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BILLS, BILLS, BILLS
The Farm Bill, H.R. 2419
On July 27, the House passed H.R. 2419, the
Farm, Nutrition, and Bioenergy Act of 2007
(otherwise known as the “Farm Bill”). Included
in that bill, as an amendment offered by
Representatives Mike Doyle (D-PA) and Steve
Israel (D-NY), is a provision drawn from H.R.
1280, the Pet Safety and Protection Act. It
would prohibit the use of Class B dealers as a
source of non-purpose bred dogs or cats for
research, teaching, or testing. It would also
require that pounds or shelters wishing to make
unwanted dogs or cats available for research
would have to register with the USDA and meet
certain provisions of the Animal Welfare Act.
FASEB has
worked successfully to prohibit such
language from being added to appropriations
bills. The Senate is expected to introduce its
version of the
Farm Bill in early September.
The America COMPETES Act, H. Rept. 110-289
Yesterday, President Bush
signed into law H. Rept. 110-289, the
conference report on the America Creating
Opportunities to Meaningfully Promote Excellence
in Technology, Education, and Science Act. Also
known as the “America COMPETES Act,” the bill
was passed by the House and Senate on August 2.
It would put the National Science Foundation,
Department of Energy Office of Science, and
National Institute of Standards and Technology
on track for a doubling of their budgets over
the next 7-10 years. The bill includes a variety
of provisions for broadening participation in
the scientific workforce, including expanding or
establishing programs for teacher training,
undergraduate education, graduate student
fellowships, and early career researchers. It
would also establish the Advanced Research
Projects Agency for Energy (ARPA-E) to overcome
barriers to the development of energy
technology.
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POLICY UPDATE: Conflict of
Interest, Biosecurity,
Training Data
FASEB Calls in Scientific Community to
Endorse Guidelines for Conflicts of Interest;
Unveils Toolkit
FASEB has issued a call to the scientific
community to adopt more consistent policies
and practices for disclosing and managing
financial relationships between academia and
industry in biomedical research. On July 17,
FASEB unveiled a framework for a national
guideline and held a meeting of more than 75
representatives of scientific societies and
other key stakeholders to discuss the process of
implementation. At the meeting, FASEB
launched the COI Toolkit (http://opa.faseb.org/pages/Advocacy/coi/Toolkit.htm)
– a
website containing recommendations, tools, and
resources for the conduct and
management of financial relationships between
academia and industry in biomedical
research. The website was designed to help
researchers, institutions, publications, and
industry put into practice FASEB’s
recommendations.
FASEB is concerned that the lack of clarity and
consistency in current conflict-of-interest
policies may cause confusion by investigators
and ultimately inhibit their ability to
protect the integrity of research. The
recommendations articulate the issue from the
investigators’ perspective because they, as a
group, determine the effectiveness of
policies and practices.
Delivering the keynote address, House Energy and
Commerce Committee Vice-Chair
Diana DeGette (D-CO), applauded FASEB’s efforts
and stated that, “By creating a more
consistent standard to the extent possible we
are more likely to avoid ambiguity and
confusion. Without such standards, we run the
risk of further confusing the public about
the integrity of research and exacerbating their
distrust.” Participants in the meeting
expressed enthusiasm for a set of common
principles and guidelines that they could use
to help better manage financial relationships
between academia and industry.
FASEB Comments on NSABB Proposed Oversight
Framework for Dual Use Research
In April, the National Science Advisory Board on
Biosecurity (NSABB) released a
draft
report outlining an oversight system for
dual use biological research (beneficial
research
which could be misused for harm) funded by the
federal government. The NSABB
document details criteria for identifying what
they call “dual use research of concern”
(DURC), which would need additional oversight.
Briefly, the NSABB proposal
recommends: 1) Mandatory training for all
scientists, trainees and staff about dual use
research; 2) All PI’s would have to review their
research program to see if it matches the
criteria for DURC based on a questionnaire
developed by NSABB; if it does not, they
would check a box on grant applications to that
effect, as well as sign yearly attestations
of ongoing review; 3) Research identified as
DURC would trigger an institutional, risk
assessment based review, perhaps through the
existing Institutional Biosafety Committee (IBC)
and development of subsequent risk management
and communications plans (NSABB also provides
tools and guidance for development of such
plans); 4)
Compliance with dual use regulations be
mandatory, perhaps tied to federal funding, and
that their should be penalties for
non-compliance; 5) Scientific societies develop
codes of conduct relevant to dual use research
and provides guidance and sample language for
creation of such a code; and finally 6) Leaves a
fair amount of latitude for interpretation
deliberately, so that agencies can make their
own detailed regulations
Upon releasing this proposal, NSABB called for
input from the scientific community as
to the impact of such a review system. An ad hoc
subcommittee, chaired by Dr. Avrum
Gottlieb (ASIP), of FASEB’s Science Policy
Committee worked to develop
comments on
the NSABB report, which were released on August
8th. FASEB raised a number of
serious concerns about the proposed oversight
system, including the lack of clarity in
identifying the need for review and potential
liability issues, possible regulatory burden,
and the unintended consequence of increased
security risks raised by the NSABB
proposal. It is unclear at this time what
NSABB’s timeline is for incorporating comments,
but it is likely they will issue a Federal
Register notice calling for additional input
sometime within the next few months.
FASEB Releases New Data Resource on
Education and Employment of Biomedical
Scientists
FASEB has released a new compilation of data
related to the education and employment
of biological and medical scientists. The
presentation, which was created by Howard
Garrison, Ph.D. and Kimberly McGuire of FASEB’s
Office of Public Affairs, represents
an overview of national survey data on many
facets of scientific training and workforce
development in the life sciences, including data
on graduate enrollment, doctoral awards,
postdoctoral appointments and employment status.
“We are hoping these graphs and figures will
foster an informed discussion of education and
employment in the biological and medical
sciences,” said Garrison. “By bringing together
the major sources of nationally representative
data, these slides represent a starting point
from which those interested in training or
career development issues can perform
additional, more in-depth analyses.”
FASEB is encouraging its member society
scientists, advocacy and policy partners, and
other interested parties to use the graphs and
figures in their own presentations or
publications. According to Garrison, the
information will be updated as new data become
available. The FASEB training and employment
data resource can be found here:
http://opa.faseb.org/pages/PolicyIssues/training_datappt.htm
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FASEB ENCOURAGES SOCIETY MEMBERS
TO
COMMENT ON NCRR’s STRATEGIC PLAN
The National Center for Research Resources (NCRR)
is seeking input for a new strategic
plan for NCRR programs for the five year period
from 2009-2013. The NCRR provides
training mechanisms, shared research resources
and technologies that facilitate NIH supported
biomedical research. With the increasing
pressure on scarce research resources, FASEB’s
Vice President for Science Policy, Mark Lively,
feels that it is essential for the views of
working scientists to be considered in NIH
planning processes, and he is
encouraging scientists to reply to the NCRR.
More information on the NCRR strategic
planning process and ways that scientists in the
community provide input may be found
on the web at
http://www.ncrr.nih.gov/Strategic_Plan/
The closing date for responding is August 24. We
are also interested in your views and
hope that you can send copies of your comments
to Laura Brockway at
lbrockway@faseb.org
CONGRESSIONAL SCHEDULE
The House and Senate are in recess until
September 4, 2007.
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