Research compliance · 22 pages
Research compliance & reporting
Answer-first explainers for the rules that govern federally funded research in the US — Uniform Guidance, the Single Audit, human- and animal-subjects oversight, export controls and financial reporting — as a neutral standards reference.
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All 22 research compliance & reporting pages
Single Audit
A Single Audit is the organisation-wide audit required under Uniform Guidance (2 CFR 200, Subpart F) for any non-federal entity that expends federal awards at or above the spending threshold in a fiscal year. The 2024 OMB revisions raised that threshold to $1,000,000, effective for fiscal years beginning on or after 1 October 2024. It is conducted under GAGAS (the “Yellow Book”).
DefinitionUniform Guidance
Uniform Guidance is 2 CFR Part 200, the U.S. Office of Management and Budget’s consolidated rulebook of uniform administrative requirements, cost principles, and audit requirements for federal awards. Nicknamed the “Super Circular”, it merged eight earlier OMB circulars into one framework in 2014. The 2024 revisions raised the Single Audit threshold to $1,000,000 and the de minimis indirect cost rate to 15%.
DefinitionSAM.gov registration
SAM.gov registration is enrolment in the System for Award Management, the official U.S. government database that entities must join before they can receive federal awards. Registration assigns a Unique Entity ID (UEI), a 12-character alphanumeric identifier that replaced the DUNS number in April 2022. Registration must be renewed annually to remain active and eligible.
DefinitionFederal Financial Report (FFR)
The Federal Financial Report (FFR), submitted on Standard Form SF-425, is the report of expenditures and financial status that a recipient files on a federal award. It reconciles cash received against costs incurred, including direct and indirect expenditures, any cost share, and unliquidated obligations. Agencies require it periodically and at award close-out to confirm proper use of funds.
DefinitionIndirect costs (F&A)
Indirect costs, also known as facilities and administrative (F&A) costs, are expenses that support research but cannot be attributed directly to a single project — such as buildings, utilities, libraries and administration. Institutions recover them through a negotiated indirect cost rate applied to direct costs. Entities without a negotiated rate may use the Uniform Guidance de minimis rate, raised to 15% under the 2024 revisions.
DefinitionCost sharing
Cost sharing (also called matching) is the portion of a project’s total cost that is not paid by the sponsor but is contributed by the recipient or a third party. It may be mandatory (required by the programme), voluntary committed (offered in the proposal and then binding), or voluntary uncommitted. Committed cost sharing must be documented, verifiable and allowable under Uniform Guidance.
DefinitionIACUC
An IACUC, or Institutional Animal Care and Use Committee, is the institution-level body responsible for overseeing animal research to ensure humane care and regulatory compliance. It reviews and approves animal-use protocols, inspects facilities, and monitors ongoing studies under the Animal Welfare Act (enforced by USDA) and the PHS Policy on Humane Care and Use of Laboratory Animals. Approval is required before animal work begins.
DefinitionBiosafety levels
Biosafety levels (BSL-1 through BSL-4) are four ascending tiers of laboratory containment that specify practices, safety equipment and facility design for working with biological agents. The level rises with the agent’s risk of infection and severity of disease. They are defined in the CDC and NIH publication Biosafety in Microbiological and Biomedical Laboratories (the BMBL), the U.S. reference standard.
DefinitionBelmont Report
The Belmont Report, published in 1979, is the foundational U.S. statement of ethical principles for research involving human subjects. It sets out three core principles — respect for persons, beneficence, and justice — and their applications: informed consent, assessment of risks and benefits, and fair selection of subjects. It became the ethical basis of the Common Rule and IRB review.
DefinitionCommon Rule
The Common Rule is the U.S. Federal Policy for the Protection of Human Subjects, codified at 45 CFR 46 (Subpart A) and adopted by numerous federal agencies. It requires Institutional Review Board review of human-subjects research, informed consent, and additional protections for vulnerable groups. A major revision took effect in 2018, adding new consent and exemption provisions. It operationalises the Belmont Report principles.
DefinitionInstitutional Review Board (IRB)
An Institutional Review Board (IRB) is a committee that reviews, approves and monitors research involving human subjects to protect participants’ rights and welfare. Required under the Common Rule (45 CFR 46), it assesses risks and benefits, the informed-consent process, and equitable subject selection before research may begin. The IRB can approve, require modifications to, or disapprove proposed studies.
DefinitionDual Use Research of Concern (DURC)
Dual Use Research of Concern (DURC) is life-sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, products or technologies that could be directly misused to threaten public health and safety, agriculture, the environment or national security. U.S. policy requires institutional review and risk mitigation; a 2024 unified policy consolidated DURC oversight with the P3CO framework for pathogens of pandemic potential.
DefinitionFinancial Conflict of Interest (FCOI)
A Financial Conflict of Interest (FCOI) arises when a researcher’s significant financial interest could directly and significantly affect the design, conduct or reporting of federally funded research. Under the U.S. Public Health Service 2011 regulation (42 CFR 50, Subpart F), investigators must disclose significant financial interests, and the institution determines whether an FCOI exists and how to manage, reduce or eliminate it.
DefinitionEffort reporting
Effort reporting is the process of certifying the proportion of an individual’s total professional activity that was devoted to, and charged to, a federal award. It confirms that salaries charged to grants are reasonable in relation to the work performed. Under Uniform Guidance (2 CFR 200), charges must be supported by records that accurately reflect the work, replacing the prescriptive effort-percentage rules of the older OMB circulars.
ComparisonGrant vs contract
The difference between a grant and a contract is purpose and control. A grant is financial assistance given to support a public purpose, with the recipient retaining substantial autonomy over how the work is carried out. A contract is a procurement instrument: the government acquires specific goods or services for its own direct benefit, with detailed deliverables and tighter oversight. Cooperative agreements sit between the two.
ComparisonITAR vs EAR
ITAR and EAR are the two principal U.S. export-control frameworks. ITAR (International Traffic in Arms Regulations), administered by the State Department’s DDTC, controls defense articles and services on the U.S. Munitions List (USML). EAR (Export Administration Regulations), administered by Commerce’s Bureau of Industry and Security, controls dual-use and commercial items on the Commerce Control List (CCL) via ECCN classification. Both recognise the fundamental-research exclusion.
DefinitionAllowable costs
Allowable costs are costs that may be charged to a federal award because they meet the Uniform Guidance cost principles in 2 CFR Part 200, Subpart E. To be allowable a cost must be reasonable and necessary, allocable to the award, conform to any limitations in the award terms, and be treated consistently. Costs failing any test are unallowable and cannot be charged.
DefinitionPrior approval
Prior approval is the requirement that a recipient obtain the federal awarding agency’s written approval before taking certain actions on an award — such as a change in scope, a change of principal investigator, or incurring particular costs. The actions requiring it are set out in 2 CFR 200.308 and in award terms. Acting without required prior approval can render the resulting costs unallowable.
DefinitionSubrecipient monitoring
Subrecipient monitoring is the responsibility of a pass-through entity to oversee each subrecipient it funds under a federal award, ensuring the subaward is used for authorised purposes and complies with award terms and the cost principles. Required by 2 CFR 200.332, it includes a risk assessment of the subrecipient, reviewing financial and performance reports, and following up on any deficiencies or audit findings.
DefinitionResearch misconduct
Research misconduct is defined by U.S. federal policy as fabrication, falsification, or plagiarism (FFP) in proposing, performing, reviewing or reporting research. For Public Health Service-funded work it is governed by the Office of Research Integrity under 42 CFR Part 93. A finding requires a significant departure from accepted practices, committed intentionally, knowingly or recklessly, and proven by a preponderance of the evidence. Honest error and honest disagreement are explicitly excluded.
DefinitionNIH Grants Policy Statement
The NIH Grants Policy Statement (NIHGPS) is the National Institutes of Health’s comprehensive statement of the terms and conditions that apply to its grant and cooperative-agreement awards. Incorporated by reference into each Notice of Award, it consolidates NIH policy on eligibility, administration, allowable costs, prior approvals and reporting, building on the federal-wide Uniform Guidance and adding NIH-specific requirements.
DefinitionTime and effort certification
Time and effort certification is the process of certifying, after the fact, the proportion of an individual’s total professional effort that was devoted to each federally funded project. It supports the salary and wage costs charged to federal awards, showing they are reasonable and reflect the work actually performed. Uniform Guidance requires the underlying records but does not mandate a specific certification form, allowing institutions some flexibility in method.
