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Date: March 10, 1995
FOR IMMEDIATE RELEASE
Contact: Bill Grigg, PHS   (202) 690-6867

Cleveland Clinic Researcher Found Guilty of Misconduct

An investigation by the U.S. Office of Research Integrity has concluded that Vivian Tanner, a former Cleveland Clinic Foundation coordinator for a study of a rare form of eye cancer, committed scientific misconduct by falsifying and fabricating data.

Ms. Tanner was found to have fabricated, over several years, the dates of examinations, the qualifications of the examiners and the results of laboratory tests.

As a result of the finding, Ms. Tanner has been barred from eligibility for and involvement in grants as well as other assistance awards and contracts from the federal government for three years. Ms. Tanner was the only individual found responsible for the falsified and fabricated information.

The finding -- which Ms. Tanner has not appealed -- 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 the Ohio clinic.

The false information was recorded on research data forms related to National Eye Institute-sponsored multicenter studies on the treatment of choroidal melanoma, a rare form of eye cancer.

Because of these falsifications and fabrications, inaccurate 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 or fabricated data were published in journals.

No clinical treatment recommendations have been based on the results of the studies.

The NEI, the Cleveland Clinic Foundation 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.

From 1985 to the present, the Cleveland Clinic project has received U.S. Public Health Service money from the NEI, a part of the National Institutes of Health within PHS.

The report of the investigation is under review by the NEI, the study leadership, and by the study's independent data safety and monitoring committee to determine what effect, if any, the falsified and fabricated data had on the study as a whole. These groups' determination will be shared with patients in the study.

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