Health Research Misconduct

The federal government spends billions each year on research for cures for a host of chronic diseases and on preventative treatments. This money is channelled to researchers mainly through the National Institutes of Health and other office within the Department of Health and Human Services' (HHS) Public Health Service. Congressional concern that federal dollars have been misspent on inappropriate research was heightened by widely publicized reports of research fraud and other scientific misconduct, such as the recent detection of falsified data in federally funded breast cancer research. HHS' Office of Research Integrity was established to foster confidence in federal health research programs in two ways: through direct investigations of misconduct allegations and oversight of investigations done by extramural research institutions. GAO found that since its inception, the Office has improved its handling of scientific misconduct cases. By continuing to follow sound investigative procedures and striving to improve its handling of cases, the office will increase public trust. However, the Office needs to overcome persistent delays in case handling and shortcomings in its management systems if it is to effectively fulfill its mission in the future.

GAO found that: (1) ORI has developed and implemented procedures for handling misconduct cases by assessing the qualifications of its investigative staff, the level of independence and professional care needed to conduct investigations, and other qualitative standards for planning, executing, and reporting investigation results; (2) the techniques ORI uses in handling misconduct cases raises a few concerns; (3) despite ORI success in implementing procedures for handling misconduct cases, it continues to experience delays in closing cases; (4) ORI needs a comprehensive assessment of its resources since it faces a substantial case backlog; and (5) ORI has initiated a number of actions to improve productivity and plans to refine its planning processes during fiscal year 1995.