[Federal Register Volume 66, Number 132 (Tuesday, July 10, 2001)]
[Notices]
[Pages 35982-35983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17150]


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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:
    David R. Jacoby, M.D., Ph.D., Harvard Medical School (HMS) and 
Massachusetts General Hospital (MGH): Based on the report of an 
investigation conducted by HMS and MGH and additional analysis carried 
out by ORI in its oversight review, the U.S. Public Health Service 
(PHS) found that Dr. Jacoby, former Instructor, Department of 
Neurology, MGH, engaged in 15 acts of scientific misconduct by 
plagiarizing and falsifying research data taken from another 
scientist's different experiment in a published journal article for use 
in a program project grant application submitted to, and funded by, the 
National Institutes of Health (NIH).
    Specifically, Dr. Jacoby plagiarized an image of a Southern blot 
analysis of genomic DNA that appeared as Figure 3A in Balague, C., 
Kalla, M., & Zhang, W.-W. ``Adeno-Associated Virus Rep78 Protein and 
Terminal Repeats Enhance Integration of DNA Sequences into the 
CellularGenome.'' J. Virology 71:3299-3306, 1997. Dr. Jacoby first 
falsified the image by adding molecular weight markers and lane labels 
that misrepresented the image as his own experimental data. He further 
falsified the image using computer software to intensify a band he 
claimed was a site-specific integration and to remove identifiable 
background spots present in the original image. The effect of Dr. 
Jacoby's falsifications was to misrepresent the image as data from his 
own experimental analysis of clonal cell lines derived from the 
infection of a human cell line with a recombinant hybrid virus 
incorporating two transgenes and adeno-associated virus genes into a 
herpes simplex virus amplicon. Dr. Jacoby's falsified image was 
material to his research because it supported his claim that the 
transgene DNA had integrated into the cell genome at a specific site. 
These plagiarized and falsified results were reported in:
    1. Appendix material supporting an application for a Program 
Project Grant, Molecular Etiology of Early Onset Torsion Dystonia, 1 
P01 NS37409-01A1, submitted by Dr. Jacoby's supervisor; Dr. Jacoby's 
supervisor relied upon falsified written and oral information provided 
to her by Dr. Jacoby in her description of his recent research 
progress;
    2. Three presentations by Dr. Jacoby's supervisor to colleagues at 
MGH in May 1998 regarding the status of the research in her laboratory; 
Dr. Jacoby's supervisor relied upon falsified written and oral 
information provided to her by Dr. Jacoby in her description of his 
recent research progress; and
    3. A grant application to NIH for continuation of Dr. Jacoby's 
Clinical Investigator Award grant, 5 K08 NS01887-03, signed by Dr. 
Jacoby on May 29, 1998.
    In addition, Dr. Jacoby subsequently altered the falsified image 
described above further by changing the location

[[Page 35983]]

of the molecular weight markers to make it appear more consistent with 
the expected experimental results. Dr. Jacoby then submitted the 
plagiarized and falsified results to a MGH colleague who included them 
in a presentation at the First Annual Meeting of the American Society 
of Gene Therapy, held in Seattle, Washington, on May 30, 1998.
    During the institutional investigation in 1998, Dr. Jacoby 
presented another falsified image as data from his own experiment. 
Specifically, he used computer software to scan Figure 3A in Balague et 
al. and then alter the locations of three major bands in an effort to 
conceal the origin of the falsified image (i.e., Figure 3A) and to 
deceive investigating officials into believing that the results were 
from an independent experiment. Dr. Jacoby then used the different band 
locations as ``evidence'' of the differences between Figure 3A by 
Balague et al. and the data purportedly from his own experiment by 
presenting the falsified image: (1) To the Chief of MGH's Neurology 
Service; (2) to a scientist assisting the Inquiry Committee by 
attempting to reproduce Dr. Jacoby's experiment; and (3) to the Inquiry 
Committee as data from his own independent experiment.
    After the institution concluded that Dr. Jacoby had engaged in 
scientific misconduct, Dr. Jacoby forged the signature of the 
institutional official for the MGH Grants and Contracts Office and 
knowingly included false and material information on his NIH non-
competing renewal application for a Clinical Investigator Award, 5 K08 
NS01887-05. Specifically, after ceasing to work in his supervisor's 
laboratory and after being told by his supervisor that she would no 
longer serve as his mentor on the Clinical Investigator Award, Dr. 
Jacoby (1) listed his former supervisor as his mentor on his 5 K08 
NS01887-05 application; (2) claimed that he was continuing to conduct 
grant-funded research in her laboratory; (3) forged the signature of 
the MGH institutional official to avoid detection by MGH; and then (4) 
submitted the completed application directly to NIH on or about August 
1, 2000.
    Dr. Jacoby's actions amount to significant and serious 
falsifications in the proposing and reporting of research. His 
falsifications gave NIH reviewers inaccurate information for their 
evaluation of the progress made by the research group at MGH in its 
PHS-supported research. His falsifications also substantially hindered 
the progress of the PHS-funded research project. Finally, his 
falsifications induced NIH to conditionally approve Dr. Jacoby's 5 K08 
NS01887-05 grant at a time when he was no longer conducting research.
    Accordingly, PHS further finds that Dr. Jacoby engaged in a pattern 
of dishonest conduct through the commission of 15 acts of data 
falsification and plagiarism, including additional steps taken to 
conceal the true nature and origin of the research data, that further 
demonstrates a lack of present responsibility to be a steward of 
Federal funds.
    Dr. Jacoby has entered into a Voluntary Exclusion Agreement with 
PHS in which he has voluntarily agreed for a period of five (5) years, 
beginning on June 12, 2001:
    (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 C.F.R. Part 76 (Debarment Regulations);
    (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 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. 01-17150 Filed 7-9-01; 8:45 am]
BILLING CODE 4150-31-P