On the front page...
Reasonable, evenly applied rules and constant conversations
about ethics are what will keep NIH's reputation for top science
and reliable health research intact, according to NIH director
Dr. Elias Zerhouni, who announced the latest and final regulations
to prevent conflicts of interest at the agency on Aug. 25. In the
works since interim final regulations were published last February,
the new revised standards were effective Aug. 31, when they appeared
in the Federal Register.
"These rules are the most restrictive of any rules we know about
in the world of biomedical research," said Zerhouni. "We have done
what we said we would. 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."
|"It's impossible to have a one-size-fits-all approach. What
we've strived to achieve here is a reasonable balance..." — NIH
director Dr. Elias Zerhouni
The total ban on outside consulting with substantially affected
organizations (SAOs) remains in place, but its impact — on
recruitment and retention of scientists at NIH — will be
reassessed within a year, Zerhouni pointed out. SAOs are generally
defined as pharmaceutical and biotechnology companies, supported
research institutions (contractors and grantees), and health care
providers and insurers. The final rules feature three significant
- No longer do all workers who file financial disclosure forms
(public SF 278 or confidential OGE 450) have to divest of holdings
in SAOs. Only about 200 senior NIH employees must divest of such
holdings and only to a certain dollar figure. In other words,
the new rules prohibit senior NIH'ers (and their spouses and
minor children) from owning stock in any one SAO above a combined
total of $15,000. The value of all of their health care sector
fund holdings may not exceed $50,000. Senior employees include
the NIH director and deputy director; employees who report directly
to the NIH director (also called "Office of Director small staff");
institute and center directors and their deputies; scientific
directors; clinical directors; and extramural program officials
who report directly to IC directors. The effective date for divestiture
is Jan. 30, 2006.
A case-by-case analysis of the holdings of all other employees
involved in decision-making will determine what, if any, holdings
they will be required to divest, explained NIH deputy director
Dr. Raynard Kington.
All investigators who are not already filers and are listed on
clinical protocols will also be required to disclose their SAO
holdings. Prior to 2003, about 200 employees were required to file
the public form; there are now about 700 public filers. About 5,500
file the confidential forms.
- In the regulations detailing outside activities, the ban on
working with "related trade, professional or similar associations" was
lifted. The final regulations added four new exceptions, which
permit NIH'ers to serve on the data and safety monitoring boards,
and grant or scientific review committees of trade/professional
associations, as long as they get approval beforehand. An employee
can deliver a "general" lecture as part of a university course,
for instance, or could accept an invitation to give a general
Grand Rounds talk. "General" means not related to their NIH research.
Also, outside jobs that involve manual or unskilled labor, hobbies
or avocations unrelated to health and scientific research activities
do not require approval. "If you want to work at Hecht's, you
can now work at Hecht's without telling us," quipped Holli Beckerman
Jaffe, director of the NIH Ethics Office.
- Finally, under the revised rules, with prior approval, all
NIH'ers (including senior-level employees) can accept gifts associated
with bona fide awards for meritorious achievement. However, if
the source of the award can be affected by the employee's duties,
or those of any subordinates, gifts of more than $200 cannot
"Our research should be based on scientific evidence that is not
influenced by any other factors," Zerhouni stressed. "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."
The final regulations, a collaborative effort by officials from
NIH, HHS and the U.S. Office of Government Ethics, reflect the
comments received via hundreds of email messages to the department
and NIH following February's Federal Register announcement.
In addition, feedback was considered from numerous meetings Zerhouni
held formally and informally with various campus groups that included
IC directors, scientific and clinical directors, extramural program
officials as well as the Assembly of Scientists and other ad hoc
"We've learned a lot from this experience," said Jaffe. "There
were deficiencies in our program, which we have fully addressed.
In the end, we're going to have a program that will be a model
for the federal government."
Meanwhile, attention and vigilance will keep NIH from complacency,
Jaffe suggested. Employees are urged to visit the web site http://www.nih.gov/about/ethics_COI.htm,
read the new regulations in full and become familiar with the policies
expressed there. Afterwards, if you have questions or are unclear
about something, contact your IC deputy ethics counselor. Jaffe
anticipates more CoI training — and more extensive ethics
courses — will be developed and required for employees in
the coming months.
"I think we realized very early that going through this process
of adjustment of a large agency with very complex function would
require tailoring," Zerhouni concluded. "It's impossible to have
a one-size-fits-all approach. What we've strived to achieve here
is a reasonable balance in collaboration with the Department of
Health and Human Services and the Office of Government Ethics,
who are ultimately responsible for these rules."
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