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Ed. Note: The following
is a press release from the National Institutes of Health.
February 1, 2005
NIH Announces Sweeping Ethics Reform
The National Institutes of
Health (NIH) announced today a new supplemental ethics regulation that
addresses the concerns raised by the activities of some of its employees,
particularly regarding outside consulting with the pharmaceutical and
biotechnology industries. The regulation was developed by the Department
of Health and Human Services (HHS), with the concurrence of the Office of
Government Ethics (OGE), the federal agency that prescribes executive
branch-wide ethics standards.
"Nothing is more important to me than preserving the trust of the public
in NIH. It is unfortunate that the activities of a few employees have
tainted the stellar reputation of the many thousands of NIH scientists who
have never compromised their integrity and have selflessly served the
nation with great distinction through their discoveries. I am confident
that these new rules will prevent the recurrence of past abuses and will
go a long way in preserving the historic role of NIH as the primary source
of unbiased scientific health information for the country," said NIH
Director Elias A. Zerhouni, M.D.
The new regulation focuses on outside activities, financial holdings, and
awards for all NIH employees.
Over the past year, the NIH has been addressing the ethics issues raised
by the outside consulting activities of several of its employees. The NIH
conducted thorough reviews of these activities, established an NIH central
review committee, convened a Blue Ribbon Panel to help develop NIH-wide
policy, responded to Congressional inquiries and testified at public
hearings in the House and Senate. It was clear that NIH needed a
substantially expanded system of oversight to ensure that conflicts of
interest — even the appearance of conflicts — were prevented.
This is an interim final regulation, which means that it goes into effect
once it is published in the Federal Register, which is expected in the
next few days, and remains in effect unless changed by subsequent
regulations. As noted in the new regulation, HHS intends to evaluate
certain provisions in the rule, including those regarding outside
activities and financial holdings, within the next year. HHS will consider
public comments about the regulation — which will be accepted for 60 days
once the Federal Register notice is published — and the knowledge gained
from the first year of implementation when deciding, which, if any,
provisions to revise.
During this period, HHS also will complete a review of existing outside
activities that is presently ongoing, develop and test more effective
oversight systems, overhaul its administrative capabilities for the
management of its ethics program, implement improved training and evaluate
the impact of this regulation. NIH scientists will continue to be able to
conduct academic activities such as teaching courses at universities,
writing general textbooks, performing scientific journal reviews,
participating in scientific meetings and providing general lectures to
physicians and scientists at continuing professional education and similar
events, as well as practicing medicine as appropriate, provided that the
activities are otherwise in accordance with existing law and adhere
strictly to the conditions specified in the new rules.
Under the new rules, all NIH employees are prohibited from engaging in
certain outside employment with: 1) substantially affected organizations,
including pharmaceutical and biotechnology companies; 2) supported
research institutions, including NIH grantees; 3) health care providers
and insurers; and 4) related trade, professional or similar associations.
Investments in organizations substantially affected by the NIH, such as
the biotechnology and pharmaceutical industries, are also not allowed for
those employees who are required to file public and confidential financial
disclosure reports, and are restricted for other staff.
"Though I believe that some outside activities are in the best interest of
the public when designed to accelerate the development of new discoveries,
we must first have better oversight systems to ensure transparency and
sound ethical practices and procedures," said Dr. Zerhouni.
NIH leadership is developing procedures to implement the regulation and
will hold training sessions as soon as possible to explain the full impact
of these new rules to employees.
For further information, visit:
NIH Conflict of Interest Information and Resources (http://www.nih.gov/about/ethics_COI.htm)
Federal Register (http://www.archives.gov/federal_register/index.html)
The National Institutes of Health (NIH), an agency of the U.S.
Department of Health and Human Services, is the Nation's medical research
agency for conducting and supporting basic, clinical, and translational
medical research. NIH comprises the Office of the Director and 27
institutes and centers and investigates the causes, treatments, and cures
for both common and rare diseases.
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