NIH Eases Up on Ethics Rules for Researchers

After six months of review, the National Institutes of Health has decided to leave in place its ban against agency scientists taking consulting fees from drug companies but will not require the scientists to sell all of their industry stock holdings, officials announced Thursday.

Scientists at the NIH also will be allowed to accept fees for delivering lectures to some groups and for serving on data monitoring boards, so long as financial support from the companies is first paid to an intermediary organization, such as a college or a hospital, as an “unrestricted grant.” The data monitoring boards are intended to protect patients who are administered experimental drugs or other treatments in clinical studies.

The revised ethics rules were described by the NIH’s director, Dr. Elias A. Zerhouni, who in February announced interim restrictions after learning about millions of dollars of fees and stock options paid by the companies to senior agency scientists.

The revisions were approved by the U.S. Office of Government Ethics. Zerhouni, alluding to criticisms and other comments received in recent months from at least 1,300 NIH employees, said the restrictions that he unveiled in February might “have been calibrated a little too stringently.” Still, Zerhouni said that the final rules, which go into effect next week, remained rigorous.

“These rules are the most restrictive of any rules we know about in the world of biomedical research,” Zerhouni said in a 50-minute conference call with reporters. “Many employees asked that we loosen the ban on paid outside consulting. We elected not to.... I think we should have a total ban.” The consulting ban has been in effect since February.

Zerhouni also said in a prepared statement: “We have a balanced set of conflict of interest rules that protect the integrity of NIH and its ability to provide the American public with an unbiased and trusted source of scientific and health information, while preserving our ability to recruit and retain world class scientists and staff.”

Recent reviews overseen by Zerhouni’s staff and by the inspector general of the Department of Health and Human Services have reflected the severity of conflicts of interest at the NIH.

In July, Zerhouni told members of Congress that 44 of a sample of 81 scientists had violated the agency’s then-existing standards. Some of the scientists consulted for companies without seeking required approval, consulted in areas that overlapped with their government duties, or “consulted in situations where the main benefit was the ability of the employer to invoke the name of NIH as an affiliation,” Zerhouni said.

More recently, the inspector general’s office reported that in 81% of the cases it reviewed, NIH officials had approved scientists’ requests to moonlight for drug companies and other outside organizations without gathering enough information to know whether the arrangements posed conflicts of interest.

Full details of the rules will be published next week in the Federal Register.

As described by Zerhouni, the revised rules require about 200 of the most senior NIH officials to sell stock holdings valued at $15,000 or more in any biomedical company.

Under the interim stock-related rules announced Feb. 1 -- which were never implemented -- the requirements would have been more severe: About 6,000 NIH scientists -- including the directors of the agency’s 27 research institutes and centers along with laboratory chiefs and other researchers -- would have been required to sell any biomedical company stock. The agency’s remaining 12,000 or so employees, including secretaries, elevator operators and landscapers, would have been ordered to sell biomedical company stock worth more than $15,000.

The interim rules would have put the NIH more in line with the ethics policy at the Food and Drug Administration.

Howard A. Young, a microbiologist and section chief at the National Cancer Institute, said Thursday by e-mail that he was “encouraged by the changes.” Young, who in recent years accepted stock options from a viral-research firm as allowed by the NIH’s earlier rules, now serves on the executive committee of the Assembly of Scientists, a group of NIH employees that has fought to overturn the more restrictive rules.

On March 9, the Assembly of Scientists proposed alternative ethics rules that would have allowed most government scientists, including laboratory and branch chiefs, to resume paid consulting for drug or biotechnology companies.

Marc L. Fleischaker, a lawyer whose law and lobbying firm, Arent Fox, represents the Assembly of Scientists, said that the group would withhold a formal response until details of the new rules were published next week. Based on summaries distributed by the NIH, Fleischaker said, “It looks like it’s a very good step in the right direction.”

Dr. Sidney Wolfe of Public Citizen, a consumer advocacy group, said Thursday that the new rules opened loopholes that could subvert the ban on consulting fees.

“The consulting fees are closed off, but you have all these other ways you can make money from the drug industry,” said Wolfe, who once was a researcher at the NIH.

Zerhouni has said that the revisions are needed to help attract and retain quality scientists. On Thursday he said that the revisions would allow “better academic interactions.”

The revised rules also reduce paperwork requirements that had made it more burdensome this year for NIH employees to serve as board members or accept compensation from outside nonprofit organizations. And the revised rules will make it less onerous for employees to accept “bona fide” monetary awards from outside organizations, Zerhouni and other NIH officials said.

Looking ahead, Zerhouni said he wanted to continue improving the NIH’s ability to track the outside activities of its scientists. Within the last years, Zerhouni said, the number of senior employees required to file financial-disclosure reports available for public inspection has increased from 200 to about 700. Some 6,000 other NIH employees file annual financial reports that are kept confidential, officials said.