Instructions for phs 398 and sf 424(R&R) Form Approved Through 08/31/2015




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U.S. Department of Health and Human Services

Public Health Service

Supplemental Grant Application Instructions

Instructions for PHS 398 and SF 424(R&R) Form Approved Through 08/31/2015


Rev. 08/2012 OMB No. 0925-0001

Table of Contents

Part II. Supplemental Instructions for Preparing the Protection
of Human Subjects Section of the Research Plan


1. Introduction 1

2. Scenarios 1

3. Instructions for Preparing the Section on Protection of Human Subjects 3

4. Instructions Pertaining to Non-Exempt Human Subjects Research 8

4.1 Protection of Human Subjects 8

4.1.1 Risks to Human Subjects 8

4.1.2 Adequacy of Protection Against Risks 9

4.1.3 Potential Benefits of the Proposed Research to Human Subjects and Others 10

4.1.4 Importance of the Knowledge to be Gained 10

4.1.5 Data and Safety Monitoring Plan 10

4.1.6 ClinicalTrials.gov Requirements 11

4.2 Inclusion of Women and Minorities 12

4.2.1 Additional Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are Proposed 13

4.3 Instructions for Completing the Targeted/Planned Enrollment Tables for Reporting Race and Ethnicity Data for Subjects in Clinical Research 14

4.4 Inclusion of Children 15



5. Human Subjects Research Policy 16

5.1 Protection of Human Subjects 17

5.2 Vulnerable Populations 18

5.3 Data and Safety Monitoring Plans for Clinical Trials 18

5.4 IRB Approval 18

5.5 Required Education in the Protection of Human Research Participants 19

5.6 NIH Policy on the Inclusion of Women and Minorities in Clinical Research 19

5.7 NIH Policy on Inclusion of Children 19

5.8 NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research 20

5.9 Research on Transplantation of Human Fetal Tissue 21

5.10 Research Using Human Embryonic Stem Cells 21

5.11 ClinicalTrials.gov Requirements 21



1. Policy 1

1.1 Applications That Include Consortium/Contractual Facilities and Administrative Costs 1

1.2 Resubmission of Unpaid RFA Applications and Resubmission of Applications with a Changed Grant Activity Code 1

1.3 NIH Policy on Resubmission Applications 2

1.4 Policy on the Acceptance for Review of Unsolicited Applications That Request $500,000 or More in Direct Costs 3

1.5 Sharing Research Resources 4

1.5.1 Data Sharing Policy 4

1.5.2 Sharing Model Organism Policy 5

1.5.3 Policy for Genome-Wide Association Studies (GWAS) 5

1.6 Inventions and Patents 5

1.7 Just-In-Time Policy 5

1.8 Other Support 6

1.9 Graduate Student Compensation 10

1.10 DUNS Number & CCR Registration 11

1.11 Public Access Policy 11

1.12 PHS Metric Program 12

1.13 Transition to the SF424 (R&R) Application and Electronic Submission through Grants.gov 12

1.14 Multiple Program Director/Principal Investigator Policy 12

1.15 New, Including Early Stage, Investigators 13

1.16 Policy on Instruction in the Responsible Conduct of Research 13

1.17 Transparency Act Reporting 15

2. Assurances and Certifications 15

2.1 Human Subjects Research 16

2.1.1 Research on Transplantation of Human Fetal Tissue 17

2.1.2 Research Using Human Embryonic Stem Cells 18

2.1.3 NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research 18

2.1.4 NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research 18

2.1.5 NIH Policy on Inclusion of Children 19

2.1.6 ClinicalTrials.gov 19

2.2 Vertebrate Animals 19

2.3 Debarment and Suspension 20

2.4 Drug-Free Workplace 21

2.5 Lobbying 21

2.6 Non-Delinquency on Federal Debt 22

2.7 Research Misconduct 22

2.8 Assurance of Compliance (Civil Rights, Handicapped Individuals, Sex Discrimination, Age Discrimination) 23

2.9 Research Involving Recombinant DNA, including Human Gene Transfer Research 23

2.10 Financial Conflict of Interest 23

2.11 Smoke-Free Workplace 24

2.12 Prohibited Research 24

2.13 Select Agent Research 26

2.14 Program Director/Principal Investigator, Fellow and Sponsor Assurance 26

2.15 Impact of Grant Activities on the Environment and Historic Properties 27

2.16 Institutions Receiving Awards for Training of Graduate Students for Doctoral Degrees 28

2.17 Kirschstein-NRSA Payback Assurance 28

2.18 Small Business Concern SBIR Verification Statement 30

2.19 Small Business Concern STTR Verification Statement 31



3. Definitions 33

4. General Information 45

4.1 Research Grant Activity Codes 45

4.2 Mail Addressed to the National Institutes of Health 47

4.3 Government Use of Information Under Privacy Act 48

4.4 Information Available to the Program Director(s)/Principal Investigator(s) 48

4.5 Information Available to the General Public 48

4.6 Access to Research Data 49

5. SBIR/STTR Award Guidelines, Reporting Requirements, and Other Considerations 49

5.1. Awards 49

5.2. Terms and Conditions of Award 50

5.3 Payment Schedule 51

5.4 Reports 51

Federal Financial Report (FFR) (OMB 425) 52

Final Report Requirements 52

Progress Reports as Part of Non-Competing Continuation Requests (All Applications with Multiple Years) 53

Final Invention Statement and Certification (HHS 568) 53

Annual Utilization Report 54

Phase II Data Collection Requirement for Government Tech-Net Database 54

5.5 Innovations, Inventions and Patents 55

Limited Rights Information and Data 55

Research Tools/Unique Research Resources 57

5.6 Joint Ventures and Limited Partnerships 58

5.7 American-Made Equipment and Products 58

5.8 Profit or Fee 58

5.9 Additional Information 58

5.10 Cost Sharing 59

5.11 Audit Requirements of For-Profit Organizations 59

5.12 Time and Effort Reporting for Commercial Organizations 59


PART II

Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan


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