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ARCHIVED - NIH Grants Policy Statement (10/03)


NIH Grants Policy Statement
(12/03)


Index A-G -- File 1 of 3


Index

Page references containing an n refer to footnotes.

A

Abbreviations list,.......................................................................................................................... 1–5

Abortion funding restriction.......................................................................................................... 43, 54

Accelerated expenditures.................................................................................................................. 84

Accessibility standards, facilities................................................................................................ 40, 148

Activation Notice (Form PHS 416-5)........................................................................................... 173, 179

Administrative requirements

changes in project and budget.............................................................................................. 102–113

closeout and final reports...................................................................................................... 139–141

conference grants................................................................................................................ 223–224

construction grants............................................................................................................... 161–166

enforcement actions............................................................................................................. 136–139

exempt property................................................................................................................... 124–125

financial management system...................................................................................................... 120

grant appeals procedures...................................................................................................... 141–142

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

grants to for-profit organizations............................................................................................. 238–240

management systems and procedures................................................................................... 120–128

monitoring........................................................................................................................... 128–136

property management.......................................................................................................... 123–126

procurement system.............................................................................................................. 12628

research results availability................................................................................................... 113–120

SBIR and STTR programs..................................................................................................... 244–245

Advances of grant funds, interest earned on......................................................................................... 78

Advertising, costs.............................................................................................................................. 87

Advisory Council on Historic Preservation........................................................................................ 146n

Affiliated organization services, cost considerations............................................................................. 85

Age Discrimination Act of 1975.................................................................................................... 39, 68

Alcoholic beverages, costs................................................................................................................. 87

Allocability test, allowability of costs and............................................................................................ 80

Allowability of costs.......................................................................................................................... 80
Also see Cost considerations and principles; specific funding mechanisms

Alteration and renovation (A&R). Also see Construction grants

costs............................................................................................................................................ 87

definition........................................................................................................................................ 6

prior-approval requirements.................................................................................... 105, 106, 161–163

public policy requirements and objectives........................................................................................ 69

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

Animals, costs.................................................................................................................................. 88

Annual Payback Activities Certification (Form PHS 6031-1)...................................................... 214–215

Appeals procedures

adverse determinations and.................................................................................................. 141–142

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

Applicable credits............................................................................................................................. 85

Application

definition........................................................................................................................................ 6

false, fictitious, or fraudulent information in............................................................................... 24–25

types of applications...................................................................................................................... 19

Application process

application forms..................................................................................................................... 22–23

application receipt points and deadlines..................................................................................... 23–24

application submission.............................................................................................................. 22–25

confidentiality of information (proprietary information)..................................................................... 25

eligibility............................................................................................................................ 19, 33–35

individual fellowships..................................................................................................... 170–171, 216

institutional research training grants....................................................................................... 190, 216

Approved budget, definition................................................................................................................. 6

Archeological and Historical Preservation Act of 1960...................................................................... 146

Architectural Barriers Act of 1968, elimination of barriers to the handicapped and.......................... 40, 148

Assurance requirements

animals.......................................................................................................................... 65–66, 207

human subjects.................................................................................................................... 59, 205

Audiovisual activities, costs................................................................................................................ 88

Audit costs....................................................................................................................................... 88

Audit requirements................................................................................................................... 134–136

consortium agreements................................................................................................................ 227

grants to for-profit organizations........................................................................................... 239–240

grants to foreign institutions, international organizations, and domestic grants with
foreign components.......................................................................................................... 232

Authorized organizational official (AOO)

definition........................................................................................................................................ 6

role and responsibilities.................................................................................................................. 18

Award, definition................................................................................................................................ 6

Award instruments, types of.............................................................................................................. 19

Awardee, usage................................................................................................................................. iii

Awarding office, definition.................................................................................................................. 6

B

Bad debts, costs................................................................................................................................ 88

Ban on human embryo research and cloning............................................................................ 39, 54–55

Bayh-Dole Act of 1980......................................................................... 113–114, 116–120, 130, 132–133

Also see Inventions and patents

Bid and proposal costs....................................................................................................................... 88

Bonding, costs.................................................................................................................................. 88

Bonus funds/incentive payments, costs............................................................................................... 98

Books and journals, costs................................................................................................................... 88

Budget

changes in............................................................................................................. 102–113, 199, 231

approved budget, definition.............................................................................................................. 6

budget period, definition.................................................................................................................. 6

NGA and..................................................................................................................................... 76

significant rebudgeting, definition.................................................................................................... 14

Building acquisition, costs.................................................................................................................. 89

C

Capital expenditures

definition........................................................................................................................................ 7

prior-approval requirements.................................................................................................. 105, 106

Career awards. See K awards

Carryover of unobligated balances.............................................................................. 103–104, 105, 132

Cash requests........................................................................................................................ 76, 77–78

CASHLINE/ACH....................................................................................................................... 76, 77

Center. See Institutes and Centers

Center for Scientific Review (CSR)

responsibilities.............................................................................................................. 17, 23, 2627

Certificates of confidentiality........................................................................................................ 39, 57

Change of grantee organization................................................................................... 105, 108110, 231

Changes in project and budget

about.......................................................................................................................................... 102

expanded authorities............................................................................................................ 102–104

grants to foreign institutions, international organizations, and domestic grants with
foreign components................................................................................................... 231–232

individual fellowships............................................................................................................ 180–181

institutional research training grants.............................................................................................. 203

prior-approval requirements.................................................................................................. 105–112

requests for prior approval.................................................................................................... 112–113

Child care costs................................................................................................................................ 89

Children

inclusion as subjects in clinical research........................................................ 41, 67, 184, 206–207, 230

Pro-Children Act of 1994................................................................................................... 42, 64–65

Citizenship requirements

general........................................................................................................................................ 34

individual fellowships............................................................................................................ 168–169

institutional research training grants....................................................................................... 189–190

Civil False Claims Act....................................................................................................................... 25

Civil rights, public policy requirements and objectives.............................................................. 68–69, 230

Civil Rights Act of 1964............................................................................................................... 39, 68

Clean Air Act.......................................................................................................................... 147–148

Clean Water Act..................................................................................................................... 147–148

Clinical research

definition........................................................................................................................................ 7

inclusion of children as subjects in.................................................................. 41, 66–67, 184, 206–207

inclusion of women and minorities as subjects in...................................... 41, 66–67, 183–184, 206, 230

Clinical trials

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

definitions................................................................................................................................. 7, 13

Cloning. See Human embryo research, cloning, and transplantation

Closeout.................................................................................................................................. 139–141

Co-investigator, definition.................................................................................................................... 8

Communications, costs...................................................................................................................... 89

Compensation

Federal employees............................................................................................................... 235236

general................................................................................................................................... 9699

students and trainees........................................................................................ 99, 177178, 199200

Competing continuation application (Type 2)....................................................................................... 20

Competing supplemental application (Type 3)...................................................................................... 20

Competitive segment, definition............................................................................................................ 8

Computer Retrieval of Information on Scientific Projects (CRISP).................................................. 30, 69

Concurrent benefits

individual fellowships................................................................................................................... 178

institutional research training grants.............................................................................................. 200

Conference grants

about.......................................................................................................................................... 219

administrative requirements.................................................................................................. 223–224

allowable costs.................................................................................................................... 221–222

application requirements.............................................................................................................. 220

application review....................................................................................................................... 220

copyrighting material................................................................................................................... 223

definitions............................................................................................................................ 219–220

eligibility..................................................................................................................................... 220

facilities and administrative costs............................................................................................ 83, 231

funding....................................................................................................................................... 221

public policy requirements and objectives...................................................................................... 220

unallowable costs................................................................................................................. 222–223

Confidentiality

certificates of............................................................................................................................... 57

Freedom of Information Act and......................................................................................... 40, 70–71

individuals' rights and welfare requirements............................................................................... 57–58

of information (proprietary information).......................................................................................... 25

of patient records.................................................................................................................... 39, 57

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

Conflict of interest, financial.............................................................................................. 40, 44–46, 61

Conformance test, allowability of costs and......................................................................................... 80

Consistency test, allowability of costs and........................................................................................... 80

Consortium agreements

about.................................................................................................................................. 224–225

administrative and other requirements................................................................................... 225–227

allowable/unallowable costs......................................................................................................... 226

approval authorities..................................................................................................................... 226

audit........................................................................................................................................... 227

costs............................................................................................................................................ 89

definition........................................................................................................................................ 8

intellectual property.............................................................................................................. 118, 228

public policy requirements and objectives............................................................................... 225–226

personal property................................................................................................................. 226–227

transfer of performance to third party by........................................................................ 103, 104, 107

written agreement................................................................................................................ 227–228

Construction grants

about.......................................................................................................................................... 144

administrative requirements.................................................................................................. 161–166

allowable and unallowable costs and activities........................................................................ 151–154

design requirements............................................................................................................. 148–151

eligibility..................................................................................................................................... 144

equal employment opportunity, labor standards, and other requirements.............................. 41, 158–161

funding....................................................................................................................................... 151

matching costs............................................................................................................................ 151

modernization, definition.............................................................................................................. 144

prior-approval requirements......................................................................................................... 161

procurement requirements for services under........................................................................ 154–158

public policy requirements and objectives.................................................................... 40, 69, 145–148

review and approval............................................................................................................. 144–145

Construction management services, procurement requirements for.............................................. 156–157

Construction. Also see Construction grants

costs............................................................................................................................................ 89

definition.................................................................................................................................... 144

facilities and administrative costs and............................................................................................. 83

Consultant, definition........................................................................................................................... 8

Consultant services, costs............................................................................................................ 89–90

Contingency funds, costs................................................................................................................... 90

Contract under a grant

costs............................................................................................................................................ 89

definition........................................................................................................................................ 8

Contract Work Hours and Safety Standards Act........................................................................ 159–160

Controlled substances

individuals' rights and welfare requirements............................................................................... 39, 58

use of funds for promotion/legalization...................................................................................... 41, 49

Cooperative agreements

definition........................................................................................................................................ 8

usage............................................................................................................................................ iii

Copyrights. Also see Publishing and copyrighting data

general....................................................................................................................................... 114

conference grants and................................................................................................................. 223

individual fellowships................................................................................................................... 182

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

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

SBIR/STTR grants and............................................................................................................... 245

COR program.......................................................................................................................... 189, 197

Cost analysis, in pre-award process.................................................................................................... 35

Cost considerations and principles

accelerated expenditures............................................................................................................... 84

affiliated organization services....................................................................................................... 85

allocation of costs and closely related work.................................................................................... 84

applicable credits.......................................................................................................................... 85

conference grants................................................................................................................ 221–223

consortium agreements................................................................................................................ 226

construction grants............................................................................................................... 151–154

cost principles......................................................................................................................... 79–80

cost transfers.......................................................................................................................... 83–84

delayed expenditures..................................................................................................................... 84

determining allowability of costs..................................................................................................... 80

direct costs................................................................................................................................... 81

facilities and administrative costs.............................................................................................. 81–83

grants to Federal institutions................................................................................................. 233–236

grants to for-profit organizations................................................................................................... 238

grants to foreign institutions, international organizations, and domestic grants with
foreign components.......................................................................................................... 231

individual fellowships............................................................................................................ 174–177

institutional research training grants....................................................................................... 196–199

pre-award costs............................................................................................................................ 94

research patient care........................................................................................................... 247–250

SBIR and STTR programs................................................................................................... 243–244

selected items of cost (table).................................................................................................. 87–101

Cost overruns

about........................................................................................................................................... 84

definition........................................................................................................................................ 8

Cost transfers............................................................................................................................. 8384

Cost Principles for Commercial Organizations (48 CFR Subpart 31.2).................................................. 79

Cost Principles for Educational Institutions (OMB Circular A-21)........................................................ 79

Cost Principles for Non-Profit Institutions (OMB Circular A-122)........................................................ 79

Cost Principles for State and Local Governments and Indian Tribal Governments
(OMB Circular A-87)............................................................................................................. 79

Cost-related prior approvals...................................................................................................... 103, 104

Cost sharing. See Matching or cost sharing

Criminal False Claims Act................................................................................................................. 25

Customs and import duties, costs........................................................................................................ 90

D

Data. See Publishing and copyrighting data; Research data and results

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

Deadlines. See Application process

Debarment and suspension....................................................................................... 39, 46–47, 138, 230

 Also see Suspension

Debt collection

enforcement actions............................................................................................................. 138–139

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

Degree requirements

individual fellowships................................................................................................................... 168

institutional research training grants.............................................................................................. 187

Delayed expenditures........................................................................................................................ 84

Depreciation or use allowances.......................................................................................................... 90

Design-build services, procurement requirements for......................................................................... 158

Design requirements for NIH-assisted construction.................................................................... 148–151

Direct costs, definition................................................................................................................... 8, 81

Domestic conference, definition....................................................................................................... 220

Domestic organization

definition........................................................................................................................................ 8

prior-approval requirements for foreign component added to grant........................................... 105, 111

Donor costs...................................................................................................................................... 90

Drug-free workplace............................................................................................................ 40, 47, 230

Drugs, costs..................................................................................................................................... 90

Dues or membership fees.................................................................................................................. 91

E

Earthquake Hazards Reduction Act of 1977...................................................................................... 149

Education Amendments of 1972, Title IX...................................................................................... 40, 68

Education in the protection of human research participants.................................................................. 61

Educational institutions, cost principles for........................................................................................... 79

Educational loans or GI bill

individual fellowships................................................................................................................... 178

institutional research training grants.............................................................................................. 200

Eligibility................................................................................................................................ 19, 33–35

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

construction grants...................................................................................................................... 144

grants to Federal institutions................................................................................................. 232–233

grants to for-profit organizations................................................................................................... 238

grants to foreign institutions, international organizations, and domestic grants with foreign
components.............................................................................................................. 228–229

individual fellowships............................................................................................................ 167–168

institutional research training grants....................................................................................... 185–186

SBIR and STTR.................................................................................................................. 241–243

Enforcement actions

about.......................................................................................................................................... 136

debt collection..................................................................................................................... 138–139

modification of award terms........................................................................................................ 136

recovery of funds........................................................................................................................ 138

suspension and termination,

withholding of support.......................................................................................................... 137, 138

Entertainment costs........................................................................................................................... 91

Environmental impact requirements.................................................................................................... 69

construction grants and................................................................................................... 42, 145–146

Equal employment opportunity requirements, construction grants................................................. 158–159

Equipment. Also see Supplies

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

allowable costs............................................................................................................................. 91

definition........................................................................................................................................ 9

management standards and procedures................................................................................. 124126

sale of........................................................................................................................................ 122

Exempt property, administrative requirements............................................................................ 124–125

Expanded authorities

about.................................................................................................................................. 102–103

carryover of unobligated balances......................................................................................... 103–104

cost-related prior approvals................................................................................................... 103, 104

definition........................................................................................................................................ 9

extension of final budget period............................................................................................. 103, 104

transfer of performance to third party by consortium agreement.............................................. 103, 104

Expenditures

accelerated and delayed................................................................................................................ 84

financial reports..................................................................................................... 131–132, 139140

unobligated balances and actual expenditures reporting.................................................................. 132

Extensions

expanded authority, of final budget period without additional NIH funding................................ 103, 104

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

prior-approval, additional NIH funding with extension...................................................... 105, 106, 112

prior-approval, additional NIH funding without extension......................................................... 105, 112

F

Facilities acquisition, alteration and renovation, and construction. See Alteration and renovation; Building acquisition; Construction; Construction grants

Facilities and administrative costs. Also see Indirect costs

construction

definition................................................................................................................................... 9, 81

conference grants.................................................................................................................. 83, 222

construction grants................................................................................................................. 83, 154

Federal institutions................................................................................................................. 83, 234

foreign and international organizations..................................................................................... 83, 231

for-profit organizations................................................................................................................ 238

individual fellowships..................................................................................................................... 83

individuals, grants to...................................................................................................................... 83

institutional research training grants......................................................................................... 83, 199

career awards.............................................................................................................................. 83

reimbursement........................................................................................................................ 8283

research patient care........................................................................................................... 248249

SBIR and STTR programs.......................................................................................................... 244

Federal Demonstration Partnership, definition....................................................................................... 9

Federal employees

payments to/on behalf of................................................................................................. 91, 232–237

 

Federal funding. See Funding

Federal institution, definition................................................................................................................. 9

Fee

definition........................................................................................................................................ 9

general......................................................................................................................................... 86

grants to for-profit organizations................................................................................................... 238

SBIR and STTR.................................................................................................................. 243–244

Fellowships. See Individual fellowships; Ruth L. Kirschstein National Research Service Awards

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

Financial assistance, definition............................................................................................................. 9

Financial conflict of interest............................................................................................... 40, 44–46, 61

Financial Management, Office of (OFM)................................... 77, 129, 132, 136, 174, 175, 230231, 233

Financial management system standards........................................................................................... 121

Financial reporting..................................................................................................... 131–132, 139–140

conference grants....................................................................................................................... 224

foreign institutions....................................................................................................................... 232

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

institutional research training grants.............................................................................................. 203

Fines and penalties............................................................................................................................ 91

Flood Disaster Protection Act of 1973, flood insurance and........................................................... 40, 146

For-profit organization, definition........................................................................................................ 10
Also see Grants to for-profit organizations

Foreign component, definition....................................................................................................... 9, 228

Foreign institution, definition............................................................................................................... 10
Also see Grants to foreign institutions, international organizations, and domestic grants with foreign components

Foreign sponsorship/training abroad, individual fellowships.................................................................. 169

Freedom of Information Act (FOIA)....................................................................................... 40, 70–71

Fringe benefits, costs......................................................................................................................... 91

Full-time and part-time training, individual fellowships................................................................. 172–173

Full-time appointment, definition......................................................................................................... 10

Funding

availability of information about...................................................................................................... 69

conference grants....................................................................................................................... 221

construction grants...................................................................................................................... 151

grants to foreign institutions, international organizations, and domestic grants with foreign components 230–231

NGA and................................................................................................................................ 74–75

prior-approval requirements........................................................................................... 105, 106, 112

Funding opportunities, types of...................................................................................................... 20–22

Funding principles............................................................................................................................. 33

Fundraising costs.............................................................................................................................. 91

G

GI Bill. See Educational loans or GI bill

Glossary

abbreviations.............................................................................................................................. 1–5

definitions................................................................................................................................. 6–15

Goods and services procurement

requirements under construction grants................................................................................. 154–158

system standards and requirements....................................................................................... 126–128

Governments. See State, local, and Indian tribal governments

Grant appeals procedures......................................................................................................... 141–142

Grant-supported project or activity, definition...................................................................................... 10

Grantee

definition...................................................................................................................................... 10

staff responsibilities................................................................................................................. 18–19

usage............................................................................................................................................ iii

Grant

definition...................................................................................................................................... 10

usage............................................................................................................................................ iii

Grants Management Officer (GMO)

definition...................................................................................................................................... 10

role and responsibilities.................................................................................................................. 17

Grants Management Specialist (GMS)

definition...................................................................................................................................... 10

role and responsibilities.................................................................................................................. 17

Grants to Federal institutions

administrative requirements......................................................................................................... 237

allowable/unallowable costs.................................................................................................. 233–236

eligibility.............................................................................................................................. 232–233

equipment accountability.............................................................................................................. 237

facilities and administrative costs................................................................................................... 83

intellectual property..................................................................................................................... 237

payment..................................................................................................................................... 233

procurement requirements........................................................................................................... 237

reporting requirements................................................................................................................. 237

VA-university affiliations............................................................................................................. 233

Grants to for-profit organizations

about......................................................................................................................................... 237

administrative requirements.................................................................................................. 238–240

allowable/unallowable costs......................................................................................................... 238

audit requirements............................................................................................................... 239–240

eligibility..................................................................................................................................... 238

intellectual property requirements.......................................................................................... 238–239

operating authorities.................................................................................................................... 239

profit or fee under....................................................................................................................... 238

program income.......................................................................................................................... 239

SBIR and STTR programs................................................................................................... 240–245

Grants to foreign institutions, international organizations, and domestic grants with foreign components

about.......................................................................................................................................... 228

administrative requirements.................................................................................................. 231–232

allowable/unallowable costs......................................................................................................... 231

application review....................................................................................................................... 229

audit requirements....................................................................................................................... 232

changes in project and budget............................................................................................... 231–232

eligibility.............................................................................................................................. 228–229

facilities and administrative costs................................................................................................... 83

funding and payment............................................................................................................ 230–231

public policy and requirements and objectives........................................................................ 229–230

reporting and record retention...................................................................................................... 232

Grants to individuals

facilities and administrative costs and............................................................................................. 83

eligibility....................................................................................................................................... 19

operating authorities...................................................................................................... 102, 103, 130

Grants.gov........................................................................................................................................ 30


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