|
|
May
2006
|
|
|
|
|
In Drug Design, a Loose Fit May Be Best
Materials Help Youth Evaluate Media Messages, Make Food, Activity Choices
NIH State-of-the-Science Panel Urges More Informed Approach to
Multivitamin / Mineral Use for Chronic Disease Prevention, May 17, 2006
Statement of Anthony S. Fauci, M.D. Director, National Institute of
Allergy and Infectious Diseases National Institutes of Health on
National Asian and Pacific Islander HIV/AIDS Awareness Day May 19, 2006,
May 17, 2006
NIEHS Researchers Link Gene Variation to Coronary Heart Disease, May 11, 2006
NIH Launches Clinical Studies Nationwide to Investigate Rare Diseases:
$71 Million Effort to Address Neglected Conditions, May 5, 2006
NIH Dedicates the C.W. Bill Young Center for Biodefense and Emerging
Infectious Diseases, May 3, 2006
Institute and center news links
NIGMS Biomedical Beat
NIDCR Science News In Brief
Back
to top
|
|
|
|
|
|
|
Eighth Annual NIH SBIR/STTR Conference, July 13, 2006
Notice to Applicants for NIH Genome-Wide Association Studies
Delays in Grant Application Submission due to Spring Flooding
Multiple PI Implementation Update
Reminder: All R03, R21, R21/R33, R33 and R34 Grant
Applications Must Use SF424 (R&R) and Grants.gov for the June 1, 2006,
Submission Date and Beyond
NIH Announces Plans to Eliminate Mailing of Paper
Assignment and Change of Assignment Letters
Maine IACUC 101 Workshop in July
Solicitation of Comments: Proposed Modifications to Policies Governing Funding of Tuition, Fees, and Health Insurance on Ruth L. Kirschstein National Research Service Awards
May IACUC 101 Workshop in Austin, Texas
Clarification of Submission Dates for the Pilot Study to Shorten the
Review Cycle for New Investigator R01 Applications
NIH Announces Interim Changes to the PHS 2590 Noncompeting Progress
Report Forms and Instructions
NIH Announces Changes to the SF424 (R&R) Instructions
NIH Announces Interim Changes to the PHS 398 Application and Instructions
NIH/AHRQ Announce Change in Business Process Concerning eRA Commons
Verifications of Electronically Submitted Applications
NIH Announces Change in Business Process: Replacing Principal
Investigator Signature on Grant Applications, Progress Reports, and
Prior Approval Requests with an Institutional Compliance Requirement
Back
to top
|
|
|
|
COMMUNICATE
WITH THE
NIH EXTRAMURAL NEXUS — WE WANT TO HEAR FROM
YOU
Feedback
(to the Editor) from recipients and
subscribers of the NIH Extramural Nexus is
vital. Your comments, questions, and suggestions for
topics will enable Nexus editorial staff to
deliver appropriate content to the extramural
community.
Back
to top
|
|
|
Printer
Friendly Version
(Adobe
Acrobat Reader Required) |
|
|
|
NEWS FROM THE DIRECTOR OF OER:
NIH Communication Plan Launched |
Dear
Extramural Community:
In an effort to demystify, provide insight, answer questions, and clear up common misconceptions about the NIH and its role in biomedical discovery, the NIH is launching a new communication plan. It is designed to increase awareness of the role that research will play in transforming medicine in the 21st century and of the tremendous benefit received by every American from the Nation’s investment in biomedical research. Communications will emphasize scientific discovery, facts about biomedical research funding, and the role of NIH in fighting disease, saving and improving lives, and transforming 21st century medicine to be more predictive, personalized, and
preemptive.
Coordinated by the NIH Office of Communication
and Public Liaison, information will be conveyed
to the extramural scientific community and other
NIH stakeholders through a variety of
communication channels—the Web (posting of
downloadable fact sheets and data snapshots),
television, radio, podcasts, professional
meetings, and regular communiqués from NIH
Director, Dr.
Zerhouni.
Expected to be fully operational in the next few
weeks, the
Research Results for the Public Web page is
already displaying several of the fact sheets that
are part of the communication plan. Some of the
available fact sheets address specific medical
conditions, such as
heart,
kidney and
Parkinson’s disease while others describe
medical concepts and research accomplishments,
such as
Amazing Research, Amazing Help and
Driving the Transformation to Predictive,
Personalized and Preemptive Medicine. Stay
tuned for fact sheets containing data describing
NIH's investments in extramural grants programs.
— Norka Ruiz Bravo, Ph.D. -
Director, OER and NIH Deputy Director for
Extramural Research
Back
to top |
Dr.
Zerhouni Testifies Before house and Senate:
$28.4 Billion FY 2007 Budget Requested |
On April 6, 2006, NIH Director Dr. Elias Zerhouni
testified before the House Subcommittee on
Labor-HHS-Education Appropriations. On May 19, Dr.
Zerhouni also presented testimony before the
United States Senate Committee on Appropriations,
Subcommittee on Labor, Health and Human Services,
Education, and Related Agencies. Dr. Zerhouni
focused his testimony on the return on the
public's investment in NIH, providing specific
examples of dollars invested per American over the
years for studying a number of diseases. He also
discussed how discoveries fueled by this
investment are transforming the practice of
medicine, and the importance of maintaining the
momentum developed over the past several years to
reach our goals. Dr. Zerhouni laid out his vision
of a future where medicine will be predictive,
personalized, and preemptive. Predictive in that
we will be able to predict better who is at risk
for disease; develop personalized interventions
for individuals rather than a "one size fits all"
approach; and preemptive, stopping the disease
before it develops in the first place.
For both the House and Senate, in requesting an FY
2007 budget of $28.4 billion, the same as the FY
2006, Dr. Zerhouni highlighted a number of NIH
accomplishments and their impact on public health,
as follows:
|
Advances in Cardiovascular Disease and
Stroke |
|
Advances in Cancer |
|
Advances in HIV/AIDS |
|
Advances Against the Threat of Pandemic Influenza |
|
Development of Biodefense Research |
|
Advances in Diabetes and Related Illnesses |
|
Advances in Image-Guided Microsurgery |
|
Advances in Health Information for Scientists and the Public |
|
New Research Tools |
|
New Diagnostic and Therapeutic Technologies |
|
The Changing Landscape of Disease |
|
Strategic Vision for NIH: from Curative to Preemptive Care |
|
Rapid Advances in the Genomic Era |
|
Translating Discoveries into Better Medical Treatment |
|
Training a New Generation of Scientists |
Additional information, presentation
materials, and testimony transcripts are available
at the
NIH Budget Requests Web page.
Back
to top |
Review of F32 Grant Applications to be Streamlined |
Beginning with the grant applications submitted for the August 5, 2006, receipt date, all study sections will use the NIH’s streamlined review process for the review of Ruth L. Kirschstein National Research Service Awards (NRSA) Postdoctoral Fellowship applications (F32). Used at NIH for many years, the streamlined review process allows reviewers more time to discuss applications likely to be supported. Reviewers will be asked to identify and not score the bottom 40 percent of the F32 applications. The bottom 40 percent of applications is generally outside the funding range. This will require unanimous agreement of the study section; if one reviewer disagrees, the application will be discussed by the entire review group. Historically, F32 applications in the top 60 percent represent over 99.5 percent of all funded postdoctoral fellowship applications. The success rate on F32 applications has varied between 30 and 45 percent.
As with nearly all research grant applications, those not scored will be reviewed and will receive summary statements with written critiques prepared by the reviewers as for scored applications. Because applications that are not scored do not receive a full discussion at the study section meeting they will not have a "Resume and Summary of Discussion” paragraph and they will not routinely be taken to the second level of review by NIH Institutes and Centers. The use of the streamlined review process for F32 applications will be assessed after one year.
Although it is unrelated to the plan to streamline Fellowship applications readers should note that fellowship applications are scheduled to transition to an electronic format for submission through Grants.gov beginning August 5, 2007.
Back
to top |
Genome-Wide Association Studies
|
The
NIH is interested in advancing genome-wide association studies
(GWAS) to identify common genetic factors that influence
health and disease. The NIH mission is to improve
public health through research, and it maintains a longstanding policy
to make available to the public the results of the research
activities that it supports. Therefore, the NIH has concluded that the
maximum public benefit of GWAS can be realized only if the
genotype and phenotype datasets derived from GWAS are made
available as rapidly as possible to a wide range of scientific
investigators.
NIH Guide Notice
NOT-OD-06-071, published on May 15, 2006, informs
investigators of the NIH plans to (1) update data-sharing
policies for research applications involving GWAS data; (2)
initiate a public consultation process to inform policy
development activities over the next few months; and (3) track
GWAS applications and awards at a central level.
Complete information is available in the Guide
announcement
Notice to Applicants for NIH Genome-Wide
Association Studies.
Back
to top |
Request for Public Comment:
Policy Issues Associated with
Undertaking a Large U.S.
Population Cohort Project on Genes, Environment,
and Disease |
The
Secretary's Advisory Committee on Genetics,
Health, and Society (SACGHS) requests your
input on the Committee's draft report,
Policy Issues Associated with Undertaking a Large
U.S. Population Cohort Project on Genes,
Environment, and Disease. SACGHS was
established by the Department of Health and Human
Services (HHS) to serve as a public forum for
deliberations on the broad range of human health
and societal issues raised by the development and
use of genetic and genomic technologies and, as
warranted, to provide advice on these issues.
In a 2004 priority-setting process, SACGHS
determined that opportunities and challenges
associated with conducting large population cohort
studies aimed at understanding the relationships
of genes, the environment, and common, complex
diseases warranted in-depth study. NIH Director
Elias A. Zerhouni, M.D., specifically requested
SACGHS's advice on the scientific, public, and
ethical processes and pathways that might help NIH
or HHS make decisions about undertaking such an
effort. Dr. Zerhouni specified that the Committee
could be most helpful to the Secretary by
conducting an inquiry that includes the following
steps:
|
Step 1: Delineate the questions that need to
be addressed in order for policymakers to
determine whether the U.S. Government should
undertake, in any form, a large population
project to elucidate the influence of
genetic variation and environmental factors
on common, complex disease. |
|
Step 2: Explore the ways in which, or
processes by which, the questions that are
identified in Step 1 can be addressed,
including the need for any intermediate
research studies, pilot projects, or policy
analysis efforts. |
|
Step 3: Taking into account the possible
ways in which the questions could be
addressed, determine which approaches are
optimal and feasible and recommends a
specific course of action for moving
forward. |
SACGHS's draft report focuses on preliminary
and intermediate questions, steps, and strategies
in five areas—research policy, research logistics,
regulatory and ethical issues, public health
implications of research results, and social
implications of research results—that should be
addressed before an informed decision can be made
about whether the United States should undertake a
large population cohort project on the interaction
of genes, environment and disease. The report also identifies
options for how these issues might be addressed. A
central theme of the report is that decisions
about such a project must take account of public
views and attitudes and that public engagement
must be sought in planning for and implementing a
large population project.
SACGHS welcomes your comments on any
aspect of the draft report. In particular, the
Committee would appreciate your assessment of
whether: 1) the policy issues identified in the
draft report are appropriately focused; 2) any
policy issues have been overlooked; and, 3) the
issues are organized in appropriate categories and
addressed in such a way as to give policymakers
sufficient understanding of why the issue is
important. In addition, the Committee would value
feedback on the sections of the draft report that
discuss the importance of public engagement and
the mechanisms that could be employed to achieve
such engagement.
Please address comments to Reed V. Tuckson,
M.D., SACGHS Chair, and email them to
Ms. Amita
Mehrotra, FAX to 301-496-9839, or mail to
Secretary's Advisory Committee on Genetics,
Health, and Society, attn: Amita Mehrotra, NIH
Office of Biotechnology Activities, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892 (20817 for
non-US Postal Service mail). In order to be
considered in the development of the final report,
comments should be submitted by close of business
Monday, July 31, 2006.
In light of the wide range of public policy
issues and questions raised in the draft report,
SACGHS hopes to receive input from the wide range
of individuals, communities and groups who may
have an interest in whether a large population
cohort project is undertaken in the U.S. If you
have colleagues who may wish to comment on the
draft report or know of other individuals,
communities, or groups that might be interested in
the issue, please forward a copy of this
information to them.
Back
to top |
CONTINUING SERIES ON PROGRAMS IN THE OER
EXTRAMURAL NEXUS
Click on
graphic to expand (opens in new window)
|
The Office of Extramural Programs (OEP) is one of the organizational components within the NIH Office of Extramural Research is a resource, catalyst and facilitator for many of the elements within the NIH Extramural Nexus (see above). The OEP provides overall administration, oversight, guidance and direction, scientific program management, and subject matter expertise to NIH staff across all Institutes and Centers and to the extramural research community regarding extramural programs and policies.
|
Research Training and Career Development
The OEP establishes, implements, coordinates
and monitors NIH extramural research
training and career development programs and
policies across NIH Institutes and Centers;
helps determine broad national needs for
basic biomedical, behavioral, and clinical
research personnel; and oversees and coordinates
trans-NIH evaluations of research training
and career development programs. |
|
Grants: Small Business Innovation Research (SBIR) and Small
Business Technology Transfer (STTR),
Academic Research Enhancement Award (AREA) and
Conference
The OEP coordinates omnibus
solicitations for NIH, CDC and FDA SBIR/STTR
funding opportunities, addresses eligibility
issues, evaluates and makes recommendations
on policy issues, and holds regular,
informational SBIR/STTR Town Meetings. |
|
Extramural Research Integrity
The OEP evaluates and oversees allegations
of scientific misconduct including harm to
humans and animals, intellectual property
theft, violations of
confidentiality/conflict of interest in peer
review, and misappropriation of funds. The
OEP also implements misconduct policies
and performs training and outreach. |
|
Human Subjects Research Policy and Protection
The OEP identifies, develops, refines and implements policies
governing NIH extramural program and review functions for
human subjects research protection, resolves human subject
concerns, and provides training and outreach. |
|
NIH Loan Repayment
The Loan Repayment Programs office recently moved to the OEP and will continue to process and award loan repayments for intramural and extramural researchers. |
|
Program Outreach and Communication including the
NIH Guide for Grants and Contracts
The OEP provides information about extramural research
opportunities, educational outreach to improve institutional
awareness of NIH policy guidelines and requirements, subject
matter expertise and extramural program guidance. OEP staff
members attend conferences to speak about NIH funding
opportunities. |
|
Review Policy: Development, Interpretation, Guidance and Oversight
The OEP assists in guiding review policy, including its
development, interpretation and guidance; and oversees issues
related to NIH peer review policies. |
|
Extramural Staff Training
The OEP develops educational training sessions for NIH extramural staff regarding the operation, regulatory and procedural requirements for extramural programs. |
|
Special Projects
Recently, OEP has been involved in the
Grants.gov/SF424 (R&R)
transition of funding mechanisms and
NIH Public Access.
|
OEP's general email address, as well as those for
key OEP staff members are available by
following this
link.
Back
to top |
Frequently Asked Questions:
NIH/Agency for
Healthcare Research and Quality Electronic
Submission Verification Process Change |
The April 7
publication of NIH Guide Notice
NIH/Agency for Healthcare Research and Quality (AHRQ) Announce Change in Business Process Concerning eRA
Commons Verifications of Electronically Submitted Applications
has brought forth many questions from the grantee community. Provided below are
answers to the most frequently asked questions regarding this business process
change.
|
What changed in the eRA Commons verification process? The
original verification process required that both the Authorized
Organization Representative/Signing Official (AOR/SO) and the
Project Director/Principal Investigator (PD/PI) access the
electronic grant application in the eRA Commons, check it for
completeness and verify it by clicking a checkbox to complete the
submission. Effective May 10, 2006, and beyond, the verification
step was replaced with a two-day period for checking the
assembled application in eRA Commons. Unless explicitly rejected
by the AOR/SO, the submission process will be complete after two
days and the application automatically will move forward to the
Division of Receipt and Referral, Center for Scientific Review. |
|
When will the application move forward for processing?
After two full days (Monday–Friday, includes holidays), if not
explicitly rejected by the AOR/SO, the application will
move automatically forward to the Division of Receipt and
Referral for processing. For example, if you submit your
application on Monday, you will have all day Tuesday and
Wednesday to view the application. The application will move
forward at 12:01 a.m. ET on Thursday morning.
|
|
Will the AOR/SO and PD/PI be notified to check the
assembled application? Yes, both the AOR/SO and the PD/PI
will be sent an email notification to check the application
for completeness. A notification also is sent if the AOR/SO
rejects the application.
|
|
Can the AOR/SO “Reject” the application if the two-day
window falls after the submission deadline? Yes, the AOR/SO can reject an application after the deadline submission if the assembled application does not correctly reflect the submission due to a Grants.gov or eRA Commons system error. The NIH is allowing the one-week correction window to address errors and warnings. |
|
What if the application received warnings, but no errors?
Warnings do not stop further processing. If no action is
taken, the application will move automatically forward after
two business days. |
|
Can the PD/PI “Reject” the application?
No. The PD/PI must work through the AOR/SO to “Reject” an
application. |
|
Are holidays included in the two-business- day period?
Yes. If a holiday occurs on Monday through Friday, the holiday
will be counted as a business day. |
|
What can I do if I find a problem after the application
moves forward for processing? The applicant should contact
the Scientific Review Administrator assigned to their
application for advice and guidance for downstream changes and
corrections. |
|
Where can I find more information about the verification
change? Complete information is available in the
eRA Commons Verification of Electronically Submitted
Applications Guide notice.
|
NIH continues to receive questions regarding the
Replacing PI Signature with Institutional Compliance Requirement
business process change that recently became effective. The
grantee community is advised to visit the respective FAQs, available on the
Grants Policy and Guidance Web site.
Back
to top |
Percent Effort to Person Months FAQs and Calculator Now Available
|
The
“person months” unit of measurement collected by the SF424 (R&R) grant
application form is a change from the PHS 398 application “percent time and
effort” measurement unit. Although person months accounting historically has
been the default method used by the majority of grantee institutions, for some
institutions and grant applicants, the switch from calculating time and effort
to calculating person months presents a new challenge.
The transition from time and effort reporting to person months reporting now
will be pain-free, thanks to newly launched Web pages that provide
Frequently Asked Questions Regarding the Usage of Person Months and a
downloadable Excel®-based interactive
conversion calculator.
The FAQ and calculator are also available via the Grants Policy
and Guidance Web site.
Back
to top |
Who is a New Investigator? |
For the purpose of review and funding,
applicants are considered New Investigators if
they have not previously served as the Principal
Investigator (PI) on any Public Health
Service-supported research project other than a
small grant (R03), an Academic Research
Enhancement Award (R15), an
exploratory/developmental grant (R21), or certain
research career awards directed principally to
physicians, dentists, or veterinarians at the
beginning of their research career (K01, K08, K12,
K22, K23, K25 and K99/R00). Current or past
recipients of Independent Scientist and other
non-mentored career awards (K02, K05, K24, and
K26) are not considered New Investigators.
Subproject Directors on multi-project grants
remain eligible to become New Investigators when
they apply for independent funding.
Over the years, special programs to assist New Investigators in obtaining independent research funding have been created. When the Multiple Principal Investigators option is selected for a grant application, all PIs must meet the definition of New Investigator in order for the application to receive special consideration in the review and funding
process.
Additional information is available at the
New Investigators Program Web site and on the
PHS 398 Instructions.
Back
to top |
|
|
|
|
|
|
The
NIH Extramural Nexus is a bimonthly update
from the NIH Office of Extramural Research. Articles,
comments, questions and suggestions may be addressed to
the Editor.
The
NIH Extramural Nexus reserves the right to
select and edit items submitted for inclusion.
To subscribe to the NIH Extramural Nexus, send a
plain text email to Listserv@list.nih.gov
including only the words Subscribe EXTRAMURALNEXUS
in the body of the message. To unsubscribe, follow the
same procedure, using the words Unsubscribe
EXTRAMURALNEXUS in the message body.
|
|
NIH
Extramural Nexus Web site and archives |
|
|