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.


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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