[Federal Register Volume 68, Number 56 (Monday, March 24, 2003)]
[Notices]
[Page 14240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6894]



[[Page 14240]]

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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 Acting Assistant Secretary for Health have taken final 
action in the following case:
    Justin Radolf, M.D., University of Connecticut Health Center: Based 
on the report of an investigation conducted by the University of 
Connecticut Health Center (UCHC Report), Dr. Radolf's admissions, and 
additional analysis conducted by ORI in its oversight review, the U.S. 
Public Health Service (PHS) found that Dr. Radolf, Professor at UCHC's 
Center of Microbial Pathogenesis, engaged in scientific misconduct in 
research supported by National Institute of Allergy and Infectious 
Diseases (NIAID), National Institutes of Health (NIH), grant R01 
AI29735-11 and incorporated false claims into a grant application 
entitled ``Tick Inhibitors of Hemostatis: Novel Therapeutic Agents and 
an Anti-Tick Vaccine'' to the United States Department of Agriculture 
(USDA). Dr. Radolf falsified and fabricated preliminary research data 
to falsely claim that the genes that he proposed to characterize were 
specifically expressed in the tick salivary gland. Dr. Radolf 
represented the products of control samples as positive tests for mRNA 
expression from different genes and presented data as positive for 
genes that had not been tested.
    Specifically, PHS finds that Dr. Radolf falsified and fabricated 
data in January 2000 by altering the labeling of a figure included in a 
USDA grant application and by falsifying the text in both the USDA 
application and in an overlapping application to a state-sponsored 
program.
    This incident of falsification and fabrication is significant 
because the data was the first direct evidence that the isolated clones 
represented genes expressed in tick salivary gland, and therefore 
represented proteins that could be targets of vaccine development to 
protect the hosts from tick-transmitted microbial diseases. The 
misinformation of the extent of the progress in this project had the 
potential to mislead grant reviewers and the scientific community about 
an area of research that could have led to the prevention of Rocky 
Mountain Spotted Fever and other tick-transmitted diseases.
    The Respondent submitted the following admission to ORI: In January 
of 2000, I engaged in scientific misconduct involving research 
supported by the National Institutes of Health. The misconduct occurred 
during the preparation of grant proposals submitted to the United 
States Department of Agriculture and Connecticut Innovations, Inc. More 
specifically, I falsified and fabricated preliminary data by 
intentionally altering the labeling of an ethidium bromide-stained 
agarose gel purporting to demonstrate the expression of genes in the 
salivary glands of feeding Dermacentor andersoni ticks. In so doing, I 
misrepresented the products of control samples as positive tests for 
the presence of mRNAs derived from unrelated genes, and I fabricated 
data to show the expression of genes that, in fact, were not tested. 
The texts of the two proposals also contained inaccurate statements 
relating to these falsified and fabricated data. By inaccurately 
portraying the extent of our progress in characterizing salivary gland 
proteins that might interfere with tick feeding, my actions would have 
misled the reviewers of the proposals into thinking that we were closer 
to the development of an anti-tick vaccine than we actually were.
    Truthfulness in the recording, presentation, and reporting of 
data--the accuracy and reliability of the research record--is the 
foundation of all scientific research. By intentionally misrepresenting 
preliminary findings in the two grant proposals, my actions violated 
this basic precept, compromised my scientific integrity, and placed my 
20-year career as a biomedical researcher in jeopardy. My actions also 
could have compromised the integrity and careers of individuals with 
whom I work, individuals who place their trust in me and who look to me 
for scientific leadership. I take full and complete responsibility for 
this misconduct. I committed this wrongful act without prompting by 
other individuals and without the consent or knowledge of others. I am 
deeply remorseful for my behavior and offer my strongest assurance to 
the Office of Research Integrity that it will never recur.
    Dr. Radolf has entered into a Voluntary Exclusion Agreement in 
which he has voluntarily agreed for a period of five (5) years, 
beginning on March 10, 2003:
    (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;
    (2) That any institution which submits an application for PHS 
support for a research project on which Dr. Radolf's participation is 
proposed or which uses Dr. Radolf in any capacity on PHS-supported 
research, or that submits a report of PHS-funded research in which Dr. 
Radolf is involved, must concurrently submit a plan for supervision of 
Dr. Radolf's duties to the funding agency for approval; the supervisory 
plan must be designed to ensure the scientific integrity of Dr. 
Radolf's research contribution; a copy of the supervisory plan must 
also be submitted to ORI by the institution; Dr. Radolf agrees that he 
will not participate in any PHS-supported research until such a 
supervision plan is submitted to ORI; and
    (3) To ensure that any institution employing him submits, in 
conjunction with each application for PHS funds or report, manuscript, 
or abstract of PHS funded research in which Dr. Radolf is involved, a 
certification that the data provided by Dr. Radolf are based on actual 
experiments or are otherwise legitimately derived, and that the data, 
procedures, and methodology are accurately reported in the application 
or report. Dr. Radolf must ensure that the institution sends the 
certification to ORI.

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. 03-6894 Filed 3-21-03; 8:45 am]
BILLING CODE 4150-31-P