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OER’s Commitment to Effective Stewardship through Service and Transparency
 It is clear that the American public has great trust in NIH, not only in terms of setting the direction for and finding new discoveries in biomedical and behavioral research, but also in terms of the billions of dollars that we annually invest and manage. Being effective and efficient stewards of this trust can be quite challenging, given the range and diversity of science at NIH, as well as transitions and issues being faced in US government. This is where the NIH Office of Extramural Research (OER) plays a key role by providing the services and supports of extramural policy and electronic research administration that serve as the critical architecture for effective stewardship, thereby laying the foundation for the ICs to pursue their scientific missions to the fullest potential.
We have found that the best way to create sound policy for the grant making and monitoring process is to listen, respond, and work with our internal NIH and external research community stakeholders. This is why you consistently see NIH and OER unveiling new services and policy changes, such as the new Reviewer Reimbursement System profiled in this issue of the Nexus. In many cases the creation of new services and policy changes is a direct response to needs expressed by either our external research community or by you who, here at NIH, work in extramural. To lessen your need to constantly adjust to new or different policies, we also attempt to cluster such changes.
In addition to being attuned and responsive to our stakeholders, OER strives to be entirely transparent in communicating the reasons for change and to provide well reasoned guidance for adapting. This is why you find us offering services such as a new process for providing detailed NIH funding information to the Public, also introduced in this issue of Nexus. We believe strongly that only by making our activities entirely transparent can we be sure that we offer our stakeholders the highest quality of service. This becomes especially true during periods of significant change, such as we are in now.
Through numerous leadership and service activities with other Federal grant-awarding agencies and departments, I and all involved OER staff make every effort to solicit and synthesize the best ideas and suggestions to improve, develop, and implement effective and efficient extramural policy and tools. In future columns, I plan to explain more fully our roles and interactions with other Federal grant-award agencies and committees and how these activities affect and shape your work at NIH. Until then be assured that I am committed to listening to you, responding to you, and working with you to further shape and ensure extramural stewardship for fulfilling the NIH mission.
- Sally Rockey, Ph.D.
Acting NIH Deputy Director for Extramural Research |
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Working to Relieve Applicant Stress
Ongoing performance issues at Grants.gov have lead to increased anxiety throughout the applicant community. Though Grants.gov is working to address the issues impacting the electronic application process and to enhance the overall performance of their system, NIH is committed to allieviating undue administrative burdens facing many of our applicants. To this end, NIH has extended the electronic application error correction window to 5 days for all opportunities with receipt dates in February 2009. This extension offers applicants sufficient time to correct system-identified errors following on-time submission. Applicants are strongly advised to see notice NOT-OD-09-045 regarding the guidelines and procedural details of this extension.
Applying early is always the safest path. However, NIH realizes that there are many road blocks to early application and hopes that the extension of the error-correction window will lessen the stress of any last minute submissions. NIH will continue to monitor the Grants.gov queue closely, and we will make adjustments to the correction window and/or submission deadlines as necessary to protect our applicants’ ability to submit on time. |
NIH Releases First Biennial Report of the Director
Dr. Raynard S. Kington, acting director of the National Institutes of Health (NIH), today announced the publication of the first
Biennial Report of the Director, a document that provides an integrated
portrait of NIH research activities. The report, per the requirements of the
NIH Reform Act of 2006, makes it easier for Congress, advocates and patient
groups, and the general public to understand the many programs within the agency.
The NIH Reform Act of 2006 affirmed the importance of NIH and its vital role
in advancing biomedical research to improve the health of the nation.
As well as bringing increased transparency to the research conducted by NIH, the report is also intended to detail current agency funding, outline future strategic
planning, and provide health related statistical information. The report is
inclusive of Fiscal Years 2006 & 2007.
Dr. Kington has said the Biennial Report “provides a panorama of the research, research training, and dissemination efforts supported by NIH. Throughout the document,
readers are given an opportunity to see the directions of discovery and understand the research that goes on across all 50 states, the territories, around the world, and at
the NIH's own laboratories." |
NIH Projects, Funding Details Now Available for Public Viewing
In mid-January, 2009 the National Institutes of Health (NIH) began a new
process for providing detailed funding information for 215 major research
areas. The process, called Research, Condition, and Disease Categorization
(RCDC) relies on the use of standardized, computerized knowledge management
tools. The RCDC process was initiated at the request of Congress to
provide consistent and transparent NIH research funding information.
Please view the Web page Estimates
of Funding for Various Diseases, Conditions, and Research Areas for
more information on this transparency effort and how to use the report table
to access project details.
For the first time, the public can use the information provided to view the
total funds spent in each category for the current fiscal year and previous
fiscal years based on grants, contracts, and intramural research (research
conducted in the NIH’s own laboratories and clinics). By clicking on each
of the categories, viewers can access full project listings for that category
and view, print, or download a detailed report. Links to patents and
publications associated with each project also will be available in the coming
months.
The 215 categories reported through the RCDC process are the same that have
historically been requested by and reported to Congress and the public at
the end of each fiscal year,
and the RCDC process does not reflect the entire NIH research portfolio and
budget.
RCDC does not impact how NIH funds research or determines research priorities
nor does it change how NIH grants awards or how researchers apply for awards.
For additional information…
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Worldwide Scientific Community Participates in NIH Summit on Eliminating Health Disparities; Results to be Provided to President Obama
 From December
15-18, 2008 the NIH held a Summit entitled “The Science of Eliminating Health
Disparities.” Over 4,400 of the best and brightest scientists, clinicians,
policy, and advocacy leaders attended the Summit. They formed a community
of biomedical research scientists, research administrators, public health
commissioners and community health care providers with a common goal to address
health disparities across the world. The assembly included diplomats from
the embassies of Botswana, China, France, India and Peru, and university professors
and deans from tribal colleges. The tone was enthusiastic and energized, with
lively side conversations and productive sharing of ideas and information.
300 speakers presented in plenary and breakout sessions organized into five
tracks:
- Translating Science to Policy and Practice
- Health Disparity Diseases and Conditions
- Health Disparity Target Populations
- Building Capacity
- Partnerships, Collaborations, and Opportunities
The presentations included some recently acquired data and conclusions, but focused more on showcasing the available tools for addressing research needs and
guidance for improving productivity in the research setting. In keeping with the summit’s emphasis on science, practice and policy, U.S. Rep. Elijah Cummings (D-MD) and
former Vermont governor Dr. Howard Dean addressed the assembly on its second day. Day three closed the summit with a town meeting on health care reform. Ideas
generated from the forum will be submitted to President Barack Obama’s administration. These ideas spanned all the topics of the symposium and ranged from specific
advice such as urging men and boys to see physicians, to the sweeping goal of assessing the health-impact of every piece of legislation.
The pre-Summit workshop, which over 1,400 young investigators attended, focused
on research training and career development opportunities; the basics of R01,
R021, and R03 applications; the peer review process; and basic and advanced
grant writing.
Dedicated to the late former U.S. Congressman Paul Rogers (D-FL),
also known as “Mr. Health” for his support of medical research and his advocacy
for increasing NIH funding, the summit was coordinated by NIH’s National
Center on Minority Health and Health Disparities. |
How Early Stage Investigators Can Request an Extension
Early Stage Investigators (ESIs) are New Investigators who are within ten
years of completing their terminal research degree or within ten years of
completing their medical residency. In some cases, there may have been
one or more lapse in the period of research or research training after the
terminal degree or the completion of medical residency. A
new NIH Guide Notice describes the procedures for requesting an extension
of the ESI period and the conditions under which such extensions will be considered.
NOTE: As we mentioned in last month’s Nexus, please be sure to update your
profile within eRA Commons so
your terminal research degree or residency completion date is accurate and
the system can identify your ESI eligibility. |
New Regulations Mandate Institutional Review Board Registration
The Office for Human Research Protections (OHRP) has added a new subpart
to the HHS protection of human subjects regulations requiring
Institutional Review Boards to register with HHS.
The new regulation applies to IRBs that review human subjects research conducted
or supported by HHS and that are designated under an assurance of compliance
approved for federal-wide use by OHRP (see 74
FR 2399). Information to be registered includes contact information, number of active research protocols, and IRB staffing. A companion regulation was issued by the
Food and Drug Administration requiring registration for IRBs reviewing clinical investigations involving FDA-regulated products (74 FR 2358). A single HHS registration system for
both regulations will be accessible on the OHRP Web site. The two rules become effective July 14, 2009, and initial
registration must be submitted by September 14, 2009. Please contact OHRP directly for additional information. |
Two Important Changes to Career Development (“K”) Awards
Individual Career Development (“K”) awardees may now request to reduce their
appointment to less than full-time for a period not to exceed 12 continuous
months.
All candidates must meet the full-time institutional appointment requirement
as well as the minimum 75% effort requirement at the time of application and
initial award, but may request to reduce their appointment to less than full-time
(but not less than three-quarter time) for up to 12 continuous months under
certain circumstances (e.g., parental leave, child care, elder care, medical
conditions, or a disability). The K awardee must continue to commit at least
75% effort to research and career development activities. See NIH Guide Notice NOT-OD-09-036,
which also restates current NIH policy for K awards with respect to leave
and temporary adjustments to percent effort, for additional details.
Individual Career Development (“K”) applications transition to Adobe, February
12, 2009
As previously announced in NOT-OD-08-073,
effective with the February 12, 2009 submission date, NIH will transition
all Research Career Development Award Programs ("K"s) – with the exception
of K12s – to electronic submission via Grants.gov using the new Adobe-based
version of the SF424 (R&R) forms. Applicants are advised to see NOT-OD-09-029 for important details about the "K" transition, including the announcement of
new business processes and additional information that will be required on
applications for the February 12 receipt date and beyond. Applicants
can find information about the ongoing transition to Adobe at http://era.nih.gov/ElectronicReceipt/adobe_transition.htm. |
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Get a Handle on Changes from the Enhancing Peer Review Process
There are lots of changes in the works related to the peer review process
which we are communicating through updates to the NIH
Web site on Enhancing Peer Review, policy notices in the NIH Guide for
Grants and Contracts, presentations at professional meetings, etc.
The chart below compares current practices with new procedures on scoring of
applications. (Original chart provided courtesy of NIAID Funding News (December 17, 2008), has been modified for use in the Nexus.)
Comparison of Existing and
New Peer Review Processes |
Function |
Old |
New |
Assignment of priority scores |
Priority scores reflect reviewer judgment
of a whole application: peer review criteria are unweighted and unrelated
to the priority score. |
Changed to preliminary impact score. Assigned
reviewers also score each criterion (remains unrelated to the overall
score) Before the review meeting, each reviewer and discussant assigned
to an application will give a preliminary impact score for that application.
The preliminary impact scores will be used to determine which applications
will be discussed. For each application that is discussed, a final
impact score will be given by each eligible committee member (without
conflicts of interest). Each member’s impact score will reflect his/her
evaluation of the overall impact that the project is likely to have
on the research field(s) involved. |
Each reviewer scores to one decimal place: 1.0 is best,
5.0 worst. |
Each reviewer scores in whole numbers: 1 is best, 9 worst. |
Determination of priority scores |
To create a raw score, reviewer scores are
averaged and rounded mathematically to two decimal places, e.g., 1.34.
The result is multiplied by 100 to give an overall priority score,
e.g., 134.
The possible scores range from 100 to 500. |
The overall impact score for each discussed
application will be determined by calculating the mean score from all
the eligible members’ impact scores, and multiplying the average by
10; the overall impact score will be reported on the summary statement.
Thus, the 81 possible overall impact scores will range from 10 - 90.
(Overall impact scores will not be reported for applications that are
not discussed.)
Scoring with fewer rating options increases potential
reliability and provides sufficient range and appropriate anchors to
encourage reviewers to use the full scale. |
Streamlined applications |
Applicants get critiques from assigned reviewers. |
Streamlined applications will receive scores
on each criterion in addition to the reviewers’ critiques to help applicants
assess whether or not they should resubmit an amended application |
Determination of percentiles |
Percentile range from 0.1 (best) to 99.5
(worst). Read How Percentiles Are Determined. |
Percentiles range from 1 to 99 in whole
numbers. Rounding is always up, e.g., 12.1 percentile becomes 13. |
With almost 1,000 possible percentile rankings,
few applications are ranked the same. |
The new scoring system may produce more applications
with identical scores (“tie” scores). Thus, other important factors,
such as mission relevance and portfolio balance, will be considered
in making funding decisions when grant applications are considered essentially
equivalent on overall impact, based on reviewer ratings. |
Percentile base |
NIH calculates percentiles using applications
submitted for three review cycles. |
Unchanged, except for the first year of
the transition to the new review processes:
- First new cycle: NIH to calculate percentiles using those applications only.
- Second new cycle: NIH to calculate percentiles using applications submitted
for first and second cycles.
|
Scores for Individual Criteria |
Scores are not provided for individual critieria. |
Before the review meeting, each reviewer
and discussant assigned to an application will give a separate score
for each of five core review criteria (Significance, Investigator(s),
Innovation, Approach, and Environment). To improve information and
transparency, for all applications, even those not discussed by the
full committee, the scores of assigned reviewers and discussant(s)
for these criteria will be reported individually on the summary statement. |
Review Criteria |
Five one-word criteria plus descriptive
information. |
One-word criteria unchanged; descriptions
modified.
Reviewers will consider each of the five review criteria in
the determination of scientific and technical merit, and give a separate
score for each. An application does not need to be strong in all categories
to be judged likely to have major scientific impact (i.e. a project
that by its nature is not innovative may be essential to advance a field). |
Policy changes may be found in the following notices, or on the Enhancing
Peer Review Web site.
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Tips for Great Grant Writing, Part 1: What is NIH Looking For?
I What Does NIH Look For in a Grant Application?
Because NIH is comprised of 24 different grant-awarding Institutes and
Centers (ICs) which provide funding, there is no simple answer to this question.
However, if you are talking to an NIH Program Official about your idea or
potential research project, you are already on the right track to receiving
NIH funding.
While NIH awards many grants specifically for research, we also
provide grant opportunities that support research-related activities, including:
construction, training, career development, conferences, resource grants
and more. Specifically,
we encourage projects that have the three following qualities:
- NIH looks for grant proposals of high scientific
caliber that are relevant to public
health needs and are within NIH Institute and Center (IC) priorities. ICs highlight their specific research priorities
on their Web sites. Applicants are encouraged to contact the appropriate IC to discuss the relevancy and/or focus of the proposed research before submitting an
application. NIH also has a number of broad NIH-wide initiatives that may be of interest.
- NIH strongly encourages investigator-initiated research across the spectrum of our mission. We issue hundreds of funding
opportunity announcements (FOAs) in the form of Program
Announcements (PAs) and requests
for applications (RFAs) to stimulate research in particular areas of science. Some PAs, called
"Parent Announcements," span the breadth of the NIH mission in order to
ensure we have a way to capture “unsolicited” applications that do not fall
within the scope of targeted announcements. The majority of NIH applications
are submitted in response to parent announcements.
- By law, NIH cannot support a project already funded or pay for research that has already been done. Projects
must be unique. Although you may not send the same application to more than one Public
Health Service (PHS) agency at the same time, you can apply to an organization outside the PHS with the same application. If the project gets funded by another
organization, however, it cannot also be funded by NIH.
Parts of this column have been extracted from the "About Grants" section
of the Office of
Extramural Research’s Home Page.
Be sure to watch this space next month for new tips on great grant writing! |
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Animal Welfare Terms and Conditions Seminar Available for Viewing
The seminar “When Terms and Conditions Are Not Met” is now available for viewing at the Office of Laboratory Animal Welfare (OLAW)/Institutional Animal Care and Use
Committee (IACUC) Staff Outreach page.
The IACUC Staff Outreach program is a free online seminar series presented
quarterly by OLAW. The December 4th seminar featured guest speakers OLAW
Director Dr. Patricia A. Brown, and OLAW Division of Assurances Director Eileen
Morgan.
The next seminar, titled “Reporting Noncompliant Events to OLAW,” is scheduled
for March 5th. |
New Animal Protocol Review FAQs
New Frequently
Asked Questions have been posted on the Office of Laboratory Animal Welfare (OLAW) Web site.
These FAQs provide guidance in response to PHS Policy-related questions such
as…
- “Does the Institutional Animal Care and Use Committee (IACUC) have to
review proposed animal research activities at the time of grant award if
the animal research activities will not be conducted until year 4 or 5 of
a grant?”
Or…
- “May an IACUC use designated member review (DMR) to review an animal study
protocol subsequent to full committee review (FCR) when modifications are
needed to secure approval?” See also NOT-OD-09-035.
OLAW welcomes questions, suggestions and comments relating to these FAQs
and any other information posted on OLAW Web pages. All communications can
be directed to OLAW
help. |
NIH Unveils New Reviewer Reimbursement System
NIH has introduced a new,
simplified and secure process to disburse honoraria and expenses to reviewers
related to their participation in peer review meetings. The new system, effective
Jan. 17, requires reviewers to log in to eRA
Commons and update their Personal Profile with their residential address,
phone number and email. Reviewers will then click on a link to a secure payment
system — the Secure Payee Reimbursement System — and enter their banking information.
Reviewers can follow these step-by-step
instructions for registration.
Registration in the new system is required
to receive disbursement. The new system replaces the U.S. Central Contractor
Registration (CCR) system that NIH previously used for this purpose. Reviewers
with CCR accounts may cancel their CCR registration, if they wish.
A big plus of the new system is that reviewers will not be spammed by third party solicitations.
The secure payment site is managed by the NIH Office of Financial Management
(OFM) and information entered as part of the new registration process will
be kept secure and confidential.
Annual renewal of the registration, as was required by CCR, is not necessary.
However, NIH will rely on reviewers to maintain and update their bank and home
information. This is especially important if a reviewer shifts residence or
moves to another bank. |
2009 NIH Regional Seminars Offer Unparalleled Learning & Networking Opportunity
What is a NIH Regional Seminar?
Held twice a year, the NIH Regional Seminars provide you with an opportunity to meet and hear from approximately 25 NIH policy officials, grants management and program staff representing various Institutes and/or Centers, as well as representatives from the Office for Human Research Protections, Office of Research Integrity, Loan Repayment Program (LRP), the SBIR/STTR program, and more. Under one roof and over two days, experts in NIH grants policy and process share a broad array of expertise and insight at an event you won’t find anywhere else – without coming to the NIH campus, of course! In addition, you’ll receive the most current information on submitting an application electronically and how to effectively utilize the eRA Commons. If that’s not enough, sign up for the optional eRA Computer Workshops for hands-on training by eRA experts.
Who Attends?
If you are an administrator or investigator new to the NIH grants process or have limited experience - then this seminar is for you. If you’re a post doc or graduate student interested in learning about NIH programs, and ready to receive tips and resources directly from NIH – then this seminar is for you. If you have experience with NIH grants but are looking for the latest changes to elements of the NIH Grants Process, as well as the opportunity to network with others in your field and NIH/HHS experts – then this seminar is for you.
Where, When, & How Do I Register?
Atlanta, Georgia -
Wednesday, April 15: eRA Hands-On Computer Workshops – (limited availability)
Thursday, April 16 & Friday,
April 17: 2-Day Regional Seminar
Registration: (Register Today!)
*Co-hosted by Georgia State University and Georgia Institute
of Technology
Las Vegas, Nevada -
Wednesday, June 24: eRA Hands-On Computer Workshops
Thursday, June 25 & Friday,
June 26: 2-Day Regional Seminar
Registration:
(Registration opens in February.)
*Co-ambassadors are the University of
Nevada, Las Vegas and the University of Nevada, Reno
Additional Information?
NIH
Guide Notice
NIH Regional Seminar home page
A sample of new sessions for 2009 include Early Stage Investigators (ESI) and the AREA (R15) Program. Additional networking opportunities this year will provide you the chance to share ideas with other attendees. We hope to see you there! |
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Where Grants Policy, Program Coordination, Compliance and Electronic Research Administration Converge