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NIH Grants Policy Statement (12/03) Index H-P -- File 2 of 3
H Handicapped individuals facility accessibility standards................................................................................................. 40, 148 nondiscrimination.......................................................................................................................... 68 Hazardous waste disposal, costs........................................................................................................ 91 Health and Human Services, Department of (HHS) points of contact.................................................................................................................. 258259 roles and responsibilities..................................................................................................... 16, 1718 Health and safety regulations and guidelines............................................................................. 40, 4849 Health insurance institutional allowance for............................................................................................................ 176 trainee 198 Health Insurance Portability and Accountability Act (HIPAA).................................................. 40, 5758 Historic properties and archeological sites, construction grants and................................................ 40, 146 Honoraria, costs................................................................................................................................ 91 Hospital, definition............................................................................................................................. 11 Hospital
cost principles...................................................................................................................... 79 Human embryo research, cloning, and transplantation requirements................................................ 5456 Human embryonic stem cell research........................................................................ 40, 5354, 184, 207 Human fetal tissue, research on.............................................................................................. 43, 5556 Human gene transfer research....................................................................................... 5152, 185, 207 Human intervention studies, data and safety monitoring............................................... 39, 6263, 183, 206 Human Research Protections, Office for.............................................................. 58, 59, 60, 61, 205, 225 Human subjects protection................................................................................................. 41, 42, 5861 data and safety monitoring.................................................................................... 39, 6263, 183, 206 education in.................................................................................................................................. 61 foreign grants...................................................................................................................... 229230 human subject, definition.......................................................................................................... 11, 59 individual fellowships................................................................................................................... 183 institutional research training grants....................................................................................... 205206 I Inclusiveness in research design, requirements for...................................... 6667, 183184, 206207, 230 Indemnification, costs........................................................................................................................ 92 Independent research and development costs........................................................................ 92, 238, 244 Indian tribal governments, cost principles for....................................................................................... 79 Indirect costs. Also see Facilities and administrative costs definition........................................................................................................................... 81n, 224n reimbursement.............................................................................................................................. 83 Individual fellowships about.......................................................................................................................................... 167 Activation Notice................................................................................................................. 173, 179 allowable/unallowable costs.................................................................................................. 174177 application........................................................................................................................... 170171 application receipt, review, and award schedule (exhibit)............................................................... 216 application review....................................................................................................................... 171 changes in project................................................................................................................ 180181 citizenship requirements....................................................................................................... 168169 compensation...................................................................................................................... 177178 concurrent benefits..................................................................................................................... 178 consecutive support..................................................................................................................... 180 copyright of material................................................................................................................... 182 degree requirements.................................................................................................................... 168 disposition of professional fees..................................................................................................... 183 educational loans or GI bill........................................................................................................... 178 eligibility.............................................................................................................................. 167168 employee benefits....................................................................................................................... 177 facilities and administrative costs................................................................................................... 83 Federal laboratories, training at............................................................................................. 174, 175 financial reporting....................................................................................................................... 180 foreign sponsorship/training abroad............................................................................................... 169 Form 1099.................................................................................................................................. 178 full-time and part-time training.............................................................................................. 172173 individuals on active military duty................................................................................................. 170 initiation of support............................................................................................................... 173174 institutional allowance.......................................................................................................... 175176 inventions and patents.......................................................................................................... 182183 leave.......................................................................................................................................... 181 NIH employees................................................................................................................... 169170 notification of action.................................................................................................................... 171 Payback Agreement............................................................................................................ 173, 179 payment.............................................................................................................................. 173174 period of support.................................................................................................................. 171172 progress reports.......................................................................................................................... 180 publication and sharing of research results.................................................................................... 182 reporting requirements......................................................................................................... 179180 sponsorship................................................................................................................................. 169 stipend supplementation............................................................................................................... 177 stipend taxability......................................................................................................................... 178 stipends and stipend levels.................................................................................................... 174175 taxability of stipends.................................................................................................................... 178 Termination Notice..................................................................................................................... 180 termination of award................................................................................................................... 182 transfers..................................................................................................................................... 180 travel to foreign training sites....................................................................................................... 177 tuition and fees........................................................................................................................... 176 Information availability requirements access to research data................................................................................................................. 71 acknowledgment of Federal funding.......................................................................................... 39, 69 Freedom of Information Act............................................................................................... 40, 7071 Privacy Act of 1974 and.......................................................................................................... 42, 72 Information resources, general..................................................................................................... 3031 Initiation of support individual fellowships............................................................................................................ 173174 institutional research training grants.............................................................................................. 196 Institutes and Centers........................................................................................................................ 16 center, definition........................................................................................................................... 11 institute, definition......................................................................................................................... 11 Institutional allowance, individual fellowships.............................................................................. 175176 Institutional Animal Care and Use Committee (IACUC), Institutional base salary, definition...................................................................................................... 11 Institutional Biosafety Committee (IBC)............................................................................................. 52 Institutional research training grants about.......................................................................................................................................... 185 allowable/unallowable costs.................................................................................................. 196199 application.................................................................................................................................. 190 application receipt, review, and award schedule (exhibit)............................................................... 216 application review................................................................................................................ 191194 carryover authority...................................................................................................................... 201 changes in the project.................................................................................................................. 203 citizenship requirements....................................................................................................... 188190 concurrent benefits..................................................................................................................... 200 copyright.................................................................................................................................... 205 degree requirements.................................................................................................................... 187 disposition of professional fees..................................................................................................... 205 educational loans or GI bill........................................................................................................... 200 eligibility.............................................................................................................................. 185186 employee benefits....................................................................................................................... 198 evaluation criteria................................................................................................................ 191192 facilities and administrative costs.................................................................................................. 199 financial status report.................................................................................................................. 203 Form 1099.................................................................................................................................. 201 health insurance.......................................................................................................................... 198 initiation of support...................................................................................................................... 196 inventions and patents................................................................................................................. 205 leave................................................................................................................................... 203204 minority recruitment plan...................................................................................................... 192193 notification of action.................................................................................................................... 194 Payback Agreement................................................................................................................... 202 period of support.................................................................................................................. 194196 prebaccalaureate training..................................................................................................... 188189 program income.......................................................................................................................... 201 progress reports................................................................................................................... 202203 public access to research data..................................................................................................... 205 publication and sharing of research results............................................................................. 204205 rebudgeting of funds.................................................................................................................... 199 reporting requirements......................................................................................................... 201203 short-term research training........................................................................................... 187188, 192 short-term training costs.............................................................................................................. 198 Statement of Appointment.................................................................................................... 201202 stipend supplementation............................................................................................................... 199 stipends and stipend levels........................................................................................................... 197 student compensation...................................................................................................... 99, 199200 taxability of stipends............................................................................................................. 200201 termination................................................................................................................................. 204 Termination Notice (Form PHS 416-7)......................................................................................... 202 travel costs................................................................................................................................. 198 tuition and fees........................................................................................................................... 198 training in responsible conduct of research............................................................................. 193194 training Program Director............................................................................................................ 186 training-related expenses............................................................................................................. 197 Institutional Review Boards (IRBs) financial conflict of interest and............................................................................................ 145 human subjects protection and.................................................................................... 6061, 205-206 Insurance. Also see specific types of insurance costs............................................................................................................................................ 92 real property........................................................................................................................ 165166 Intellectual
property................................................................................................... 113 conference materials................................................................................................................... 223 for-profit organizations......................................................................................................... 238239 individual
fellowships............................................................................................................ 182 institutional research training grants.............................................................................................. 205 Federal institutions...................................................................................................................... 237 SBIR and STTR programs.......................................................................................................... 245 Interest costs............................................................................................................................................ 92 earned on advances of grant funds................................................................................................. 78 Intergovernmental Review of Federal Programs (EO 12372)........................................................ 41, 147 International conference, definition................................................................................................... 220 International organization definition.......................................................................................................................... 11 facilities and administrative costs................................................................................................... 83 Inventions and patents. Also see Bayh-Dole Act of 1980 costs............................................................................................................................................ 92 extramural invention reporting compliance responsibilities (exhibit).......................................... 117119 Final Invention Statement and Certification................................................................................... 141 individual fellowships............................................................................................................ 182183 institutional research training grants.............................................................................................. 205 invention reporting............................................................................................................... 132133 royalties and licensing fees from.................................................................................................. 123 Investigational
new drug (INDs) applications/investigational device J Just-in-time procedures, in pre-award process............................................................................... 3233 K K awards facilities and administrative costs and............................................................................................. 83 prior-approval requirements for retention of funds.................................................................. 105, 112 Key personnel, definition................................................................................................................... 11 L Labor standards, construction grants.................................................................................... 41, 159161 Laboratory
Animal Welfare, Office of (OLAW).................................................................... 65 Leave costs............................................................................................................................................ 92 individual fellowships................................................................................................................... 181 institutional research training grants....................................................................................... 203204 Legal services, costs......................................................................................................................... 92 Library services, costs....................................................................................................................... 92 Licensing costs............................................................................................................................................ 92 fees from copyrights, inventions, and patents................................................................................. 123 Limited English proficiency, nondiscrimination................................................................................ 41, 69 Liquidated damages provisions, construction grants.................................................................... 159160 Lobbying........................................................................................................................ 41, 4950, 230 costs............................................................................................................................................ 93 M Management systems and procedures about.......................................................................................................................................... 120 assessment in pre-award process................................................................................................... 35 financial management system............................................................................................... 120121 program income................................................................................................................... 121123 procurement
system............................................................................................................. 126 property management system .............................................................................................. 123124 MARC U*STAR program................................................................................................ 188189, 200 Matching or cost sharing affiliated organization services, costs.................................................................................... 85 construction grants...................................................................................................................... 151 definition...................................................................................................................................... 12 Meals, costs..................................................................................................................................... 93 Metric system use requirements............................................................................................ 41, 72, 147 Military recruiting, access to institutions of higher learning......................................................... 41, 7273 Minorities contracting with minority-owned firms for goods and services........................................................ 128 inclusion as subjects in clinical research................................................... 41, 6667, 183184, 206, 230 recruitment plan, institutional research training grants............................................................. 192193 Misconduct. See Research misconduct Modernization, definition.................................................................................................................. 144 Modular applications and awards about.......................................................................................................................................... 217 application requirements....................................................................................................... 217218 application review and award............................................................................................... 218219 modular application, definition........................................................................................................ 12 post-award administration............................................................................................................ 219 Monitoring. Also see Reporting about.......................................................................................................................................... 128 audits.................................................................................................................................. 134136 data and safety monitoring requirements................................................................ 39, 6263, 183, 206 definition...................................................................................................................................... 12 record retention and access.................................................................................................. 133134 reporting............................................................................................................................. 129133 Moving, costs. See Recruitment costs; Relocation costs; Transportation of property Multiple Project Assurances (MPAs)............................................................................................... 59n N National Advisory Council or Board (Council) review.......................................................................... 29 National Environmental Policy Act of 1969 (NEPA).................................................................... 42, 145 National External Audit Review Center............................................................................................ 239 National Health Service Corps (NHSC) scholars, payback reporting requirements............................... 215 National Historic Preservation Act................................................................................................... 146 National Register of Historic Places................................................................................................. 146 New application (Type 1).................................................................................................................. 20 New investigator, definition................................................................................................................ 12 NIH Electronic Research Administration Commons (NIH eRA Commons).......................................... 30 NIH Guide for Grants and Contracts.............................................................................................. 30, iv NIH
Guidelines for Research Involving Recombinant NIH Loan Repayment Program................................................................................................ 200, 213 NIH
Policy and Guidelines on the Inclusion of Children as Participants NIH
Policy and Guidelines on the Inclusion of Women and Minorities as Subjects Non-Competing Grant Progress Report (PHS 2590) (Type 5)................................................ 20, 129130 Non-discrimination.......................................................................................................... 39, 6869, 230 Non-profit institutions, cost principles for............................................................................................ 79 Nondelinquency on Federal debt....................................................................................... 42, 5253, 230 Nondiscrimination.......................................................................................................... 6869, 167, 230 Nonexempt property, administrative requirements...................................................................... 125126 Nonsegregated facilities requirement, construction grants................................................................... 159 Notice of Grant Award (NGA) about........................................................................................................................................... 74 budget 76 definition...................................................................................................................................... 12 funding................................................................................................................................... 7475 terms
and conditions..................................................................................................... 35 Notification of action individual fellowships................................................................................................................... 171 institutional research training grants.............................................................................................. 194 Nursery items, costs.......................................................................................................................... 93 O Occupational Health and Safety Administration (OSHA), standards regulations.................................... 49 Organization, definition...................................................................................................................... 12 Other support, definition.................................................................................................................... 12 Overtime. See Salaries and wages P Parental leave individual fellowships................................................................................................................... 181 institutional research training grants.............................................................................................. 204 Patents. See Inventions and patents Patient records, confidentiality of.................................................................................................. 39, 57 Payback Agreement (Form PHS 6031) individual fellowships............................................................................................................ 173, 179 institutional research training grants.............................................................................................. 202 Payback reporting requirements about................................................................................................................................... 208, 209 Annual Payback Activities Certification................................................................................ 214215 breaks in support and.................................................................................................................. 215 certification of payback activities.......................................................................................... 214215 change of address....................................................................................................................... 215 definitions............................................................................................................................ 209 extension of payback................................................................................................................... 213 financial payback................................................................................................................. 212213 implementation.................................................................................................................... 208209 initiation of payback service......................................................................................................... 211 interest and interest rate calculation...................................................................................... 212213 National Health Service Corps scholars........................................................................................ 215 policy and principal calculation..................................................................................................... 212 service payback................................................................................................................... 210212 short-term training....................................................................................................................... 209 time commitment................................................................................................................. 210211 timing of service obligation........................................................................................................... 212 waiver................................................................................................................................ 213214 Payment about............................................................................................................................ 7677 cash requests.......................................................................................................................... 7778 CASHLINE/ACH........................................................................................................................ 77 foreign
institutions................................................................................................................ 230 individual fellowships............................................................................................................ 173174 interest earned on advances of grant funds..................................................................................... 78 SMARTLINK II/ACH................................................................................................................. 77 Payroll distribution, costs.............................................................................................................. 9798 Peer review process disposition of applications.............................................................................................................. 29 initial review criteria................................................................................................................ 2728 initial review responsibilities..................................................................................................... 2627 initial scientific review appeals................................................................................................. 2829 National Advisory Council or Board review.................................................................................... 29 Pension plan costs............................................................................................................................. 93 Period of support project period, general............................................................................................................. 74 individual fellowships............................................................................................................ 171172 institutional research training grants....................................................................................... 194196 Phase III clinical trial, definition......................................................................................................... 13 PHS Policy on Humane Care and Use of Laboratory Animals.................................................. 5666 Physical destruction insurance, construction grants............................................................................ 165 Postdoctoral training individual fellowship degree requirements..................................................................................... 168 institutional research training grant degree requirements................................................................ 187 payback obligations..................................................................................................................... 209 Pre-award process about........................................................................................................................................... 32 cost analysis................................................................................................................................. 35 costs..................................................................................................................................... 94, 105 eligibility................................................................................................................................. 3335 funding principles.......................................................................................................................... 33 just-in-time procedures............................................................................................................ 3233 management systems assessment.................................................................................................. 35 prior-approval requirements for costs........................................................................................... 105 Prebaccalaureate training, institutional research training grants.................................................... 188189 Predoctoral training individual fellowship degree requirements..................................................................................... 168 institutional research training grant degree requirements................................................................ 186 payback obligations..................................................................................................................... 209 Preservation
of Open Competition and Government Neutrality Towards Government Contractors' Principal Investigator (PI). Also see Program Director; Project Director definition...................................................................................................................................... 13 role and responsibilities............................................................................................................ 1819 Principles for Determining Costs Applicable to Research and Development under Grants and Contracts with Hospitals 79, 246 Prior-approval requests............................................................................................................ 112113 Prior-approval requirements about.. .......................................................................................................................... 105 additional NIH funding with extension............................................................................ 105, 106, 112 additional NIH funding without extension............................................................................... 105, 112 alteration and renovation projects under nonconstruction grants............................................... 161163 alterations and renovations.................................................................................................... 105, 106 capital expenditures.............................................................................................................. 105, 106 carryover of unobligated balances................................................................................................ 105 change in grantee organizational status.................................................................................. 110111 change in scope............................................................................................................ 105, 106107 change of grantee organization...................................................................................... 105, 108110 changes in status of PI and key personnel.............................................................................. 105, 107 construction grants...................................................................................................................... 161 deviation from award terms and conditions and NGA restrictions............................................ 105, 111 foreign component added to domestic organization grant......................................................... 105, 111 pre-award
costs.......................................................................................................................... 105 prior approval, definition................................................................................................................ 13 real property management standards..................................................................................... 163166 retention of funds when K award is made.............................................................................. 105, 112 transfer of amounts from trainee costs.................................................................................. 106, 112 transfer of funds between construction and nonconstruction work........................................... 106, 112 Priority score, definition..................................................................................................................... 13 Privacy Act of 1974............................................................................................................... 42, 69, 72 Pro-Children Act of 1994 requirements.................................................................................... 42, 6465 Procurement requirements construction grants............................................................................................................... 154156 in grants to Federal institutions..................................................................................................... 237 system
standards................................................................................................................. 126 Professional fees, disposition of individual fellowships................................................................................................................... 183 institutional research training grants.............................................................................................. 205 Profit. See Fee Program, definition............................................................................................................................ 13 Program
Director, definition............................................................................................................... 13 Program Fraud and Civil Remedies Act of 1986............................................................................ 25, 42 Program income................................................................................................................... 121-123 alternatives for use of........................................................................................................ 122 definition............................................................................................................................ 13 grants to for-profit organizations................................................................................................... 239 institutional research training grants.............................................................................................. 201 reporting..................................................................................................................................... 123 Program Official (PO) definition...................................................................................................................................... 13 role and responsibilities.................................................................................................................. 17 Progress Report for Continuation Support (Form PHS 416-9)............................................................. 180 Progress reports conference grants...................................................................................................... 223224 definition......................................................................................................................... 13 final progress report.......................................................................................................... 140 individual fellowships......................................................................................................... 180 institutional research training grants....................................................................................... 202203 requirements....................................................................................................................... 129131 Project
Director, definition................................................................................................................. 13 Project period, definition.................................................................................................................... 14 Property management system standards and procedures............................................................ 123124 Proprietary information...................................................................................................................... 25 Prudent Practices for Safety in Laboratories....................................................................................... 49 Public disclosure conference materials................................................................................................................... 223 environmental impact requirements in construction grants.................................................. 42, 145146 Public Health Security and Bioterrorism Preparedness and Response Act of 2002........................... 42, 48 Public policy requirements and objectives...................................................................................... 3643 animal welfare.............................................................................................. 39, 6566, 185, 207, 229 civil rights........................................................................................................................ 6869, 230 conference grants....................................................................................................................... 220 consortium agreements........................................................................................................ 225226 construction grants............................................................................................................... 145148 determining applicability/inclusion (exhibit)................................................................................ 3943 facilities acquisition, alteration and renovation, and construction requirements.................................... 69 grants
for foreign institutions, international organizations, inclusiveness in research design requirements.................................................................... 6667, 230 individual fellowships............................................................................................................ 183185 information availability requirements......................................................................................... 6972 institutional research training grants....................................................................................... 205206 metric system use requirements......................................................................................... 41, 72, 147 military
recruiting and ROTC program access to institutions of higher SBIR and STTR programs.......................................................................................................... 243 Public relations costs......................................................................................................................... 94 Publications costs............................................................................................................................................ 94 information resources.............................................................................................................. 3031 Publishing and copyrighting data conference materials................................................................................................................... 223 individual fellowship research results............................................................................................ 182 institutional research training grants research results.............................................................. 204205 rights.. .............................................................................................................................. 114115 [ Click "Next Document" below to Continue ]
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