U.S. Department of Health and Human Services

1、U.S. Department of Health and Human ServicesPublic Health ServiceGrant Application (PHS 398)Instructions for PHS 398Form Approved Through 06/30/2012Rev. 06/2009OMB No. 0925-0001Table of Contents HYPERLINK l PartI Part I.Instructions for Preparing and Submitting an Application TOC h z t Heading 1,1,H

2、eading 2,2,Heading 3,3,Table Heading,4,Heading 5 - TOC,4 HYPERLINK l _Toc277090943 1.ForewordI- PAGEREF _Toc277090943 h 1 HYPERLINK l _Toc277090944 1.1Application Guide FormatI- PAGEREF _Toc277090944 h 2 HYPERLINK l _Toc277090945 1.2NIH Extramural Research and Research Training ProgramsI- PAGEREF _T

3、oc277090945 h 3 HYPERLINK l _Toc277090946 1.3Research Grant Programs and Program GuidelinesI- PAGEREF _Toc277090946 h 3 HYPERLINK l _Toc277090947 1.4Interactions with PHS StaffI- PAGEREF _Toc277090947 h 4 HYPERLINK l _Toc277090948 1.5Grants Policy StatementsI- PAGEREF _Toc277090948 h 7 HYPERLINK l _

4、Toc277090949 1.6ReferencesI- PAGEREF _Toc277090949 h 7 HYPERLINK l _Toc277090950 1.7AuthorizationI- PAGEREF _Toc277090950 h 8 HYPERLINK l _Toc277090951 1.7.1Collection of Personal Demographic DataI- PAGEREF _Toc277090951 h 8 HYPERLINK l _Toc277090952 1.8Paperwork BurdenI- PAGEREF _Toc277090952 h 9 H

5、YPERLINK l _Toc277090953 2.General InstructionsI- PAGEREF _Toc277090953 h 9 HYPERLINK l _Toc277090954 2.1IntroductionI- PAGEREF _Toc277090954 h 9 HYPERLINK l _Toc277090955 2.2Registration ProcessesI- PAGEREF _Toc277090955 h 10 HYPERLINK l _Toc277090956 2.2.1(Reserved)I- PAGEREF _Toc277090956 h 10 HY

6、PERLINK l _Toc277090957 2.2.2DUNS Registration for the Applicant Organization & Subaward/Consortium OrganizationsI- PAGEREF _Toc277090957 h 10 HYPERLINK l _Toc277090958 2.2.3Central Contractor Registration (CCR) for the Applicant OrganizationI- PAGEREF _Toc277090958 h 10 HYPERLINK l _Toc277090959 2.

7、2.4eRA Commons RegistrationI- PAGEREF _Toc277090959 h 11 HYPERLINK l _Toc277090960 2.3(Reserved)I- PAGEREF _Toc277090960 h 12 HYPERLINK l _Toc277090961 2.4Funding OpportunitiesI- PAGEREF _Toc277090961 h 12 HYPERLINK l _Toc277090962 2.4.1NIH Guide for Grants and ContractsI- PAGEREF _Toc277090962 h 12

8、 HYPERLINK l _Toc277090963 2.4.2Funding Opportunity Announcements (FOAs)I- PAGEREF _Toc277090963 h 13 HYPERLINK l _Toc277090964 2.5(Reserved)I- PAGEREF _Toc277090964 h 13 HYPERLINK l _Toc277090965 2.6Format SpecificationsI- PAGEREF _Toc277090965 h 13 HYPERLINK l _Toc277090966 2.7Resubmission Applica

9、tionsI- PAGEREF _Toc277090966 h 15 HYPERLINK l _Toc277090967 2.8Revision ApplicationI- PAGEREF _Toc277090967 h 17 HYPERLINK l _Toc277090968 2.9Similar, Essentially Identical, or Identical ApplicationsI- PAGEREF _Toc277090968 h 17 HYPERLINK l _Toc277090969 2.10(Reserved)I- PAGEREF _Toc277090969 h 18

10、HYPERLINK l _Toc277090970 2.11(Reserved)I- PAGEREF _Toc277090970 h 18 HYPERLINK l _Toc277090971 2.12(Reserved)I- PAGEREF _Toc277090971 h 18 HYPERLINK l _Toc277090972 2.13Post-Submission of Application MaterialsI- PAGEREF _Toc277090972 h 18 HYPERLINK l _Toc277090973 2.14Application Submission DatesI-

11、 PAGEREF _Toc277090973 h 19 HYPERLINK l _Toc277090974 2.15Submission, Review and Award CyclesI- PAGEREF _Toc277090974 h 20 HYPERLINK l _Toc277090975 2.16Resources for Finding HelpI- PAGEREF _Toc277090975 h 21 HYPERLINK l _Toc277090976 2.16.1(Reserved)I- PAGEREF _Toc277090976 h 21 HYPERLINK l _Toc277

12、090977 2.16.2Finding Help for the eRA Commons RegistrationI- PAGEREF _Toc277090977 h 21 HYPERLINK l _Toc277090978 2.16.3Finding Help for Application PreparationI- PAGEREF _Toc277090978 h 21 HYPERLINK l _Toc277090979 3.Submission of the Grant ApplicationI- PAGEREF _Toc277090979 h 22 HYPERLINK l _Toc2

13、77090980 3.1Cover LetterI- PAGEREF _Toc277090980 h 22 HYPERLINK l _Toc277090981 3.2Number of CopiesI- PAGEREF _Toc277090981 h 23 HYPERLINK l _Toc277090982 3.3Bindings and PackagingI- PAGEREF _Toc277090982 h 23 HYPERLINK l _Toc277090983 3.4Application Mailing AddressI- PAGEREF _Toc277090983 h 24 HYPE

14、RLINK l _Toc277090984 4.Completing the PHS 398 Forms and Format PagesI- PAGEREF _Toc277090984 h 24 HYPERLINK l _Toc277090985 4.1Face PageI- PAGEREF _Toc277090985 h 25 HYPERLINK l _Toc277090986 4.2Description, Project/Performance Sites, Senior/key Personnel, Other Significant Contributors, and Human

15、Embryonic Stem CellsI- PAGEREF _Toc277090986 h 31 HYPERLINK l _Toc277090987 4.2.1Description: Project Summary and RelevanceI- PAGEREF _Toc277090987 h 31 HYPERLINK l _Toc277090988 4.2.2Project/Performance Site(s)I- PAGEREF _Toc277090988 h 32 HYPERLINK l _Toc277090989 4.2.3Senior/key PersonnelI- PAGER

16、EF _Toc277090989 h 32 HYPERLINK l _Toc277090990 4.2.4Other Significant ContributorsI- PAGEREF _Toc277090990 h 32 HYPERLINK l _Toc277090991 4.2.5Human Embryonic Stem CellsI- PAGEREF _Toc277090991 h 33 HYPERLINK l _Toc277090992 4.3Research Grant Table of ContentsI- PAGEREF _Toc277090992 h 33 HYPERLINK

17、 l _Toc277090993 4.4Budget InstructionsI- PAGEREF _Toc277090993 h 33 HYPERLINK l _Toc277090994 4.5Budget for Entire Proposed Period of SupportI- PAGEREF _Toc277090994 h 36 HYPERLINK l _Toc277090995 4.6Biographical SketchI- PAGEREF _Toc277090995 h 36 HYPERLINK l _Toc277090996 4.6.1Other Support Infor

18、mationI- PAGEREF _Toc277090996 h 38 HYPERLINK l _Toc277090997 4.7ResourcesI- PAGEREF _Toc277090997 h 39 HYPERLINK l _Toc277090998 4.8All Personnel ReportI- PAGEREF _Toc277090998 h 39 HYPERLINK l _Toc277090999 5.Preparing the Research Plan, the Checklist, and the AppendixI- PAGEREF _Toc277090999 h 41

19、 HYPERLINK l _Toc277091000 5.1(Reserved)I- PAGEREF _Toc277091000 h 41 HYPERLINK l _Toc277091001 5.2(Reserved)I- PAGEREF _Toc277091001 h 41 HYPERLINK l _Toc277091002 5.3(Reserved)I- PAGEREF _Toc277091002 h 41 HYPERLINK l _Toc277091003 5.4Research Plan Format and Notice of Proprietary InformationI- PA

20、GEREF _Toc277091003 h 41 HYPERLINK l _Toc277091004 5.4.1Research Plan FormatI- PAGEREF _Toc277091004 h 41 HYPERLINK l _Toc277091005 5.4.2Notice of Proprietary InformationI- PAGEREF _Toc277091005 h 41 HYPERLINK l _Toc277091006 5.5Content of Research PlanI- PAGEREF _Toc277091006 h 42 HYPERLINK l _Toc2

21、77091007 5.5.1Introduction (Resubmission or Revision Applications only)I- PAGEREF _Toc277091007 h 43 HYPERLINK l _Toc277091008 5.5.2Specific AimsI- PAGEREF _Toc277091008 h 43 HYPERLINK l _Toc277091009 5.5.3Research StrategyI- PAGEREF _Toc277091009 h 43 HYPERLINK l _Toc277091010 5.5.4Inclusion Enroll

22、ment Report (Renewal or Revision Applications only)I- PAGEREF _Toc277091010 h 44 HYPERLINK l _Toc277091011 5.5.5Bibliography and References Cited/Progress Report Publication ListI- PAGEREF _Toc277091011 h 44 HYPERLINK l _Toc277091012 5.5.6Protection of Human SubjectsI- PAGEREF _Toc277091012 h 45 HYP

23、ERLINK l _Toc277091013 5.5.7Inclusion of Women and MinoritiesI- PAGEREF _Toc277091013 h 45 HYPERLINK l _Toc277091014 5.5.8Targeted/Planned Enrollment TableI- PAGEREF _Toc277091014 h 45 HYPERLINK l _Toc277091015 5.5.9Inclusion of ChildrenI- PAGEREF _Toc277091015 h 45 HYPERLINK l _Toc277091016 5.5.10V

24、ertebrate AnimalsI- PAGEREF _Toc277091016 h 45 HYPERLINK l _Toc277091017 5.5.11Select Agent ResearchI- PAGEREF _Toc277091017 h 46 HYPERLINK l _Toc277091018 5.5.12Multiple Project Director/Principal Investigator (PD/PI) Leadership PlanI- PAGEREF _Toc277091018 h 47 HYPERLINK l _Toc277091019 5.5.13Cons

25、ortium/Contractual ArrangementsI- PAGEREF _Toc277091019 h 47 HYPERLINK l _Toc277091020 5.5.14Letters of Support (e.g., Consultants)I- PAGEREF _Toc277091020 h 47 HYPERLINK l _Toc277091021 5.5.15Resource Sharing Plan(s)I- PAGEREF _Toc277091021 h 48 HYPERLINK l _Toc277091022 5.6ChecklistI- PAGEREF _Toc

26、277091022 h 48 HYPERLINK l _Toc277091023 5.7AppendixI- PAGEREF _Toc277091023 h 49 HYPERLINK l _Toc277091024 6.The Peer Review ProcessI- PAGEREF _Toc277091024 h 50 HYPERLINK l Human_Subjects_PartII Part II.Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Researc

27、h Plan HYPERLINK l _Toc277091025 1.IntroductionII- PAGEREF _Toc277091025 h 1 HYPERLINK l _Toc277091026 2.ScenariosII- PAGEREF _Toc277091026 h 1 HYPERLINK l _Toc277091027 3.Instructions for Preparing the Section on Protection of Human SubjectsII- PAGEREF _Toc277091027 h 3 HYPERLINK l _Toc277091028 4.

28、Instructions Pertaining to Non-Exempt Human Subjects ResearchII- PAGEREF _Toc277091028 h 7 HYPERLINK l _Toc277091029 4.1Protection of Human SubjectsII- PAGEREF _Toc277091029 h 7 HYPERLINK l _Toc277091030 4.1.1Risks to Human SubjectsII- PAGEREF _Toc277091030 h 7 HYPERLINK l _Toc277091031 4.1.2Adequac

29、y of Protection Against RisksII- PAGEREF _Toc277091031 h 8 HYPERLINK l _Toc277091032 4.1.3Potential Benefits of the Proposed Research to Human Subjects and OthersII- PAGEREF _Toc277091032 h 9 HYPERLINK l _Toc277091033 4.1.4Importance of the Knowledge to be GainedII- PAGEREF _Toc277091033 h 9 HYPERLI

30、NK l _Toc277091034 4.1.5Data and Safety Monitoring PlanII- PAGEREF _Toc277091034 h 9 HYPERLINK l _Toc277091035 4.1.6ClinicalT RequirementsII- PAGEREF _Toc277091035 h 10 HYPERLINK l _Toc277091036 4.2Inclusion of Women and MinoritiesII- PAGEREF _Toc277091036 h 11 HYPERLINK l _Toc277091037 4.2.1Additio

31、nal Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are ProposedII- PAGEREF _Toc277091037 h 13 HYPERLINK l _Toc277091038 4.3Instructions for Completing the Targeted/Planned Enrollment Tables for Reporting Race and Ethnicity Data for Subjects in Clinical ResearchII- PAGEREF _

32、Toc277091038 h 13 HYPERLINK l _Toc277091039 4.4Inclusion of ChildrenII- PAGEREF _Toc277091039 h 15 HYPERLINK l _Toc277091040 5.Human Subjects Research PolicyII- PAGEREF _Toc277091040 h 16 HYPERLINK l _Toc277091041 5.1Protection of Human SubjectsII- PAGEREF _Toc277091041 h 16 HYPERLINK l _Toc27709104

33、2 5.2Vulnerable PopulationsII- PAGEREF _Toc277091042 h 17 HYPERLINK l _Toc277091043 5.3Data and Safety Monitoring Plans for Clinical TrialsII- PAGEREF _Toc277091043 h 17 HYPERLINK l _Toc277091044 5.4IRB ApprovalII- PAGEREF _Toc277091044 h 18 HYPERLINK l _Toc277091045 5.5Required Education in the Pro

34、tection of Human Research ParticipantsII- PAGEREF _Toc277091045 h 18 HYPERLINK l _Toc277091046 5.6NIH Policy on the Inclusion of Women and Minorities in Clinical ResearchII- PAGEREF _Toc277091046 h 19 HYPERLINK l _Toc277091047 5.7NIH Policy on Inclusion of ChildrenII- PAGEREF _Toc277091047 h 19 HYPE

35、RLINK l _Toc277091048 5.8NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical ResearchII- PAGEREF _Toc277091048 h 19 HYPERLINK l _Toc277091049 5.9Research on Transplantation of Human Fetal TissueII- PAGEREF _Toc277091049 h 21 HYPERLINK l _Toc277091050 5.10Research Using Human Embryo

36、nic Stem CellsII- PAGEREF _Toc277091050 h 21 HYPERLINK l _Toc277091051 5.11ClinicalT RequirementsII- PAGEREF _Toc277091051 h 21 HYPERLINK l Policy_PartIII Part III.Policies, Assurances, Definitions, and Other Information HYPERLINK l _Toc277091052 1.PolicyIII- PAGEREF _Toc277091052 h 1 HYPERLINK l _T

37、oc277091053 1.1Applications That Include Consortium/Contractual Facilities and Administrative CostsIII- PAGEREF _Toc277091053 h 1 HYPERLINK l _Toc277091054 1.2Resubmission of Unpaid RFA Applications and Resubmission of Applications with a Changed Grant Activity CodeIII- PAGEREF _Toc277091054 h 1 HYP

38、ERLINK l _Toc277091055 1.3NIH Policy on Resubmission ApplicationsIII- PAGEREF _Toc277091055 h 2 HYPERLINK l _Toc277091056 1.4Policy on the Acceptance for Review of Unsolicited Applications That Request $500,000 or More in Direct CostsIII- PAGEREF _Toc277091056 h 3 HYPERLINK l _Toc277091057 1.5Sharin

39、g Research ResourcesIII- PAGEREF _Toc277091057 h 4 HYPERLINK l _Toc277091058 1.5.1Data Sharing PolicyIII- PAGEREF _Toc277091058 h 4 HYPERLINK l _Toc277091059 1.5.2Sharing Model Organism PolicyIII- PAGEREF _Toc277091059 h 5 HYPERLINK l _Toc277091060 1.5.3Policy for Genome-Wide Association Studies (GW

40、AS)III- PAGEREF _Toc277091060 h 5 HYPERLINK l _Toc277091061 1.6Inventions and PatentsIII- PAGEREF _Toc277091061 h 5 HYPERLINK l _Toc277091062 1.7Just-In-Time PolicyIII- PAGEREF _Toc277091062 h 5 HYPERLINK l _Toc277091063 1.8Other SupportIII- PAGEREF _Toc277091063 h 6 HYPERLINK l _Toc277091064 1.9Gra

41、duate Student CompensationIII- PAGEREF _Toc277091064 h 7 HYPERLINK l _Toc277091065 1.10DUNS Number & CCR RegistrationIII- PAGEREF _Toc277091065 h 8 HYPERLINK l _Toc277091066 1.11Public Access PolicyIII- PAGEREF _Toc277091066 h 9 HYPERLINK l _Toc277091067 1.12PHS Metric ProgramIII- PAGEREF _Toc277091

42、067 h 9 HYPERLINK l _Toc277091068 1.13Transition to the SF424 (R&R) Application and Electronic Submission through GIII- PAGEREF _Toc277091068 h 9 HYPERLINK l _Toc277091069 1.14Multiple Program Director/Principal Investigator PolicyIII- PAGEREF _Toc277091069 h 9 HYPERLINK l _Toc277091070 1.15New, Inc

43、luding Early Stage, InvestigatorsIII- PAGEREF _Toc277091070 h 10 HYPERLINK l _Toc277091071 1.16(Reserved)III- PAGEREF _Toc277091071 h 10 HYPERLINK l _Toc277091072 1.17Transparency Act ReportingIII- PAGEREF _Toc277091072 h 10 HYPERLINK l _Toc277091073 2.Assurances and CertificationsIII- PAGEREF _Toc2

44、77091073 h 10 HYPERLINK l _Toc277091074 2.1Human Subjects ResearchIII- PAGEREF _Toc277091074 h 11 HYPERLINK l _Toc277091075 2.1.1 Research on Transplantation of Human Fetal TissueIII- PAGEREF _Toc277091075 h 12 HYPERLINK l _Toc277091076 2.1.2 Research Using Human Embryonic Stem CellsIII- PAGEREF _To

45、c277091076 h 13 HYPERLINK l _Toc277091077 2.1.3NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical ResearchIII- PAGEREF _Toc277091077 h 13 HYPERLINK l _Toc277091078 2.1.4NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical ResearchIII- PAGEREF _Toc277091078 h

46、 13 HYPERLINK l _Toc277091079 2.1.5NIH Policy on Inclusion of ChildrenIII- PAGEREF _Toc277091079 h 14 HYPERLINK l _Toc277091080 2.1.6ClinicalTIII- PAGEREF _Toc277091080 h 14 HYPERLINK l _Toc277091081 2.2Vertebrate AnimalsIII- PAGEREF _Toc277091081 h 15 HYPERLINK l _Toc277091082 2.3Debarment and Susp

47、ensionIII- PAGEREF _Toc277091082 h 16 HYPERLINK l _Toc277091083 2.4Drug-Free WorkplaceIII- PAGEREF _Toc277091083 h 16 HYPERLINK l _Toc277091084 2.5LobbyingIII- PAGEREF _Toc277091084 h 16 HYPERLINK l _Toc277091085 2.6Non-Delinquency on Federal DebtIII- PAGEREF _Toc277091085 h 17 HYPERLINK l _Toc27709

48、1086 2.7Research MisconductIII- PAGEREF _Toc277091086 h 17 HYPERLINK l _Toc277091087 2.8Assurance of Compliance (Civil Rights, Handicapped Individuals, Sex Discrimination, Age Discrimination)III- PAGEREF _Toc277091087 h 18 HYPERLINK l _Toc277091088 2.9Research Involving Recombinant DNA, including Hu

49、man Gene Transfer ResearchIII- PAGEREF _Toc277091088 h 18 HYPERLINK l _Toc277091089 2.10Financial Conflict of InterestIII- PAGEREF _Toc277091089 h 19 HYPERLINK l _Toc277091090 2.11Smoke-Free WorkplaceIII- PAGEREF _Toc277091090 h 19 HYPERLINK l _Toc277091091 2.12Prohibited ResearchIII- PAGEREF _Toc27

50、7091091 h 20 HYPERLINK l _Toc277091092 2.13Select Agent ResearchIII- PAGEREF _Toc277091092 h 20 HYPERLINK l _Toc277091093 2.14Program Director/Principal Investigator AssuranceIII- PAGEREF _Toc277091093 h 21 HYPERLINK l _Toc277091094 2.15Impact of Grant Activities on the Environment and Historic Prop

51、ertiesIII- PAGEREF _Toc277091094 h 21 HYPERLINK l _Toc277091095 2.16Institutions Receiving Awards for Training of Graduate Students for Doctoral DegreesIII- PAGEREF _Toc277091095 h 22 HYPERLINK l _Toc277091096 3.DefinitionsIII- PAGEREF _Toc277091096 h 23 HYPERLINK l _Toc277091097 4.General Informati

52、onIII- PAGEREF _Toc277091097 h 33 HYPERLINK l _Toc277091098 4.1Research Grant Activity CodesIII- PAGEREF _Toc277091098 h 33 HYPERLINK l _Toc277091099 4.2Mail Addressed to the National Institutes of HealthIII- PAGEREF _Toc277091099 h 35 HYPERLINK l _Toc277091100 4.3Government Use of Information Under

53、 Privacy ActIII- PAGEREF _Toc277091100 h 36 HYPERLINK l _Toc277091101 4.4Information Available to the Program Director(s)/Principal Investigator(s)III- PAGEREF _Toc277091101 h 36 HYPERLINK l _Toc277091102 4.5Information Available to the General PublicIII- PAGEREF _Toc277091102 h 37 HYPERLINK l _Toc2

54、77091103 4.6Access to Research DataIII- PAGEREF _Toc277091103 h 37 PART IInstructions for Preparing and Submittingan Application1.ForewordThe PHS 398 instructions contain information for preparing grant applications to the National Institutes of Health (NIH) and other Public Health Service agencies.

55、Applicants to PHS agencies other than NIH should contact the agency using the PHS Agency Contacts Table in 1.4 below because some awarding components have application requirements that differ from those for NIH.NIH continues to transition grant activity codes from the PHS 398 to the SF424 (R&R) and

56、electronic submission through G. This PHS 398 is required for all grant activity codes that have not transitioned to the SF424 (R&R), including Resubmission, Renewal, Revision, changes of grantee institution, and cooperative agreement applications. Once an activity code has transitioned to electroni

57、c submission the applicant must apply through G using the SF424 (R&R) and electronic PHS 398 components that are provided as part of the electronic application forms. For more information on NIHs transition plans, including a timeline for the transition of various activity codes, see the website for

58、 Electronic Submission of Grant Applications: HYPERLINK :/grants/ElectronicReceipt/ t _blank :/grants/ElectronicReceipt/.Bookmark this website ( HYPERLINK :/grants/funding/phs398/phs398.html :/grants/funding/phs398/phs398.html) for easy electronic access to this document.Policy ChangesThese instruct

59、ions incorporate numerous clarifications, updates and policy announcements that have appeared in the NIH Guide for Grants and Contracts since the 11/2007 revision of the PHS 398 application. Since the Guide also publishes multiple funding opportunity announcements, the Office of Extramural Research

60、posts Policy Notices, clarifications and other updates on this webpage: HYPERLINK :/grants/policy/notices.htm o :/grants/policy/notices.htm t _blankNIH Policy Notices. Applicants are expected to be aware of any relevant Notices that appear in the Guide.Substantive changes to instructions and form pa