The following memorandum was sent to all NIH staff on August
25, 2005 from NIH Director Elias A. Zerhouni, M.D.
August 25, 2005
Topic: Ethics Rules Announcement
Today we are announcing final regulations regarding reporting of certain
financial interests, stock divestiture, outside activities, and awards.
The regulations were developed by the Department of Health and Human
Services (HHS), in close collaboration with NIH, with the concurrence
of the Office of Government Ethics (OGE), the Federal agency that prescribes
executive branch-wide ethics standards.
Appropriate adjustments were made to the interim final rules, based
on a careful review of all comments about those regulations submitted
by NIH staff, the public, and scientific organizations. We believe these
final rules 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.
Three principles guided the crafting of the rules:
- The public must be assured that research decisions made at NIH are
based on scientific evidence and not by inappropriate influences.
- 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.
- To advance the science and stay on the cutting edge of research, NIH
employees must be allowed interaction with professional associations,
participation in public health activities, and genuine teaching opportunities.
The major features of the final rules announced today are:
- 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.
- 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. As defined by the final
regulations, these senior employees include the NIH Director and Deputy
Director; all direct reports to the NIH Director; all Institute/Center
(IC) Directors, Deputy Directors, Scientific Directors, and Clinical
Directors; extramural program officials who report directly to an IC
Director; and other employees designated as senior because they possess
equivalent levels of decision-making responsibility. 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.
- The receipt of monetary awards from outside sources will continue
to be contingent upon prior approval, and be limited to awards that have
been determined through a pre-screening process to be bona fide. The
revised regulations will bar senior employees from receiving the cash
component of pre-screened awards offered by donors who have matters pending
under their official responsibility.
- Employees who file either a public (SF 278) or a confidential (OGE
450) financial disclosure report, and those non-filers who serve as clinical
investigators identified on an NIH clinical study, are required to report
their interests in substantially affected organizations, as well as those
of their spouse and minor children, and to indicate the amount held in
- To facilitate academic and scientific interactions, these final regulations
will allow, subject to prior approval and review by ethics officials,
outside activities with professional and scientific organizations, service
on data and safety monitoring boards, Grand Rounds lectures, and scientific
- The regulations maintain current provisions that permit NIH scientists,
to the extent allowed under existing government-wide rules and with prior
approval, to engage in compensated academic outside activities, such
as teaching courses at universities, writing general textbooks, performing
scientific journal reviews or editing, and providing general lectures
to physicians and scientists as part of a continuing professional education
program. NIH scientists can also engage in the practice of medicine and
other health professions with prior approval and in accordance with existing
rules. Outside activities that involve hobbies, sports, civic organizations
or interests unrelated to the NIH mission are permissible, generally
without prior approval.
As before, these regulations apply in addition to existing statutes
and the OGE Standards of Ethical Conduct. The NIH Ethics Office is developing
procedures and information systems to implement the final regulations
and will hold extensive training sessions with staff over the coming
months. If you have immediate questions about these rules, please contact
your Institute/Center Deputy Ethics Counselor.
Over the past months, I have greatly appreciated your thoughtful and
candid input. I received more than a thousand emails about the interim
regulations, and they were invaluable in helping us to arrive at a resolution
that I believe is fair and balanced. I encourage you to continue sending
me your comments and opinions at firstname.lastname@example.org.
This has been a difficult time for NIH. I appreciate your patience,
and most of all, your commitment to outstanding science that is conducted
in a manner that is above reproach.
For more information, go to: http://www.nih.gov/about/ethics_COI.htm.