FINDINGS OF SCIENTIFIC MISCONDUCT
Release Date: June 27, 2000
NOTICE: OD-00-043
Department of Health and Human Services
Notice is hereby given that based on oversight by the Office of Research
Integrity (ORI) and decision by the Assistant Secretary for Health, the U.S.
Public Health Service has taken final action in the following case:
Lingxun Duan, M.D., Thomas Jefferson University: The U.S. Public Health
Service (PHS) alleges that Dr. Duan, former Research Assistant Professor of
Medicine, Division of Infectious Diseases, Department of Medicine, Jefferson
Medical College, Thomas Jefferson University, engaged in scientific
misconduct by reporting research that was inconsistent with original data or
could not be supported because original data were not retained. The research
in question was supported by a National Institute of Allergy and Infectious
Diseases (NIAID), National Institutes of Health (NIH), grant, R01 AI36552,
entitled Intracellular antibodies and HIV 1.
Specifically, the research in question was reported in an NIAID, NIH, grant
application, in an FDA-approved phase I gene therapy investigational new drug
(IND) application entitled Intracellular immunization against HIV-1
infection using an anti-rev single chain variable fragment (SFV), and in two
publications: (1) Duan, L., Bagasra, O., Laughlin, M.A., Oakes, J.W., &
Pomerantz, R.J., Potent inhibition of human immunodeficiency virus type I
replication by an intracellular anti-Rev single chain antibody, Proc. Natl.
Acad. Sci. USA 91:5075-5079, 1994, and (2) Levy-Mintz, P., Duan, L., Zhang,
H., Hu, B., Dornadula, G., Zhu, M., Kulkosky, J., Bizub-Bender, D., Skalka,
A.M., and Pomerantz, R.J., Intracellular expression of single-chain variable
fragments to inhibit early stages of the viral life cycle by targeting human
immunodeficiency virus type 1 integrase, J. Virol. 70:8821-8823, 1996.
Dr. Duan denies all allegations of scientific misconduct and contends that
some of his original data is missing. Both Dr. Duan and PHS are desirous of
concluding this matter without further expense of time and other resources.
Thus, Dr. Duan has entered into a Voluntary Exclusion Agreement (Agreement)
with PHS, in which Dr. Duan has voluntarily agreed:
(1) to exclude himself from any contracting of subcontracting with any agency
of the United States government and from eligibility for, or involvement in,
nonprocurement transactions (e.g., grants and cooperative agreements) of the
United States Government as defined in 45 C.F.R. Part 76 for a period of two
(2) years, beginning on June 7, 2000,
(2) that for a period of one (1) year after the conclusion of the voluntary
exclusion period, any institution that submits an application for PHS support
for a research project on which his participation is proposed or that uses
him in any capacity on PHS supported research, or that submits a report of
PHS funded research in which Dr. Duan is involved, must concurrently submit a
plan for supervision of his duties to the funding agency for approval, the
supervisory plan must be designed to ensure the scientific integrity of Dr.
Duan’s research contribution, and the institution must also submit a copy of
the supervisory plan to ORI,
(3) to exclude himself from serving in any advisory capacity to PHS,
including, but not limited to, service on any PHS advisory committee, board,
and/or peer review committee, or as a consultant for a period of two (2)
years, beginning on June 7, 2000,
(4) that he will not oppose the submission to journals of a statement
summarizing the current state of the science with respect to the scientific
matters at issue relating to grant R01 AI36552, which has been jointly agreed
to by Thomas Jefferson University and the United States of America.
FOR FURTHER INFORMATION CONTACT:
Acting Director, Division of Investigative Oversight
Office of Research Integrity
5515 Security Lane, Suite 700
Rockville, MD 20852
(301) 443-5330
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