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NIH eases ethics rules

Stock ownership allowed but ban on consulting for biotech and drug companies remains

By | August 26, 2005

The National Institutes of Health (NIH) will ease previously issued ethics rules, the agency announced yesterday (August 25). The leader of a group of senior intramural NIH scientists that had criticized the rules expressed relief at the announcement.

The final regulations allow most NIH scientists and employees to own stock in biotech and drug companies, and to participate in activities with nonprofit professional and scientific organizations. But a total ban on outside consulting with pharmaceutical, biotech, and medical device companies remains in place for all employees.

The final regulations soften a set of "sweeping" ethics reforms announced February 1 that had been severely criticized by scientists and others as being overly broad. Critics said they would have impaired NIH's ability to recruit and retain talented scientists.

"We are extremely satisfied with what we understand the regulations will be," said Ezekiel Emanuel, chief of clinical bioethics at NIH's Warren G. Magnuson Clinical Center and a member of the executive committee of the Assembly of Scientists, an organization representing NIH intramural researchers. "It comes pretty close to what we had suggested five months ago," he told The Scientist.

The new rules limit stock ownership in biotech, drug, and other "substantially affected organizations" to $15,000 per company for about 200 senior NIH employees and their families, including institute and center directors and their deputies, as well as scientific and clinical directors. The earlier rule would have applied the holdings cap to about 12,000 NIH employees and would have required about 6,000 intramural scientists, all senior officials, and those having contracting and grant-making authority to divest of all stock in drug and biotech companies.

After receiving some 1,300 comments to the earlier rules, "we decided to adjust in terms of degree some of the decisions we had made before," NIH director Elias A. Zerhouni told reporters yesterday. "The issues that we were facing were not related to stock holdings in great part." The final regulations also ease earlier restrictions on involvement with nonprofit academic, scientific, and professional societies, and participating in civic activities.

"Our research should be based on scientific evidence that is not influenced by any other factors," Zerhouni said. "The trust of the public and the ability for us to provide scientific advice that is untainted is the number one goal of all of our efforts."

While resolving the conflict of interest issue is a "positive step," Emanuel said, larger morale issues still remain for NIH scientists. These include unnecessary restrictions on travel, increasingly burdensome paperwork required to approve outside activities and, most importantly, the need to increase salaries for junior-level scientists.

"NIH has to pay competitive salaries to attract good junior people. That's how we get our senior people," Emanuel said. "If we can't replenish the younger ranks, NIH will become a dying institution."

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The Scientist