NIH Scientists’ Outside Work Not Scrutinized, HHS OIG Says
In 81% of recent arrangements reviewed by the HHS Office of Inspector General, ethics officials at NIH approved senior scientists' requests to engage in outside work for drug companies and other external organizations without gathering adequate documentation to help determine whether the arrangements posed conflicts of interest, the Los Angeles Times reports. A copy of the 72-page report was obtained on Thursday by the Times and is scheduled to be made public on Friday.
The report stated, "In no instance was the documentation we reviewed adequate for us to make a definitive determination regarding whether an activity was appropriate," adding, "Inadequate documentation for outside activities can, intentionally or unintentionally, hide potential violations." The OIG review focused on arrangements from 2001 to 2003 made by 174 senior scientists. The review focused only on those scientists who, as of January 2004, were required to file a publicly accessible financial disclosure report. Directors, deputy directors and scientific directors of the NIH's research institutes were covered by the review. The terms of the OIG review excluded many other high-ranking scientists, including laboratory and branch chiefs, according to the Times.
OIG found that of the 174 scientists whose paperwork was reviewed, 69 requested and received approvals to work with outside organizations. Of those, NIH ethics officials approved 319 of 355 requested outside engagements -- almost 90% of the total. Forty-five of the engagements involved consulting or scientific-advisory arrangements with biomedical companies.
In the report, OIG said that information submitted by the scientists to NIH ethics officials "included insufficient detail regarding the nature of the outside activities, the nature of employees' official job duties, the differences between the outside activities and their official job duties, the outside organizations, and any NIH funding or partnerships with the outside organizations." The advance descriptions of the outside positions that NIH scientists proposed accepting "were too general to demonstrate that employees' official duties would not overlap," the report found.
OIG reviewers "could not determine the appropriateness of eight activities, and they also determined that two of the activities appeared to violate regulations," according to the report. In addition, the report said, "It is quite possible that, due to the approach taken in this review, we have underestimated the number of activities that should not have been approved." In a written reply to OIG, NIH Director Elias Zerhouni cited actions recently taken to address outside work arrangements. However, he said that he generally agreed with the inspector general's findings, conclusions and recommendations. A spokesperson for HHS Inspector General Daniel Levinson declined to comment (Willman, Los Angeles Times, 8/5).