PUBLICATION OF THE REVISED NATIONAL INSTITUTES OF HEALTH GRANTS POLICY STATEMENT Release Date: February 27, 2001 NOTICE: NOT-OD-01-015 National Institutes of Health The National Institutes of Health (NIH) is pleased to announce the publication of the revised NIH Grants Policy Statement (NIHGPS, rev. 03/01). The NIHGPS (rev. 03/01) is effective for all NIH grants and cooperative agreements with budget periods beginning on or after March 1, 2001, and will supersede, in its entirety, the NIH Grants Policy Statement (10/98) as a standard term and condition of award. The NIHGPS published in October of 1998 remains the standard term and condition for all grants and cooperative agreements with budget periods that began between October 1, 1998 and February 28, 2001. The NIHGPS makes available to NIH grantees, in a single document, up- to-date policy guidance that will serve as the terms and conditions of NIH awards. This document is also designed to be useful to those interested in NIH grants by providing information about NIH. The organization of the document has changed slightly. The previous NIHGPS had four parts: Part I - General, Part II - Terms and Conditions, Part III - Other Terms, and Part IV - Contacts. The revised NIHGPS has combined Parts II and III, so the organization is as follows: Part I Part I provides a glossary of commonly used terms, describes NIH and its relationship to other organizations within the Department of Health and Human Services (HHS), specifies grantee, NIH, and other HHS staff responsibilities, outlines the application and review processes, and explains the various resources available to those interested in the NIH grants process. Part II Part II serves as the terms and conditions that are incorporated by reference in all NIH grant awards. It also specifies, in separate sections, requirements that pertain to construction grants, training grants and fellowships, conference grants, consortium agreements, grants to foreign and international organizations (and domestic grants with substantial foreign components), grants to Federal institutions and payments to (or on behalf of) Federal employees, grants to for- profit organizations, modular grants, and research patient care activities. Part III Part III contains general contact information to aid the reader. This format allows general information, application information, and other types of reference material to be separated from legally binding terms and conditions that are contained in Part II. The NIHGPS (rev. 03/01) is available in HTML version from http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. A PDF version is available from the Grants Policy Page (from http://www.nih.gov, access the "Grants Page" link under "Grants & Funding Opportunities," then click on "Grants Policy," then click on the "NIH Grants Policy Statement.") Copies of the revised NIHGPS will not be printed or mailed. Links to the 10/98 NIHGPS will remain the same. Interim changes to NIH grants policies will be published in the NIH Guide for Grants and Contracts (NIH Guide). The NIH Guide is published on the NIH Home Page at http://www.nih.gov (access the "Grants Page" link under "Grants & Funding Opportunities," then click on the "NIH Guide"). Conforming changes will be made to both the HTML and PDF versions of the NIHGPS, with a date indicator showing the effective date of the change. Notable policy changes that are implemented with this NIHGPS include: 1. The separate requirement for approval of significant rebudgeting has been eliminated. It is now incorporated as an indicator of a change in scope. This is effective immediately for all NIH awards. This change eliminates the need to reply to question #2 of the four streamlined noncompeting award process (SNAP) questions. 2. The term collaborator has been changed to co-investigator. This change is intended to more accurately describe the role of individuals who are involved with the principal investigator (PI) in the scientific development or execution of the project. This change in terminology does not change the role and/or responsibilities of the PI as detailed in the NIHGPS or the PHS 398 application. 3. The criteria to allocate costs normally assignable to multiple projects ( closely related work ) has changed. A grantee may allocate costs normally assignable to multiple projects to one of those projects or else treat multiple projects as a single cost objective regardless of the funding IC or whether the awards involve the same or different PIs. However, identifying projects as closely related continues to be a prior approval requirement. 4. For grantees subject to OMB Circular A-21, Cost Principles for Educational Institutions, the 10/98 NIHGPS states that grantees subject to OMB Circular A-21 may not rebudget from direct costs to accommodate a facilities and administrative (F&A) rate increase unless the rate in effect at the time of award was provisional. This requirement is now eliminated from the NIHGPS. Grantees may rebudget between direct and F&A costs (in either direction) without NIH prior approval, provided there is no change in the scope of the approved project. 5. The addition of a foreign component requires prior approval for all recipients, regardless of terms of award. 6. A statistical sampling basis is now acceptable for physical inventory of equipment. NIH has included a section on modular applications and awards in the revised NIHGPS. Expanded or clarified coverage has been provided in several areas, including the following: 1. A clinical hold placed by the Food and Drug Administration (FDA) is added as an example of change of scope. 2. A list of actions that require prior approval is provided in table format. 3. Clarifying language on the use of 1099 forms for both fellowship and training grants is included. 4. The allowability of foreign travel costs purchased under a code share is discussed. 5. The revised NIHGPS contains an explicit reference that it is the grantee organization’s responsibility to ensure that all sites engaged in research involving human subjects have an appropriate OHRP-approved assurance and IRB approval of the research, consistent with 45 CFR 46. 6. A continued and increased emphasis on timely and accurate reporting is reflected throughout the document. 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 identified on the NIH Notice of Grant Award.
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