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Date: Thursday, March 14, 1996 FOR IMMEDIATE RELEASE Contact: HHS Press Office (202) 690-6343
An investigation by the U.S. Office of Research Integrity (ORI) has concluded that Gail Daubert, R.N., a former Northwestern University coordinator for a study of a rare form of eye cancer, committed scientific misconduct by falsifying data. Ms. Daubert was found to have falsified, over several years, 211 data items, including falsely stating that a radiation oncologist had evaluated patients prior to entry on the study, and falsifying the dates of examinations and procedures and results of laboratory tests.
While she has not admitted to the scientific misconduct, Ms. Daubert has agreed to voluntarily exclude herself from eligibility for and involvement in grants as well as other assistance awards and contracts from the federal government for three years, subject to specified exceptions. Ms. Daubert was the only individual found responsible for the falsified information. The voluntary settlement agreement ends the investigation by ORI, a part of the Department of Health and Human Services, of problems related to the Collaborative Ocular Melanoma Study at Northwestern University.
The false information was recorded on research data forms related to the National Eye Institute (NEI) sponsored multicenter studies on the treatment of choroidal melanoma, a rare form of eye cancer.
The ORI investigation uncovered no instances where the health, safety, or treatment of patients entered on the study were compromised, although falsified clinical data that were potentially detrimental to the study were entered into the clinical trial database. However because the study is an ongoing project, no scientific reports affected by the falsified data were published in journals.
No clinical treatment recommendations have been based on the results of the studies. NEI, Northwestern University, and the coordinating center for the study at Johns Hopkins School of Medicine cooperated fully with the investigation, ORI officials said. A routine audit by the Hopkins study center led to the investigation.
The results of the investigation are under review by NEI, the study leadership, and by the study's independent data safety and monitoring committee to determine what effect, if any, the falsified data had on the study as a whole. These groups' determination will be shared with patients in the study.