NIH Grants Policy Statement (03/01) - NIH Grants Policy Statement-Table of Contents

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NATIONAL INSTITUTES OF HEALTH
Office of Extramural Research

NIH Grants Policy Statement (03/01)
Table of Contents

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NIH Grants Policy Statement (03/01/2001) - Effective for all NIH grants and cooperative agreements with budget periods beginning on March 1, 2001 through November 30, 2003. See 12/03 NIHGPS for subsequent budget periods or 10/98 NIHGPS for prior budget periods. Download or View the complete 03/01 NIHGPS in Adobe Acrobat PDF format (size = 1.3MB). See 02/27/2001 NIH Guide for description and notable changes since the 1998 version.

Changes to the NIHGPS - The following changes have been made to the NIHGPS as announced in the 03/20/2001 NIH Guide Notice:
     o Table II-2 has been updated to show 03/01 effective date and "YES" to carrovers;
     o Included the NIH Guidance for Research on Human Fetal Tissue;
     o Included clarification on the topic of Standards of Conduct.
Changes are noted in both the HTML and the complete Adobe Acrobat version of this document above. You may also download only those pages that have changed in Acrobat format.

Introduction - NIH Grants Policy Statement

Part I: NIH Grants-General Information

Glossary

Acronyms and Abbreviations

The National Institutes of Health as a Grant-making Organization

Roles and Responsibilities

NIH and HHS Staff

Application and Review Processes

Support Mechanisms

Types of Applications

Funding Opportunities

Application Submission

Application Forms

Table I-1 Required Forms for Completing Applications

Application Receipt Points and Deadlines

Legal Implication of Application

Confidentiality of Information (Proprietary Information)

The Peer Review Process

National Advisory Council or Board Review

Appeals of Initial Scientific Review

Disposition of Applications

Sources of Information about NIH's Grants Process and Programs

Part II: Terms and Conditions of NIH Grant Awards

Subpart A: General

Completing the Preaward Process

Funding Principles

Cost Analysis and Assessment of Management Systems

Overview of Terms and Conditions
Public Policy Requirements and Objectives

Table II-1 Public Policy Requirements and Objectives

Ethical and Safe Conduct in Science and Organizational Operations

Standards of Conduct

Financial Conflict of Interest

Debarment and Suspension

Drug-Free Workplace

Health and Safety Guidelines

Limitation on Use of Funds for Promotion or Legalization of Controlled Substances

Research Misconduct

Nondelinquency on Federal Debt

Recombinant DNA Molecules

Scope and Applicability

Institutional Biosafety Committee

Serious Adverse Event Reporting

Human Pluripotent Stem Cell Research

NIH Guidelines for Research Using Human Pluripotent Stem Cells

Human Pluripotent Stem Cell Review Group

Restriction on Distribution of Sterile Needles

Smoke-Free Workplace

Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services

Ban on Human Embryo Research and Cloning

Research on Human Fetal Tissue

NIH Guidance for Research on Human Fetal Tissue

Confidentiality

Protection of Research Subjects' Identity

Confidentiality of Patient Records

Controlled Substances

Assurance Requirements and Institutional Review Boards

Education in the Protection of Human Research Participants

Data and Safety Monitoring

Investigational New Drug Applications/Investigational Device Exceptions

Pro-Children Act of 1994

Research on Transplantation of Fetal Tissue

Requirements for Inclusiveness in Research Design

Inclusion of Women and Minorities as Subjects in Clinical Research

Inclusion of Children as Subjects in Clinical Research

Age Discrimination Act of 1975

Civil Rights Act of 1964

Education Amendments of 1972

Rehabilitation Act of 1973

Environmental Impact and Other Requirements Related to Acquisition, Alteration and Renovation, and Construction of Facilities

Availability of Information

Acknowledgment of Federal Funding

The Freedom of Information Act

Access to Research Data

The Privacy Act

Other Public Policy Requirements and Objectives

Military Recruiting and Reserve Officer Training Corps Program Access to Institutions of Higher Education

The Notice of Grant Award

Additional Terms and Conditions

Payment

SMARTLINK II/ACH

Interest Earned on Advances of Grant Funds

Cost Considerations

The Cost Principles

Direct Costs and Facilities and Administrative (Indirect) Costs

Cost Transfers, Overruns, and Accelerated and Delayed Expenditures

Allocation of Costs and Closely Related Work

Applicable Credits

Services Provided by Affiliated Organizations

Allowability of Costs/Activities

Selected Items of Cost

Administrative Requirements

Changes in Project and Budget

Prior Approval Requirements

Table II-2 Summary of Actions Requiring NIH Prior Approval

Expanded Authorities

Requests for Approval

Noncompeting Continuation Awards

Streamlined Noncompeting Award Process

Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources

Rights in Data (Publication and Copyrighting)

Sharing Biomedical Research Resources

Inventions and Patents

Management Systems and Procedures

Financial Management System Standards

Table II-3 Requirements for Program Income Accountability

Sale of Real Property, Equipment, and Supplies

Reporting of Program Income

Royalties and Licensing Fees from Copyrights, Inventions, and Patents

Property Management System Standards

Equipment and Supplies

Exempt Property

Nonexempt Property

Revocable License

Procurement System Standards and Requirements

Approval Requirements

Contracting with Small Businesses, Minority-Owned Firms, and Women's Business Enterprises

Progress Reports as Part of Noncompeting Continuation Requests

Financial Reports

Unobligated Balances and Actual Expenditures

Invention Reporting

Report to the Office of Research Integrity

Lobbying Disclosure

Record Retention and Access

Enforcement Actions

Modification of the Terms of Award

Suspension, Termination, and Withholding of Support

Other Enforcement Actions

Recovery of Funds

Debt Collection

Final Financial Status Report

Final Progress Report

Final Invention Statement and Certification

Grant Appeals Procedures

Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

Construction Grants

Review and Approval

Public Policy Requirements and Objectives

The National Environmental Policy Act of 1969

Public Disclosure

Flood Insurance

Historic Properties and Archeological Sites

Intergovernmental Review Under Executive Order 12372

Relocation Assistance and Real Property Acquisition

Other Public Policy Requirements

Other Design Requirements for NIH-Assisted Construction

Elimination of Architectural Barriers to the Physically Handicapped

Guidelines for Design and Construction of Hospital and Healthcare Facilities (1996-97)

American Society of Heating, Refrigeration, and Air Conditioning Engineers Handbook-HVAC Applications (1995)

Seismic Safety for Federally Assisted Construction

Life Safety Code

Standards on Fire Protection for Laboratories Using Chemicals

Prudent Practices for Safety in Laboratories (1995)

National Sanitation Foundation Standard No. 49 for Class II (Laminar Flow) Biohazard Cabinetry (1992)

International Standard Plumbing Code (1996)

Industrial Ventilation: A Manual of Recommended Practice (1998)

Health Care Facilities Handbook (1997)

Standards for Nonflammable Medical Gas Systems

National Electric Code

Laboratory Ventilation Workbook (1994)

Allowability of Costs/Activities

Allowable Costs/Activities

Unallowable Costs/Activities

Procurement Requirements for Construction Services Under NIH Construction Grants

Construction Management Services

Design-Build Services

Equal Employment Opportunity, Labor Standards, and Other Contract Requirements

Equal Employment Opportunity

Non-Segregated Facilities

Labor Standards

Contract Work Hours and Safety Standards Act

Liquidated Damages

Disposition of Unclaimed Wages

Administrative Requirements

Prior Approval Requirements

Construction Grants

Alteration and Renovation Projects under Non-construction Grants

Real Property Management Standards

Use and Disposition

Real Estate Appraisals

Notice of Federal Interest

Insurance Requirements

Exhibit II-1 Alteration and Renovation Cost Estimate Outline

National Research Service Awards

Nondiscrimination

Individual National Research Service Awards (Fellowships)

Research Training Program

Degree Requirements

Foreign Sponsorship

Individuals on Active Military Duty

Application Requirements and Receipt Dates

Concurrent Applications

Application Availability

Notification of Action

Period of Support

Physicians/Clinicians

Interruptions (Break-In-Service)

Other Exceptions

Initiation of Support

Financial Provisions

Stipend Supplementation

Concurrent Benefits

Educational Loans or GI Bill

Taxability of Stipends

Employee Benefits

Institutional Allowance

Tuition and Fees

Travel to Foreign Training Sites

Reporting Procedures

Activation Notice

Payback Agreement

Termination Notice

Consecutive Support

Progress Reports, Financial Status Reports, Changes in the Project

Progress Reports

Financial Status Report

Changes in the Project

Other Terms and Conditions

Vacations and Holidays

Sick Leave and Other Leave

Disposition of Professional Fees

Human Subjects/Animal Welfare/Recombinant DNA Molecules

Vertebrate Animals

Recombinant DNA Molecules

Institutional National Research Service Awards (Training Grants)

Applicant Eligibility

Research Training Program

Degree Requirements

Predoctoral Training

Postdoctoral Training

Short-Term Research Training

Prebaccalaureate Training

Application Requirements and Receipt Dates

Short-Term Research Training Positions

Minority Recruitment Plan

Training in the Responsible Conduct of Research

Notification of Action

Period of Support

Institutional Grants

NRSA Limitations

Physicians/Clinicians

Interruptions (Break-in-Service)

Other Exceptions

Initiation of Support

Financial Provisions

Stipend Supplementation

Student Compensation

Concurrent Benefits

Educational Loans or GI Bill

Taxability of Stipends

Employee Benefits

Other Direct Costs

Training-Related Expenses

Trainee Tuition and Fees

Trainee Travel Costs

Rebudgeting of Funds

Trainee-Related Expenses

Expenditure of Funds

Facilities and Administrative (F&A) Costs

Reporting Procedures

Statement of Appointment (Form PHS 2271)

Grantee Submission

Interim Revisions

Payback Agreement (Form PHS 6031)

Termination Notice (Form PHS 416-7)

Consecutive Support

Progress Reports, Financial Status Reports, and Changes in the Project

Progress Reports

Financial Status Report (FSR)

Changes in the Project

Other Terms and Conditions

Vacations and Holidays

Sick Leave and Other Leave

Disposition of Professional Fees

Human Subjects/Animal Welfare/Recombinant DNA Molecules

Vertebrate Animals

Recombinant DNA Molecules

Payback Reporting Requirements for Recipients

Prior to August 13, 1981

Effective August 13, 1981

Effective June 10, 1993 (NIH Revitalization Act)

Predoctoral Recipients

Postdoctoral Recipients

Short-term Training

Service Payback

Time Commitment

Initiation of Payback Service

Source of Funding

Timing of Service Obligation

Alternative Service

Financial Payback

Policy and Principal Calculation

Interest & Interest Rate Calculation

Extensions of Payback

Extensions of the 2 Year Period to Initiate Payback

Basis for Extensions

Extension to Complete Payback Service

Waiver Criteria

Certification of Payback Activities

Annual Payback Activities Certification (Form PHS 6031-1)

Annual Certification

Change of Address

Breaks in NRSA Support

National Health Service Corps

Appendix II-1 Receipt, Review, and Award Schedule

Appendix II-2 NRSA Financial Provisions

Appendix II-3 NRSA Forms

Modular Applications and Awards

Application Requirements

Biographical Sketch

Non-compliant Applications

Evaluation and Award

Post-Award Administration

Support of Scientific Meetings (Conference Grants)

Public Policy Requirements and Objectives

Allowability of Costs/Activities

Administrative Requirements

Intellectual Property: Publications and Copyright

Reporting and Record Retention

Progress/Final Report

Expenditure Report

Consortium Agreements

Administrative and Other Requirements

Public Policy Requirements and Objectives

Application of Cost Principles

Approval Authorities

Tangible Personal Property

Exempt Property

Nonexempt Property

Intellectual Property

Written Agreement

Awards to Foreign Institutions, International Organizations, and Domestic Grants with Foreign Components

Public Policy Requirements and Objectives

Funding and Payment

Allowability of Costs/Activities

Administrative Requirements

Changes in Project and Budget

Change in Scope

Change of Grantee Organization

Reporting and Record Retention

Grants to Federal Institutions and Payments to (or on Behalf of) Federal Employees under Grants

Department of Veterans Affairs (VA)-University Affiliations

Allowability of Costs/Activities

Administrative Requirements

Equipment Accountability

Procurement Requirements

Intellectual Property: Inventions and Patents

Reporting Requirements

Grants to For-Profit Organizations

Allowability of Costs

Cost Principles

Independent Research and Development Costs

Facilities and Administrative Costs (Indirect Costs)

Administrative Requirements

Intellectual Property: Inventions and Patents

Operating Authorities

Small Business Innovation Research and Small Business Technology Transfer Programs

Public Policy Requirements and Objectives

Allowability of Costs and Fee

Facilities and Administrative Costs (Indirect Costs)

Administrative Requirements

Market Research

Intellectual Property: Rights in Data, and Inventions and Patents

Research Patient Care Costs

Allowability of Costs

Computation of Research Patient Care Costs

Facilities and Administrative Costs

Special Procedures for Certain Hospitals

Consortium Participants/Contractors Under Grants

Financial Responsibilities

Program Requirements

Part III: Points of Contact

Master List of Links to Documents External to the NIHGPS

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