US health agency softens disputed ethics rules
By Maggie Fox, Health and Science Correspondent
WASHINGTON (Reuters) - The U.S. National Institutes of Health issued revised ethics regulations on Thursday with new rules on investments and consulting in the health industry that are aimed at cleaning up the agency's image.
The rules, some of which were softened after reviewing complaints, require certain top-level employees and their family members to get rid of investments that might be seen as affecting their judgment.
They also prohibit employees from consulting for pharmaceutical, biotechnology or medical device manufacturing companies, health care providers or insurers, and research institutions that receive NIH grants.
"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," NIH director Dr. Elias Zerhouni said in a statement.
NIH employees who had criticized the initial rules gave cautious approval.
"In general, I think they have done a good job," said Dr. Ezekiel Emanuel, part of a group called the Assembly of Scientists that had criticized the initial ethics plan.
"Pending actually reading the new rules, we are generally optimistic. We think they have adopted almost everything that the Assembly of Scientists says the rules should have."
The rules were first announced in February after reports of one NIH researcher who was paid $500,000 over 5 years by a private company, and other similar cases.
But many scientists chafed under some of the restrictions, which required employees to list their stock holdings and even sell off shares to prevent potential conflicts of interest. They said secretaries, support staff and others who did not make financial decisions should not be bound by the rules.
They also complained that top-notch researchers and administrators would be scared off by some of the requirements.
The NIH is considered the world's leading research institution, with 18,000 employees and a $28 billion annual budget. Much of its money goes to fund research at universities, or to begin developing products that are later licensed to commercial companies.
Researchers often sacrifice the high salaries of private practice or working for a drug company in exchange for the prestige of working at NIH, as well as what is seen as an opportunity to do some good in the world.
But some of it staff had relationships with potential beneficiaries that critics considered too cozy.
The NIH said employees need to be able to take part in professional associations and "genuine teaching opportunities."
"The basic prohibition on outside consulting by NIH staff with substantially affected organizations, such as pharmaceutical, biotechnology or medical device manufacturing companies, health care providers or insurers, and supported research institutions remains unchanged," the NIH said in a statement.
"Divestiture of all holdings in substantially affected organizations in excess of $15,000 per company will be required for all senior NIH employees and their spouses and minor children," it added.
"All other employees may be required to divest if, after review, a potential conflict resulting from their holdings or those of their spouses and minor children would impede their ability to do their government job."
Certain employees will also need to file reports disclosing their investments, and prior approval will be needed for any cash awards, the NIH said.
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