May 30-31, 2001
Washington, DC

Convened by

Co-Sponsored with

Michael J. Brown is the Intellectual Property Counsel & Technology Transfer Manager for the Institute for Genomic Research in Rockville, Maryland, where he reviews and drafts Institute policies and procedures relating to intellectual property, technology transfer and misconduct in science. Brown, who serves on the Intellectual Property Committee, Institutional Review Board, Institutional Animal Care and Use Committee, and the Conflicts Review Committee, also drafts, reviews and negotiates research, license, subcontract and technology transfer related agreements; serves as liaison with academic institutions, governmental agencies, businesses and industries related to research and technology issues; and coordinates patent prosecution and trademark protection with outside-counsel.

Brown received a BS in Biological Basis of Behavior from the University of Pennsylvania in 1983, a MPA in Health Policy and Management from the Robert F. Wagner Graduate School of Public Service at New York University in 1986 and a JD from the University of Maryland School of Law in 1993.

Dawn R. Crumel serves as Senior Associate General Counsel for Health Affairs to Howard University. She counsels Howard University Hospital, the College of Medicine, the College of Dentistry and the College of Pharmacy, Nursing & Allied Health Sciences on regulatory compliance, bio-ethics, medical staff and transactional matters, including clinical research. Previously, she served the University of Pennsylvania Health System, where she counseled the health system on acquisitions, fraud and abuse, bio-ethics, pharmaceutical, hospice, home health, health and disease management and patient issues. She serves on the Ethics Committee of the Howard University Hospital and served on the Ethics Committee of the Hospital of the University of Pennsylvania. She was a health care associate with Buchanan Ingersoll and clerked for the Supreme Court of New Jersey. Ms. Crumel has an undergraduate degree in Biomedical Ethics from Brown University and graduated from the University of Pennsylvania Law School.

Leanne Cusumano is the Head of the Outreach and Oversight Section within the Investigations Division, Office of Inspector General, at the National Science Foundation (NSF). She directs the Outreach Program for the Office of the Inspector General (OIG). OIG’s Outreach program is designed to engage administrators, principal investigators, postdoctoral researchers, students, and others administering or conducting federally supported research in conversations about ethical issues and grant administration. Ms. Cusumano is also responsible for investigating civil, criminal, and administrative allegations of wrongdoing, including allegations of research misconduct, involving NSF-funded programs.

Prior to joining NSF, Ms. Cusumano was Regulatory Counsel with the U.S. Food and Drug Administration (FDA). Her work at FDA focused on the regulation of pediatric clinical trials with an emphasis on the ethical conduct of such trials. Ms. Cusumano also worked on issues related to fraud and research misconduct in FDA-regulated research, including fabrication and falsification; debarment; and civil money penalty actions. Ms. Cusumano received the Secretary’s Award for Distinguished Service while with FDA. Before joining FDA, Ms. Cusumano was a litigator with a law firm in Washington, D.C., where her work included white collar crime, employment law, and securities’ fraud cases.

Ms. Cusumano received her J.D. from the Marshall-Wythe School of Law at the College of William and Mary, where she was Student Note Editor for the William and Mary Law Review and a member of the Moot Court Bar. Ms. Cusumano received her B.A. in International Affairs from the Elliot School of International Affairs at the George Washington University.

Kendra Dimond is a member of Arent Fox Kintner Plotkin & Kahn, PLLC in Washington, D.C., and practices in the Health Law Group. Ms. Dimond represents and advises clients on research, clinical, and regulatory compliance issues. Her clients include healthcare providers, academic medical centers, hospitals, and long-term care facilities, as well as individual physician's and product manufacturers on research, clinical, and regulatory compliance issues. She counsels institutions on structuring compliance plans and represents health care providers in regulatory matters before state and federal agencies. Ms. Dimond was Investigative Counsel to the U.S. Senate Special Committee on Aging under Senators Heinz and Cohen, where she was actively involved in health-related issues. She later joined the Office of General Counsel of the Department of Health and Human Services, National Institutes of Health (NIH). Ms. Dimond advised NIH on matters relating to the investigation of fraud and misconduct in scientific research, and subsequently directed the NIH Office of Legislative Policy and Analysis. In that capacity she was directly involved in Congressional and other governmental investigations and inquiries involving research support and research fraud issues. She has worked closely with the Office of Research Integrity the former Office for Protection from Research Risks and the new Office for Human Research Protections.

Anita Eisenstadt has served as Assistant General Counsel at the National Science Foundation since 1990 as the primary attorney for the Foundation on regulation of research issues, including misconduct in science and research involving human subjects. She has worked closely with the Office of Science and Technology Policy in developing the Federal Government-wide Research Misconduct Policy. She has been a featured speaker on misconduct in science in a number of fora. In addition to research misconduct, Ms. Eisenstadt is responsible for international, Antarctic, environmental, legislative and Federal personnel law matters at the Foundation.

Ms. Eisenstadt received her B.A. from the University of Michigan with High Distinction in 1979 and her J.D. cum laude from Wayne State University Law School in 1982. Prior to joining the National Science Foundation, she clerked for an appellate court judge, worked in private practice, served as a Senior Marketing Attorney at Volkswagen of America, Inc, and worked as a legislative and personnel attorney at the U.S. Department of Labor.

Gary B. Ellis specializes in formulating national policy regarding the ethical conduct of biomedical and behavioral research. He serves as Executive Secretary of the National Science and Technology Council, the Cabinet-level Council through which the President coordinates science, space, and technology policy across the Federal Government. From 1993-2000, Dr. Ellis directed the Office for Protection from Research Risks at the National Institutes of Health. Dr. Ellis directed the Division of Health Promotion and Disease Prevention at the Institute of Medicine of the National Academy of Sciences from 1989-1992. From 1983-1989, Dr. Ellis served as a science policy analyst at the Office of Technology Assessment, Congress of the United States.

A graduate of the University of Michigan (B.S., botany and zoology, 1976), Dr. Ellis obtained graduate degrees (M.S., biological sciences, 1977; Ph.D., biological sciences, 1980) from Northwestern University. He conducted postdoctoral research in male reproductive physiology at the University of Texas at Austin from 1980-1983.

Paul Friedman's early education included a degree in mathematics and a Yale MD, with a research year in England. After residency in radiology and military service as a radiologist, he spent two years studying pulmonary pathology at Yale, joining the faculty of the new medical school at UCSD in 1968 becoming a full professor in 1975. Dr. Friedman served (part time) as Dean for Academic Affairs from 1982 to 1995 where he developed an interest in research ethics that was reflected in national appointments to committees and participation in AAAS, AAMC, NIH, and ORI-sponsored conferences and courses. He has published about 90 journal articles and numerous book chapters and editorials. He has also developed a computer program and edited a special issue of Academic Medicine on research integrity. Dr. Friedman is presently a full time radiologist.

Gregory Glover is a partner in the Washington, D.C. office of Ropes & Gray, a licensed physician and registered patent attorney. His practice focuses on providing advice to pharmaceutical, chemical and biotechnology companies and trade associations on Food and Drug Administration regulations, intellectual property law, and technology licensing. He also serves as a lecturer at the University of California School of Law where he teaches a course entitled, "Exclusive Rights in the Biotechnology and Pharmaceutical Industries."

Dr. Glover received his AB in biochemical sciences from Harvard College, and his JD from Harvard Law School. Following law school, he completed medical school at Duke University, and served as an intern in Internal Medicine at New England Deaconess Hospital in Boston.

Julie Gottlieb holds a master's degree from the Johns Hopkins Nitze School of Advanced International Studies and a bachelor's degree from Brown University. She worked in the field of Latin American economic development for several years before joining Johns Hopkins in 1995. As Senior Director of the Office of Policy Coordination, she is responsible for coordinating the review and development of policy in areas such as conflict of interest and conflict of commitment, professional and research misconduct, and use of the Johns Hopkins name. Her office staffs the Committee on Conflict of Interest as well as its oversight subcommittees and it reviews faculty disclosures of outside activity. Ms. Gottlieb also staffs the School's Standing Committee on Discipline and other ad hoc policy development committees.

C. Kristina Gunsalus serves as Associate Provost at the University of Illinois at Urbana-Champaign, where she is responsible for a range of academic policy and administrative duties, including department head training/support and academic policy interpretations and revision. On her campus, she is known as the "department of yucky problems," with duties encompassing oversight of the discrimination & harassment grievance procedure, problem personnel cases and membership on the workplace violence team. Her prior experience at the University includes technology transfer, management of conflicts of interest, human subject protection, and long-term service as the campus Research Standards Officer with responsibility for responding to allegations of professional misconduct by faculty and students. A licensed attorney, Ms. Gunsalus graduated Magna Cum Laude from the University of Illinois College of Law and has an AB with Distinction in History from the University of Illinois at Urbana-Champaign. She served on the Committee on Research Integrity of the Association of American Medical Colleges and the Government-University-Industry Research Roundtable Ad Hoc Group on Conflict of Interest. She was a member of the United States Commission on Research Integrity and served for four years as chair of the American Association for the Advancement of Science Committee on Scientific Freedom and Responsibility. In her spare time, Ms. Gunsalus is President of the Urbana Board of Education (school board).

Judith E. Leonard has served as General Counsel to the University of Arizona since November of 1998. Prior to her association with the University of Arizona she served as an attorney with the U.S. Department of Education, including a one-year assignment in the Executive Office of the President as General Counsel of the Office of National Drug Control Policy. Previous to this time she served as an Assistant Attorney General in the State of Arizona and from 1983-1990 as Associate University Counsel and Assistant to the Dean of the School of Medicine at the University of North Carolina at Chapel Hill. Ms. Leonard has been active in state and federal bar associations in the areas of education and health law. She is also a member of the National Association of College and University Attorneys and serves on its publications committee. Ms. Leonard graduated from the University of North Carolina (J.D., 1980; M..Ed., 1974) and Cornell University (B.S., 1972). She is admitted to practice law in Arizona and North Carolina.

Nancy Morrison O'Connor is a partner in the law firm of Bracewell & Patterson, L.L.P., in its Washington, D.C. office. Ms. O'Connor has practiced management labor law on a national level for 25 years in Houston, Texas and Washington, D.C. Prior to joining Bracewell & Patterson, she was Vice President, Human Resources and Employee Benefits, for Allbritton Communications Company. She was appointed Litigation Expert for the Office of Research Integrity investigating and prosecuting allegations of scientific misconduct. Ms. O'Connor has represented clients engaged in various industries, including health care, higher education, disaster relief, and service in matters concerning employment discrimination, civil rights, and contract negotiations. Ms. O'Connor is a graduate of Gettysburg College (Political Science) and was a Rotary Scholar at the University of Wales, Gwynedd. She graduated from Notre Dame Law School, where she received its first Barrett Trial Advocacy Award, was a William J. Brennan Scholar and was elected Editor on its law review.

Chris Pascal currently holds the position of Director, Office of Research Integrity, within the Office of Public Health and Science at the Department of Health and Human Services, Rockville, Maryland. Mr. Pascal began his government career over 20 years ago by working as Chief Counsel for the Alcohol, Drug Abuse, and Mental Health Administration within the U.S. Department of Health and Human Services. After 15 years, he became Chief Counsel for the Office of Research Integrity within the U.S. Public Health Service, moving on three years later to become Director of the Division of Research Investigations. Shortly thereafter, Mr. Pascal assumed his present position. Mr. Pascal took his baccalaureate degree at Auburn University and his J.D. degree at Duke University School of Law. He did a postdoctoral fellowship in psychology and law in the Psychiatry Department at Duke University Medical Center.

Susan E. Sherman is a Senior Attorney with the Office of the General Counsel, U.S. Department of Health and Human Services (DHHS), and has been with the office since 1990. She currently serves as the legal advisor to the DHHS Office of Human Research Protections, providing advice on legal issues related to human subjects protection in clinical research, and previously served as an attorney with the National Institutes of Health (NIH) branch of the Office of the General Counsel, providing advice to programs of the NIH on legal matters related to grants policy and administration, animal welfare, and scientific misconduct, and representing NIH interests in litigation handled by the U.S. Department of Justice. Ms. Sherman earned a J.D. degree with honors from the National Law Center of George Washington University in 1990, a master’s degree in health science from the Johns Hopkins School of Hygiene and Public Health in 1983, and a bachelor’s degree from Vassar College in 1980.

Sheila Cohen Zimmet is the Director of Research Assurance and Compliance for Georgetown University, a position she assumed this January, after having served as counsel for Georgetown University Medical Center since 1984. Ms. Zimmet began her professional career as a neonatal intensive care nurse after earning her undergraduate nursing degree from Georgetown University in 1971. After she received her JD from Georgetown in 1975, she pursued a legal career with the federal government in the fields of occupational and mine safety and health. She returned to Georgetown University in 1984, where her health care legal practice focused on her primary areas of interest in clinical, bioethical and biomedical research issues, in addition to higher education issues involving students, faculty and staff that are common to academic medical centers. In January 2001, Ms. Zimmet became the first Director of Research Assurance and Compliance for Georgetown University.