Transcription of Supplemental Grant Application Instructions
1 Updated 03/2016 Supplemental Grant Application Instructions For All Competing Applications and Progress Reports Form Approved Through 10/31/2018 OMB No. 0925-0001 and OMB No. 0925-0002 ii table OF CONTENTS PART II Supplemental Instructions FOR PREPARING THE PROTECTION OF HUMAN SUBJECTS SECTION OF THE RESEARCH PLAN, AND HUMAN SUBJECTS RESEARCH POLICY table of Contents .. i 1. Introduction .. II-1 2. Scenarios .. II-1 Scenario A. No Human Subjects Research .. II-1 Scenario B. Non-Exempt Human Subjects Research .. II-1 Scenario C. Exempt Human Subjects Research .. II-2 Scenario D.
2 Delayed-Onset Human Subjects Research .. II-2 Scenario E. Human Subjects Research Involving a Clinical Trial .. II-2 Scenario F. Human Subjects Research Involving an NIH-Defined Phase III Clinical Trial .. II-3 Scenario A. No Human Subjects Research Proposed .. II-3 Scenario B. Non-Exempt Human Subjects Research .. II-4 Scenario C: Human Subjects Research Claiming Exemption 1, 2, 3, 4, 5, or 6 .. II-4 Scenario D: Delayed-Onset Human Subjects Research .. II-5 Scenario E: Clinical Trial (Not NIH-defined Phase III Clinical Trial) .. II-6 Scenario F: NIH Defined Phase III Clinical Trial.
3 II-7 4. Instructions Pertaining to Non-Exempt Human Subjects Research .. II-8 Protection of Human Subjects .. II-8 Risks to Human Subjects .. II-8 Adequacy of Protection Against Risks .. II-9 Potential Benefits of the Proposed Research to Human Subjects and Others .. II-10 Importance of the Knowledge to be Gained .. II-10 Data and Safety Monitoring Plan .. II-10 Requirements .. II-11 Inclusion of Women and Minorities .. II-12 Additional Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are Proposed .. II-13 Instructions for Completing the PHS Inclusion Enrollment Report(s) for Sex/Gender, Race, and Ethnicity.
4 II-14 Inclusion of Children .. II-15 5. Human Subjects Research Policy .. II-17 Protection of Human Subjects .. II-17 Research Involving the Use of Newborn Blood Spots .. II-18 Vulnerable Populations .. II-18 Data and Safety Monitoring Plans for Clinical Trials .. II-19 IRB II-19 iii Required Education in the Protection of Human Research Participants .. II-20 NIH Policy on the Inclusion of Women and Minorities in Clinical Research .. II-20 NIH Policy on Reporting Race and Ethnicity Data for: Subjects in Clinical Research .. II-21 NIH Policy on Inclusion of Children.
5 II-22 Research on Transplantation of Human Fetal Tissue .. II-22 Research Using Human Embryonic Stem Cells .. II-22 Requirements .. II-22 PART III POLICIES, ASSURANCES, DEFINITIONS, AND OTHER INFORMATION 1. Policy .. III-1 Applications That Include Consortium/Contractual Facilities and Administrative Costs .. III-1 Resubmission of Unfunded RFA Applications .. III-1 NIH Policy on Resubmission Applications .. III-2 Policy on the Acceptance for Review of Unsolicited Applications That Request $500,000 or More in Direct Costs .. III-2 Sharing Research Resources.
6 III-3 Data Sharing Policy .. III-3 Sharing Model Organism Policy .. III-4 NIH Genomic Data Sharing (GDS) Policy .. III-4 Inventions and Patents .. III-5 Just-In-Time Policy .. III-5 Other III-6 Graduate Student Compensation .. III-14 DUNS Number & SAM Registration .. III-14 Public Access Policy .. III-15 PHS Metric Program .. III-16 Transition to the SF424 (R&R) Application and Electronic Submission through Multiple Program Director/Principal Investigator Policy .. III-16 New, Including Early Stage, Investigators .. III-16 Policy on Instruction in the Responsible Conduct of Research.
7 III-17 Transparency Act Reporting .. III-19 Encouragement for Institutions to Develop Individual Development Plans for Graduate Students and Postdoctoral Researchers .. III-19 Recruitment and Retention Plan to Enhance Diversity .. III-19 2. Assurances and Certifications .. III-20 Human Subjects Research .. III-20 Vertebrate Animals .. III-21 Research Involving Chimpanzees .. III-22 Debarment and Suspension .. III-22 Drug-Free Workplace .. III-23 Lobbying .. III-23 Non-Delinquency on Federal Debt .. III-24 iv Research Misconduct .. III-25 Assurance of Compliance (Civil Rights, Handicapped Individuals, Sex Discrimination, Age Discrimination).
8 III-25 Limited English Proficiency .. III-26 Research Involving Recombinant or Synthetic Nucleic Acid Molecules, including Human Gene Transfer Research .. III-26 Financial Conflict of Interest .. III-26 Smoke-Free Workplace .. III-28 Prohibited Research .. III-28 Select Agent Research .. III-29 Dual Use Research of Concern .. III-30 Program Director/Principal Investigator, Fellow and Sponsor Assurance .. III-31 Impact of Grant Activities on the Environment and Historic Properties .. III-31 Institutions Receiving Awards for Training of Graduate Students for Doctoral Degrees.
9 III-32 Kirschstein-NRSA Payback Assurance .. III-33 SBIR Funding Agreement Certification .. III-34 STTR Funding Agreement Certification .. III-36 Small Business Concern SBIR VCOC Certification Statement .. III-38 3. Definitions .. III-40 4. General Information .. III-58 Research Grant Activity Codes .. III-58 Mail Addressed to the National Institutes of Health .. III-60 Government Use of Information Under Privacy Act .. III-61 Information Available to the Program Director(s)/Principal Investigator(s) .. III-61 Information Available to the General Public .. III-61 Access to Research Data.
10 III-62 5. SBIR/STTR Award Guidelines, Reporting Requirements, and Other Considerations .. III-62 Awards and Cost Principles .. III-62 Terms and Conditions of Award .. III-62 Payment Schedule .. III-63 Reports .. III-64 Reporting Requirements Specific to SBIR/STTR Grants .. III-65 Innovations, Inventions and Patents .. III-65 Limited Rights Information and Data .. III-66 Research Tools/Unique Research Resources .. III-68 Joint Ventures and Limited Partnerships .. III-68 American-Made Equipment and Products .. III-68 Profit or Fee .. III-69 Audit Requirements of For-Profit Organizations.
