Chair
of the Department of Biostatistics and Medical Informatics at the
University of Wisconsin-Madison and Director of Biostatistics Shared
Resource at the University of Wisconsin Comprehensive Cancer Center.
Prior to his current appointment, he was Assistant Professor (1988-1994)
and Associate Professor (1994-1995) of Biostatistics at Harvard
University and Dana-Farber Cancer Institute, Associate Professor of
Biostatistics at the University of Michigan in Ann Arbor, MI and
Director of Biostatistics at the University of Michigan Comprehensive
Cancer Center (1995-1997), and Visiting Associate Professor of
Ophthalmology at Johns Hopkins University (1995). Dr. Kim is recognized
nationally and internationally for his contributions in statistical
methods for interim analysis in clinical trials and clustered and
repeated measures analysis and in clinical oncology research and has
published extensively in statistical methods for clinical trials and in
cancer clinical trials. He is Co-chair of the Protocol Review and
Monitoring Committee and the Data and Safety Monitoring Committee of the
University of Wisconsin Comprehensive Cancer Center, reviewing the
scientific merit of clinical trial protocols, the safety of
participants, and the scientific validity of data. He was a member of
the Lung Cancer Concept Evaluation Panel, Division of Cancer Treatment
and Diagnosis, National Cancer Institute (NCI) (1999-2002) and a member
of Subcommittee E on Cancer Epidemiology, Prevention and Control, NCI
Initial Review Group (2001-2005). He was a member of the Autoimmune
Diseases Data and Safety Monitoring Board, National Institute of Allergy
and Infectious Diseases (NIAID) (2000-2004) and has been serving as
member of the HIV/AIDS Therapeutic Trials Data and Safety Monitoring
Board, NIAID since 1998. These activities all relate to human studies
review and ongoing review and monitoring of participant safety and study
scientific validity in clinical trials.

Dr. Kim was elected member of the Regional Committee of the Eastern
North American Region (ENAR) of the International Biometrics Society and
ENAR representative to the Biological Sciences Section of the American
Association for Advancement of Science. He is an Associate Editor for
Biometrics, an official journal of the International Biometric Society.
He served as Founding Chair of the National Working Group of Cancer
Center Biostatistics Directors during 1996-2003. He is Chair of the
Program Committee for the Annual Meeting of the Society for Clinical
Trials in 2006. He is a Fellow of the American Statistical Association.
Dr. Kim received his Bachelor of Science (B.S.) degree in Computer
Science and Statistics in 1978 and Master of Science (M.S.) degree in
Statistics in 1980, both from Seoul National University, Seoul, Korea
and Doctor of Philosophy (Ph.D.) degree in Statistics from the
University of Wisconsin-Madison in 1985.

**Dr. Lois Lehman-McKeeman**

Dr. Lois Lehman-McKeeman is currently a Distinguished Research Fellow in
Discovery Toxicology at the Bristol-Myers Squibb Company in Princeton,
NJ. She received a BS degree in Toxicology from the Philadelphia College
of Pharmacy & Science and holds a Ph.D. in Toxicology from the
University of Kansas Medical Center. She was employed in the Human and
Environmental Safety Division of the Procter and Gamble Company for 15
years prior to joining Bristol Myers Squibb in 2001. Lois has active
research interests and programs broadly in mechanisms of toxicity, with
emphasis on secondary mechanisms of carcinogenesis. She is also working
to develop and apply metabonomic and transcriptomic technologies to
mechanistic toxicology. She has been active professionally in the
Society of Toxicology (SOT) serving on numerous SOT committees, and she
held elective office in the SOT as Councilor from 2000-2002. In 2003 she
was appointed Editor of Toxicological Sciences, a position she currently
holds, and she serves on a number of other editorial boards. She has or
is presently sitting on a variety of national and international advisory
committees for EPA, NIH, IARC and IPCS. She is a fellow in the Academy
of Toxicological Sciences, and she was the recipient of the Robert Scala
Award in Toxicology for research excellence in an industrial laboratory
in 1994 and the Society of Toxicology Achievement Award in 2003.

**Dr. Michael Lebowitz**

Michael Lebowitz has a Ph.D. in, Epidemiology & International Health,
and Environmental Health Sciences (with minors in Sociology and
Biostatistics), and a Ph.C. in Preventive Medicine (with a minor in
Biomedical Sciences) from the University of Washington (Seattle). He
also has an MA in Biostatistics (with a minor in Demography) and a BA in
Psychology from the University of California (Berkeley). He completed
his clinical training in cardio-pulmonary medicine at the University of
London Postgraduate Cardio-thoracic Institute. He started in public
health in 1962, and worked in both county and state health departments
in Epidemiology and Biostatistics.

His areas of expertise are environmental health sciences, occupational
medicine, and chronic & infectious disease epidemiology. Dr. Lebowitz
has served on the EPA Science Advisory Board, on National Academy of
Sciences (NRC-NAS/IOM) committees, and has been a consultant and
peer-reviewer for EPA, NIH, NIOSH and other agencies for over 30 years.
He has also served as member/chair of committees for WHO, PAHO, and
UNEP. He has been an expert consultant and witness for state and federal
government agencies, various NGOs and CBOs. He has over 400
peer-reviewed publications.

He is a fellow of the American College of Chest Physicians, the American
College of Epidemiology, and the Collegium Ramazzini. He is an elected
member of the International Academy of Indoor Air Sciences, the American
Epidemiological Society, the International Epidemiological Association,
Delta Omega (the honorary public health society), and as an honorary
member of the Hungarian Society of Hygiene. He is a founding member of
the International Society of Exposure Analysis (ISEA) and the
International Society of Environmental Epidemiology, and a charter
member the Society of Epidemiological Research. He has been a member of
other medical and scientific societies. He is a past President of ISEA
and recipient of its highest award (the Wesolowski Award), and is past
Chair of the national prevention research centers national program. He
has been received various honors and awards from The University of
Arizona College of Public Health and Graduate College. He has been
Principal Investigator (PI) of many grants.

**Dr. Jerry Menikoff**

Dr. Jerry Menikoff is Associate Professor of Law, Ethics & Medicine and
Director of the Institute for Bioethics, Law and Public Policy at the
University of Kansas School of Medicine. Since 1998 he has served as
chairperson of the Institutional Review Board at that institution. He is
also currently Medical Director of Hospital Ethics at the University of
Kansas Hospital, and an Associate Professor of Law at the University of
Kansas School of Law. He received his undergraduate degree from Harvard
University (magna cum laude in Mathematics, 1973), and also received in
1977 a J.D. (magna cum laude; Editor and Officer of the Harvard Law
Review) and M.P.P. (Public Policy) from Harvard. Dr. Menikoff earned an
M.D. in 1986 from Washington University (St. Louis). He served as a
judicial clerk to the Honorable Irving R. Kaufman, Chief Judge, United
States Court of Appeals for the Second Circuit, and has been a faculty
fellow at the MacLean Center for Clinical Medical Ethics at the
University of Chicago, and at the Center for Ethics and the Professions
at Harvard University.

For the past several years, Dr. Menikoff's research interests have
concentrated on bioethics in general, and more particularly on the
ethics of research with human subjects. His widely used textbook *Law
and Bioethics: An Introduction* (Georgetown University Press 2001) is
now in its second printing, and was chosen in 2002 by the Association of
American University Presses as one of "The Best of the Best from the
University Presses: Books You Should Know About." He is a coauthor of
the recently published textbook (and accompanying teacher's manual),
*The Ethics and Regulation of Research with Human Subjects* (LexisNexis
2005). His newest book, providing an evaluation of how the United States
regulates research with human subjects, will be published in 2006 by
Oxford University Press. He has on a number of recent occasions been
hired as a consultant by the federal Office for Human Research
Protections, and was one of the eight panelists convened by that agency
to review the controversial issues raised by the ARDS Network studies
(see Jeffrey M. Drazen, *Controlling Research Trials*, New Engl. J. Med.
2003;348:1377-80). He has recently written about the issues that led to
the creation of the EPA Human Studies Review Board in *Of Babies, Bugs,
and Bombast: A Look Behind the Crash-and-Burn of the CHEERS Pesticide
Study*, 4(14) Medical Research Law & Policy Report 586 (BNA) (July 20,
2005), and is a member of the Advisory Board for the Medical Research
Law & Policy Report.

**Dr. Robert M. Nelson**

Dr. Robert M. Nelson is Associate Professor of Anesthesiology and
Critical Care at The Children's Hospital of Philadelphia (CHOP) and the
University of Pennsylvania School of Medicine. After receiving his MD
degree from Yale University in 1980, Dr. Nelson trained in pediatrics
(Massachusetts General Hospital), neonatology and pediatric critical
care (University of California, San Francisco). He has received formal
training in theology, religious and medical ethics, receiving a Master
of Divinity degree from Yale Divinity School in 1980 and a Ph.D. in The
Study of Religion from Harvard University in 1993. Dr. Nelson has
lectured and published widely on ethical and regulatory issues in
pediatric research and clinical care. Dr. Nelson is Chair of the
Pediatric Advisory Committee (PAC) of the Food and Drug Administration,
and former Chair of the PAC Pediatric Ethics Subcommittee. He also
serves as a member of the Subcommittee on Research Involving Children of
the DHHS Secretary's Advisory Committee on Human Research Protections.
Dr. Nelson was a member of the Committee on Clinical Research Involving
Children of the Institute of Medicine (through March 2004), and former
Chair of the Committee on Bioethics of the American Academy of
Pediatrics (through 2001). Currently he is Director of the Center for
Research Integrity, established at CHOP to further the responsible
conduct of pediatric research. Dr. Nelson's current research explores
different aspects of child assent and parental permission such as
adolescent risk perception, the development of a child's capacity to
assent, and the degree to which parental choice is perceived as
voluntary. His research has been funded by the National Institutes of
Health, the Greenwall Foundation and The National Science Foundation.

**Dr. Sean Philpott**

Dr. Sean Philpott is a tenured Research Scientist (Assoc. Research
Professor) in the Department of Infectious Disease at the New York State
Department of Health, an Adjunct Professor in the Department of
Biomedical Sciences of the University at Albany School of Public Health,
and is the Executive Managing Editor of the American Journal of
Bioethics. He serves on the New York State Department of Health
Institutional Review Board and is a member of the New York Working Group
on Bioethics. He is involved in a Fogarty Institute-funded project to
teach research ethics to Central and Eastern European scientists,
physicians, lawyers and other professionals. Dr. Philpott also serves as
consultant to various governmental and non-governmental bodies, such as
the Forum for Collaborative HIV Research.\
\
He received his undergraduate degrees in biology and medical
anthropology from the University of California at San Diego, and
completed his Ph.D. in Microbiology at the University of California at
Berkeley. In addition to his on-going laboratory studies of HIV
pathogenesis, Dr. Philpott is particularly interested in the ethical
issues associated with biomedical research, including the protection of
human subjects in industrialized and developing countries and the
management of conflicts of interest in academia.

**Dr. Richard Sharp**

Dr. Richard R. Sharp (Ph.D. Philosophy, Michigan State University, 1999)
is an Assistant Professor of Medicine with the Center for Medical Ethics
and Health Policy, Baylor College of Medicine (BCM). Dr. Sharp's
professional interests center on ethical issues in biomedical research
and genetics. He has written on ethical considerations in testing
asymptomatic persons for genetic predispositions to disease,
understandings of race and ethnicity in genomic research, and the
identification of genetic sensitivities to environmental toxicants. Dr.
Sharp is the principle investigator for several ongoing research
projects, including: 1) Indian and Hindu perspectives on genetic
variation research, 2) Patient attitudes regarding the collection and
use of biological materials for genomic research, 3) Patient
perspectives on the role of consumer advocacy groups, and 4) Ethical,
legal, and social issues in toxicogenomic research. Dr. Sharp directs
the fourth course in the BCM Ethics Track, Research in Clinical Medical
Ethics, and participates in the teaching of clinical ethics to medical
students, residents, and clinical fellows at Ben Taub General Hospital
and The Methodist Hospital. He also lectures on topics in research
ethics in the Clinical Scientist Training Program and the Research
Ethics Symposium, a training program on research conduct for clinical
fellows, post-doctoral fellows, and graduate students in the biological
sciences. Dr. Sharp coordinates Ethics Grand Rounds for The Methodist
Hospital and serves on their Ethics Committee. Dr. Sharp has served on
advisory committees for the American Thoracic Society, the European
Respiratory Society, the Alpha One Foundation, the Woodrow Wilson
Center, and the National Institutes of Health. Before joining the Center
in 2002, Dr. Sharp worked as a Biomedical Ethicist at the National
Institute of Environmental Health Sciences where he directed the Program
in Environmental Health Policy and Ethics.