[Federal Register Volume 65, Number 122 (Friday, June 23, 2000)]
[Notices]
[Pages 39149-39150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Research Integrity Office Findings; Lingxun Duan, M.D.

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: 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:

[[Page 39150]]

    (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 CFR 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.

Chris B. Pascal, J.D.,
Acting Director, Office of Research Integrity.
[FR Doc. 00-15900 Filed 6-22-00; 8:45 am]
BILLING CODE 4160-17-P