Zerhouni Proposes to Reform NIH
Ethics Process
June 25, 2004 - Emphasizing the need for a "scrubbed
environment," National Institutes of Health Director Elias
Zerhouni, M.D., June 22 outlined
a series of aggressive proposals to strengthen the ethics system
at NIH in response to concerns about consulting agreements between
agency employees and industry. He announced his proposals at the
third in a series of hearings on this issue before the House Energy
and Commerce Subcommittee on Oversight and Investigations. Subcommittee
Chairman James Greenwood (R-Pa.) and other members of the subcommittee
generally praised the new initiatives while reserving final judgment
until learning more about the implementation of the proposals.
Dr. Zerhouni described three core elements of reforming the ethics
process at NIH: applying review of applications for outside activities
by scientific peers; requiring full disclosure and transparency
in the program; and working to reduce, restrict, or eliminate the
types of activities about which the subcommittee has raised concerns.
Stating it is imperative that "Congress and the American people
trust that the decisions made by our scientists are motivated solely
by public health priorities and scientific opportunities, not personal
financial concerns, " Dr. Zerhouni announced that NIH will
prohibit employees from:
- Holding of stock in individual biotechnology and pharmaceutical
companies, as is done at the Food and Drug Administration;
- Accepting any award unless the award has been pre-screened by
an independent advisory committee of non-government individuals,
and a determination is made that the award meets the regulatory
definition of bona fide. NIH also will seek to prohibit any official
- including institute and center directors - who are responsible,
either directly or indirectly through subordinates, for a funding
decision affecting the entity offering the award, from receiving
the cash component of an award;
- Holding membership on corporate boards of the pharmaceutical
and biotechnology industries. Employees should be allowed to participate
in industry scientific advisory boards as ad-hoc participants
only if such participation has been reviewed by the NIH Ethics
Advisory Committee (NEAC) and approved by the NIH Deputy Ethics
Counselor (DEC); and
- Consulting (including speaking) with NIH grantee institutions
for compensation or any other form of personal remuneration. NIH
will continue to encourage consultation with grantee institutions
as part of official duties. In addition, NIH senior leadership
will be prohibited from consulting (including speaking) with non-profits
that are not grantee institutions.
Senior employees, as well as all employees involved in extramural
funding decisions, would be prohibited from consulting with industry
for compensation or any other form of remuneration. Other employees
would be permitted to consult only if the arrangement has been reviewed
by the NEAC and approved by the DEC, and 1) payment may not include
stock or stock options; 2) annual compensation from all outside
activities with industry must be limited, and no more than half
of that limit may come from any one source; and 3) the number of
hours annually that an employee can spend on all outside activities
with industry is capped at 400 hours;
Dr. Zerhouni also said he will seek authority from Office of Governmental
Ethics (OGE) for NIH to determine which of its employees must submit
public financial disclosures. He told the subcommittee NIH is working
toward requiring that outside activities with industry be publicly
disclosed. This will include disclosure to CRADA partners. NIH employees
will continue to be required to disclose the amount of compensation
earned from outside activities.
To continue to be able to recruit and retain the best scientific
expertise while expediting translation of research advances, Dr.
Zerhouni said he "will encourage NIH scientists to continue
teaching, speaking or writing about their research as part of their
official duties." To encourage scientific interactions involving
the exchange of knowledge and the exercise of intellectual leadership
by NIH scientists, NIH will continue to allow certain types of outside
activities - including teaching and lecturing opportunities and
collaborations with the private sector - but only under clear, rigorous
rules meant to eliminate conflicts of interest.
In addition, NIH will
- Require that supervisors fulfill their responsibilities in both
reviewing proposed outside activities and in monitoring the effect
that the activity might have on the employee's official duties;
- Improve its ability to manage and track approved activities
with outside organizations by increasing the accountability of
managers, creating a centralized system, conducting random audits
of files pertaining to activities with outside organizations,
and continuing the rigorous review by peers; and
- Develop and implement a new, more understandable method of training
employees on ethics rules, and we will establish a web site that
displays rules in plain language, updates employees on regulatory
trends and changes and discusses - anonymously - ongoing cases
as examples of best practices or unacceptable practices.
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
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