[Federal Register Volume 61, Number 51 (Thursday, March 14, 1996)]
[Notices]
[Pages 10584-10585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6026]
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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) has made final findings of scientific misconduct in the following
case:
Gail L. Daubert, R.N., Northwestern University: Based on an
investigation conducted by its Division of Research Investigations, ORI
found that Gail Daubert, R.N., while serving as clinic coordinator for
the Collaborative Ocular Melanoma Study (COMS) at Northwestern
University, committed scientific misconduct by falsifying clinical
trial data. The multicenter COMS involves research on the treatment of
choroidal melanoma, a rare form of eye cancer. It is supported by the
National Eye Institute. The study is still ongoing, and no results have
been published.
ORI found that Ms. Daubert falsified 211 data items, including
falsely stating that a radiation oncologist had evaluated patients
prior to randomization, falsely reporting laboratory blood test results
were normal when they were abnormal, falsely reporting that dates for
patient visits or procedures had been performed within the specified
protocol window when the actual date was outside the protocol window,
and falsely reporting that a COMS certified examiner had performed an
evaluation or procedure when a noncertified examiner had performed the
task.
Ms. Daubert has entered into a Voluntary Exclusion Agreement with
ORI in which she does not admit to any acts of scientific misconduct,
but she has agreed to exclude herself voluntarily, for the three (3)
year period beginning March 4, 1996, from:
(1) 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 CFR
Part 76 and 48 CFR Subparts 9.4 and 309.4 (Debarment Regulations);
and
(2) 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.
The above voluntary exclusion, however, shall not apply to Ms.
Daubert's future training or practice of clinical medicine as a nurse,
unless that practice involves research or research
[[Page 10585]]
training, or to Ms. Daubert's participation in or eligibility for any
Federal program relating to student loans, education grants, or
educational assistance of any type or kind, for which she would
otherwise be qualified to receive or be considered to receive
(educational assistance), unless that educational assistance involves
research or research training.
FOR FURTHER INFORMATION CONTACT: Director, Division of Research
Investigations, Office of Research Integrity, 5515 Security Lane, Suite
700, Rockville, MD 20852.
Lyle W. Bivens,
Director, Office of Research Integrity.
[FR Doc. 96-6026 Filed 3-13-96; 8:45 am]
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