NIH Grants Policy Statement

1 NIHG rantsPolicyStatementINTRODUCTIONThe national Institutes of health Grants Policy Statement (NIHGPS) is intended to make available to NIH recipients, in a single document, the Policy requirements that serve as the terms and conditions of NIH grant awards. These terms and conditions apply not only to the prime recipients, but also flow down to any subawards as well as to subrecipients unless specified otherwise in the regulation or the terms and conditions of the specific NIH award (see "Consortium Agreements" on page IIB-112).This document also is designed to be useful to those interested in NIH Grants by providing information about NIH its organization, its staff, and its Grants process. The NIHGPS is available online at This version includes many links within the document as well as links to some web resources outside of this document. Users are strongly encouraged to use the on-line version of this document to benefit from these ORGANIZATIONThe NIHGPS has three parts, which allows general information, application information, and other types of reference material to be separated from legally binding terms and conditions: lPart I: NIH Grants General Information.

2 Part I (chapters 1 and 2) contains a glossary defin-ing commonly used terms and abbreviations used throughout the document; describes NIH and its relationship to other organizations within the Department of health and Human Services (HHS); specifies recipient, NIH, and other HHS staff responsibilities and outlines the grant application and review processes. lPart II: Terms and Conditions of NIH Grant Awards. Part II (chapters 3-19) includes generally applicable terms and conditions (Part IIA). This part also specifies the terms and conditions that apply to particular types of Grants , recipients, and activities that differ from, supplement, or elab-orate on the standard terms and conditions (Part IIB). These requirements, in separate chapters, pertain to multiple PD/PI applications and awards; construction, modernization and major alter-ation and renovation Grants ; research training Grants and fellowships; career development awards; modular applications and awards; conference Grants , consortium agreements; Grants to foreign and international organizations (and Grants with substantial foreign components awarded to domestic organizations), Grants to Federal institutions and payments to Federal employees; Grants to commercial organizations; and research patient care activities.

3 LPart III: Points of Contact. Part III (chapter 20) lists pertinent offices with their contact conventions are followed throughout this document. The term grant is used to mean both Grants and cooperative agreements; however, for clarity, certain sections mention both Grants and cooper-ative agreements. The term recipient generally is used to refer to recipients of Grants and awardees of cooperative agreements; however the terms recipient or awardee also are used. NIH may be used in this document to refer to the entire organization or to its component organizations, or else to contrast an action by NIH, including actions by its ICs, with an action by a recipient or other organization. A ref-erence to Part II (IIA or IIB) or Part III without further elaboration means the corresponding part of the NIHGPS was originally published with an effective date of October 1, 1998. It was subsequently revised several years thereafter with the turn of each new fiscal year (October).

4 This revision of the NIHGPS is an update of the April, 2021 publication. It applies to all NIH Grants and cooperative agree-ments for budget periods beginning on or after October 1, 2021. This version incorporates new and mod-ified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or Policy processes since the previous version of the GPS from April, 2021. An explanation of the major changes to the NIHGPS since the previous edi-tion is included in the NIH Guide for Grants and Contracts notice announcing the reissuance of the INFORMATIONThe Office of Policy for Extramural Research Administration (OPERA) develops and maintains this doc-ument. Changes in statutes, regulations, or policies that take effect before the next revision of the NIHGPS will be published separately in the NIH Guide for Grants and Contracts.

5 Recipients are respons-ible for reviewing the NIH Guide for Grants and Contracts, which is published on the NIH home page at , for changes and for implementing them, as appropriate. Subscribe to the NIH Guide for Grants and Contracts Listserv at OF CONTENTS1 Definition of TermsI-72 THE national INSTITUTES OF health AS A GRANT-MAKING Roles and NIH and HHS Recipient eRA eRA Commons eRA Commons Registration for the eRA Commons Registration for the eRA Commons Registration for Other Individuals Participating in NIH Pro-gress Application Information and Support Types of Award Types of Types of Funding Opportunity Announcements (FOAs) Legal Implications of Policies Affecting Applications That Include Consortium/Contractual F&A Acceptance for Review of Unsolicited Applications Requesting $500,000 or More in Direct Resubmission of Unfunded RFA Submission of Resubmission New Investigators and Early Stage Program Director/Principal Investigator, Individual Fellowship and Sponsor Post-Submission Grant Application DUNS Number and SAM Registration Graduate Student NIH Genomic Data Human Fetal Tissue from elective Biographical Sketches (Biosketches)

6 Application Application Receipt Information and Paper Electronically Submitted Modified Submission Policy for Appointed Members of NIH Review and Advisory Group and Reviewers with Recent Substantial Similar, Essentially Identical, or Identical Application Fraud, Waste and Abuse of NIH Grant Availability and Confidentiality of Availability of Confidentiality of Protecting Sensitive Data and Information Used in The Peer Review Initial Overall Scored Review Additional Review Additional Review Appeals of Initial Scientific national Advisory Council or Board Disposition of Completing the Pre-Award Just-in-Time Submitting Revised Project Summary/Abstracts, Specific Aims, and/or Public health Relevance Determining Applicant Organization Determining Eligibility of Cost Analysis and Assessment of Management SystemsI-833 OVERVIEW OF TERMS AND Federalwide Standard Terms and Conditions for Research GrantsIIA-24 PUBLIC Policy REQUIREMENTS, OBJECTIVES AND OTHER APPROPRIATION Public Policy Requirements and Animal Welfare Animal Welfare Assurance Verification of IACUC Foreign Recipients and Foreign Performance Reporting to Civil Rights Civil Rights Act of Educational Amendments of Rehabilitation Act of Age Discrimination Act of Limited English Clinical Trials Registration and Reporting in NIH Policy on Dissemination of NIH-Funded Clinical Trial Food and Drug Administration Amendments Act (FDAAA) Certificates of Confidentiality of Alcohol and Drug Abuse Patient Confidentiality of Patient Records.

7 health Insurance Portability and Accountability Controlled Debarment and Drug-Free Federal Funding Accountability and Transparency Act (FFATA) Federal Information Security Management Financial Conflict of Fly America health and Safety Regulations and Human Stem Cell Human Pluripotent Stem Cell Research Prohibited with NIH Human Fetal Tissue Research on Transplantation of Human Fetal Non-Transplantation Research on Human Fetal Tissue from Elective Human Subjects Federalwide Assurance Certification of IRB Reporting to Funding Agency and OHRP Education in the Protection of Human Research Data and Safety Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Inclusion of Women and Minorities as Subjects in Clinical Research and Reporting Sex/Gender, Racial, and Ethnic Good Clinical Practice Training for NIH Awardees Involved in NIH-fun-ded Clinical NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Investigational New Drug Applications/Investigational Device Lobbying Metric Military Recruiting and Reserve Officer Training Corps Program Access to Institutions of Higher national Environmental Policy Nondelinquency on Federal President's Emergency Plan for AIDS Relief (PEPFAR) PEPFAR PEPFAR Agreements Between the Government and Foreign Non-Governmental Organizations (NGOs) Pro-Children Act of Public health Public health Security and Bioterrorism Preparedness and Response Act (Select Agents)

8 Select Agent Awards to Select Agent Awards to Foreign Organizations and Inter- national Select Agent Awards to Institutions with Foreign Dual Use Research of Agents Regulated Under the Chemical Weapons Reporting and Assurance Requirements for Institutions Receiving Awards for Training of Graduate Students for Doctoral Research Involving Recombinant or Synthetic Nucleic Acid Molecules (includ-IIA-47viNIHG rantsPolicyStatementing Human Gene Transfer Research) Scope and Institutional Biosafety Investigators and Institutional Research Seat Belt Smoke-Free Standards of Text Messaging While Trafficking in USA Patriot Federal Awardee Performance and Integrity Information System (FAPIIS) Mandatory Never Contract with the Prohibition on Certain Telecommunications and Video Surveillance Services or Appropriation Acknowledgment of Federal Dissemination of False or Deliberately Misleading Gun Human Embryo Research and Cloning Lobbying Appropriation Promotion or Legalization of Controlled Restriction on Abortion Exceptions to Restrictions on Restriction on Distribution of Sterile Salary Cap/Salary Restriction of Pornography on Computer Restriction on Disclosure of Political Affiliation for Federal Scientific Advisory Committee CandidatesIIA-565 THE NOTICE OF Notice of Award Associated Applications and/or Additional Terms and ConditionsIIA-616 Smartlink Cash Interest Earned on Advances of Grant Improper Payments Elimination and Recovery Improvement ActIIA-637 COST The Cost Direct Costs and Facilities and Administrative

9 Reimbursement of Facilities and Administrative Cost Transfers, Overruns, and Accelerated and Delayed Allocation of Costs and Closely Related Applicable Services Provided by Affiliated Allowability of Selected Items of CostIIA-728 ADMINISTRATIVE Changes in Project and NIH Standard Terms of Carryover of Unobligated Balances from One Budget Period to Any Sub-sequent Budget Cost-Related Prior Extension of Final Budget Period of a Previously Approved Project Period without Additional NIH Transfer of the Performance of Substantive Programmatic Work to a Third Party by Means of a Consortium Direct Charging Salaries of Administrative and Clerical Supplemental Compensation under Written Institutional Policy for Intra-IHE Faculty Consulting that Exceed a Faculty Member's Base Salary, Under Certain Prior Approval Additional No-cost Extension or Extension Greater Than 12 Months or Late Notification of Initial No-Cost Alterations and Capital Carryover of Unobligated Change in Change in Status, Including Absence of PD/PI and Other Senior/Key Per-sonnel Named in the Change of Recipient Change in Recipient Organizational Deviation from Award Terms and Conditions.

10 Including Restrictions in the Foreign Component Added to a Grant to a Domestic or Foreign Provide Subawards Based on Fixed Need for Additional NIH Funding without Extension of Budget and Pro-ject Need for Additional NIH Funding with Extension of the Final Budget Period of a Project Pre-Award Rebudgeting of Funds from Trainee Rebudgeting of Funds Between Construction and Non-construction Retention of Research Grant Funds When a Career Development Award is Requests for Prior Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Rights in Data (Publication and Copyrighting) NIH Public Access Sharing Research Data Sharing Sharing Model Genomic Data Sharing (GDS) Policy / Policy for Genome-Wide Asso-ciation Studies (GWAS) Inventions and Interim Research Management Systems and Financial Management System Program Reporting Program Sale of Real Property, Equipment, and Royalties and Licensing Fees from Copyrights, Inventions, and Property Management System Real Equipment and Procurement System Standards and Approval Contracting with Small Businesses, Minority-Owned Firms, and Women's Business Domestic Preferences for Non-Competing Continuation Progress Streamlined Non-Competing Award Progress Reports for Multiyear Funded Final Research Performance Progress Report (F-RPPR)