The National Institutes of Health has announced regulations that prohibit its entire stafffrom secretaries to postdocs to senior staff to the director himselffrom engaging in outside arrangements with pharmaceutical and biotechnology companies, owning stock in health-related companies, and accepting awards from organizations or institutions that have a relationship with NIH.
The regulations went into effect on February 3 and are open for comment until April 4. The agency intends to review certain provisions of the regulations throughout the next year. "My goal here is to create a bright line that is so clear that ... we'll not have any ambiguity in terms of interpreting where that line is," said NIH director Elias Zerhouni, M.D. "The vast majority of scientists [at NIH] have served selflessly ... and have given of themselves with great distinction, and we owed it to them to come up with regulations that will protect their reputation."
The broadest part of the new regulations covers outside activities: Compensated or uncompensated employment (including consulting or advisory board service) and compensated teaching, speaking, writing, and editing are prohibited with so-called substantially affected organizations such as biotechnology, pharmaceutical, and medical device companies; hospitals and other health care providers; health insurers; or health, science, or research-related trade organizations, professional associations, and consumer or advocacy groups.
Holli Beckerman Jaffe, J.D., director of the NIH Ethics Office, clarified that NIH employees will still be able to participate in committee activities and serve as officers of trade and professional associations as long as the activity is as an official job duty and has been approved by the employee's ethics officer.
Employees will still be able to receive compensation for teaching college courses; teaching, speaking, or writing as part of a continuing professional education program; clinical and other health-related professional medical practice; and writing and editing scientific journals, articles, chapters, or textbooksas long as none of those activities are with a substantially affected organization. Researchers will also be able to give uncompensated lectures as part of their official duties.
"What we want to disconnect is the private interest of either the scientist or the entity that is asking the scientist to talk, but we do not want to break the bond of scientific interchange that needs to happen," Zerhouni said.
Other new regulations concern stock ownership and accepting awards. The 700 NIH employees who file public disclosure reports and the 5,500 who file confidential disclosure reports will be prohibited from holding stock in any biotechnology, pharmaceutical, or medical device company or in any other company involved in the research, development, or manufacture of medical devices or equipment. The rest of NIH employees will have to limit holdings to $15,000 in any one such company. The rules also apply to spouses of NIH employees.
The awards regulation stipulates that senior employees cannot accept a gift or award of more than $200 given to them because of their official position or from a prohibited source. People who are not on the senior staff or who do not have official duty matters that involve the donor may accept such awards. NIH intends to create a list of organizations from which awards may be accepted. Exceptions will be made for prestigious awards such as the Nobel Prize and the Lasker Award.
The motivation for all of the regulations, Zerhouni said, is to keep the public's trust. "Nothing is more important for NIH than preserving the public's trust in our advice, our science, in our ability to provide public health advice," Zerhouni said.
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