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###### Department of Health and Human Services

###### Office of the Secretary 

# AGENCY:

Office of the Secretary, HHS. 

# ACTION:

Notice. 

# 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:                               ( print 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