02-9619. Findings of Scientific Misconduct

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

Atsushi Handa, M.D., Ph.D., National Institutes of Health: Based on the report of an investigation conducted by the National Institutes of Health (NIH) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Atsushi Handa, M.D., Ph.D., former visiting fellow in the intramural program of the National Heart, Lung, and Blood Institute (NHLBI), NIH, engaged in scientific misconduct by falsifying and fabricating data published in two publications.

Specifically, PHS found that Dr. Handa:

(1) Fabricated or falsified the following data in a paper published in J. Gen. Virol. 81:2077-2084, 2000: (A) Data for the AAV-3 construct for days 2, 5, and 7 and data for the AAV-2 construct for days 5 and 7 in Table 1; (B) day 2 data in Table 2; and (C) Figure 4; and

(2) Falsified the following data in a paper published in J. Gen. Virol. 81:2461-2469, 2000: (A) Figure 3; and (B) data in Table 2; retracted at J. Gen. Virol. 82:2837, 2000.

These actions were serious because the purported findings on the GV virus C/hepatitis G and AAV-2 viruses could have had major impact in areas such as hepatitis research and gene therapy.

Dr. Handa has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed:

(1) To exclude himself from any contracting or 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 (Debarment Regulations), for a period of five (5) years, beginning on April 4, 2002;

(2) 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 five (5) years, beginning on April 4, 2002; and

(3) To submit a letter of retraction to the editor of the Journal of General Virology identifying the missing data as well as the falsified or fabricated data in Figure 3A and Table 2 of the paper published in J. Gen. Virol. 81:2461-2469, 2000, within 30 days of the effective date of this Agreement. This retraction requirement will remain on the ALERT System until Dr. Handa sends, and ORI receives, a copy of the retraction letter that is consistent with the above language.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative Oversight, Office of Research Integrity, 5515 Security Lane, Suite 700, Rockville, MD 20852. [phone].

Chris B. Pascal,

Director, Office of Research Integrity.