Washington

Scene of conflict: revamped ethical guidelines at the NIH are being criticized as too restrictive. Credit: NIH

The US National Institutes of Health (NIH) is facing a revolt by employees over its tightened rules on conflicts of interest.

The restrictions, which dramatically alter a policy set up in 1995, were announced on 1 February (see Nature 433, 557; 2005 10.1038/433557a). They are the result of intense pressure on the NIH from an angry Congress, after a series of embarrassing disclosures revealed that a number of senior agency scientists had been making hundreds of thousands of dollars as consultants for commercial firms.

But the move has angered NIH employees, who say that the rules go too far. They point to talented young researchers who will be discouraged from coming to the agency because their inventions have been taken up by biotechnology companies (see ‘Caught between a rock and a hard place’). And they fear for long-standing employees whose life savings could be hit hard by regulations on owning stocks.

“Many of the rules are frightening,” says Abner Notkins, chief of experimental medicine at the National Institute of Dental and Craniofacial Research. “They've gone to a damaging extreme.”

“The vast majority of NIH employees have done nothing wrong. We are all being punished for the transgressions of a few,” adds Elaine Jaffe, chief of haematopathology at the National Cancer Institute.

Under the rules, all forms of paid and unpaid consulting for biomedical companies are banned, and there are numerous restrictions on teaching and serving on company boards. Senior scientists are not allowed to accept academic prizes worth more than $200. The rules also require some 6,000 senior NIH employees to sell any stock in biomedical companies owned by themselves, their spouses or their children by this July. The NIH's other 11,500 employees are each limited to $15,000 of stocks in any given biomedical firm.

Protesters say that the rules will hurt the agency's recruiting and retention of scientists, and force significant financial losses on many employees, especially those who are past the age of easily finding another job. Notkins points out that people who bought shares in Pfizer a year ago at $37, for example, would be obliged to sell them at the current price of $27.

Raynard Kington, NIH deputy director, counters that the rules are tough but necessary. “The preponderance of the evidence suggested that our ethics oversight system didn't work,” he says. “Our number one priority was to ensure the public's trust in the integrity of the science of this agency.”

He points out that, like it or not, NIH scientists can have an impact on financial markets — as they did in December, when Pfizer shares fell sharply after the National Cancer Institute halted a clinical trial amid safety concerns about the company's painkiller Celebrex.

Kington and other NIH officials have been probing the cases of some 100 NIH scientists who congressional investigators found were not complying with the old ethics rules. It has emerged that at least half of these people did not violate the rules, but were mistakenly identified because, for example, they had the same name as another researcher who had consulted for a drug firm.

“Even if 80% of them are cleared,” says Kington, “having 20% on that list who may have violated the rules says something about the system.”

But hundreds of NIH employees say that the agency's response is too extreme. In an online vote last month, 700 of them elected an executive committee for the Assembly of Scientists, a dormant group of intramural scientists that has reconstituted itself to try to soften the new rules.

The revival was spearheaded by Ezekiel Emanuel, chairman of the NIH Department of Clinical Bioethics, and quickly led to a two-hour meeting late last week between the assembly's executive committee and officials including agency director Elias Zerhouni and Kington. The assembly is also consulting the American Civil Liberties Union to see whether the new rules violate the privacy and freedom-of-speech rights of NIH employees.

In the meantime, the reality of the changes is becoming apparent on the NIH campus. Last week, officials at the National Cancer Institute circulated a call for nominations for the $50,000 Paul Marks Prize for Cancer Research, offered by the Memorial Sloan-Kettering Cancer Center in New York. “Federal employees ... could accept the honor and the plaque, but not the monetary prize,” the e-mail noted.

Kington said last week that the NIH is committed to assessing the impact of the new rules on recruitment and retention, and making modifications if “an appropriate evidence base” shows that they are necessary. He asked NIH employees to “provide their input as clearly as possible”. Comments from the public are being accepted until 3 April at ethics@hhs.gov.