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............................................................................................ 145–146
human subjects protection and.................................................................................... 60–61,
205-206
Insurance.
Also see specific types of insurance
costs............................................................................................................................................ 92
real
property........................................................................................................................ 165–166
Intellectual
property................................................................................................... 113–114, 116–120
conference
materials................................................................................................................... 223
for-profit
organizations......................................................................................................... 238–239
individual
fellowships............................................................................................................ 182–183
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).................................................................... 65–66,
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............................................................................................................. 126–128
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..................................................................................................... 35–36,
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............................................................................................................................ 209–210
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................................................................................................................ 230–231
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............................................................................................................. 74–75
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................................................................................................................. 126–128
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
[ Click "Next Document" below to Continue ]
|
