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ARCHIVED - NIH Grants Policy Statement (10/03)


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.................................................................................................................. 258–259

roles and responsibilities..................................................................................................... 16, 17–18

Health and safety regulations and guidelines............................................................................. 40, 48–49

Health insurance

institutional allowance for............................................................................................................ 176

trainee 198

Health Insurance Portability and Accountability Act (HIPAA).................................................. 40, 57–58

Historic properties and archeological sites, construction grants and................................................ 40, 146

Honoraria, costs................................................................................................................................ 91

Hospital, definition............................................................................................................................. 11

Hospital cost principles...................................................................................................................... 79
Also see Research patient care costs

Human embryo research, cloning, and transplantation requirements................................................ 54–56

Human embryonic stem cell research........................................................................ 40, 53–54, 184, 207

Human fetal tissue, research on.............................................................................................. 43, 55–56

Human gene transfer research....................................................................................... 51–52, 185, 207

Human intervention studies, data and safety monitoring............................................... 39, 62–63, 183, 206

Human Research Protections, Office for.............................................................. 58, 59, 60, 61, 205, 225

Human subjects protection................................................................................................. 41, 42, 58–61

data and safety monitoring.................................................................................... 39, 62–63, 183, 206

education in.................................................................................................................................. 61

foreign grants...................................................................................................................... 229–230

human subject, definition.......................................................................................................... 11, 59

individual fellowships................................................................................................................... 183

institutional research training grants....................................................................................... 205–206

I

Inclusiveness in research design, requirements for...................................... 66–67, 183–184, 206–207, 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.................................................................................................. 174–177

application........................................................................................................................... 170–171

application receipt, review, and award schedule (exhibit)............................................................... 216

application review....................................................................................................................... 171

changes in project................................................................................................................ 180–181

citizenship requirements....................................................................................................... 168–169

compensation...................................................................................................................... 177–178

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.............................................................................................................................. 167–168

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.............................................................................................. 172–173

individuals on active military duty................................................................................................. 170

initiation of support............................................................................................................... 173–174

institutional allowance.......................................................................................................... 175–176

inventions and patents.......................................................................................................... 182–183

leave.......................................................................................................................................... 181

NIH employees................................................................................................................... 169–170

notification of action.................................................................................................................... 171

Payback Agreement............................................................................................................ 173, 179

payment.............................................................................................................................. 173–174

period of support.................................................................................................................. 171–172

progress reports.......................................................................................................................... 180

publication and sharing of research results.................................................................................... 182

reporting requirements......................................................................................................... 179–180

sponsorship................................................................................................................................. 169

stipend supplementation............................................................................................................... 177

stipend taxability......................................................................................................................... 178

stipends and stipend levels.................................................................................................... 174–175

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, 70–71

Privacy Act of 1974 and.......................................................................................................... 42, 72

Information resources, general..................................................................................................... 30–31

Initiation of support

individual fellowships............................................................................................................ 173–174

institutional research training grants.............................................................................................. 196

Institutes and Centers........................................................................................................................ 16

center, definition........................................................................................................................... 11

institute, definition......................................................................................................................... 11

Institutional allowance, individual fellowships.............................................................................. 175–176

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.................................................................................................. 196–199

application.................................................................................................................................. 190

application receipt, review, and award schedule (exhibit)............................................................... 216

application review................................................................................................................ 191–194

carryover authority...................................................................................................................... 201

changes in the project.................................................................................................................. 203

citizenship requirements....................................................................................................... 188–190

concurrent benefits..................................................................................................................... 200

copyright.................................................................................................................................... 205

degree requirements.................................................................................................................... 187

disposition of professional fees..................................................................................................... 205

educational loans or GI bill........................................................................................................... 200

eligibility.............................................................................................................................. 185–186

employee benefits....................................................................................................................... 198

evaluation criteria................................................................................................................ 191–192

facilities and administrative costs.................................................................................................. 199

financial status report.................................................................................................................. 203

Form 1099.................................................................................................................................. 201

health insurance.......................................................................................................................... 198

initiation of support...................................................................................................................... 196

inventions and patents................................................................................................................. 205

leave................................................................................................................................... 203–204

minority recruitment plan...................................................................................................... 192–193

notification of action.................................................................................................................... 194

Payback Agreement................................................................................................................... 202

period of support.................................................................................................................. 194–196

prebaccalaureate training..................................................................................................... 188–189

program income.......................................................................................................................... 201

progress reports................................................................................................................... 202–203

public access to research data..................................................................................................... 205

publication and sharing of research results............................................................................. 204–205

rebudgeting of funds.................................................................................................................... 199

reporting requirements......................................................................................................... 201–203

short-term research training........................................................................................... 187–188, 192

short-term training costs.............................................................................................................. 198

Statement of Appointment.................................................................................................... 201–202

stipend supplementation............................................................................................................... 199

stipends and stipend levels........................................................................................................... 197

student compensation...................................................................................................... 99, 199–200

taxability of stipends............................................................................................................. 200–201

termination................................................................................................................................. 204

Termination Notice (Form PHS 416-7)......................................................................................... 202

travel costs................................................................................................................................. 198

tuition and fees........................................................................................................................... 198

training in responsible conduct of research............................................................................. 193–194

training Program Director............................................................................................................ 186

training-related expenses............................................................................................................. 197

Institutional Review Boards (IRBs)

financial conflict of interest and............................................................................................ 145146

human subjects protection and.................................................................................... 60–61, 205-206

Insurance. Also see specific types of insurance

costs............................................................................................................................................ 92

real property........................................................................................................................ 165–166

Intellectual property................................................................................................... 113114, 116120

conference materials................................................................................................................... 223

for-profit organizations......................................................................................................... 238–239

individual fellowships............................................................................................................ 182183

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).......................................... 117–119

Final Invention Statement and Certification................................................................................... 141

individual fellowships............................................................................................................ 182–183

institutional research training grants.............................................................................................. 205

invention reporting............................................................................................................... 132–133

royalties and licensing fees from.................................................................................................. 123

Investigational new drug (INDs) applications/investigational device
exceptions (IDEs)....................................................................................................... 41, 63–64

J

Just-in-time procedures, in pre-award process............................................................................... 32–33

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, 159–161

Laboratory Animal Welfare, Office of (OLAW).................................................................... 6566, 207

Leave

costs............................................................................................................................................ 92

individual fellowships................................................................................................................... 181

institutional research training grants....................................................................................... 203–204

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.................................................................... 159–160

Lobbying........................................................................................................................ 41, 49–50, 230

costs............................................................................................................................................ 93

M

Management systems and procedures

about.......................................................................................................................................... 120

assessment in pre-award process................................................................................................... 35

financial management system............................................................................................... 120–121

program income................................................................................................................... 121–123

procurement system............................................................................................................. 126128

property management system .............................................................................................. 123–124

MARC U*STAR program................................................................................................ 188–189, 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, 72–73

Minorities

contracting with minority-owned firms for goods and services........................................................ 128

inclusion as subjects in clinical research................................................... 41, 66–67, 183–184, 206, 230

recruitment plan, institutional research training grants............................................................. 192–193

Misconduct. See Research misconduct

Modernization, definition.................................................................................................................. 144

Modular applications and awards

about.......................................................................................................................................... 217

application requirements....................................................................................................... 217–218

application review and award............................................................................................... 218–219

modular application, definition........................................................................................................ 12

post-award administration............................................................................................................ 219

Monitoring. Also see Reporting

about.......................................................................................................................................... 128

audits.................................................................................................................................. 134–136

data and safety monitoring requirements................................................................ 39, 62–63, 183, 206

definition...................................................................................................................................... 12

record retention and access.................................................................................................. 133–134

reporting............................................................................................................................. 129–133

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
DNA Molecules
.................................................................................... 48, 51–52, 185, 207–208

NIH Loan Repayment Program................................................................................................ 200, 213

NIH Policy and Guidelines on the Inclusion of Children as Participants
in Research Involving Human Subjects
................................................................................ 184, 207

NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects
in Clinical Research
............................................................................................... 66–67, 184, 206

Non-Competing Grant Progress Report (PHS 2590) (Type 5)................................................ 20, 129–130

Non-discrimination.......................................................................................................... 39, 68–69, 230

Non-profit institutions, cost principles for............................................................................................ 79

Nondelinquency on Federal debt....................................................................................... 42, 52–53, 230

Nondiscrimination.......................................................................................................... 68–69, 167, 230

Nonexempt property, administrative requirements...................................................................... 125–126

Nonsegregated facilities requirement, construction grants................................................................... 159

Notice of Grant Award (NGA)

about........................................................................................................................................... 74

budget 76

definition...................................................................................................................................... 12

funding................................................................................................................................... 74–75

terms and conditions..................................................................................................... 3536, 74, 76

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................................................................................ 214–215

breaks in support and.................................................................................................................. 215

certification of payback activities.......................................................................................... 214–215

change of address....................................................................................................................... 215

definitions............................................................................................................................ 209210

extension of payback................................................................................................................... 213

financial payback................................................................................................................. 212–213

implementation.................................................................................................................... 208–209

initiation of payback service......................................................................................................... 211

interest and interest rate calculation...................................................................................... 212–213

National Health Service Corps scholars........................................................................................ 215

policy and principal calculation..................................................................................................... 212

service payback................................................................................................................... 210–212

short-term training....................................................................................................................... 209

time commitment................................................................................................................. 210–211

timing of service obligation........................................................................................................... 212

waiver................................................................................................................................ 213–214

Payment

about............................................................................................................................ 76–77

cash requests.......................................................................................................................... 77–78

CASHLINE/ACH........................................................................................................................ 77

foreign institutions................................................................................................................ 230231

individual fellowships............................................................................................................ 173–174

interest earned on advances of grant funds..................................................................................... 78

SMARTLINK II/ACH................................................................................................................. 77

Payroll distribution, costs.............................................................................................................. 97–98

Peer review process

disposition of applications.............................................................................................................. 29

initial review criteria................................................................................................................ 27–28

initial review responsibilities..................................................................................................... 26–27

initial scientific review appeals................................................................................................. 28–29

National Advisory Council or Board review.................................................................................... 29

Pension plan costs............................................................................................................................. 93

Period of support

project period, general............................................................................................................. 7475

individual fellowships............................................................................................................ 171–172

institutional research training grants....................................................................................... 194–196

Phase III clinical trial, definition......................................................................................................... 13

PHS Policy on Humane Care and Use of Laboratory Animals.................................................. 56–66

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................................................................................................................................. 33–35

funding principles.......................................................................................................................... 33

just-in-time procedures............................................................................................................ 32–33

management systems assessment.................................................................................................. 35

prior-approval requirements for costs........................................................................................... 105

Prebaccalaureate training, institutional research training grants.................................................... 188–189

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'
Labor Relations on Federal and Federally Funded Construction Projects
 (EO 13202).......................................................................................................................... 42, 159

Principal Investigator (PI). Also see Program Director; Project Director

definition...................................................................................................................................... 13

role and responsibilities............................................................................................................ 18–19

Principles for Determining Costs Applicable to Research and Development under Grants and Contracts with Hospitals       79, 246

Prior-approval requests............................................................................................................ 112–113

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............................................... 161–163

alterations and renovations.................................................................................................... 105, 106

capital expenditures.............................................................................................................. 105, 106

carryover of unobligated balances................................................................................................ 105

change in grantee organizational status.................................................................................. 110–111

change in scope............................................................................................................ 105, 106–107

change of grantee organization...................................................................................... 105, 108–110

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
Also see Cost considerations and principles

prior approval, definition................................................................................................................ 13

real property management standards..................................................................................... 163–166

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, 64–65

Procurement requirements

construction grants............................................................................................................... 154–156

in grants to Federal institutions..................................................................................................... 237

system standards................................................................................................................. 126128

Professional fees, disposition of

individual fellowships................................................................................................................... 183

institutional research training grants.............................................................................................. 205

Profit. See Fee

Program, definition............................................................................................................................ 13

Program Director, definition............................................................................................................... 13
Also see Principal Investigator; Project Director

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...................................................................................................... 223–224

definition......................................................................................................................... 13

final progress report.......................................................................................................... 140

individual fellowships......................................................................................................... 180

institutional research training grants....................................................................................... 202–203

requirements....................................................................................................................... 129–131

Project Director, definition................................................................................................................. 13
Also see Principal Investigator; Program Director

Project period, definition.................................................................................................................... 14

Property management system standards and procedures............................................................ 123–124

Proprietary information...................................................................................................................... 25

Prudent Practices for Safety in Laboratories....................................................................................... 49

Public disclosure

conference materials................................................................................................................... 223

environmental impact requirements in construction grants.................................................. 42, 145–146

Public Health Security and Bioterrorism Preparedness and Response Act of 2002........................... 42, 48

Public policy requirements and objectives...................................................................................... 36–43

animal welfare.............................................................................................. 39, 65–66, 185, 207, 229

civil rights........................................................................................................................ 68–69, 230

conference grants....................................................................................................................... 220

consortium agreements........................................................................................................ 225–226

construction grants............................................................................................................... 145–148

determining applicability/inclusion (exhibit)................................................................................ 39–43

facilities acquisition, alteration and renovation, and construction requirements.................................... 69

grants for foreign institutions, international organizations,
and domestic grants with foreign components ............................................................. 229–230

inclusiveness in research design requirements.................................................................... 66–67, 230

individual fellowships............................................................................................................ 183–185

information availability requirements......................................................................................... 69–72

institutional research training grants....................................................................................... 205–206

metric system use requirements......................................................................................... 41, 72, 147

military recruiting and ROTC program access to institutions of higher
learning.................................................................................................................. 41, 72–73

SBIR and STTR programs.......................................................................................................... 243

Public relations costs......................................................................................................................... 94

Publications

costs............................................................................................................................................ 94

information resources.............................................................................................................. 30–31

Publishing and copyrighting data

conference materials................................................................................................................... 223

individual fellowship research results............................................................................................ 182

institutional research training grants research results.............................................................. 204–205

rights.. .............................................................................................................................. 114–115


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