REVISED OCTOBER 2018. This document applies to all NIH grants and cooperative agreements for budget periods beginning on or after October 1, 2018

public policy requirements and objectives, Military Recruiting and ROTC Program Access to Institutions of Higher Education, seat belt use, labor standards under federally assisted construction, smoke free workplace, drug free workplace, flood disaster protection act, flood insurance, national environmental policy act, intergovernmental review of federal programs, uniform relocation assistance and real property acquisition policies act, standards of conduct, federal funding accountability and transparency act (FFATA), president's emergency plan for AIDS relief (PEPFAR), nondelinquency of federal debt, national historic preservation act, archaeological and historic preservation act, lead-based paint poisoning prevention act, investigational new drug applications/investigational device exceptions, inclusion of women/minorities as subjects in clinical research, metric system, lobbying, appropriation mandate, limited english proficiency, pro-children act, safe drinking water, salary limitation cap, restriction on distribution of sterile needles, select agents, public health security and bioterrorism preparedness and response act, usa patriot act, u.s. flag air carriers, text messaging while driving, restriction on abortions and exceptions, wild and scenic rivers act, protection of wetlands, promotion of legalization of controlled substances, public health security and bioterrorism preparedness and response act, research misconduct, research involving recombinant or synthetic nucleic acid molecules, reporting and assurance requirements for instutions receiving awards for training of graduate students for doctoral degrees, inclusion of children as subjects in clinical research, copeland act, controlled substances, conservation of petroleum and natural gas, data and safety monitoring, dual use research of concern, dissemination of false or deliberately misleading information, davis-bacon act, confidentiality of alcohol and drug abuse patient/client records, architectural barriers act, animal welfare, certificates of confidentiality, coastal zone management act, clinical trials.gov, clean air and clean water act, earthquake hazards reduction act, seismic safety of federal and federally assisted or regulated new building construction, human subjects protections, gun control, fly america act, hotel and motel fire safety act, human fetal tissue research, human embryo research and cloning ban, health and safety regulations and guidelines, endangered species act, equal employment opportunity, financial conflict of interest, federal information system security, age discrimination act, civil rights act, health insurance portability and accountability act (HIPAA), debarment and suspension, education amendment (title IX), rehabilitation act, lobbying, trafficking in persons

4.1 Public Policy Requirements and Objectives

NIH intends to uphold high ethical, health, and safety standards in both the conduct of the research it funds and the expenditure of public funds by its recipients. The public policy requirements specified in this section set many of those standards. NIH will not accept forms or other documentation bearing generic departmental signatures or their electronic equivalent (e.g., Department of Sponsored Research). All forms and documentation submitted to the NIH must reflect the name of the individual, electronic or otherwise, with the appropriate institutional authority to submit such information. The signature of the AOR on the application certifies that the organization complies, or intends to comply, with all applicable policies, certifications and assurances referenced (and, in some cases, included) in the application instructions. The policies, certifications and assurances listed in this section may or may not be applicable to the project, program, or type of applicant organization. Requirements/objectives are listed in alphabetical order.

As noted in this section, some requirements may necessitate the submission of a separate document (e.g., human subjects assurance, certification of IRB approval or institutional exemption, civil rights assurance). Applicants and recipients should take particular note of these requirements (for example, see specific sections on Human Subjects Protections and Civil Rights Protections), the absence or inadequacy of which may delay an award or render an applicant ineligible for award.

The recipient is responsible for: 1) establishing and maintaining the necessary processes to monitor its compliance and that of its employees, consortium participants, and contractors with these requirements; 2) taking appropriate action to meet the stated objectives; and, 3) informing NIH of any problems or concerns.

If a grant is awarded on the basis of false or misrepresented information, or if a recipient does not comply with these public policy requirements, NIH may take any necessary and appropriate action, including using any of the remedies described in Administrative Requirements-Enforcement Actions or other available legal remedies.

Exhibit 4 contains information to help the recipient determine what public policy requirements, objectives and appropriations mandates apply to its activities and whether a requirement should be included in a consortium agreementA formalized agreement whereby a research project is carried out by the recipient and one or more other organizations that are separate legal entities. Under the agreement, the recipient must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. These agreements typically involve a specific level of effort from the consortium organization's PD/PI and a categorical breakdown of costs, such as personnel, supplies, and other allowable expenses, including F&A costs. The relationship between the recipient and the collaborating organizations is considered a subaward relationship. (See Consortium Agreements chapter in IIB). or a contract for routine goods or services under the grant (see Glossary in Part I for definitions). The exhibit distinguishes between these types of transactions under a grant and indicates (by "Y" for Yes or "NA" for Not Applicable) whether a given requirement normally would apply. However, even if the exhibit indicates that a requirement is not applicable that requirement potentially could be applicable in a specific situation, e.g., if a contract under a grant involves research activity. Therefore, this exhibit should be used as general guidance only. The recipient should consult the terms and conditions of its award and should contact the GMO if it has any question concerning the applicability of a particular public policy requirement or objective.

Exhibit 4 also indicates where, in the NIHGPS, the individual public policy requirements, objectives and appropriation mandates are covered in more detail. The recipient should also consult its attorney, as appropriate, regarding particular questions about the governing statute or regulation as applied to its specific circumstances. Other cited policies or documents may provide additional information.

In addition to the requirements addressed in this section, there are applicable NIH administrative requirements outlined in the Administrative Requirements chapter.

Some programs may have special requirements and are covered in IIB.

Exhibit 4. Public Policy Requirements, Objectives and Appropriation Mandates *

Requirement, Objective, or Appropriation Mandate Recipient Subaward/Consortium Participant Contractor under Grant (routine goods/services)
Military Recruiting and ROTC Program Access to Institutions of Higher Education 4.1.19 Y N N
Seat Belt Use 4.1.28 Y NA NA
Labor Standards under Federally Assisted Construction 10.5.3

Y

(Construction Grants and major A&R Contracts Exceeding $100,000)

NA Y
Smoke-Free Workplace 4.1.29 Y NA NA
Drug-Free Workplace 4.1.7 Y NA NA
Flood Disaster Protection Act of 1973 –- Flood Insurance 10.10.1

Y

(Construction grants only)

NA NA
National Environmental Policy Act of 1969 (including Public Disclosure) 4.1.20 and 10.10.1 Y NA NA
Intergovernmental Review of Federal Programs under EO 12372 10.10.1

Y

(Construction grants only)

NA NA
Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 10.10.1 Y NA NA
Standards of Conduct 4.1.30 Y NA NA
Federal Funding Accountability and Transparency Act (FFATA) 4.1.8 and 8.4.1.5.5 Y

NA

If under $25,000

NA

If under $15,000

President's Emergency Plan for AIDS Relief (PEPFAR Program 4.1.22 Y Y Y
Nondelinquency on Federal Debt 4.1.21 Y Y NA
National Historic Preservation Act of 1966 - Archaeological and Historic Preservation Act of 1974 10.10.1

Y

(Construction Grants; any award involving major or minor A&R, or any work resulting in physical changes to real property)

Y Y
Lead-Based Paint Poisoning Prevention Act 10.10.1

Y

(Construction grants only)

Y Y
Investigational New Drug Applications/Investigational Device Exceptions 4.1.16 Y Y Y
Inclusion of Women/Minorities as Subjects in Clinical Research 4.1.15.8 Y Y NA
Metric System 4.1.18 and 10.10 Y Y Y
Lobbying (Appropriation Mandate) 4.2.6 Y Y Y
Limited English Proficiency 4.1.2.5 Y Y NA
Pro-Children Act of 1994 4.1.23 Y Y Y
Safe Drinking Water Act 10.10.1

Y

(Construction grants only)

Y Y
Salary Limitation/Cap (Appropriation Mandate) 4.2.10 Y Y NA
Restriction on Distribution of Sterile Needles (Appropriation Mandate) 4.2.9 Y Y Y
Select Agents (see Public Health Security & Bioterrorism Preparedness and Response Act) 4.1.24.1.1 Y Y Y
USA Patriot Act 4.1.33 Y Y Y
U.S. Flag Air Carriers 7.9.1 Y Y Y
Text Messaging While Driving 4.1.31 Y Y Y
Restriction on Abortions & Exceptions (Appropriation Mandates) 4.2.8 & 4.2.8.1 Y Y Y
Wild and Scenic Rivers Act of 1968 10.10.1

Y

(Construction grants only)

Y Y
Protection of Wetlands (EO 11990) 10.10.1

Y

(Construction grants only)

Y Y
Promotion or Legalization of Controlled Substances (Appropriation Mandate) 4.2.7 Y Y Y
Public Health Security and Bioterrorism Preparedness and Response Act (Select Agents) 4.1.24.1.1 Y Y Y
Research Misconduct 4.1.27 Y Y NA
Research Involving Recombinant or Synthetic Nucleic Acid Molecules (including Human Gene Transfer Research) 4.1.26 Y Y Y
Reporting and Assurance Requirements for Institutions Receiving Awards for Training of Graduate Students for Doctoral Degrees 4.1.25 Y Y NA
Inclusion of Individuals Across the Lifespan as Participants in Research 4.1.15.7 Y Y NA
Copeland Act, when required by statute 10.10.1

Y

(Construction grants only)

Y Y
Controlled Substances 4.1.5 Y Y Y
Conservation of Petroleum and Natural Gas (EO 12185) 10.10.1

Y

(Construction grants only)

Y Y
Data and Safety Monitoring 4.1.15.6 Y Y Y
Dual Use Research of Concern 4.1.24.2 Y Y Y
Dissemination of False or Deliberately Misleading Information (Appropriation Mandate) 4.2.3 Y Y Y
Davis-Bacon Act, when required by statute 10.10.1

Y

(Construction grants only)

Y Y
Confidentiality of Alcohol and Drug Abuse Patient/Client Records 4.1.4.2 Y Y Y
Architectural Barriers Act of 1968 10.10

Y

(Construction grants and any grant involving major A&R)

Y Y
Animal Welfare 4.1.1 Y Y Y

Acknowledgment of Federal Funding (Appropriation Mandate) 4.2.1

Y Y NA
Certificates of Confidentiality 4.1.4.1 Y Y Y
Coastal Zone Management Act of 1972 10.10

Y

(Construction grants only)

Y Y
Clinical Trials.gov 4.1.3 Y Y NA
Clean Air and Clean Water Act 10.10.1

Y

(Construction grants only); for contracts exceeding $100,000

Y Y
Earthquake Hazards Reduction Act of 1977 and Seismic Safety of Federal and Federally Assisted or Regulated New Building Construction (EO 12699) 10.10

Y

(Construction grants only)

Y NA
Human Subjects Protections 4.1.15 Y Y Y
Gun Control 4.2.4 Y Y Y
Fly America Act 4.1.11 Y Y Y
Hotel and Motel Fire Safety Act of 1990 14.6.1

Y

(Conference Grants Only)

Y Y
Human Fetal Tissue Research (Including Transplantation Research) 4.1.14 Y Y Y
Human Stem Cell Research 4.1.13 Y Y Y
Human Embryo Research and Cloning Ban (Appropriation Mandate) 4.2.5 Y Y Y
Health and Safety Regulations and Guidelines 4.1.12 Y Y Y
Endangered Species Act of 1973 10.10.1

Y

(Construction grants only)

Y Y
Equal Employment Opportunity 10.5

Y

(Construction grants and any grant involving major A&R)

Y

NA

If under $10,000

Financial Conflict of Interest 4.1.10

Y

(NA to Phase I of the SBIR/STTR programs and to Federal institutions)

Y NA
Federal Information System Security Management Act 4.1.9 Y Y Y
Age Discrimination Act of 1975 4.1.2.4

Y

(NA to foreign and international organizations)

Y

(NA to foreign and international organizations)

Y

(NA to foreign and international organizations)

Civil Rights Act of 1964 (Title VI) 4.1.2.1

Y

(NA to foreign and international organizations)

Y

(NA to foreign and international organizations)

Y

(NA to foreign and international organizations)

Health Insurance Portability and Accountability Act (HIPAA) 4.1.4.3

Y

(if a covered entity)

Y

(if a covered entity)

Y

(if a covered entity)

Debarment and Suspension 4.1.6

Y

(NA to certain foreign organizations)

Y

(NA to certain foreign organizations)

Y

If contract equals or exceeds $25,000 (NA to certain foreign organizations)

Education Amendments of 1972 (Title IX) 4.1.2.2

Y

(NA to foreign and international organizations)

Y

(NA to foreign and international organizations)

Y

(NA to foreign and international organizations)

Rehabilitation Act of 1973 (section 504) 4.1.2.3 and 10.10.1

Y

(NA to foreign and international organizations)

Y

(NA to foreign and international organizations)

Y

(NA to foreign and international organizations)

Lobbying (Federalwide Certification) 4.1.17

Y

Certification required if total costs expected to exceed $100,000

Y

Certification required if greater than $100,000 only

Y

Certification required on contracts greater than $100,000 only

Trafficking in Persons 4.1.32

Y

Private entities

Y

Private entities

NA

* NA: A designation of NA in this table indicates that a particular requirement does not apply to an otherwise eligible recipient, consortium participant, or contractor or may not apply because the type of activity covered is one not normally performed by such an entity.

Please note that the core set of National Policy Requirements for participating Federal research agencies is maintained by the National Science Foundation and is posted at: http://www.nsf.gov/bfa/dias/policy/rtc/index.jsp.