- I. REGULATORY FRAMEWORK
OMB A-21: Cost Principles for Educational Institutions: This Circular establishes principles for determining costs applicable to grants, contracts, and other agreements with educational institutions. The principles deal with the subject of cost determination, and make no attempt to identify the circumstances or dictate the extent of agency and institutional participation in the financing of a particular project. The principles are designed to provide that the federal government bears its fair share of total costs, determined in accordance with generally accepted accounting principles, except where restricted or prohibited by law. http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html
OMB A-110: Administrative Requirements for Grants and Agreements: This Circular sets forth standards for obtaining consistency and uniformity among federal agencies in the administration of grants to and agreements with institutions of higher education, hospitals and other non-profit organizations. The principles contained in this document set the standards for how universities do business with federal awarding agencies, the financial systems that the universities must put into place, and how the universities must administer the awards. http://www.whitehouse.gov/omb/circulars/a110/a110.html
OMB A-133: Audits of States, Local Governments, and Nonprofit Organizations: This Circular is issued pursuant to the Single Audit Act of 1984, and the Single Audit Act Amendments of 1996. It sets forth standards for obtaining consistency and uniformity among federal agencies for the audit of States, local governments, and non-profit organizations expending federal awards. It requires an annual external audit of non-profits receiving federal funds. A sample of federal awards and their direct cost transactions are selected for testing (auditing) to determine that expenditures and procedures were appropriate, allowable, and allocable to the award.
Code of Federal Regulations: www.gpoaccess.gov/CFR
FAR (Federal Acquisition Regulations): http://farsite.hill.af.mil
Federal Register: www.gpoaccess.gov/fr/index.html
U.S. Code (U.S.C.): http://www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE
II ETHICAL CONDUCT IN SCIENCE & ORGANIZATIONAL OPERATIONS
Standards in Conduct: Grantees are to establish safeguards to prevent employees, consultants, members of governing bodies, and others who may be involved in grant-supported activities from using their positions for purposes that are, or give the appearance of being, motivated by a desire for private financial gain for themselves or others, such as those with whom they have family, business, or other ties. These safeguards must be reflected in written standards of conduct. Training for the PSU research community is available at: www.citiprogram.org
Misconduct in Science: Agencies and research institutions are partners who share responsibility for the research process. Federal agencies have ultimate oversight authority for Federally funded research, but research institutions bear primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with their own institution. Training for the PSU research community is available at: www.citiprogram.org
NSF Responsible and Ethical Conduct of Research (RCR): An institution must have a plan in place to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research. www.nsf.gov/pubs/policydocs/pappguide/nsf11001/aag_4.jsp#IVA . RCR training for the PSU research community is available at: www.citiprogram.org
Conflict of Interest: Each grantee institution employing more than fifty persons to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced or eliminated prior to the expenditure of the award funds. http://grants.nih.gov/grants/policy/coi/nih_review.htm.
The PSU Conflict of Interest policy is contained within the PSU Faculty Handbook, which is located at: https://www.plymouth.edu/office/vpaa/files/2012/05/Faculty-Handook-revised-3-7-2012.pdf
Financial Conflict of Interest in PHS-Funded Research Projects: The Public Health Service (PHS) regulations regarding financial conflict of interest were revised in 2011. It was designed to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. (42 C.F.R. Part 50, Subpart F). The PSU Financial Conflict of Interest for PHS-Funded Projects is located at: https://www.plymouth.edu/office/sponsored-programs/policies/
Data Access: Regulations concerning data access and data quality promotes the quality, objectivity, utility, and integrity of federal government information. http://thecre.com/quality/agency-database.html
III PROTECTION OF LIVING THINGS
Human Subject Protection (IRB): All research involving human subjects supported or otherwise subject to regulation by any Federal agency is covered by a policy set forth in a Common Rule, “Protection of Human Subjects”. (http://www.access.gpo.gov/nara/cfr/waisidx_99/45cfr690_99.jspl). Human Research Protection Training (NIH): http://cme.cancer.gov/c01. HHS Office of Human Research Protection: http://www.hhs.gov/ohrp/ The PSU IRB information is located at: http://www.plymouth.edu/office/institutional-review-board/
Animal Welfare (IACUC): Any grantee performing research on vertebrate animalsshall comply with the Animal Welfare Act [7 U.S.C. 2131 et seq.] and the regulations promulgated thereunder by the Secretary of Agriculture [9 CFR 1.1-4.11] pertaining to the humane care, handling, and treatment of vertebrate animals held or used for research, teaching or other activities supported by Federal awards. (USDA and PHS): www.aphis.usda.gov/animal_welfare/index.shtml. The PSU IACUC information is located at the OSP website: http://www.plymouth.edu/office/sponsored-programs/
Confidentiality of Patient Records/HIPAA Patient Privacy Rule: HIPAA protects the privacy of individually identifiable health information and sets national standards for the security of electronic protected health information; and the confidentiality provisions of the Patient Safety Rule, which protect identifiable information being used to analyze patient safety events and improve patient safety. www.hhs.gov/ocr/hipaa
Inclusion of Children, Women and Minorities in Clinical Research: The NIH is mandated by law (NIH Revitalization Act of 1993, PL103-43) to ensure the inclusion of women and minority groups in clinical research. The goal is to ensure that individuals are included in clinical research in a manner that is appropriate to the scientific question under study. http://grants.nih.gov/grants/funding/women_min/women_min.htm
Endangered Species Act of 1973: The 1973 Endangered Species Act provided for the conservation of ecosystems upon which threatened and endangered species of fish, wildlife, and plants depend. http://www.fws.gov/laws/lawsdigest/esact.html
IV STANDARD CERTIFICATION DIRECTIVES
Byrd Amendment on Lobbying & Lobby Disclosure Act, 1995: This regulation (Section 1352, Title 31, U.S. Code) prohibits the use of any appropriated funds to pay any person for influencing or attempting to influence an officer or employee of Federal Agency, a member of Congress, an officer or employee of Congress, or an employee of a member of Congress in connection with any of the following: awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement. A certification is required for an award of a Federal contract, grant or cooperative agreement exceeding $100,000.
Hatch Act: The Hatch Act (5 U.S.C. § 7321 – 7326) restricts the political activity of individuals principally employed by state or local executive agencies and who work in connection with programs financed in whole or in part by federal loans or grants.
Davis Bacon Act: The Davis-Bacon Act (40 U.S.C §§276a et seq.) establishes minimum wages to be paid to laborers and mechanics on construction contracts to which the U.S. is a party involving public buildings or public works within the United States.
Trafficking in Persons: Section 106(g) of the Trafficking Victims Protection Act of 2000, as amended (22 U.S.C. 7104), requires that all grant awarding agencies must include a condition authorizing termination of an award if the grantee or a subgrantee engages in certain activities related to trafficking in persons.
Debarment & Suspension: Suspension and Debarment actions prevent companies and individuals from participating in government contracts, subcontracts, loans, grants and other assistance programs. The effect of Suspension and debarment actions by a Federal agency is government-wide and protects the government from doing business with individuals/companies/recipients who pose a business risk to the government. (2 CFR Part 180 and 2 CFR Part 1532). Refer to the Excluded Parties List for a list of those who are debarred or suspended: https://www.epls.gov
Non-Delinquency on Federal Debt: A Federal policy theme has been collection of debts owed the Federal Government. In 1982 the U.S. Congress passed the Debt Collection Act. On November 25, 1988, the Office of Management and Budget issued OMB Circular A-129 (Rev.) on Managing Federal Credit Programs. A-129 in part addresses delinquent debt collection, and grants, contracts, and other administrative debt. http://www.whitehouse.gov/omb/circulars_a129rev
Bayh-Dole Act: In 1980, the Bayh-Dole Act (PL 96-517, Patent and Trademark Act Amendments of 1980) created a uniform patent policy among the many federal agencies funding research. As a result of this law, universities retain ownership to inventions made under federally funded research. In return, universities are expected to file for patent protection and to ensure commercialization upon licensing. The royalties from such ventures are shared with the inventors; a portion is provided to the University and department/college; and the remainder is used to support the technology transfer process.
V ANTI-DISCRIMINATION (EMPLOYMENT)
Civil Rights Act of 1964: Section 602 of the Civil Rights Act of 1964 (42 U.S.C §200d et seq.) provides that no person in the U.S. shall, on the grounds of race, color or national origin, be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under any program or activity receiving Federal financial assistance.
Rehabilitation Act of 1973/Americans Disabilities Act: Section 504 of the Rehabilitation Act of 1973, as amended (29 U.S.C §794) provides that “no otherwise qualified individual with a disability in the United States…shall, solely by reason of her or his disability, be excluded from the participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance….”
Sex Discrimination Act: Subject to certain exceptions regarding admission policies at certain religious and military organizations, Title IX of the Education Amendments of 1972 (20 U.S.C §§1681-1686), prohibits the exclusion of persons on the basis of sex from any education program or activity receiving Federal financial assistance.
Age Discrimination Act, 1975: The Age Discrimination Act of 1975, as amended (42 U.S.C §6101 et seq.), provides that pursuant to regulations issued by DHHS “no person in the United States shall, on the basis of age, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any program or activity receiving Federal financial assistance.”
Equal Employment Opportunity (EEO): The Equal Employment Opportunity Act of 1972 (Public Law 92-261) instituted the federal Equal Employment Opportunity program, which is designed to ensure fair treatment to all segments of society without regard to race, religion, color, national origin, or sex.
Affirmative Action for Vietnam Vets, 1972: Requires affirmative action be taken to employ Vietnam era veterans, special disabled and disabled veterans by employers receiving $10,000 or more in Federal funds. This was amended in 1992 to cover all veterans (38 U.S.C § 4212).
Drug-Free Schools and Campuses Act of 1989: Part 86 of the Drug and Alcohol Abuse Prevention Regulations (Education Department General Administrative Regulations [EDGAR]), requires as a condition of receiving funds or any other form of financial assistance under any federal program, an institution of higher education must certify that it has adopted and implemented a program to prevent the unlawful possession, use, or distribution of illicit drugs and alcohol by students and employees. If audited, failure to comply with the Drug and Alcohol Abuse Prevention Regulations may cause an institution to forfeit eligibility for federal funding.
Drug Free Workplace: The Drug-Free Workplace Act of 1988 (41 U.S.C. § 701 et seq.) requires that all organizations receiving grants from any Federal agency agree to maintain a drug-free workplace. By signing the application, the organization agrees that the grantee will provide a drug-free workplace and will comply with the requirement of notification if an employee is convicted of violating a criminal drug statute. (Government wide requirements for Drug-Free Workplace for Financial Assistance are found in 2 CFR part 182.)
VI STANDARD ADMINISTRATIVE REQUIREMENTS
Buy American Act: Grantees and sub-recipients must comply with the requirements of the “Buy American Act” (41 U.S.C. 10a-c) which requires that they purchase only American-made equipment and products in expending grant funds.
Fly American Act: The Fly America Act is applicable to all travel funded by Federal funds and requires the use of “U.S. flag” airlines, with a few exceptions. (49 U.S.C. Subtitle VII, Part A, subpart I, Chapter 401, 40118 – Government-Financed Air Transportation.)
Smoke-Free Workplace: Federal grantees are strongly encouraged to provide smoke-free workplaces and to promote the nonuse of tobacco products. The term “workplace” is defined to mean office space (including private offices and other workspace), conference or meeting rooms, corridors, stairways, lobbies, rest rooms, cafeterias, and other public spaces.
Use of Seat Belts: Pursuant to EO 13043 (April 16, 1997), Increasing the Use of Seat Belts in the United States, grantees are encouraged to adopt and enforce on-the-job seat belt policies and programs for their employees when operating vehicles, whether organizationally owned or rented or personally owned.
Salary/Day Rate Caps: None of the funds appropriated in the governing appropriation Act for the NIH, shall be used to pay the salary of an individual through a grant or other extramural mechanism at a rate in excess of Executive Level 1. Applications and proposals with categorical direct cost budgets reflecting direct salaries of individuals in excess of Executive Level 1 per year will be adjusted in accordance with the legislative salary limitation. Current and historical information on the applicable salary cap for each fiscal year is found on the NIH OER Salary Cap Summary webpage: http://grants.nih.gov/grants/policy/salcap_summary.htm
Military/ROTC Recruiting: Section 588 of the National Defense Authorization Act of 1995, amended (10 U.S.C. §983), precludes grant awards to institutions of higher education that Department of Defense determines have an anti-Reserve Officer Training Corps (ROTC) policy or practice (regardless of when implemented) that either prohibits or, in effect, prevents the Secretary of Defense from gaining entry to campuses or access to students or information for military recruiting.
Acknowledgement of Federal Grant Support: All grantees must acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid invitations, and other documents describing projects or programs funded in whole or in part with Federal money. Grantees are required to state (1) the percentage and dollar amounts of the total program or project costs financed with Federal money and (2) the percentage and dollar amount of the total costs financed by nongovernmental sources.
Federal Funding Accountability & Transparency Act, 2006: The Federal Funding Accountability and Transparency Act of 2006, as amended (FFATA), (2 CFR part 170) requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000.
No Text Messaging While Driving: Executive Order 13513 (E.O. 13513) requires each Federal agency to encourage contractors, subcontractors, and grant and cooperative agreement recipients and subrecipients to adopt and enforce policies that ban text messaging while driving company-owned or -rented vehicles or Government Owned Vehicles, or while driving Personally Owned Vehicles when on official Government business or when performing any work for or on behalf of the Government.
Freedom of Information Act: This Act guarantees access by the general public to data held by its government. It establishes a “right-to-know” legal process by which requests may be made for government-held information, to be received freely or at minimal cost, barring standard exceptions.
VII ENVIRONMENTAL PROTECTION
Clean Air Act: This Act applies to all agreements in amounts in excess of $100,000 and requires, at proposal submission, that the applicant must certify whether any facilities to be used in the proposed work are listed by the EPA (Environmental Protection Agency) on the list of violating facilities. The certification also requires the awardee to comply with all requirements of Section 14 of the Clean Air Act relating to inspection, monitoring, entry, reports, and facilities. Federal awards are withheld from any applicant on the EPA violation facility list.
Clean Water Act: This Act applies to all agreements in excess of $100,000 and requires, at proposal submission, that the applicant must certify whether any facilities to be used in the proposed work are listed by the EPA (Environmental Protection Agency) on the list of violating facilities. The certification requires the awardee to comply with all requirements of the Clean Water Act relating to: inspection, monitoring, entry, reports, and facilities. Federal awards are withheld from any applicant on the EPA violation facility list.
National Environmental Policy Act (NEPA) of 1969: This Act requires Federal agencies to consider the reasonably foreseeable environmental consequences of all grant-supported activities. As part of the implementation of this Act, grantees are required to promptly notify the sponsor Federal agency of any reasonably foreseeable impacts on the environment from grant-supported activities, or certify that no such impacts will arise upon receipt of a grant award.
VIII SAFETY, SECURITY & BIOSAFETY
Export Control Act: Export controls, set forth in regulations administered by several federal agencies, [DOC (Department of Commerce) via the EAR (Export Control Regulation); DOS (Department of State) via ITAR (International Traffic in Arms Regulations); DOT (Department of Treasury) via OFAC (Office of Foreign Assets Control) regulations] impose access, dissemination, and participation restrictions on the transfer and retransfer of “controlled” software code and information and on the export and re-export of tangible items. An export is defined as the shipment of tangible items and the transmission or transfer of software code or information to another country, while a “deemed export” is the disclosure of controlled software code or information to foreign nationals in the United States. The U.S. Department of Commerce must issue an export license or provide an exception to or exclusion from license requirements before any controlled tangible item, software or information in the U.S. on the Commerce Control List (CCL) may be exported or re-exported. Likewise, if a tangible item, software or information is on the U.S. Munitions List (USML), the U.S. State Department must issue an export license or provide for an exception to or exclusion from licensing requirements.
USA PATRIOT Act: The act, which is a direct outgrowth of the September 11, 2001 tragedy, places restrictions on persons who possess select agents and provides criminal penalties for possession of such agents that cannot be justified for specific peaceful purposes. The obligation for compliance is applied to the individual and requires the prohibition of restricted persons from: a) shipping/transporting; and b) possessing/receiving select agents listed and not exempted under the 1996 Anti-Terrorism and Effective Death Penalty Act’s implementing regulations.
Public Health Security & Bio-terrorism Preparedness, 2002: The law is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. It applies to all Federal awards and requires all persons possessing biological agents/toxins deemed a threat to animal or plant health and/or animal or plant products to notify the USDA (US Department of Agriculture), APHIS (Animal Plant Health Inspection Service). Select Agents and Toxins Listing: www.selectagents.gov
Data & Safety Monitoring: It is the policy of the NIH that each Institute and Center (IC) should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials. http://grants.nih.gov/grants/policy/hs/data_safety.htm
Recombinant DNA Molecules: The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) (January 2011 or latest revision) apply to all research projects that involve recombinant DNA and are conducted at or sponsored by an organization that receives NIH support for recombinant DNA research. A copy of the NIH Guidelines is available at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
Controlled Substances: If controlled substances are proposed to be administered as part of a research protocol or if research is to be conducted on the drugs themselves, applicants/grantees must ensure that the DEA requirements, including registration, inspection, and certification, as applicable, are met. Regional DEA offices can supply forms and information concerning the type of registration required for a particular substance for research use.