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Date: Friday, April 26, 1996 FOR IMMEDIATE RELEASE Contact: HHS Press Office(202)690-6343
The U.S. Office of Research Integrity (ORI) announced today that Joan Gans, R.N., a former employee of the Denver Community Program for Clinical Research on AIDS (CPCRA) Unit at the department of public health, Denver Department of Health and Hospitals, committed scientific misconduct by falsifying and fabricating patient data for clinical studies involving AIDS research. The National Institute of Allergy and Infectious Diseases (NIAID) supports a number of CPCRA units, including the one in Denver, to conduct clinical research in primary care settings with the objective of determining optimal care for HIV-infected patients.
Based on a record audit conducted by NIAID and her admission, ORI found that Ms. Gans altered research data that made otherwise ineligible patients appear to be eligible. In addition, Ms. Gans altered radiology forms, a finding which precipitated the NIAID audit.
Ms. Gans admitted to the scientific misconduct and has agreed to voluntarily exclude herself from eligibility for and involvement in grants and cooperative agreements from the federal government for two years, subject to specified exceptions. Further, Ms. Gans has agreed to a requirement for implementation of a supervisory plan for any Public Health Service-supported research in which she is involved for one year following the two-year voluntary exclusion and has agreed to exclude herself from serving in any advisory capacity to PHS for three years. Ms. Gans was the only individual found responsible for the falsified and fabricated information.
These findings of scientific misconduct do not change the overall results of the ongoing research being conducted by the CPCRA units.
ORI officials stated that the Denver CPCRA Unit, department of public health, Denver Department of Health and Hospitals, cooperated fully with ORI, as did NIAID, whose audit led to the findings of scientific misconduct.
The Division of AIDS, NIAID, convened a special team of CPCRA investigators to review these findings and the NIAID audit report and developed recommendations for improving the data collection process at the Denver CPCRA Unit. These recommendations have been fully implemented, and the Denver CPCRA is actively recruiting and following patients for CPCRA studies. ORI's findings against Ms. Gans end its review of allegations related to the Denver CPCRA Unit.