NIH Grants Policy Statement   (10/98)
Part II: Terms and Conditions of NIH Grant Awards-Part 1 of 7

COMPLETING THE PREAWARD PROCESS Following the peer review process, applications that an IC may fund are reviewed for a number of other considerations. These include, as applicable, alignment with NIH's funding principles (see below), review of the project budget, assessment of the applicant's management systems, and determination of applicant compliance with eligibility and public policy requirements. Based on the outcome of these reviews, the IC will determine whether an award can be made, if special conditions are required, and the appropriate level of funding. Although these reviews and determinations are initially made prior to the issuance of a new award, grantees must continue to comply with eligibility and public policy requirements and maintain adequate management systems throughout the period of support. The preaward process for noncompeting continuation applications is a streamlined version of this process, including an assessment of progress (see "Administrative Requirements     Noncompeting Continuation Awards"). Funding Principles NIH awards grants on the basis of reasonable and allowable costs consistent with the principles of sound cost management and in consideration of IC priorities (e.g., program relevance), constraints on the growth of average grant costs, and available funds. NIH has also adopted the following core funding principles specifically for research project grants: NIH will award noncompeting research project grants at committed levels. Determination of commitments for future years must take into consideration stability of support for investigators, optimum portfolio balance, and opportunities to address emerging problems. Eligibility NIH awards may be made only to eligible applicants. Continued funding is dependent on the grantee's maintaining eligibility. In general, domestic or foreign, public or private, non-profit or for-profit organizations are eligible to receive NIH grants. However, on the basis of statutory, regulatory, or published policy limitations, under certain programs or types of awards, NIH may limit eligibility to, or exclude from eligibility, classes or types of entities. Examples would be limitations on the participation of foreign entities, and programs under which only small businesses are eligible applicants. The determination of eligibility includes verification of the applicant's status. The applicant may be required to provide proof of its status through documentation or by signing a certification (e.g., a small business applying under the SBIR or STTR programs). In addition to reviewing applicants' organizational eligibility, NIH may consider other eligibility factors relating to the applicant's ability to responsibly handle and account for Federal funds and to carry out the project. These factors include the applicant's intended role in the project, where the project will be performed, the role of the PI in the project, and his/her employment and citizenship status. Although some of these same considerations are reviewed as part of the peer review, at this stage in the process NIH's concern is making an award to a legal entity that will be accountable both for the performance of the approved project or activity and the appropriate expenditure of funds. NIH will not make an award to an applicant that does not have a substantive role in the project and would simply serve as a conduit for another entity. The IC GMO will also verify whether the applicant, proposed PI, or other key personnel are debarred or suspended from participation in Federal assistance programs, and whether the applicant is delinquent on the repayment of any Federal debt (see "Public Policy Requirements and Objectives     Ethical and Safe Conduct in Science and Organizational Operations" for certification requirements). Although PIs and other personnel under research projects are not required to be U.S. citizens, NIH will not intercede on behalf of non-citizens whose stay in the United States may be limited by their visa status. As a result, NIH requires the applicant to determine and indicate, in its application, that such individuals' visas will allow them to remain in this country long enough for them to be productive on the project. If a grant is awarded on the basis of this information and the individual's visa does not allow for such a stay, NIH may terminate the grant (see "Administrative Requirements     Changes in Project and Budget" and "Administrative Requirements     Enforcement Actions     Suspension, Termination, and Withholding of Support"). The eligibility requirements for trainees and fellows are addressed in "National Research Service Awards" in Part III. NIH continues its oversight of eligibility considerations, from both a legal and programmatic perspective, in the postaward phase by monitoring changes in grantee and project status and taking actions necessary to protect the Federal Government's interests. Cost Analysis and Assessment of Management Systems The GMO will ensure that a cost analysis is performed on any application that includes a detailed budget. Cost analysis involves obtaining cost breakdowns, validating cost data, evaluating specific elements of cost, and examining data to determine the necessity for, and the reasonableness and allowability of, the costs included in the application budget. The extent of cost analysis will depend on the type of funding instrument, the complexity of the project, prior experience with the applicant, and other factors. Detailed information on the applicable cost principles and on allowable and unallowable costs under NIH grants is provided in "Cost Considerations" in this Part. In addition to considering the specific information provided in the application, the GMO determines the adequacy of the applicant's financial and business management systems that will support the expenditure of and accountability for NIH funds. When an applicant has had no prior Federal grants or cost-reimbursement contracts, the GMO may review the applicant's financial management and other management systems before award, or within a reasonable time after award, to determine their adequacy and acceptability. For an applicant with prior NIH or other Federal cost-reimbursement awards, the GMO may review recent audit reports and other available information to determine whether the applicant's management systems meet the standards established in 45 CFR Part 74 or 92, as appropriate. The GMO will advise the applicant if additional information is required. On the basis of the review results, the GMO will determine the need for any corrective action and may impose special conditions on the award. OVERVIEW OF TERMS AND CONDITIONS Parts II and III of this policy statement are the terms and conditions of NIH grants and cooperative agreements and will be incorporated by reference in all NIH awards as specified in "Introduction     Background and Supersession". These terms and conditions are not intended to be all-inclusive. In addition to the requirements included in this policy statement, NIH grants are subject to the requirements of: The authorizing program legislation; Program regulations, including those at 42 CFR Part 52; Other statutory requirements, such as those included in appropriations acts; and HHS requirements in 45 CFR Part 74 or 92, as appropriate for the type of recipient organization and the type of activity (e.g., research). Notice of these latter requirements will generally be provided in the Notice of Grant Award (NGA), but such notice is not required in order for the award to be subject to the requirements of pertinent statutes and regulations. An individual award may also contain award-specific terms and conditions. For example, the GMO may include terms or conditions necessary to address concerns about an applicant's management systems. Program and administrative policies and the terms and conditions of individual awards are intended to supplement, rather than substitute for, governing statutory and regulatory requirements. Thus, the requirements of this policy statement apply in addition to governing statutory and regulatory requirements, and award-specific terms apply in addition to the requirements of this policy statement. This policy statement is intended to be compliant with governing statutes and the requirements of 45 CFR Parts 74 and 92, as modified by previously approved waivers and deviations. However, if there is a perceived conflict between or among these three categories of requirements; i.e., statutory and regulatory requirements, this policy statement, and award-specific terms and conditions, or if the grantee has other questions concerning award terms and conditions, the grantee should request written clarification from the IC GMO. This may be done at any time; however, if the inclusion of the term or condition would cause the grantee not to accept the award or to be unable to comply, the question should be raised before funds are requested from the HHS payment system. By drawing funds from the HHS payment system, the grantee agrees to the terms and conditions of the award as interpreted and applied by the awarding office. PUBLIC POLICY REQUIREMENTS AND OBJECTIVES The following subsections deal with public policy requirements and objectives applicable to NIH awards. The term "public policy" indicates that the requirement is based on social, economic, or other objectives or considerations that may be attached to the expenditure of Federal funds by grantees and contractors, in general, or may relate to the expenditure of Federal funds for research or other specified activities, in particular. In addition to cross-cutting requirements that apply to Federal agencies and their grant programs, NIH grantees are subject to requirements contained in NIH's annual appropriations acts that apply to the use of NIH grant funds. Some of those requirements are included here since they have been included in the appropriations acts for several years without change, but those requirements may be changed or other requirements may be added in the future. 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 grantees. The public policy requirements specified below set many of those standards. The signature of the authorized official on the application indicates that the organization is in compliance with, or intends to comply with, these requirements. Applicants and grantees should take particular note of requirements for assurances or certifications, the absence or inadequacy of which may delay an award or make an applicant ineligible for award. In general, assurances are required on a one-time basis, with updating or changes as necessary, and certifications are required annually and are accomplished by the authorized institutional official's signature on the application (see discussion of individual requirements below). The grantee is responsible for establishing and maintaining the necessary processes to monitor its compliance and that of its employees and contractors with these requirements, taking appropriate action to meet the stated objectives, and informing NIH of any problems or concerns. If a grant is awarded on the basis of false or misrepresented information, or if a grantee 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. The HHS Inspector General (IG) maintains a post office box and a toll-free hotline for receiving information from individuals concerning fraud, waste, or abuse under HHS grants and cooperative agreements. This information is kept confidential, and callers are not required to give their names. The address and telephone number are included in Part IV. Table 2 is provided to assist the grantee in determining the applicability of particular public policy requirements and objectives to its own activities as well as in determining whether to include a requirement in a consortium agreement or a contract for routine purchased goods or services under the grant (see "Glossary" for definitions). The table distinguishes between these types of transactions under a grant and indicates whether a given public policy requirement would normally apply. However, even if the table indicates a requirement is "Not Applicable," that public policy requirement could potentially be applicable in a specific situation; e.g., if a contract under a grant involves research activity. Therefore, this table should be used as general guidance only. The grantee should consult the terms and conditions of its award and contact the awarding office GMO if there is any question concerning the applicability of a particular public policy requirement or objective. The listing in Table 2 provides summary information on each requirement and indicates where, in this policy statement, it is covered in more detail. However, the governing statute, regulations, or other cited policies or documents should be consulted for complete information. TABLE 2 Public Policy Requirements and Objectives Requirement or Objective Grantee Consortium Participant Contractor under Grant (Rou tine Goods/Services)* GPS Section for Additional Information Acknowledgment of Federal Funding X X N/A Part II-Availability of Information Part III-National Research Service Awards Age Discrimination Act of 1975 X N/A to foreign and international organizations X N/A to foreign and international organizations) X N/A to foreign and international organizations Part II-Civil Rights Part III-National Research Service Awards; Awards to Foreign Institutions, International Organizations and Domestic Grants with Substantial Foreign Components (hereafter, in this Table, Awards to Foreign Institutions) Animal Welfare X X X Part II-Animal Welfare Part III-National Research Service Awards; Awards to Foreign Institutions Ban on Human Embryo Research and Cloning X X X Part II-Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients or Recipients of Services (hereafter, in this Table, Requirements Affecting the Rights and Welfare of Individuals) Civil Rights Act of 1964 (Title VI) X N/A to foreign and international organizations X N/A to foreign and international organizations X N/A to foreign and international organizations Part II-Civil Rights Part III-National Research Service Awards; Awards to Foreign Institutions Confidentiality of Patient Records X X X Part II-Requirements Affecting the Rights and Welfare of Individuals Conflict of Interest X (42 CFR Part 50 N/A to SBIR/STTR Phase I) X N/A Part II-Ethical and Safe Conduct in Science and Organizational Operations Controlled Substances X X X Part II-Requirements Affecting the Rights and Welfare of Individuals Debarment and Suspension X (N/A to certain foreign organizations) X (N/A to certain foreign organizations) If contract equals or exceeds $100,000; N/A to certain foreign organizations Part II-Ethical and Safe Conduct in Science and Organizational Operations Part III-Awards to Foreign Institutions Drug-Free Workplace X N/A N/A Part II-Ethical and Safe Conduct in Science and Organizational Operations Part III-Awards to Foreign Institutions Education Amendments of 1972 (Title IX) X (N/A to foreign and international organizations X (N/A to foreign and international organizations) X (N/A to foreign and international organizations) Part II-Civil Rights Part III-National Research Service Awards; Awards to Foreign Institutions Elimination of Architectural Barriers to the Handicapped X N/A X Part III-Construction Grants Flood Insurance X N/A NA Part III-Construction Grants The Freedom of Information Act Applies to covered material in NIH's possession Applies to covered material in NIH's possession Applies to covered material in NIH's possession Part II-Availability of Information Health and Safety Guidelines X X Applies as required by Federal, State or local regulations Part II-Ethical and Safe Conduct in Science and Organizational Operations Historic Properties/Archeological Sites X N/A X Part III-Construction Grants Human Subjects X X X Part II-Requirements Affecting the Rights and Welfare of Individuals Part III-National Research Service Awards; Awards to Foreign Institutions Inclusion of Children as Subjects in Clinical Research X X N/A Part II-Requirements for Inclusiveness in Research Design Part III-National Research Service Awards; Awards to Foreign Institutions Inclusion of Women/Minorities as Subjects in Clinical Research X X N/A Part II-Requirements for Inclusiveness in Research Design Part III-National Research Service Awards; Awards to Foreign Institutions Intergovernmental Review under EO 12372 X N/A N/A Part III-Construction Grants Investigational New Drug Applications X X X Part II-Requirements Affecting the Rights and Welfare of Individuals Labor Standards under Federally Assisted Construction X N/A X Part III-Construction Grants Limitation on Use of Funds for Promotion or Legalization of Controlled Substances X X X Part II-Ethical and Safe Conduct in Science and Organizational Operations Lobbying Certification required if total costs expected to exceed $100,000 Certification required if greater than $100,000 only Certification required on contracts greater than $100,000 only Part II-Ethical and Safe Conduct in Science and Organizational Operations Metric System X X X Part II-Other Public Policy Requirements and Objectives Part III-Construction Grants Military Recruiting/ROTC Program Access to Institutions of Higher Education X X X Part II-Other Public Policy Requirements and Objectives Misconduct in Science X X N/A Part II-Ethical and Safe Conduct in Science and Organizational Operations Part III-Awards to Foreign Institutions National Environmental Policy Act of 1969 X N/A N/A Part III-Construction Grants Nondelinquency on Federal Debt X Applies to individuals as participants N/A Part II-Ethical and Safe Conduct in Science and Organizational Operations Part III-Awards to Foreign Institutions The Privacy Act Applies to covered material in NIH's possession Applies to covered material in NIH's possession Applies to covered material in NIH's possession Part II-Availability of Information Pro-Children Act of 1994 X X X Part II-Requirements Affecting the Rights and Welfare of Individuals Program Fraud and Civil Remedies and False Claims Acts X X N/A Part I-Application and Review Processes-Legal Implication of Application Protection of Research Subjects' Identity X X X Part II-Requirements Affecting the Rights and Welfare of Individuals Public Disclosure X N/A N/A Part III-Construction Grants Recombinant DNA and Institutional Biosafety Committees X X X Part II-Ethical and Safe Conduct in Science and Organizational Operations Part III-National Research Service Awards Rehabilitation Act of 1973 (section 504) X (N/A to foreign and international organizations) X (N/A to foreign and international organizations) X (N/A to foreign and international organizations) Part II-Civil Rights Part III-National Research Service Awards; Awards to Foreign Institutions Relocation Assistance and Real Property Acquisition X N/A N/A Part III-Construction Grants Research on Transplantation of Fetal Tissue X X X Part II-Requirements Affecting the Rights and Welfare of Individuals Restriction on Distribution of Sterile Needles X X X Part II-Ethical and Safe Conduct in Science and Organizational Operations Seat Belt Use X N/A N/A Part II-Ethical and Safe Conduct in Science and Organizational Operations Smoke-Free Workplace X N/A N/A Part II-Ethical and Safe Conduct in Science and Organizational Operations Year 2000 Compliance X X X Part II-Other Public Policy Requirements and Objectives *A designation of N/A in this table indicates that a particular requirement does not apply to an otherwise eligible grantee, consortium participant or contractor or may not apply because the type of activity covered is one not normally performed by such an entity. 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