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From:
"Ellen Penchuk, IBCLC" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Fri, 26 Aug 2005 10:13:11 -0400
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I was rather shocked to get this update. One could only hope that the NIH 
will follow their own guidelines. And where were these rules when the 
Breastfeeding Campaign was being attacked? These principles would have been 
most welcomed. Were the HHS Supplemental Standards of Ethical Conduct in 
effect during this timeframe? Comments? Valerie? are you there in the 
hurricane?

NIH ANNOUNCES FINAL ETHICS RULES
Ban on Outside Consulting with Industry Remains in Force 
 
The National Institutes of Health (NIH) announced today 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. The
announcement came following a careful review of all comments about the
interim ethics regulation submitted by NIH staff, the public, and scientific
organizations. 
 
Elias A. Zerhouni, M.D., NIH Director, said, "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."
 
Three principles guided the crafting of the rules:
 
1. The public must be assured that research decisions made at NIH are based
on scientific evidence and not by inappropriate influences.
 
2. 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. 
 
3. 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. 
 
"NIH is the Nation's premier research institution thanks to the high caliber
of men and women who serve there," said HHS Secretary Mike Leavitt. "These
rules will help NIH and its employees maintain the highest ethical
standards, while sustaining their ability to conduct and support the best
medical research in the world."
 
The major features of the final rules announced today are: 
 
 1. 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. 
 
 2. 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 in each IC;
extramural program officials who report directly to an IC Director; and
other employees designated as such 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. 
 
 3. 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 final
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. 
 
 4. 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 such
investments. 
 
 5. To facilitate academic and scientific interactions, the final
regulations will allow, subject to prior approval and review by ethics
officials, outside activities with professional or scientific organizations,
service on data and safety monitoring boards, Grand Rounds lectures, and
scientific grant review. 
 
 6. 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 government-wide and HHS Supplemental Standards of Ethical Conduct. NIH
leadership is developing procedures and information systems to implement the
final regulations and will hold extensive training sessions with staff over
the coming months.
 
For more information, please go to: http://www.nih.gov/about/ethics_COI.htm.


Ellen Penchuk, IBCLC, RLC

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