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<TITLE>NOT-OD-04-009: PUBLICATION OF THE REVISED NIH GRANTS POLICY STATEMENT (REV. 12/03): POLICY CHANGES, CLARIFICATIONS, AND ENHANCEMENTS</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: PUBLICATION OF THE REVISED NIH GRANTS POLICY STATEMENT (REV. 12/03): POLICY CHANGES, CLARIFICATIONS, AND ENHANCEMENTS NOT-OD-04-009. NIH">
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PUBLICATION OF THE REVISED NIH GRANTS POLICY STATEMENT (REV. 12/03):
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POLICY CHANGES, CLARIFICATIONS, AND ENHANCEMENTS
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RELEASE DATE: November 26, 2003
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NOTICE: NOT-OD-04-009
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National Institutes of Health
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(<a href="http://www.nih.gov">http://www.nih.gov</A>)
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The National Institutes of Health (NIH) is pleased to announce the
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publication of the revised NIH Grants Policy Statement (NIHGPS, rev.
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12/03). The NIHGPS (12/03) is applicable to all NIH grants and
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cooperative agreements with budget periods beginning on or after
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December 1, 2003. This revision supersedes, in its entirety, the NIH
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Grants Policy Statement (03/01) as a standard term and condition of
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award. However, the March 2001 NIHGPS continues to be the standard
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term and condition for all NIH grants and cooperative agreements with
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budget periods that began between March 1, 2001 and November 30, 2003.
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The NIHGPS provides both up-to-date policy guidance that serve as NIH
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standard terms and conditions of awards for grants and cooperative
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agreements, and extensive guidance to individuals that are interested
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in NIH grants.
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The NIHGPS (rev. 12/03) incorporates NIH policy changes since March
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2001, public policy changes, policy clarifications, as well as document
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enhancements. Sections of the revised policy statement have been
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rewritten to provide clarity; however, the overall policies in these
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sections have not changed. The document is available in the following
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electronic formats: HTML and PDF
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<a href="http://grants.nih.gov/grants/policy/nihgps_2003/index.htm">http://grants.nih.gov/grants/policy/nihgps_2003/index.htm</A>. Links to
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the 10/98 and 3/01 NIHGPS will remain the same.
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NIH will publish interim grants policy changes through the issuance of
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NIH Guide Notices. Each change will be described, including its
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applicability and effective date; and the necessary language to
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implement it as a term or condition of award provided.
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Policy changes that are implemented with the 12/03 NIHGPS include:
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o Closely related work: the option for grantees to pursue prior
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approval to account for multiple projects under a single cost objective
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has been eliminated. NIH will now apply the relatedness provision of
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OMB Circular A-21 (C., 4., d., (3))to all NIH recipients which states
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if a specific cost can not be reasonably allocated to a specific
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project; it can be charged to any of the benefiting projects on any
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reasonable basis.
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o Cost transfers: policy now states that transfers of costs from one
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project to another or from one competitive segment to the next solely
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to cover cost overruns are unallowable.
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o Cost overruns: included a definition to the glossary that states:
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"Any amount charged in access of the Federal share of costs for the
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project period (competitive segment)."
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Below are examples of NIH policy changes that have occurred since March
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2001. Please note that the list below should not be considered all-
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inclusive; therefore, please refer to the NIH Guide for Grants and
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Contracts for details on other changes since March 2001
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<a href="http://grants.nih.gov/grants/policy/notices.htm">http://grants.nih.gov/grants/policy/notices.htm</A>.
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o Expanded Authorities: Application of expanded authorities as a
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standard term and condition to all NIH awards.
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o Examples of the latest changes in the application submission
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policies:
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o NIH will continue to accept no more than two revised
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applications after the submission of the original
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application; however, the two year limitation has been
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eliminated;
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o Resubmission of Application policy changed to allow
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grantees to resubmit unfunded applications as new
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applications in the following instances: 1) unsuccessful
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applications for an RFA can be resubmitted as a new
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investigator-initiated application 2) previously
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unsuccessful investigator-initiated applications can be
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resubmitted in response to an RFA as a new application, and
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3) unfunded applications that are reviewed for one research
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grant mechanism may be resubmitted for a different grant
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mechanism and should be prepared as a new application.
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o Data Sharing: Implementation of the NIH data-sharing policy.
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o Just-in-Time procedures: Expanded to include option to submit IACUC
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approval.
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o NRSA Section Highlights:
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o In accordance with the amendment of the Public Health
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Service Act, NIH renamed the National Research Service
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Awards to the Ruth L. Kirschstein National Research Service
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Awards;
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o Includes the regulatory changes of NRSA part-time training;
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o Audit: Threshold for A-133 audits has increased from $300,000 to
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$500,000 for fiscal years ending on or after 12/31/2003.
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Public Policy Changes that are discussed in the 12/03 NIHGPS:
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o Stem Cell Research
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o USA PATRIOT Act
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o Public Health Security and Bioterrorism Preparedness and Response Act
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of 2002
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o HIPAA Privacy Rule
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Policy Clarifications since March 2001:
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o Clinical Practice Compensation (Institutional Base Salary):
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Compensation may be considered in the institutional base salary as long
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as all criteria are met: 1) clinical practice must be guaranteed by the
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university, 2) clinical practice must be reported on the university's
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appointment form and paid by the university, and 3) clinical practice
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effort must be included and accounted for in the university's effort
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reporting.
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o Key Personnel: Expanded definition to describe the contribution of
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key personnel as "measurable" whether or not salaries are requested.
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Zero percent effort and "as needed" are not acceptable for individuals
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that the grantee identifies as key personnel.
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o PI Eligibility: Elaborated on eligibility criteria for certain
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mechanisms/programs, no change in policy.
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o A discussion on the unallowability of patent costs has been added to
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the NIHGPS. The policy now states that Invention, Patent, or Licensing
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Costs are unallowable as either direct or F&A costs because the
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creation of intellectual property is not a requirement of NIH grant
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awards. Such costs include licensing or option fees, attorney's fees
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for preparing or submitting patent application, patent maintenance, or
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recordation of patent-related information.
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o Consortium Written Agreements: Outlined that it is the responsibility
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of the grantees to include applicable requirements of the policy
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statement in their written agreements and highlighted that agreements
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must also include a reference to the financial conflict of interest
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policy, intellectual property, and data sharing requirements.
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Document Enhancements:
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o NIH Grants Policy Statement and the PHS 398 application glossaries
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have been merged, where appropriate.
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o Other Support Policy: Previously located in the PHS 398 application
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has been included in the NIH Grants Policy Statement.
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o Glossary included in a table format.
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o Select Items of Cost section included in a table format.
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o Bayh-Dole Inventions reporting requirements are now included in a
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table format.
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o Cross Referencing Roles with eRA: NIH Grants Policy Statement role
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titles have been cross-referenced with the NIH eRA role titles, e.g.:
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authorized organizational official (also known as the signing
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official).
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o Abbreviations and acronyms: are used throughout the policy statement
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without parenthetical; therefore, readers should refer to the master
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list to identify unfamiliar terms abbreviations and/or acronyms.
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o Index included.
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ADDITIONAL INQUIRIES
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Additional questions about the NIHGPS may be directed to the NIH
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Division of Grants Policy at (301) 435-0949 or the Grants Management
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Specialist that is identified on the NIH Notice of Grant Award.
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</pre>
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<P><HR><P>
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<A HREF="/grants/guide/WeeklyIndex.cfm?WeekEnding=11-28-03">Weekly TOC for this Announcement</A><br>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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