Legal Requirements

Legislation

Congress has the authority to impose conditions on the receipt of federal assistance funds. The cornerstone of Congress’ authority in the grants area is Article I, Section 8, of the United States Constitution, referred to as the Spending Power Clause. This allows Congress to enact specific laws (statutes) that authorize federal agencies to award grants and impose reasonable conditions on the receipt of federal assistance funds. Two of the most important are authorizing legislation and appropriation legislation

Authorizing Legislation

The authority to award grants is contained in the basic substantive legislation establishing a federal program. Such legislation may authorize program expenditures for a specific or indefinite number of years. In the NCI's case, the Public Health Service Act, Section 301 (42 United States Code [USC] 241), contains the general authority, as indicated by Congress, under which research grants are awarded.

Appropriation Legislation

Subsequent to the enactment of authorizing legislation, Congress generally enacts appropriation laws permitting funds to be obligated for a specific program. Appropriation bills begin in the House of Representatives and Congress greatly influences both program and grants administration decisions by controlling the amount of funds authorized annually and by setting conditions on the use of funds.

Regulations

Because the language of many laws is vague, federal agencies often need to publish regulations to clarify the details. A “rule” or “regulation” is a formal document issued by a federal agency that has general or particular applicability and legal effect. Compliance with federal regulations and statutes must be taken seriously. When finalized, regulations have the full force and effect of law.

The Code of federal Regulations (CFR), a codification of permanent rules published in the federal Register, contains the regulations for reviewing and administering NCI grants. These requirements provide additional guidance regarding program requirements and management. (Some programs have guidelines instead of or in addition to regulations.)

Two of the most important sections pertaining to NCI grants are:

• 42 CFR Part 52: Grants for Research Projects
• 45 CFR Part 75: Uniform Administrative Requirements, Cost Requirements, and Audit Requirements for HHS Awards

Office of Management and Budget (OMB) Circulars

In addition to the provisions of authorizing legislation and implementing regulations, the OMB issues government-wide circulars for managing grants that apply to all federal Executive agencies. When these agencies are required to apply the directives, the effect on recipients is often the same as regulation. Among the circulars relevant to grants administration are those that have to do with administrative requirements, cost principles, and audits.

Uniform Guidance: 2 CFR 200

Agency Implementations

In addition to issuing regulations to specify details of the enabling statutes, agencies often find it helpful to publish handbooks, guidelines, or manuals. The NCI implements federal regulations by following the policies contained in the NIH Grants Policy Statement and the NIH Guide to Grants and Contracts.

NIH Grants Policy Statement

The NIH Grants Policy Statement is a condensation of the NIH and the Department of Health and Human Services (HHS) grants administration policies, laws, and regulations. It provides both up- to-date policy guidance that serves as NIH standard terms and conditions of awards for grants and cooperative agreements and extensive guidance to individuals who are interested in NIH grants.

NIH Guide to Grants and Contracts

The NIH Guide to Grants and Contracts is the official publication for NIH medical and behavioral research grant policies, guidelines, and funding opportunities. It is also used by the NIH contracting offices and other HHS agencies to announce their funding opportunities. The NIH Guide serves in lieu of the federal Register in compliance with the Administrative Procedures Act.

Order of Precedence

As a general rule, requirements imposed by statute (42 USC 241 et seq.) and requirements imposed by program or general regulations (42 CFR Part 52 and 45 CFR Parts 75) are supplemented by program policies and terms and conditions of individual grants. When grant requirements are inconsistent, the following order of precedence usually applies: Constitutional mandates govern statutory provisions, and statutory mandates govern regulatory provisions. Regulations published in the Federal Register generally govern unpublished requirements, including grant terms and conditions. Questions concerning any apparent conflict in requirements or precedence of requirements governing grants should be addressed to the Grants Management Officer, who may consult with the Office of the General Counsel.

Standards of Conduct

The NIH depends on the funded research community to utilize a system of self-regulation coupled with appropriate NIH oversight. Ethical concerns, such as human subjects protection (45 CFR Part 46), promotion of animal welfare (P.L. 99-158 Section 495), removal of financial conflict of interest (42 CFR Part 50, Subpart F), and prevention of scientific misconduct (42 CFR Part 50, Subpart A) are all a part of this self-regulation.

The principle of self-regulation requires a high level of trust in the fundamental integrity of the research community and sufficient oversight to enable the NIH to assure the public that self-regulation is providing adequate safeguards for the ethical integrity of science.