FINDINGS OF SCIENTIFIC MISCONDUCT

RELEASE DATE:  March 24, 2003

NOTICE:  NOT-OD-03-037

Department of Health and Human Services (DHHS)

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.

INQUIRIES

For further information contact:

Director
Division of Investigative Oversight
Office of Research Integrity
5515 Security Lane, Suite 700
Rockville, MD  20852
Telephone:  301-443-5330

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