About 1000 allegations of scientific misconduct were received by the NIH Office of Research Integrity (1993-97). Only 150 cases contained sufficient information to warrant further investigation.These cases resulted in 76 findings of scientific misconduct and 74 findings of no misconduct. The US Public Health Service (USPHS) imposed 170 administrative actions on the 76 respondents; 54 respondents (71%) were debarred from receiving Federal (USA) funding for periods ranging from 18 months to 8 years. Other actions included prohibition from USPHS advisory service (91%); supervised research (26%); certification of data (13%); certification of sources (9%); and correction or retraction of articles (13%).4
Since 1991, an increased number of institutions have been suspended by the US Government for violations of regulations and protocols (Figure 7.9). The Office for the Protection of Research has identified the following major problem areas: failure of the IRB to conduct continuing review at least once per year; failure of the IRB to review and approve protocol changes prior to their implementation; inappropriate use of expedited IRB review; failure of the informed consent documents to include adequate description of reasonably foreseeable risks and an adequate description of any benefits that may reasonably be expected.
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