Scientific Misconduct Notices


Scientific Misconduct Notices

News Stories on Human Research Protection and
Commentary by Vera Hassner Sharav

April 22, 2002

Scientific misconduct is a big problem undermining the integrity of the scientific literature. Data falsification leads others to erroneous conclusions that may have adverse consequences for patients in clinical research and clinical practice. On April 19 The Office of Research Integrity (ORI) issued two notices of Scientific Misconduct:

Atsushi Handa, M.D., Ph.D., of NIH was found to have published fabricated and falsified data. In ORIs notice in the Federal Register (below) it states: "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."

A second ORI notice of Scientific Misconduct: Joao Carlos deSales, San Francisco Department of Public Health, who was found to have switched randomization of subjects.
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http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-9619-filed
[Federal Register: April 19, 2002 (Volume 67, Number 76)] [Notices] [Page 19438-19439] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr19ap02-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary
Findings of Scientific Misconduct
AGENCY: Office of the Secretary, HHS
ACTION: Notice
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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

[[Page 19439]]

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
(301) 443-5330

Chris B. Pascal, Director, Office of Research Integrity.
[FR Doc. 02-9619 Filed 4-18-02; 8:45 am] BILLING CODE 4150-31-P

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-9620-filed

Notice: Findings of Scientific Misconduct Federal Register: April 19, 2002 (Volume 67, Number 76) Page 19438
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:
Joao Carlos deSales, San Francisco Department of Public Health:
Based on the report of an investigation conducted by the San Francisco Department of Public Health (SFDPH) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Joao Carlos deSales, former study counselor at SFDPH, engaged in scientific misconduct by falsifying data supported under National Institutes of Health subcontract SFP-N01-A1-35176-HMEISTERI-94 to SFDPH under National Institute of Allergy and Infectious Diseases (NIAID), NIH, contract 5-N01-AI35176-019, "Domestic Master Contract for HIV Vaccine Efficacy Trials,” awarded to ABT Associates, Inc.

Specifically, from April through September of 1999, Mr. deSales switched randomization assignments on four pairs of subjects and subsequently altered the research records to conceal his conduct. Mr. deSales’ switching of the randomization assignments, if undetected, could have biased the study so as to invalidate the conclusions on the effectiveness of intensive counseling sessions on reducing the rate of new HIV infections. Mr. deSales has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed for a period of three (3) years, beginning on April 4, 2002: (1) 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; and (2) that any institution that submits an application for PHS support for a research project on which Mr. deSales’ participation is proposed or which uses him in any capacity on PHS supported research, or that submits a report of PHS-funded research in which Mr. deSales 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 his research contribution. A copy of the supervisory plan must also be submitted to ORI by the institution.

FOR FURTHER INFORMATION, CONTACT:
Director, Division of Investigative Oversight
Office of Research Integrity
5515 Security Lane, Suite 700, Rockville, MD 20852. (301) 443-5330.

Chris B. Pascal, Director, Office of Research Integrity.
[FR Doc. 02-9620 Filed 4-18-02; 8:45 am] BILLING CODE 4150-31-P