| Government Announcements
Agencies To Change How Chemicals are Tested for Safety
By Sara Frueh
Posted March 3, 2008
February 19—The U.S. Environmental Protection Agency, the NIH Chemical
Genomics Center, and the National Institute of Environmental Health
Sciences have announced a collaboration to change how chemicals are
tested for risks they pose to humans. The agencies will research and
implement a new approach that will move away from traditional animal
testing and toward tests that use cells. The approach was envisioned in
the National Research Council's 2007 report Toxicity Testing in the 21st
Century: A Vision and a Strategy.
The report recommended a major shift away from animal testing—which
is slow, expensive, and has raised questions about its relevance to
humans—to in vitro methods using cells, cell lines, and cellular
components, preferably of human origin. Researchers should focus on
identifying "toxicity pathways"—cellular pathways that, when
sufficiently perturbed by a chemical, can be expected to lead to adverse
health effects. It also recommended the use of high-throughput tests
that can rapidly assess hundreds or thousands of chemicals over a wide
range of doses.
Shifting to these methods would expand the number of chemicals that
could be tested, generate data potentially more relevant to humans, and
reduce the time, money, and animals involved in testing, the report
said.
According to the new 5-year agreement, described in Science, the
agencies will work together to test the new approaches and identify
toxicity pathways. The colloboration will also sponsor workshops to
train and get input from scientists, as well as lay the groundwork for
using data from the new approach to inform the regulation of chemicals.
CSR News Flash
Posted January 4, 2008
January 6, 2008
Center for Scientific Review
National Institutes of Health
U.S. Department of Health and Human Services
NIH Gives Chartered Reviewers New Flexibility Submitting Applications
NIH has just increased the incentives for scientists to serve as
chartered or "permanent" members on its peer review groups so it can
better identify the most promising research for funding. These
researchers, who typically serve four years reviewing NIH grant
applications, now have more flexibility in submitting their own grant
applications.
A recent
NIH Guide Notice explains a new policy that gives these reviewers the
option to submit-as soon as they are developed-R01, R21 or R34
applications that would normally be submitted for standard submission
dates. Chartered members are strongly encouraged to add a cover letter
to their applications requesting this option.
This new policy was developed to better compensate chartered reviewers,
who can be disadvantaged by deadlines that force them to develop their
own applications while reviewing those submitted to NIH by others.
These reviewers may still request a review by a standing study section
other than their own. In this case, they must submit their applications
in accord with established deadlines. A second
NIH Guide Notice explains that current "windows" for reviewers to submit
many of these applications late will remain available.
Continuous submission will be carefully evaluated to see whether
eligibility should be extended. The NIH Guide Notice provides details on
this new practice.
About CSR
The Center for Scientific Review organizes the peer review groups that
evaluate the majority of grant applications submitted to the National
Institutes of Health. These groups include experienced and respected
researchers from across the country and abroad. Since 1946, CSR's
mission has been to see that NIH grant applications receive fair,
independent, expert, and timely reviews—free from inappropriate
influences—so NIH can fund the most promising research. CSR also
receives all incoming applications and assigns them to the NIH
institutes and centers that fund grants.
For more information, go to our Web site—http://www.csr.nih.gov—or phone 301-435-1111.
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EPA's National Exposure Research Laboratory Offers Draft Document on
Scientific and Ethical Approaches for Observational Exposure Studies
Posted November 2, 2007
A new draft document on Scientific and Ethical Approaches for Observational Exposure Studies (SEAOES) is currently available for public review and comment. It will remain available for comment until November 19, 2007. In order to protect human health it is critical to understand why and how people are exposed to chemicals in the environment. Observational studies are an important method for collecting information and data. To ensure that the procedures used in EPA's observational studies meet the most
up-to-date scientific and ethical standards, researchers in EPA's
National Exposure Research Laboratory have drafted the document on
Scientific and Ethical Approaches for Observational Exposure Studies.
The draft document was developed through input from
nationally-recognized experts, an initial request for public comment,
and external peer review. The document provides information on key
scientific and ethical issues and will be used by our researchers as
they plan and perform observational studies. As part of the process for
developing the document, we asked EPA's Human Studies Review Board
(HSRB) to review and comment on the draft document. The HSRB discussed
the draft document at their October 24, 2007, meeting, which was open to
the public and media. The Board strongly endorsed the purpose and
content of the draft document. They provided constructive comments on
all sections of the document and identified a few areas that could
benefit from further elaboration. The Board overall found that the
document was fundamentally sound.
EPA wants you to know that the document will remain available for public
comment until November 19, 2007. Procedures for providing public
comment are described in the attached Federal Register Notice. The
FRN has instructions to download and/or comment on the draft document
from the EPA docket. Additional information is available on EPA's
Web site, www.epa.gov/nerl/sots. |
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