NIH Grants Policy Statement (12/03) - Index R-W and Footnotes -- File 3 of 3

Grants Policy
Policy & Guidance
Compliance & Oversight
Research Involving Human Subjects
Office of Laboratory Animal Welfare (OLAW)
Animals in Research
Peer Review Policies & Practices
Intellectual Property Policy
Invention Reporting (iEdison)

Global OER Resources
Glossary & Acronyms
Frequently Used Links
Frequent Questions

NIH Grants Policy Statement

(12/03)

Index R-W and Footnotes -- File 3 of 3

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Real estate appraisals...................................................................................................................... 164

Real property

acquisition of......................................................................................................................... 42, 147

definition...................................................................................................................................... 14

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

Real property management standards and procedures

general standards................................................................................................................. 163–164

insurance requirements........................................................................................................ 165–166

notice of Federal interest in real property...................................................................................... 165

real estate appraisals................................................................................................................... 164

use and disposition...................................................................................................................... 164

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

Recipient. Also see Grantee

definition...................................................................................................................................... 14

usage,. iii

Recombinant DNA molecules research................................................................ 42, 48, 51–52, 185, 207

Record retention and access..................................................................................................... 133–134

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

Recovery of funds, enforcement actions........................................................................................... 138

Recruitment costs............................................................................................................................. 94

Registration fees (symposiums/seminars)............................................................................................ 94

Rehabilitation Act of 1973............................................................................................................ 42, 68

Reimbursement method of payment.................................................................................................. 138

Relocation assistance................................................................................................................. 42, 147

Relocation costs................................................................................................................................ 95

Rental or lease of facilities and equipment, costs................................................................................. 95

Reporting

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

expenditures........................................................................................................................ 131–132

invention reporting................................................................................................. 117–119, 132, 141

final reports......................................................................................................................... 139–141

financial reports..................................................................................................... 129–133, 223–224

Federal institutions...................................................................................................................... 237

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

human gene transfer research....................................................................................................... 52

individual fellowships............................................................................................................ 179–180

institutional research training grants....................................................................................... 201–203

inventions................................................................................................................................... 132

program income.................................................................................................................. 122–123,

progress reports.................................................................................................... 129–131, 223–224

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

Research, definition.............................................................................................................. 14, 59, 210

Research data and results

availability........................................................................................................................... 113–114

definition of and access to............................................................................................................. 71

public access under institutional research training grants................................................................ 205

rights. See Publishing and copyrighting data

sharing 115–116, 245

Research design requirements, inclusiveness in.......................................... 66–67, 183–184, 206–207, 230

Research misconduct...................................................................................................... 43, 50–51, 229

definition...................................................................................................................................... 14

Research patient care costs

about.......................................................................................................................................... 246

allowable costs........................................................................................................ 96, 101, 247–249

computing costs.......................................................................................................................... 248

consortium participants/contractors under grant............................................................................. 249

definitions............................................................................................................................ 246–247

facilities and administrative costs.................................................................................................. 249

financial responsibilities............................................................................................................... 250

policy......................................................................................................................................... 247

special procedures...................................................................................................................... 249

travel costs................................................................................................................................. 101

Reserve funds, cost principles............................................................................................................ 96

Reserve Officer Training Corps (ROTC) program, access to institutions of higher
learning....................................................................................................................... 41, 72–73

"Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought"
(42 CFR Part 50, Subpart F)..................................................................................................... 44–45

responsible conduct of research......................................................................................... 184, 193–194

Revised (Amended) Application......................................................................................................... 20

Revocable license agreement.................................................................................................... 126–128

Royalties and licensing fees from copyrights, inventions, and patents................................................... 123

Ruth L. Kirschstein National Research Service Awards.
Also see Institutional research training grants; Individual fellowships

about.......................................................................................................................................... 166

background......................................................................................................................... 166–167

nondiscrimination........................................................................................................................ 167

payback reporting requirements............................................................................................ 208–215

Sabbatical leave, costs....................................................................................................................... 96

Safety issues

biosafety................................................................................................................................. 49, 52

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

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

safety and annual reporting, human gene transfer research.............................................................. 52

Salaries and wages

cost considerations for allocation of costs and closely related work.................................................. 84

costs...................................................................................................................................... 96–99

dual appointment payments........................................................................................................... 98

disposition of unclaimed wages, construction grants................................................................ 160–161

institutional base salary, definition................................................................................................... 11

Sale of real property, equipment, and supplies.................................................................................... 122

Scientific meetings. See Conference grants

Scientific Review Administrator (SRA), role and responsibilities..................................................... 17–18

Seat belt use................................................................................................................................ 43, 54

Seismic Safety of Federal and Federally Assisted or Regulated New Building
Construction (EO 12699)...................................................................................................... 149

Senior fellows, individual fellowship degree requirements................................................................... 168

Service charges, costs....................................................................................................................... 99

Severance pay, costs......................................................................................................................... 99

Sharing research results and resources

research data.............................................................................................................................. 115

unique research resources.................................................................................................... 115–116

Short-term research training................................................................................ 187–188, 192, 198, 209

Sick and other leave

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

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

Significant rebudgeting, definition....................................................................................................... 14

Single Project Assurances (SPAs)................................................................................................... 59n

Small business innovation research and technology transfer programs (SBIR and STTR)

administrative requirements.................................................................................................. 244–245

allowable costs and profit/fee............................................................................................... 243–244

data sharing requirements............................................................................................................ 245

differences between SBIR and STTR................................................................................... 240–241

eligibility.............................................................................................................................. 241–243

facilities and administrative costs (indirect costs)........................................................................... 244

intellectual property requirements................................................................................................. 245

market research requirements.............................................................................................. 244–245

minimum level of effort............................................................................................................... 243

phases of.................................................................................................................................... 240

place of performance........................................................................................................... 242–243

public policy requirements and objectives...................................................................................... 243

Small businesses

contracting for goods and services............................................................................................... 128

small business concern, definition and qualification............................................................ 14, 241–242

SMARTLINK II/ACH................................................................................................................ 76, 77

Smoke-free workplace................................................................................................................. 43, 54

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

Standards of conduct,.................................................................................................................. 43, 44

responsible conduct of research..................................................................................... 184, 193–194

Standards of Privacy of Individuals Identifiable Health Information (Privacy Rule).......................... 57–58

State, local, and Indian tribal governments

cost principles............................................................................................................................... 79

State government, definition........................................................................................................... 15

Uniform Administrative Requirements for Grants and Cooperative
Agreements to............................................................................................................ 16, 228

Statement of Appointment (Form PHS 2271)............................................................................. 201–202

Statement of Miscellaneous Income (IRS Form 1099)

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

institutional research training grants.............................................................................................. 201

Sterile needle/syringe distribution restriction................................................................................... 43, 54

Stipends

costs............................................................................................................................................ 99

definition...................................................................................................................................... 15

levels for individual fellowships............................................................................................. 174–175

levels for institutional research training grants............................................................................... 197

supplementation................................................................................................................... 177, 199

taxability...................................................................................................................... 178, 200–201

Streamlined non-competing award process (SNAP)................................................................... 130–131

Students

compensation of............................................................................................... 99, 177–178, 199–200

Subject costs. See Research patient care costs

Submission of applications

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

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

legal implications of application................................................................................................. 24–25

receipt points and deadlines............................................................................................... 23–24, 216

Supplies................................................................................................................................... 100, 222
Also see Equipment

Support mechanisms......................................................................................................................... 19

Suspension. Also see Debarment and suspension

costs.......................................................................................................................................... 100

definition...................................................................................................................................... 15

enforcement actions.................................................................................................................... 137

Taxability of stipends......................................................................................................... 178, 200–201

Teaching, definition......................................................................................................................... 210

Technology transfer policy. See Bayh-Dole Act of 1980; Inventions and patents

Terminal leave

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

institutional research training grants.............................................................................................. 204

Termination

costs.......................................................................................................................................... 100

definition...................................................................................................................................... 15

enforcement actions.................................................................................................................... 137

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

institutional research training grants.............................................................................................. 204

Termination Notice (Form PHS 416-7)

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

institutional research training grants.............................................................................................. 202

Terms and conditions of award. Also see Administrative requirements; Cost considerations and principles;
Notice of Grant Award; Payment; Pre-award process; Public policy requirements and objectives

definition...................................................................................................................................... 15

modification of award terms, enforcement actions......................................................................... 136

overview................................................................................................................................ 35–36

prior-approval requirements for deviation from....................................................................... 105, 111

Title insurance................................................................................................................................ 165

Total project costs, definition.............................................................................................................. 15

Trailers and modular units, costs....................................................................................................... 100

Trainee costs........................................................................................................................... 100, 198

prior-approval requirements for transfer of amounts............................................................... 106, 112

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

Training Program Director, institutional research training grants......................................................... 186

Training-related expenses, institutional research training grants........................................................... 197

Transfer of funds between construction and nonconstruction work,
prior-approval requirements............................................................................................ 106, 112

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

Transfers, individual fellowships....................................................................................................... 180

Transplantation, human fetal tissue.......................................................................................... 43, 55–56

Transportation of property, costs...................................................................................................... 100

Travel

costs.......................................................................................................................................... 101

to foreign training sites................................................................................................................ 177

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

trainees in institutional research training grants.............................................................................. 198

Tuition and fees

individual fellowships................................................................................................................... 176

institutional research training grants.............................................................................................. 198

Uniform Relocation Assistance and Real Property Acquisition
Policies Act of 1970............................................................................................................. 147

United States, definition..................................................................................................................... 15

Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and
Obstruct Terrorism Act (USA PATRIOT Act).............................................................................. 43, 48

Unobligated balances

authorities for carryover of.............................................................................. 103, 105, 132, 201, 239

reporting.................................................................................................................................... 132

Unpaid leave

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

institutional research training grants.............................................................................................. 204

Use allowances................................................................................................................................ 90

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

Vacation and holiday leave

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

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

Vertebrate animals. See Animal welfare

Withholding of support

definition...................................................................................................................................... 15

enforcement actions............................................................................................................. 137, 138

Women

contracting with women's business enterprises for goods and services............................................ 128

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

Footnotes:

[1] This is the only location in the NIHGPS where these terms are defined. If an abbreviation used in the NIHGPS is unfamiliar, the reader should consult this list for its meaning.

[2] HHS components include SAMHSA, FDA, CDC, IHS, AHRQ, HRSA, ACF, AoA, OPHS, and CMS.

[3] Although the government-wide requirements do not cover grants to for-profit organizations, HHS has included them in the coverage of 45 CFR Part 74.

[4] ONR is the cognizant agency for negotiation of F&A costs for some NIH grantees.

[5] Some ICs review applications for Institutional National Research Service Awards (T32) only once a year. See the Appendix in Part II of the NIHGPS.

[6] This certification is accomplished by the signature of the AOO on the application. States need only certify as to their principals.

[7] 42 CFR Part 73, Select Agents and Toxins; and 7 CFR Part 331 and 9 CFR Part 121, Possession, Use, and Transfer of Biological Agents and Toxins.

[8] As of February 28, 2001, OHRP no longer accepted applications for Multiple Project Assurances (MPAs) or Single Project Assurances (SPAs) limited to HHS-supported research, to special categories of research, or to individual research projects. Current MPAs will remain in effect until the designated expiration date or December 31, 2003, whichever comes first; however, MPA organizations may file a new FWA at any time prior to that date. OHRP will not accept changes to existing MPAs (except for IRB membership updates). If changes are necessary, the organization should file an FWA. Current SPAs will remain in effect through the expiration of their respective grant (or contract) award and any non-competing continuation award.

[9] Protecting Human Research Subjects: Institutional Review Board Guidebook, 1993, Stock No. 017-040-00525-3, may be ordered from the Superintendent of Documents, telephone: 202-512-1800. This Guidebook is also available from OHRP’s website (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm ).

[10]Larger non-profit organizations that are specifically listed in Attachment C to OMB Circular A-122 are subject to the Federal cost principles applicable to commercial organizations (48 CFR Subpart 31.2) rather than to the cost principles for non-profit organizations.

[11] This term and the term “indirect costs” may be used interchangeably to determine applicable policies. For NIH purposes, including the NIHGPS, these costs will be referred to as F&A costs; however, other documents or non-NIH functions may refer to them as “indirect costs.”

[12] For this purpose, “data” means recorded information, regardless of the form or media on which it may be recorded, and includes writings, films, sound recordings, pictorial reproductions, drawings, designs, or other graphic representations, procedural manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or computer programs (software), statistical records, and other research data.

[13] State governments will use, manage, and dispose of equipment acquired under a grant in accordance with state laws and procedures as specified in 45 CFR 92.32.

[14] The determination leading to such disputes may be made by an HHS official other than the GMO and may affect NIH grants as well as other HHS grants.

[15] This list may be obtained from the State Liaison Officers designated by their respective states to administer this program or from the Advisory Council on Historic Preservation, 1100 Pennsylvania Avenue NW, Washington, DC 20004 (telephone: 202-606-8503; website: http://www.achp.gov/). The National Trust for Historic Preservation is located at 1785 Massachusetts Avenue NW, Washington, DC 20036 (telephone: 202-588-6000; website: http://www.nationaltrust.org/).

[16] References are to the latest editions of cited publications. Grantees and their contractors are responsible for determining what applies at the time of the affected activity.

[17] In 2002, the National Research Service Awards program was renamed the Ruth L. Kirschstein National Research Service Awards program as a tribute to Dr. Kirschstein’s years of exceptional service to the nation.

[18] NIH ICs use the term F&A costs for all types of applicants and recipients; however, for-profit organizations will find that DFAS and organizations external to NIH refer to these costs as “indirect costs.”

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