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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