FINDINGS OF SCIENTIFIC MISCONDUCT 

NIH GUIDE, Volume 25, Number 10, March 29, 1996

 

P.T. 34



Keywords:

  Ethics/Values in Science & Technol 

  Grants Administration/Policy+ 

 

Department of Health and Human Services

 

Notice is hereby given that the Office of Research Integrity (ORI)

has made final findings of scientific misconduct in the following

cases:

 

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 non-certified

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 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 C.F.R. Part 76 and

48 C.F.R. 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 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.

 

Cathy Q. Lee, Massachusetts General Hospital:  On February 28, 1996,

ORI found that Cathy Q. Lee, Ph.D., Postdoctoral Fellow, Molecular

Endocrinology Laboratory at the Massachusetts General Hospital,

committed scientific misconduct by engaging in falsification and

fabrication of research data incorporated in a manuscript prepared

for submission (but not submitted) to the EMBO Journal (Lee, C.Q.,

Yun, Y., and Habener, J.F.  "Transactivation of functions of cAMP-

responsive transcription factor CREB-327 mediated by amphiphatic

helical domains flanking the requisite serine-119 phosphorylated by

protein kinase-A.") and by engaging in improper data selection and

falsification of data published in the EMBO Journal (Lee, C.Q., Yun,

Y., Hoeffler, J.P., and Habener, J.F.  "Cyclic-AMP responsive

transcriptional activation of CREB-327 involves interdependent

phosphorylated subdomains."  EMBO Journal 9:4455-4465, 1990.).  This

research was supported by a Public Health Service grant.

 

Dr. Lee has entered into a Voluntary Exclusion Agreement with ORI in

settlement of ORI's finding of scientific misconduct and has agreed:

 

(1) to exclude herself voluntarily from any contracting or

subcontracting with any agency of the United States Government and

from eligibility for, or involvement in, Federal nonprocurement

transactions (e.g., grants and cooperative agreements) of the United

States Government, as defined in 45 C.F.R. Part 76 and 48 C.F.R.

Subparts 9.4 and 309.4 (Debarment Regulations) for a period of two

years beginning on February 28, 1996; the above voluntary exclusion,

however, shall not apply to Dr. Lee's future clinical laboratory

training or practice, unless that training or practice involves

research or research training;

 

(2) that for a period of one year beginning immediately after the two

year voluntary exclusion above, any institution that submits an

application for PHS support for a research project on which the

Respondent's participation is proposed or which uses the Respondent

in any capacity on PHS supported research, must concurrently submit a

plan for supervision of the Respondent's duties; the supervisory plan

must be designed to ensure the scientific integrity of the

Respondent's research contribution, and the institution must submit a

copy of the supervisory plan to ORI; and

 

(3) to exclude herself voluntarily 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 a period of three years beginning on February 28,

1996.

 

A letter retracting the article entitled "Cyclic-AMP responsive

transcriptional activation of CREB-327 involves interdependent

phosphorylated subdomains" (EMBO Journal 9:4455-4465, 1990) has been

published in the EMBO Journal (EMBO Journal 13:2736, 1994).

 

INQUIRIES

 

For further information, contact:

 

Director, Division of Research Investigations

Office of Research Integrity

5515 Security Lane, Suite 700

Rockville, MD  20852

Telephone:  (301) 443-5330

 

.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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