The bureaucratic response

In addition to its high-profile hearings and excess of publicity, the "Baltimore case" had another significant impact on the course of events, in that it attracted considerable publicity to the quality of government misconduct investigations. In late 1994, the Office of Research Integrity issued a finding of misconduct against Imanishi-Kari, which she then appealed against.53 In June 1996, the Departmental Appeals Board for the US Department of Health and Human Services ruled that the Office of Research Integrity had not proved either fabrication or falsification, and rejected the evidence on which the case had rested, so the case was officially closed over seven years after it had begun.

The National Science Foundation and National Institutes of Health, the two parts of the United States government most directly concerned with funding basic research, have responded quite differently to Congressional pressure to investigate misconduct. During the 1970s, concern about government ethics and contracting practices had resulted in the creation of special oversight offices throughout the Executive Branch. The head of each office, called an Inspector General, was assigned separate audit responsibility and charged with investigating any potential financial mismanagement or non-performance of duties by agency employees, grantees, and contractors. By placing its research misconduct unit within its Inspector General's office, the National Science Foundation avoided the stigma associated with a separate "ethics police force", and made a strong statement about the link between ethical behaviour and overall accountability for expenditure of federal funds. Since publishing its regulations in 1987, the Foundation has steadily refined its processes and mounted a number of major investigations without attracting significant congressional criticism.

At NIH, however, continued media scrutiny of new cases - and the agency's delays in investigating old ones - contributed to an atmosphere of bureaucratic confusion. Although NIH had begun to formulate its policies for grantees in 1981, Congress directed the Secretary of Health and Human Services in 1985 to develop regulations for all applicants for grants, contracts, and cooperative agreements, requiring them to report allegations and investigations to the government (Public Law 99-158), a requirement further strengthened with passage of additional legislation in 1993 (Public Law 103-43). An Office of Scientific Integrity was established for NIH, but both the office and the proposed guidelines attracted so much criticism from the biomedical community and the Congress that control of ethics investigations was eventually moved from NIH to its parent agency, the Public Health Service, within the Department of Health and Human Services, and the office renamed. The new Office of Research Integrity achieved somewhat more bureaucratic stability; but in Spring 2000, it was further reorganised. Responsibility for formal investigations was assigned elsewhere and the office's mandate changed to reflect increased federal involvement in ethical training for researchers.54 At present, cases that require official inquiry are referred to the Department of Health and Human Services' Office of Inspector General, which is staffed primarily by attorneys and trained investigators.

The other recent attempt to bring consistency to federal policies is an effort to write a government-wide definition of misconduct. This effort, guided by the Office of Science and Technology within the White House, has been repeatedly delayed by bureaucratic and partisan politics, but regulations were finally published in December 2000 (see page 24) but will not be fully implemented for years. The progress (or lack of progress) in developing a consensus definition exemplifies how, in the US, admirable ideals and a desire to achieve worthy goals can become easily entangled in the bureaucratic processes of a lively democracy.

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