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News Stories on Human ResearchProtection and April 22, 2002 ScientificMisconduct Notices FYI Scientific misconduct is a big problem undermining theintegrity of the scientific literature. Data falsification leads others toerroneous conclusions that may have adverse consequences for patients inclinical research and clinical practice. On April 19 The Office of ResearchIntegrity (ORI) issued two notices of Scientific Misconduct: Atsushi Handa, M.D., Ph.D., of NIH was found to havepublished fabricated and falsified data. In ORIs notice in the Federal Register(below) it states: "These actions were serious because the purportedfindings on the GV virus C/hepatitis G and AAV-2 viruses could have had majorimpact in areas such as hepatitis research and gene therapy." A second ORI notice of Scientific Misconduct: Joao CarlosdeSales, San Francisco Department of Public Health, who was found to haveswitched randomization of subjects. Office of the Secretary SUMMARY: Notice is hereby given that the Office ofResearch Integrity (ORI) and the Assistant Secretary for Health have taken finalaction in the following case: Atsushi Handa, M.D., Ph.D., National Institutes ofHealth: Based on the report of an investigation conducted by the NationalInstitutes of Health (NIH) and additional analysis conducted by ORI in itsoversight 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 byfalsifying and fabricating data published in two publications. Specifically, PHSfound that Dr. Handa: (1) Fabricated or falsified the following data in a paperpublished in J. Gen. Virol. 81:2077-2084, 2000: (A) Data for the AAV-3 constructfor days 2, 5, and 7 and data for the AAV-2 construct for days 5 and 7 in Table1; (B) day 2 data in Table 2; and (C) Figure 4; and (2) Falsified the followingdata 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 findingson the GV virus C/hepatitis G and AAV-2 viruses could have had major impact inareas such as hepatitis research and gene therapy. Dr. Handa has entered into aVoluntary Exclusion Agreement in which he has voluntarily agreed: (1) To excludehimself from any contracting or subcontracting with any agency of the UnitedStates Government and from eligibility for, or involvement in, nonprocurementtransactions (e.g., grants and cooperative agreements) of the United StatesGovernment as defined in 45 CFR part 76 (Debarment Regulations), for a period offive (5) years, beginning on April 4, 2002; (2) To exclude himself from servingin any advisory capacity to PHS, including but not limited to service on any PHSadvisory committee, board, and/or peer review committee, or as a consultant, fora period of five (5) years, beginning on April 4, 2002; and (3) To submit aletter of retraction to the editor of the Journal of General Virologyidentifying the missing data as well as the falsified or fabricated data inFigure 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 retractionrequirement will remain on the ALERT System until Dr. Handa sends, and ORIreceives, a copy of the retraction letter that is consistent with the abovelanguage. FOR FURTHER INFORMATION CONTACT: Chris B. Pascal, Director, Office of ResearchIntegrity. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-9620-filed Notice: Findings of Scientific Misconduct FederalRegister: April 19, 2002 (Volume 67, Number 76) Page 19438 Specifically, from April through September of 1999, Mr.deSales switched randomization assignments on four pairs of subjects andsubsequently altered the research records to conceal his conduct. Mr. deSales’switching of the randomization assignments, if undetected, could have biased thestudy so as to invalidate the conclusions on the effectiveness of intensivecounseling sessions on reducing the rate of new HIV infections. Mr. deSales hasentered into a Voluntary Exclusion Agreement in which he has voluntarily agreedfor a period of three (3) years, beginning on April 4, 2002: (1) to excludehimself from serving in any advisory capacity to PHS, including but not limitedto 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 forPHS support for a research project on which Mr. deSales’ participation isproposed or which uses him in any capacity on PHS supported research, or thatsubmits a report of PHS-funded research in which Mr. deSales is involved, mustconcurrently submit a plan for supervision of his duties to the funding agencyfor approval. The supervisory plan must be designed to ensure the scientificintegrity of his research contribution. A copy of the supervisory plan must alsobe submitted to ORI by the institution. FOR FURTHER INFORMATION, CONTACT: Chris B. Pascal, Director, Office of ResearchIntegrity. |