A new supplemental ethics regulation announced last week by the National Institutes of Health (NIH) will prohibit agency scientists from engaging in a number of outside activities, including consulting arrangements with "substantially affected organizations," which include all pharmaceutical and biotechnology companies and NIH-supported research institutions. Under the new regulation, NIH staff who are required to file specific financial disclosure reports will not be allowed to hold or acquire stock or other financial interests in biotechnology, pharmaceutical, medical device, and other companies involved in research or the development of many medical products.

"Nothing is more important to me than preserving the trust of the public in NIH," said NIH Director Dr. Elias A. Zerhouni. During a news conference on February 1, Dr. Zerhouni stressed that his goal with the new interim regulation was "to create a bright line that is so clear" there will be no "ambiguity in terms of interpreting where that line is."

The new regulation comes amid concerns raised by members of Congress over the past year about consulting or other business arrangements between some NIH scientists and industry that they alleged may have violated federal conflict-of-interest regulations or at least created the appearance of such conflicts.

Other provisions in the new regulation include a prohibition among senior NIH employees on the receipt of gifts or awards valued at more than $200 given because of their official position or from a prohibited source. The exception to the prohibition are awards that are considered among the most prestigious in the fields of medicine or scientific research, such as the Nobel Prize or Lasker Award, or those for which the employee simply receives a plaque or certificate and free attendance at the award event.

"Clearly we do not want to impair scientific interchange that is justified and valid," Dr. Zerhouni noted during the news conference. As a result, activities such as teaching classes, editing and writing of textbooks, and providing continued medical education courses will continue to be allowed. "We do not want to isolate our scientists from the mainstream of science," he said.

The new regulation took effect on February 3, when it was published in the Federal Register, and will remain in effect unless changed by subsequent regulations. The ban on outside activities will allow NIH to put in place the systems needed to effectively manage scientists' outside activities, Dr. Zerhouni said. Over the next year, HHS will review some of the provisions in the regulation, including some of the new prohibitions, and invites comment from the public during the 60-day comment period. That review, Dr. Zerhouni said, will include an evaluation of the regulation's impact on staff recruitment and retention.