PUBLICATION OF THE REVISED NIH GRANTS POLICY STATEMENT (REV. 12/03): 
POLICY CHANGES, CLARIFICATIONS, AND ENHANCEMENTS

RELEASE DATE:  November 26, 2003

NOTICE: NOT-OD-04-009

National Institutes of Health
 (http://www.nih.gov)

The National Institutes of Health (NIH) is pleased to announce the 
publication of the revised NIH Grants Policy Statement (NIHGPS, rev. 
12/03).  The NIHGPS (12/03) is applicable to all NIH grants and 
cooperative agreements with budget periods beginning on or after 
December 1, 2003. This revision supersedes, in its entirety, the NIH 
Grants Policy Statement (03/01) as a standard term and condition of 
award.  However, the March 2001 NIHGPS continues to be the standard 
term and condition for all NIH grants and cooperative agreements with 
budget periods that began between March 1, 2001 and November 30, 2003.

The NIHGPS provides both up-to-date policy guidance that serve as NIH 
standard terms and conditions of awards for grants and cooperative 
agreements, and extensive guidance to individuals that are interested 
in NIH grants.

The NIHGPS (rev. 12/03) incorporates NIH policy changes since March 
2001, public policy changes, policy clarifications, as well as document 
enhancements. Sections of the revised policy statement have been 
rewritten to provide clarity; however, the overall policies in these 
sections have not changed. The document is available in the following 
electronic formats: HTML and PDF 
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm.  Links to 
the 10/98 and 3/01 NIHGPS will remain the same.

NIH will publish interim grants policy changes through the issuance of 
NIH Guide Notices.  Each change will be described, including its 
applicability and effective date; and the necessary language to 
implement it as a term or condition of award provided.

Policy changes that are implemented with the 12/03 NIHGPS include:

o Closely related work: the option for grantees to pursue prior 
approval to account for multiple projects under a single cost objective 
has been eliminated.  NIH will now apply the relatedness provision of 
OMB Circular A-21 (C., 4., d., (3))to all NIH recipients which states 
if a specific cost can not be reasonably allocated to a specific 
project; it can be charged to any of the benefiting projects on any 
reasonable basis.
o Cost transfers: policy now states that transfers of costs from one 
project to another or from one competitive segment to the next solely 
to cover cost overruns are unallowable.
o Cost overruns:  included a definition to the glossary that states:  
"Any amount charged in access of the Federal share of costs for the 
project period (competitive segment)."

Below are examples of NIH policy changes that have occurred since March 
2001. Please note that the list below should not be considered all-
inclusive; therefore, please refer to the NIH Guide for Grants and 
Contracts for details on other changes since March 2001 
http://grants.nih.gov/grants/policy/notices.htm.

o Expanded Authorities:  Application of expanded authorities as a 
standard term and condition to all NIH awards.
o Examples of the latest changes in the application submission 
policies:  
o NIH will continue to accept no more than two revised 
applications after the submission of the original 
application; however, the two year limitation has been 
eliminated;
o Resubmission of Application policy changed to allow 
grantees to resubmit unfunded applications as new 
applications in the following instances: 1) unsuccessful 
applications for an RFA can be resubmitted as a new 
investigator-initiated application 2) previously 
unsuccessful investigator-initiated applications  can be 
resubmitted in response to an RFA as a new application, and 
3) unfunded applications that are reviewed for one research 
grant mechanism may be resubmitted for a different grant 
mechanism and should be prepared as a new application.
o Data Sharing:  Implementation of the NIH data-sharing policy.
o Just-in-Time procedures: Expanded to include option to submit IACUC 
approval.
o NRSA Section Highlights:
o In accordance with the amendment of the Public Health 
Service Act, NIH renamed the National Research Service 
Awards to the Ruth L. Kirschstein National Research Service 
Awards;
o Includes the regulatory changes of NRSA part-time training;
o Audit:  Threshold for A-133 audits has increased from $300,000 to 
$500,000 for fiscal years ending on or after 12/31/2003.

Public Policy Changes that are discussed in the 12/03 NIHGPS: 

o Stem Cell  Research 
o USA PATRIOT Act
o Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 
o HIPAA Privacy Rule

Policy Clarifications since March 2001:

o Clinical Practice Compensation (Institutional Base Salary):  
Compensation may be considered in the institutional base salary as long 
as all criteria are met: 1) clinical practice must be guaranteed by the 
university, 2) clinical practice must be reported on the university's 
appointment form and paid by the university, and 3) clinical practice 
effort must be included and accounted for in the university's effort 
reporting.
o Key Personnel:  Expanded definition to describe the contribution of 
key personnel as "measurable" whether or not salaries are requested.  
Zero percent effort and "as needed" are not acceptable for individuals 
that the grantee identifies as key personnel.
o PI Eligibility:  Elaborated on eligibility criteria for certain 
mechanisms/programs, no change in policy.
o A discussion on the unallowability of patent costs has been added to 
the NIHGPS.  The policy now states that Invention, Patent, or Licensing 
Costs are unallowable as either direct or F&A costs because the 
creation of intellectual property is not a requirement of NIH grant 
awards. Such costs include licensing or option fees, attorney's fees 
for preparing or submitting patent application, patent maintenance, or 
recordation of patent-related information.

o Consortium Written Agreements: Outlined that it is the responsibility 
of the grantees to include applicable requirements of the policy 
statement in their written agreements and highlighted that agreements 
must also include a reference to the financial conflict of interest 
policy, intellectual property, and data sharing requirements.

Document Enhancements:

o NIH Grants Policy Statement and the PHS 398 application glossaries 
have been merged, where appropriate.
o Other Support Policy:  Previously located in the PHS 398 application 
has been included in the NIH Grants Policy Statement.
o Glossary included in a table format.
o Select Items of Cost section included in a table format.
o Bayh-Dole Inventions reporting requirements are now included in a 
table format.
o Cross Referencing Roles with eRA:  NIH Grants Policy Statement role 
titles have been cross-referenced with the NIH eRA role titles, e.g.: 
authorized organizational official (also known as the signing 
official). 
o Abbreviations and acronyms: are used throughout the policy statement 
without parenthetical; therefore, readers should refer to the master 
list to identify unfamiliar terms abbreviations and/or acronyms.
o Index included.

ADDITIONAL INQUIRIES
Additional questions about the NIHGPS may be directed to the NIH 
Division of Grants Policy at (301) 435-0949 or the Grants Management 
Specialist that is identified on the NIH Notice of Grant Award.

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