August 25, 2005

US National Institutes of Health releases ethics rules

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.

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 require many 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

They also complained that top-notch researchers and
administrators would be scared off by the rules.

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.

But some of it staff had relationships with potential
beneficiaries that critics considered too cozy.

"Senior management and people who play an important role in
research decisions must meet a higher standard of disclosure
and divestiture than people who are not decision-makers," the
NIH said in a statement.

But it 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

"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.