NIH Grants Policy StatementINTRODUCTIONThe National Institutes of Health Grants Policy Statement (NIHGPS) is intended to make available toNIH recipients, in a single document, the policy requirements that serve as the terms and conditions ofNIH grant awards. These terms and conditions apply not only to the prime recipients, but also flow downto any subawards as well as to subrecipients unless specified otherwise in the regulation or the termsand conditions of the specific NIH award (see "Consortium Agreements" on page IIB-110).This document also is designed to be useful to those interested in NIH grants by providing informationabout NIH—its organization, its staff, and its grants process. This version includes many links within the document as well aslinks to some web resources outside of this document. Users are strongly encouraged to use the on-lineversion of this document to benefit from these links.NIHGPS ORGANIZATIONThe NIHGPS has three parts, which allows general information, application information, and other typesof reference material to be separated from legally binding terms and conditions:lllPart I: NIH Grants—General Information. Part I (chapters 1 and 2) contains a glossary defining commonly used terms and abbreviations used throughout the document; describes NIH andits relationship to other organizations within the Department of Health and Human Services(HHS); specifies recipient, NIH, and other HHS staff responsibilities and outlines the grantapplication and review processes.Part II: Terms and Conditions of NIH Grant Awards. Part II (chapters 3-19) includes generallyapplicable terms and conditions (Part IIA). This part also specifies the terms and conditions thatapply to particular types of grants, recipients, and activities that differ from, supplement, or elaborate 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 alteration and renovation grants; research training grants and fellowships; career developmentawards; modular applications and awards; conference grants, consortium agreements; grants toforeign and international organizations (and grants with substantial foreign components awardedto domestic organizations), grants to Federal institutions and payments to Federal employees;grants to for-profit organizations; and research patient care activities.Part III: Points of Contact. Part III (chapter 20) lists pertinent offices with their contact information.CONVENTIONSCertain conventions are followed throughout this document. The term “grant” is used to mean both grantsand cooperative agreements; however, for clarity, certain sections mention both grants and cooperativeagreements. The term “recipient” generally is used to refer to recipients of grants and awardees ofcooperative agreements; however the terms “recipient” or “awardee” also are used. “NIH” may be usedin this document to refer to the entire organization or to its component organizations, or else to contrastan action by NIH, including actions by its ICs, with an action by a recipient or other organization. A reference to “Part II (IIA or IIB)” or “Part III” without further elaboration means the corresponding part ofthe NIHGPS.SUPERSESSIONii

NIH Grants Policy StatementThe NIHGPS was originally published with an effective date of October 1, 1998. It was subsequentlyrevised several years thereafter with the turn of each new fiscal year (October). This revision of theNIHGPS is an update of the December publication. It applies to all NIH grants and cooperativeagreements for budget periods beginning on or after October 1. This version incorporates new andmodified requirements, clarifies certain policies, and implements changes in statutes, regulations, andpolicies that have been implemented through appropriate legal and/or policy processes since the previousversion of the GPS from December. An explanation of the major changes to the NIHGPS since theprevious edition is included in the NIH Guide for Grants and Contracts notice announcing the reissuanceof the NIHGPS.ADDITIONAL INFORMATIONThe Office of Policy for Extramural Research Administration (OPERA) develops and maintains this document. Changes in statutes, regulations, or policies that take effect before the next revision of theNIHGPS will be published separately in the NIH Guide for Grants and Contracts. Recipients areresponsible for reviewing the NIH Guide for Grants and Contracts, which is published on the NIH homepage, for changes and for implementing them, as appropriate. Subscribe to the NIH Guide for Grants and Contracts Listserv at i

NIH Grants Policy StatementTABLE OF CONTENTS1 GLOSSARY1.1 Abbreviations1.2 Definition of Terms2 THE NATIONAL INSTITUTES OF HEALTH AS A GRANT-MAKINGORGANIZATION2.1 Roles and Responsibilities2.1.1 NIH and HHS Staff2.1.2 Recipient Staff2.2 eRA Commons2.2.1 eRA Commons Registration2.2.1.1 eRA Commons Registration for the Organization2.2.1.2 eRA Commons Registration for the PD/PI2.2.1.3 eRA Commons Registration for Other Individuals Participating in NIH Progress Reports2.3 Application Information and Processes2.3.1 Support Mechanisms2.3.2 Eligibility2.3.3 Types of Award Instruments2.3.4 Types of Applications2.3.5 Types of Funding Opportunity Announcements (FOAs)2.3.6 Legal Implications of Applications2.3.7 Policies Affecting Applications2.3.7.1 Applications That Include Consortium/Contractual F&A; Costs2.3.7.2 Acceptance for Review of Unsolicited Applications Requesting 500,000 orMore in Direct Costs2.3.7.3 Resubmission of Unfunded RFA Applications2.3.7.4 Submission of Resubmission Application2.3.7.5 New Investigators and Early Stage Investigators2.3.7.6 Program Director/Principal Investigator, Individual Fellowship and SponsorAssurance2.3.7.7 Post-Submission Grant Application Materials2.3.7.8 DUNS Number and SAM Registration Requirements2.3.7.9 Graduate Student Compensation2.3.7.10 NIH Genomic Data Sharing2.3.7.11 Human Fetal Tissue from elective abortions2.3.7.12 Biographical Sketches (Biosketches)2.3.8 Application Forms2.3.9 Application Receipt Information and Deadlines2.3.9.1 Paper Applications2.3.9.2 Electronically Submitted Applications2.3.9.3 Modified Submission Policy for Appointed Members of NIH Review andAdvisory Group and Reviewers with Recent Substantial Service2.3.9.4 Similar, Essentially Identical, or Identical Applications2.3.9.5 Application Non-conformity2.3.10 Fraud, Waste and Abuse of NIH Grant Funds2.3.11 Availability and Confidentiality of Information2.3.11.1 Availability of Information2.3.11.2 Confidentiality of I-61I-63I-63I-63I-64I-65I-65I-66

NIH Grants Policy Statement2.3.12 Protecting Sensitive Data and Information Used in Research2.4 The Peer Review Process2.4.1 Initial Review2.4.1.1 Responsibilities2.4.1.2 Overall Impact2.4.1.3 Scored Review Criteria2.4.1.4 Additional Review Criteria2.4.1.5 Additional Review Considerations2.4.2 Appeals of Initial Scientific Review2.4.3 National Advisory Council or Board Review2.4.4 Disposition of Applications2.5 Completing the Pre-Award Process2.5.1 Just-in-Time Procedures2.5.2 Submitting Revised Project Summary/Abstracts, Specific Aims, and/or PublicHealth Relevance Statement2.5.3 Determining Applicant Organization Eligibility2.5.4 Determining Eligibility of Individuals2.5.5 Cost Analysis and Assessment of Management Systems3 OVERVIEW OF TERMS AND CONDITIONS3.1 Federalwide Standard Terms and Conditions for Research Grants4 PUBLIC POLICY REQUIREMENTS, OBJECTIVES AND OTHERAPPROPRIATION MANDATES4.1 Public Policy Requirements and Objectives4.1.1 Animal Welfare Requirements4.1.1.1 Animal Welfare Assurance Requirements4.1.1.2 Verification of IACUC Approval4.1.1.3 Consortiums4.1.1.4 Foreign Recipients and Foreign Performance Sites4.1.1.5 Reporting to OLAW4.1.2 Civil Rights Protections4.1.2.1 Civil Rights Act of 19644.1.2.2 Educational Amendments of 19724.1.2.3 Rehabilitation Act of 19734.1.2.4 Age Discrimination Act of 19754.1.2.5 Limited English Proficiency4.1.3 Clinical Trials Registration and Reporting in Requirement4.1.3.1 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information4.1.3.2 Food and Drug Administration Amendments Act (FDAAA)4.1.4 Confidentiality4.1.4.1 Certificates of Confidentiality4.1.4.2 Confidentiality of Alcohol and Drug Abuse Patient Records4.1.4.3 Confidentiality of Patient Records: Health Insurance Portability andAccountability Act4.1.5 Controlled Substances4.1.6 Debarment and Suspension4.1.7 Drug-Free Workplace4.1.8 Federal Funding Accountability and Transparency Act (FFATA)4.1.9 Federal Information Security Management Act4.1.10 Financial Conflict of IA-18IIA-19IIA-19IIA-19IIA-21IIA-21IIA-21IIA-22

NIH Grants Policy Statement4.1.11 Fly America ActIIA-244.1.12 Health and Safety Regulations and GuidelinesIIA-254.1.13 Human Stem Cell ResearchIIA- Human Pluripotent Stem Cell Research Prohibited with NIH FundingIIA-264.1.14 Human Fetal Tissue ResearchIIA- Research on Transplantation of Human Fetal TissueIIA- Non-Transplantation Research on Human Fetal Tissue from ElectiveAbortionsIIA-294.1.15 Human Subjects ProtectionsIIA-304.1.15.1 Federalwide Assurance RequirementsIIA-324.1.15.2 Certification of IRB ApprovalIIA-334.1.15.3 Reporting to Funding Agency and OHRPIIA-334.1.15.4 OHRP OversightIIA-344.1.15.5 Education in the Protection of Human Research ParticipantsIIA-344.1.15.6 Data and Safety MonitoringIIA-344.1.15.7 Inclusion of Individuals Across the Lifespan as Participants in ResearchInvolving Human SubjectsIIA-354.1.15.8 Inclusion of Women and Minorities as Subjects in Clinical Research andReporting Sex/Gender, Racial, and Ethnic ParticipationIIA-364.1.15.9 Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical TrialsIIA-364.1.15.10 NIH Policy on the Use of a Single Institutional Review Board for MultiSite ResearchIIA-374.1.16 Investigational New Drug Applications/Investigational Device ExceptionsIIA-384.1.17 Lobbying ProhibitionIIA-394.1.18 Metric SystemIIA-404.1.19 Military Recruiting and Reserve Officer Training Corps Program Access toInstitutions of Higher EducationIIA-404.1.20 National Environmental Policy ActIIA-404.1.21 Nondelinquency on Federal DebtIIA-414.1.22 President's Emergency Plan for AIDS Relief (PEPFAR) ProgramIIA-414.1.22.1 PEPFAR AgreementsIIA-414.1.22.2 PEPFAR Agreements Between the U.S. Government and Foreign NonGovernmental Organizations (NGOs)IIA-424.1.23 Pro-Children Act of 1994IIA-434.1.24 Public Health SecurityIIA-444.1.24.1 Public Health Security and Bioterrorism Preparedness and Response Act(Select Agents)IIA-444. Select Agent Awards to U.S. InstitutionsIIA-444. Select Agent Awards to Foreign Organizations and International OrganizationsIIA-444. Select Agent Awards to U.S. Institutions with Foreign SubcomponentsIIA-454.1.24.2 Dual Use Research of ConcernIIA-454.1.24.3 Agents Regulated Under the Chemical Weapons ConventionIIA-464.1.25 Reporting and Assurance Requirements for Institutions Receiving Awards forTraining of Graduate Students for Doctoral DegreesIIA-464.1.26 Research Involving Recombinant or Synthetic Nucleic Acid Molecules (includ- IIA-47vi

NIH Grants Policy Statementing Human Gene Transfer Research) Scope and AvailabilityIIA-474.1.26.2 Institutional Biosafety CommitteeIIA-474.1.26.3 Investigators and Institutional StaffIIA-484.1.27 Research MisconductIIA-484.1.28 Seat Belt UseIIA-494.1.29 Smoke-Free WorkplaceIIA-504.1.30 Standards of ConductIIA-504.1.31 Text Messaging While DrivingIIA-504.1.32 Trafficking in PersonsIIA-514.1.33 USA Patriot ActIIA-514.1.34 Federal Awardee Performance and Integrity Information System (FAPIIS)IIA-514.1.35 Mandatory DisclosuresIIA-524.1.36 Never Contract with the EnemyIIA-534.1.37 Prohibition on Certain Telecommunications and Video Surveillance Services orEquipmentIIA-534.2 Appropriation MandatesIIA-534.2.1 Acknowledgment of Federal FundingIIA-544.2.3 Dissemination of False or Deliberately Misleading InformationIIA-544.2.4 Gun ControlIIA-544.2.5 Human Embryo Research and Cloning BanIIA-544.2.6 Lobbying—Appropriation ProhibitionIIA-544.2.7 Promotion or Legalization of Controlled SubstancesIIA-554.2.8 Restriction on Abortion FundingIIA-554.2.8.1 Exceptions to Restrictions on AbortionsIIA-554.2.9 Restriction on Distribution of Sterile NeedlesIIA-564.2.10 Salary Cap/Salary LimitationIIA-564.2.11 Restriction of Pornography on Computer NetworksIIA-564.2.12 Restriction on Disclosure of Political Affiliation for Federal Scientific AdvisoryCommittee CandidatesIIA-565 THE NOTICE OF AWARDIIA-575.1 Notice of Award NotificationIIA-595.2 Associated Applications and/or AwardsIIA-595.3 FundingIIA-595.4 BudgetIIA-605.5 Additional Terms and ConditionsIIA-616 PAYMENTIIA-626.1 Smartlink II/ACHIIA-626.2 Cash RequestIIA-626.3 Interest Earned on Advances of Grant FundsIIA-636.4 Improper Payments Elimination and Recovery Improvement ActIIA-637 COST CONSIDERATIONIIA-647.1 GeneralIIA-647.2 The Cost PrinciplesIIA-647.3 Direct Costs and Facilities and Administrative CostsIIA-657.4 Reimbursement of Facilities and Administrative CostsIIA-667.5 Cost Transfers, Overruns, and Accelerated and Delayed ExpendituresIIA-697.6 Allocation of Costs and Closely Related WorkIIA-70vii

NIH Grants Policy Statement7.7 Applicable CreditsIIA-707.8 Services Pr