A successful system of scientific data audits for clinical trials: a report from the Cancer and Leukemia Group B
Article Abstract:
The incidence of scientific fraud may be low in clinical trials carried out by the Cancer and Leukemia Group B (CALGB). Clinical trials are research studies that evaluate new medical procedures and drugs in human volunteers. The CALGB is a cooperative group that conducts clinical trials funded by the National Cancer Institute. A study examined the results of 691 audits of CALGB-associated research institutions between 1982 and 1992. The main CALGB institutions were compared to affiliates. Both improved their compliance with federal regulations. Adequate completion of patient consent forms also increased. Deviation from planned drug treatment regimens did not change from an incidence of 11%. Only two episodes of scientific misconduct were found and both took place before 1984. Unfavorable audits are sufficiently important to the institutions that 99 have withdrawn from CALGB because of them.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1993
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The scientific misconduct process: a scientist's view from the inside
Article Abstract:
The Research Integrity Adjudications Panel (RIAP) effectively reviews cases of alleged scientific misconduct by conducting full and open hearings. The RIAP within the U.S. Department of Health and Human Services reviews appeals of decisions by the Office of Research Integrity (ORI). Decisions of ORI can lead to loss of reputation or livelihood when a scientist is found guilty. The review ensures the due process of the accused by allowing open examination of witnesses and the presentation of exculpatory evidence. Scientists can make valuable contributions by participating on the panel.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1998
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Improving the scientific misconduct hearing process
Article Abstract:
The Office of Research Integrity (ORI) should make immediate changes in its review process. ORI is part of the Department of Health and Human Services and is the agency responsible for investigating charges of scientific misconduct. However, many scientists are dissatisfied with the agency's track record. No scientists are present on the panels and the hearings often resemble a legal proceeding rather than a scientific inquiry. Scientists should be included on the panels as well as patent attorneys and administrative law judges.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1997
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