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 .
. 1996 Mar 29;25(10):2-3.