| overman74@hotmail.com 2005-09-28, 9:42 am |
| A wolf in CT? Think you might have seen a coyote maybe. Don't think
there are wolves in that state.
Didn't know Yale was working on tick vaccine. Let's hope it is better
than the Lyme vaccine. I don't plan to be first in line for this new
one when it comes out.
Hope it is not being investigated with the same ethical standards as
Dr. Radolf used in his tick vaccine studies/grant applications:
Case Summary - Justin Radolf, M.D.
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[Federal Register: March 24, 2003 (Volume 68, Number 56)]
[Notices]
[Page 14240]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr03-67]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Scientific Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice
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]
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