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ARCHIVED - NIH Grants Policy Statement (10/03)


NIH Grants Policy Statement
(12/03)

Part II: Terms and Conditions of NIH Grant Awards
Subpart A: General -- File 1 of 5


Part II: Terms and Conditions of NIH Grant Awards

Subpart A: General

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, review of the project budget, assessment of the applicant’s management systems, determination of applicant eligibility, and compliance with public policy requirements. The applicant may be asked to submit additional information (such as other support or verification of IACUC review) or to undertake certain activities (such as negotiation of an F&A cost rate) in anticipation of an award. However, such requests by NIH do not guarantee that an award will be made. Following review of all applicable information, the IC will determine whether an award can be made, if special conditions are required, and what level of funding is appropriate.

Although these reviews and determinations occur before NIH makes 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 pre-award process for non-competing continuation awards is a streamlined version of this process, including an assessment of progress (see “Administrative Requirements—Monitoring—Reporting—Non-Competing Grant Progress Reports”).

Just-in-Time Procedures

NIH uses just-in-time procedures for certain programs and award mechanisms. These procedures call for limited information (e.g., a budget justification and a biographical sketch) to be submitted with investigator-initiated applications and allow for a possible NIH request for additional information, including information concerning other support, when the application is under consideration for funding. Just-in-time procedures also allow an applicant to defer certification of IRB approval of the project’s proposed use of human subjects, verification of IACUC approval of the project’s proposed use of live vertebrate animals, and evidence of compliance with the education in the protection of human research participants requirement until after completion of the peer review and just prior to funding. (Applications in response to RFAs also may be subject to these procedures. The RFA will specify the timing and nature of required submissions.)

Information on other support will be requested as part of the just-in-time procedures. IC scientific program and grants management staff will review this information before award to ensure the following:

l      Sufficient levels of effort are committed to the project.

l      There is no scientific, budgetary, or commitment overlap.

Ø      Scientific overlap occurs when (1) substantially the same research is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific research objective and the research design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source.

Ø      Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Ø      Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application.

Overlap, whether scientific, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the IC with the applicant and the PI at the time of award.

l      Only funds necessary to the approved project are included in the award.

For modular applications, the applicant is not required to submit detailed budget information in the application. In lieu of the standard budget forms, the applicant requests total direct costs for each year of support requested. The request must be accompanied by budget narrative for all personnel (by position, title, and level of effort), including consultants and “to be appointed” positions, and, when applicable, for consortium/contractual costs. NIH will request additional budget information in exceptional circumstances only. Other support information will be requested only for modular applications likely to result in an award. (See Subpart B of this part for more detailed coverage of modular applications and awards.)

Funding Principles

The amount of NIH funding is based on reasonable and allowable costs consistent with the principles of sound cost management, considering IC priorities (e.g., program relevance), constraints on the growth of average grant costs, and available funds. NIH also has adopted the following core funding principles specifically for research project grants:

l      NIH generally will award non-competing continuation research project grants at committed levels.

l      When determining commitments for future years, NIH will consider 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 are 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 by submitting documentation; otherwise the AOO’s signature on the application certifies that the applicant is eligible to apply for and receive an award (e.g., a small business applying under the SBIR or STTR programs).

In addition to reviewing organizational eligibility, NIH may consider other 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, the location where the project will be performed, the role of the PI in the project, and the PI’s employment and citizenship status. Although some of these same considerations are reviewed as part of the peer review, NIH’s concern at this stage in the process is making an award to a legal entity that will be accountable for both 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 GMO also will verify whether the applicant, proposed PI, or other key personnel are debarred or suspended from participation in Federal assistance programs (see “Public Policy Requirements and Objectives—Ethical and Safe Conduct in Science and Organizational Operations” for certification requirements).

Generally, PIs and other personnel supported by NIH research grants are not required to be U.S. citizens. However, some NIH programs/mechanisms have a citizenship requirement. Any citizenship requirement will be stated in the PA or RFA. In these cases, individuals are required to have the appropriate citizenship status when the award is made rather than when the application is submitted. For example, under K awards or Kirschstein-NRSA individual fellowships, the individual to be trained must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence at the time of award.

NIH requires the applicant to determine that individuals’ visas will allow them to remain in this country long enough for them to be productive on the research project, but NIH does not provide guidance on or assess the different types of visas. NIH expects grantee organizations to have policies, consistently applied regardless of the source of funds, to address this area. If a grant is awarded and an individual’s visa will not allow a long enough stay to be productive on the project, 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 additional eligibility requirements for fellows are addressed in “Ruth L. Kirschstein National Research Service Awards” in Subpart B of this part of the NIHGPS.

In the post-award phase, NIH monitors changes in grantee and project status to ensure they meet legal and programmatic requirements and takes actions necessary to protect the Federal government’s interests.

The GMO will ensure that a cost analysis is performed on any application that requires 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 and award mechanism, the complexity of the project, prior experience with the applicant, and other factors. Information on the applicable cost principles and on allowable and unallowable costs under NIH grants is provided in “Cost Considerations.”

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 45 CFR Part 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.

The remainder of Part II serves as the terms and conditions of NIH grants and cooperative agreements and is incorporated by reference in all NIH grant and cooperative agreement awards. Subpart A includes those terms and conditions that apply, in general, to NIH awards. Subpart B either expands on Subpart A coverage or specifies additional or alternate terms and conditions for particular types of awards, recipients, or activities.

These terms and conditions are not intended to be all-inclusive. In addition to the requirements in the NIHGPS, some of which repeat or highlight requirements found in the following, NIH grants are subject to all of the applicable requirements of the following:

l      Authorizing program legislation

l      Program regulations, including those in 42 CFR Part 52

l      Other statutory requirements, such as those included in appropriations acts

l      HHS requirements in 45 CFR Part 74 or 45 CFR Part 92, as appropriate for the type of recipient organization and the type of activity (e.g., research).

Notice of requirements not specified in the NIHGPS generally will be provided in the NGA, but such notice is not required for the award to be subject to the requirements of pertinent statutes and regulations. An individual award also may 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 the NIHGPS apply in addition to governing statutory and regulatory requirements not cited herein, and award-specific terms apply in addition to the requirements of the NIHGPS.

This NIHGPS is written in “plain language” and is meant to be an aid to the interpretation of statutory and regulatory requirements. These terms and conditions are 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, in the case of a conflict, the statutes and regulations govern.

If there is a perceived conflict between or among these three categories of requirements—statutory and regulatory requirements, the terms and conditions in the NIHGPS, 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 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.

Public Policy Requirements and Objectives

This section addresses 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, consortium participants, and contractors, in general, or may relate to the expenditure of Federal funds for research or other specified activities. In addition to cross-cutting requirements that some or all Federal agencies must apply to their grant programs, NIH grantees are subject to requirements contained in HHS’s annual appropriations acts that apply to the use of NIH grant funds, applicable provisions in other Federal agencies’ appropriations acts, including Treasury, and other Federal statutes. 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 in this section set many of those standards. The signature of the AOO on the application certifies that the organization complies, or intends to comply, with all applicable certifications and assurances referenced (and, in some cases, included) in the application instructions.

Instructions for applications submitted on the PHS 398 include the following topics, which also are discussed in this section of the NIHGPS:

l      Debarment and Suspension (specific certification language included in application instructions)

l      Drug-Free Workplace

l      Lobbying (specific certification language included in application instructions)

l      Financial Conflict of Interest

l      Research Misconduct

l      Nondelinquency on Federal Debt

l      Human Embryonic Stem Cell Research

l      Human Subjects

l      Research on Transplantation of Fetal Tissue

l      Recombinant DNA Molecules and Human Gene Transfer Research

l      Vertebrate Animals

l      Women and Minority Inclusion Policy

l      Inclusion of Children Policy

l      Age Discrimination

l      Civil Rights

l      Sex Discrimination

l      Handicapped Individuals.

Public policy requirements under Kirschstein-NRSA individual fellowships are specified in the application instructions for the PHS 416-1 and are discussed in “Ruth L. Kirschstein National Research Service Awards—Individual Fellowships” in Subpart B of this part.

As noted in this section, some certifications and assurances may require submission of a separate document (e.g., human subjects assurance, IRB certification, civil rights assurance). Applicants and grantees should take particular note of these requirements (for example, see “Human Subjects” and “Civil Rights”), the absence or inadequacy of which may delay an award or make an applicant ineligible for award.

The grantee is responsible for establishing and maintaining the necessary processes to monitor its compliance and that of its employees, consortium participants, 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.

Exhibit 2 contains information to help the grantee determine what public policy requirements and objectives apply to its activities and whether a requirement should be included in a consortium agreement or a contract for routine goods or services under the grant (see “Glossary” 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 public policy requirement normally would apply. However, even if the exhibit indicates that a requirement is not applicable that public policy 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 grantee 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 2 also indicates where, in the NIHGPS, the individual public policy requirements and objectives are covered in more detail. The grantee should consult the governing statute, regulations, or other cited policies or documents for complete information.


 


Exhibit 2. Public Policy Requirements and Objectives

Requirement
or
objective


Grantee


Consortium
participant

Contractor under grant (routine goods/services)*


NIHGPS section for
additional information

Acknowledgment of Federal Funding

Y

Y

NA

Availability of Information

Ruth L. Kirschstein National Research Service Awards

Age Discrimination Act of 1975

Y

(NA to foreign and
international organizations)

Y

(NA to foreign and international organizations)

Y

(NA to foreign and international
organizations)

Civil Rights

Grants to Foreign Institutions, International Organizations and Domestic Grants with Foreign Components (hereafter, Grants to Foreign Institutions)

Animal Welfare

Y

Y

Y

Animal Welfare

Ruth L. Kirschstein National Research Service Awards

Grants to Foreign Institutions

Ban on Human
Embryo Research and Cloning

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients or Recipients of Services (hereafter, Requirements Affecting the Rights and Welfare of Individuals)

Certificates of Confidentiality

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Civil Rights Act of 1964 (Title VI)

Y
(NA* to foreign and international organizations)

Y
(NA to foreign and international organizations)

Y
(NA to foreign and international
organizations)

Civil Rights

Grants to Foreign Institutions

Confidentiality of
Patient Records

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Controlled Substances

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Data and Safety Monitoring

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Ruth L. Kirschstein National Research Service Awards

Debarment and
Suspension

Y
(NA to certain foreign
organizations)

Y
(NA to certain foreign
organizations)

If contract equals or exceeds $100,000
(NA to certain
foreign
organizations)

Ethical and Safe Conduct in Science and Organizational Operations

Grants to Foreign Institutions

Drug-Free Workplace

Y

NA

NA

Ethical and Safe Conduct in Science and Organizational Operations

Grants to Foreign Institutions

Education
Amendments of 1972
(Title IX)

Y
(NA to foreign and
international
organizations

Y
(NA to foreign and international organizations)

Y
(NA to foreign and international organizations)

Civil Rights

Grants to Foreign Institutions

Elimination of
Architectural Barriers to the Handicapped

Y

NA

Y

Construction Grants

Financial Conflict of Interest

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

Y

NA

Ethical and Safe Conduct in Science and Organizational Operations

Grants to Federal Institutions and Payments to (or on behalf of) Federal Employees under Grants

Flood Insurance

Y

NA

NA

Construction Grants

Freedom of
Information Act

Y
(Applies to certain research data produced by specified types of
grantees; NA to commercial organizations)

Y
(Applies to certain research data produced by specified types of
grantees; NA to commercial organizations)

Y
Applies to certain research data
produced by specified types of entities; NA to commercial organizations)

Availability of Information

Additional Health and Safety Regulations and Guidelines

Y

Y

Apply as required by Federal, State or local regulations

Ethical and Safe Conduct in Science and Organizational Operations

Health Insurance Portability and Accountability Act (HIPAA)

Y
(if a covered entity)

Y
(if a covered entity)

Y
(if a covered entity)

Requirements Affecting the Rights and Welfare of Individuals

 

Historic Properties/
Archeological Sites

Y

NA

Y

Construction Grants

Human Embryonic Stem Cell Research

Y

Y

Y

Ethical and Safe Conduct in Science and Organizational Operations

Ruth L. Kirschstein National Research Service Awards

Human Subjects

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Ruth L. Kirschstein National Research Service Awards

Grants to Foreign Institutions

Inclusion of Children as Subjects in Clinical Research

Y

Y

NA

Requirements for Inclusiveness in Research Design

Ruth L. Kirschstein National Research Service Awards

Grants to Foreign Institutions

Inclusion of Women/Minorities as Subjects in Clinical Research

Y

Y

NA

Requirements for Inclusiveness in Research Design

Ruth L. Kirschstein National Research Service Awards

Grants to Foreign Institutions

Intergovernmental Review under EO 12372

Y

NA

NA

Construction Grants

Investigational New Drug Applications/
Investigational Device Exceptions

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Labor Standards
under Federally
Assisted Construction

Y

NA

Y

Construction Grants

Limited English Proficiency

Y

Y

NA

Civil Rights

Limitation on Use of Funds for Promotion or Legalization of Controlled Substances

Y

Y

Y

Ethical and Safe Conduct in Science and Organizational Operations

Lobbying

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

Ethical and Safe Conduct in Science and Organizational Operations

Metric System

Y

Y

Y

Other Public Policy Requirements and Objectives

Construction Grants

Military Recruiting and ROTC Program Access to Institutions of Higher Education

Y

Y

Y

Other Public Policy Requirements and Objectives

National
Environmental Policy Act of 1969

Y

NA

NA

Construction Grants

Nondelinquency on Federal Debt

Y

Y

NA

Ethical and Safe Conduct in Science and Organizational Operations

Grants to Foreign Institutions

Preservation of Open Competition and Government Neutrality
Toward Government Contractors’ Labor Relations on Federal
and Federally Funded Construction Projects

Y

NA

NA

Construction Grants

Privacy Act

Y
Applies to
covered
material in
NIH’s
possession

Y
Applies to
covered
material in NIH’s possession

Y
Applies to covered material in NIH’s possession

Availability of Information

Pro-Children Act of 1994

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Program Fraud and Civil Remedies and False Claims Acts

Y

Y

NA

Application and Review Processes—Legal Implication of Application

Protection of
Research Subjects’ Identity

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Public Disclosure

Y

NA

NA

Construction Grants

Public Health Security and Bioterrorism Preparedness and Response Act

Y

Y

Y

Ethical and Safe Conduct in Science and Organizational Operations

 


Exhibit 2. Public Policy Requirements and Objectives--Continued

Requirement
or
objective


Grantee


Consortium
participant

Contractor under grant (routine goods/services)*


NIHGPS section for
additional information

Recombinant DNA Molecules and Human Gene Transfer Research

Y

Y

Y

Ethical and Safe Conduct in Science and Organizational Operations

Ruth L. Kirschstein National Research Service Awards

Rehabilitation Act of 1973 (section 504)

Y
(NA to foreign and
international organizations)

Y
(NA to foreign and international organizations)

Y
(NA to foreign and international
organizations)

Civil Rights

Grants to Foreign Institutions

Research Misconduct

Y

Y

NA

Ethical and Safe Conduct in Science and Organizational Operations

Grants to Foreign Institutions

Research on Human Fetal Tissue

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Research on Transplantation of Fetal Tissue

Y

Y

Y

Requirements Affecting the Rights and Welfare of Individuals

Restriction on Abortions

Y

Y

Y

Ethical and Safe Conduct in Science and Organizational Operations

Restriction on
Distribution of Sterile Needles

Y

Y

Y

Ethical and Safe Conduct in Science and Organizational Operations

Seat Belt Use

Y

NA

NA

Ethical and Safe Conduct in Science and Organizational Operations

Smoke-Free
Workplace

Y

NA

NA

Ethical and Safe Conduct in Science and Organizational Operations

Standards of Conduct

Y

NA

NA

Ethical and Safe Conduct in Science and Organizational Operations

Uniform Relocation Assistance and Real Property
Acquisition Policies Act

Y

NA

NA

Construction Grants

USA PATRIOT Act

Y

Y

Y

Ethical and Safe Conduct in Science and Organizational Operations

 

*A designation of NA 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.

 

Ethical and Safe Conduct in Science and Organizational Operations

NIH grants are subject to requirements intended to ensure that recipient organizations handle their Federal awards responsibly. Grantees are required to adopt and enforce policies that minimize the opportunity for improper financial gain on the part of the organization, its employees, and organizations and individuals with whom they may collaborate, and that limit the potential for research results to be tainted by possible personal financial or other gain.

In addition, NIH grantees are expected to provide safe and healthful working conditions for their employees and foster work environments conducive to high-quality research.

NIH requires grantees 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. Except as provided below, NIH does not require a grantee to establish separate standards of conduct if it maintains such standards for its non-grant-supported activities, as long as those standards are consistent with State and local laws and cover, at a minimum, expected conduct in regard to financial interests, gifts, gratuities and favors, nepotism, and such other areas as political participation and bribery. The standards also must do the following:

l      Address the conditions under which outside activities, relationships, or financial interests are proper or improper.

l      Provide for advance notification of outside activities, relationships, or financial interests to a responsible organizational official.

l      Include a process for notification and review by the responsible official of potential or actual violations of the standards.

l      Specify the nature of penalties that the grantee may impose. These penalties would be in addition to any penalties that NIH or a cognizant Federal agency may impose for infractions that also violate the terms or conditions of award.

The grantee is not required to submit its general standards of conduct to NIH for review or approval. However, a copy must be made available to each of its officers, each employee and consultant working on the grant-supported project or activity, each member of the governing board, if applicable, and, upon request, to NIH. The grantee is responsible for enforcing its standards of conduct, taking appropriate action on individual infractions, and, in the case of financial conflict of interest, informing the IC CGMO if the infraction is related to an NIH award. (A listing of the NIH CGMOs is available at http://grants.nih.gov/grants/stafflist_gmos.htm.) If a suspension or separation action is taken by a grantee against a PI or other key personnel under an NIH grant, the grantee must request prior approval of the proposed replacement as specified in “Administrative Requirements—Changes in Project and Budget—Prior-Approval Requirements.”

Financial Conflict of Interest

NIH requires grantees and investigators to comply with the requirements of 42 CFR Part 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought.” That subpart promotes objectivity in research by establishing standards to ensure that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will not be biased by any conflicting financial interest of an investigator. These requirements do not apply to Phase I of the SBIR/STTR programs.

The signature of the AOO on the face page of the application serves as certification of compliance with the requirements of 42 CFR Part 50, Subpart F. Under those requirements the organization must do the following:

l      Have a written and enforced administrative process to identify and manage, reduce, or eliminate conflicting financial interests with respect to research projects for which NIH funding is sought

l      Before spending any NIH funds awarded under a new award, inform the CGMO of the existence of any conflicting financial interests it identified of the type covered by 42 CFR 50.605

l      When informing the CGMO that a financial conflict of interest has been identified, ensure that the interest has been addressed in accordance with the regulations by indicating whether the conflict has either been managed, reduced, or eliminated

l      Continue to make similar reports on subsequently identified conflicts within 60 days of identifying them

l      Make additional information available to NIH, upon request, as to how it handled conflicting interests in accordance with the regulations.

As described in the regulations, examples of how financial conflicts of interest might be addressed include the following:

l      Public disclosure of significant financial interests

l      Monitoring of research by independent reviewers

l      Modification of the research plan

l      Disqualification from participation in all or a portion of the research funded by PHS

l      Divestiture of significant financial interests

l      Severance of relationships that create actual or potential conflicts.

Grantees also must ensure that consortium agreements address whether the consortium participant’s employees will be subject to the financial conflict of interest requirements of the consortium participant or to those of the grantee (see “Consortium Agreements” in Subpart B of this part).

Some IRBs also consider investigator financial conflict of interest in their deliberations, although they are not required to do so (see “Public Policy Requirements and Objectives—Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Human Subjects”).

Following are some strategies used by IRBs:

l      Make IRB members aware of the organization’s conflict of interest policies and procedures.

l      Include a statement in the informed consent form that all clinical investigators comply with the organizational guidelines.

l      Ask investigators to complete a short questionnaire about whether they—or any person responsible for the design, conduct, or reporting of research—have an economic interest in or act as an officer or a director of any outside entity whose financial interest could reasonably appear to be affected by the research.

l      Instruct IRB members during their orientation on how to identify and respond to a perceived financial, academic, or other conflict of interest.

Suggestions for grantees to consider when implementing the requirements of this regulation are available in the NIH publication, Financial Conflict of Interest–Objectivity in Research: Institutional Policy Review, available on the NIH website at http://grants.nih.gov/grants/policy/coi/nih_review.htm.

Debarment and Suspension

HHS regulations published in 45 CFR Part 76 implement the government-wide debarment and suspension system for HHS’ non-procurement transactions. “Non-procurement transactions” include grants, cooperative agreements, scholarships, fellowships, and loans. Accordingly, applicants for NIH grants (“primary covered transactions”), including applicants for Kirschstein-NRSA individual fellowships, are required to certify[6] that, to the best of their knowledge and belief, they and their principals (including PIs and other key personnel)

l      are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from covered transactions by any Federal department or agency;

l      have not, within the 3-year period preceding the application, been convicted of, or had a civil judgment rendered against them for

Ø      committing fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) transaction or contract under a public transaction;

Ø      violating a Federal or State antitrust statute;

Ø      embezzlement, theft, forgery, bribery, falsification or destruction of records; or

Ø      making false statements or receiving stolen property;

l      are not presently indicted or otherwise criminally or civilly charged by a governmental entity (Federal, State, or local) with commission of any of the offenses enumerated above; and

l      have not, within a 3-year period preceding the application, had any public transaction (Federal, State, or local) terminated for cause or default.

If the applicant is unable to certify to these statements, it must, nonetheless, submit the certification and attach an explanation. The inability to certify does not automatically disqualify an organization from receiving an NIH award; however, failure to submit the required certification or the necessary explanation will cause NIH not to make an award. Appendix A of 45 CFR Part 76 contains the full text of the instructions and the certification.

A variety of “lower-tier” transactions also are subject to the certification requirement. Contractors under grants (where the contract requires the provision of goods or services that will equal or exceed $100,000) and all consortium participants must certify that they are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any Federal agency. Grantees also are required to obtain a certification from each trainee under a Kirschstein-NRSA institutional research training grant before their appointment. If an entity or individual is unable to certify to this effect, an explanation should be attached to its proposal or to the document that defines the legal relationship between the parties (for example, the consortium agreement).

Regardless of whether a certification is required or made, organizations or individuals that are suspended, debarred, or voluntarily excluded from eligibility cannot receive NIH grants or be paid from NIH grant funds, whether under a primary or lower-tier transaction, during the period of suspension, debarment, or exclusion. Because individuals who have been debarred, suspended, declared ineligible, or voluntarily excluded from covered transactions may not receive Federal funds for a specified period of time, charges made to the NIH grants for such individuals (e.g., salary) are unallowable.

Drug-Free Workplace

The Drug-Free Workplace Act of 1988 (Public Law 100-690, Title V, Subtitle D, as amended) requires that all organizations receiving grants from any Federal agency agree to maintain a drug-free workplace. By signing the application, the AOO agrees that the grantee will provide a drug-free workplace and will comply with the requirement to notify NIH if an employee is convicted of violating a criminal drug statute. Failure to comply with these requirements may be cause for debarment. HHS implementing regulations are set forth in 45 CFR Part 76, “Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants).”

Health and Safety Regulations and Guidelines

Public Health Security and Bioterrorism Preparedness and Response Act

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) is designed to provide protection against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland or other criminal acts. The Act was implemented, in part, through regulations published by CDC at 42 CFR 73, Select Agents and Toxins. Those regulations supersede the requirements at 42 CFR 76.2 (Interstate Shipment of Etiological Agents), which established certain shipping and handling requirements on laboratory facilities that send or receive select agents. Copies of these regulations are available from the Import Permit Program and Select Agent Program, respectively, CDC, 1600 Clifton Road, MS E-79, Atlanta, GA 30333; telephone: 404-498-2255. These regulations also are available at http://www.cdc.gov/od/ohs/biosfty/shipregs.htm.

Research involving select agents and recombinant DNA molecules also is subject to the NIH Guidelines for Research Involving DNA Molecules (NIH Guidelines) (see “NIH Guidelines for Research Involving DNA Molecules and Human Gene Transfer Research” in this subsection for applicability of these guidelines). The NIH Guidelines apply to (1) research projects involving recombinant DNA that are conducted at or sponsored by an organization that receives NIH support for recombinant DNA research (for research performed abroad, the NIH Guidelines apply if the research is supported by NIH funds) and (2) research projects involving testing in humans of materials containing recombinant DNA developed with NIH funds, if the organization that developed the materials sponsors or participates in those projects. The NIH Guidelines are available at http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm.

USA PATRIOT Act

The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act) (P.L. 107-56) amends 18 U.S.C. 10 and provides criminal penalties for possession of any biological agent, toxin, or delivery system of a type or in a quantity that is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose. The Act also establishes restrictions on access to specified materials. “Restricted persons,” as defined by the Act, may not possess, ship, transport, or receive any biological agent or toxin that is listed as a select agent (see “Public Health Security and Bioterrorism Preparedness and Response Act” in this subsection).

Additional Health and Safety Regulations and Guidelines

Grantees are responsible for meeting Federal, State, and local health and safety standards and for establishing and implementing necessary measures to minimize their employees’ risk of injury or illness in activities related to NIH grants. In addition to applicable Federal, State, and local laws and regulations, the following regulations must be followed when developing and implementing health and safety operating procedures and practices for both personnel and facilities:

l      29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by the Occupational Health and Safety Administration (OSHA) and included in 29 CFR Part 1910. These regulations are available at http://www.osha.gov/comp-links.html.

l      Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). Copies may be obtained from the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

The following guidelines are recommended for use in developing and implementing health and safety operating procedures and practices for both personnel and facilities:

l      Biosafety in Microbiological and Biomedical Laboratories, CDC and NIH, HHS. This publication is available at http://bmbl.od.nih.gov/index.htm.

l      Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This publication can be obtained by telephoning 800-624-8373. It also is available at http://www.nap.edu/catalog/4911.html.

Grantee organizations are not required to submit documented assurance of their compliance with or implementation of these regulations and guidelines. However, if requested by the awarding office, grantees should be able to provide evidence that applicable Federal, State, and local health and safety standards have been considered and have been put into practice.

Limitation on Use of Funds for Promotion or Legalization of Controlled Substances

Grantees are prohibited from knowingly using appropriated funds to support activities that promote the legalization of any drug or other substance included in Schedule I of the schedule of controlled substances established by section 202 of the Controlled Substances Act, 21 U.S.C. 812. This limitation does not apply if the grantee notifies the GMO that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage (see “Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Controlled Substances”).

Lobbying

Recipients of Federal grants, cooperative agreements, contracts, and loans are prohibited by 31 U.S.C. 1352, “Limitation on use of appropriated funds to influence certain Federal contracting and financial transactions,” from using appropriated Federal funds to pay any person for influencing or attempting to influence any officer or employee of an agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress with respect to the award, continuation, renewal, amendment, or modification of any of these instruments. These requirements are implemented for HHS in 45 CFR Part 93, which also describes types of activities, such as legislative liaison activities and professional and technical services, which are not subject to this prohibition.

Applicants for NIH awards with total costs expected to exceed $100,000 are required to certify that they

l      have not made, and will not make, such a prohibited payment;

l      will be responsible for reporting the use of nonappropriated funds for such purposes; and

l      will include these requirements in consortium agreements and contracts under grants that will exceed $100,000 and obtain necessary certifications from those consortium participants and contractors.

The signature of the AOO on the application serves as the required certification of compliance for the applicant organization. Disclosure reporting is addressed in “Administrative Requirements—Monitoring—Reporting.”

NIH appropriated funds may not be used to pay the salary or expenses of an employee of a grantee, consortium participant, or contractor or those of an agent related to any activity designed to influence legislation or appropriations pending before Congress or any State legislature. This prohibition extends to the use of funds for publicity or propaganda purposes, including the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before Congress or a State legislature except in presentation to the Congress or State legislature itself or as part of normal, recognized legislative-executive relationships. Also see Cost Considerations—Allowability of Costs and Activities—Selected Items of Cost.”

Research Misconduct

The grantee will inquire into and, if necessary, investigate and resolve promptly and fairly all instances of alleged or apparent research misconduct. Title 42 CFR Part 50, Subpart A, “Responsibilities for PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science,” specifies grantee responsibilities in dealing with and reporting possible research misconduct. By signing the application, the AOO certifies that the organization has established administrative policies as required by 42 CFR 50, Subpart A, and will comply with those policies and the requirements of the regulations. The regulations are available from the ORI on its home page (http://www.ori.dhhs.gov) and, in hard copy, at the address shown in Part III.

As stated throughout the NIHGPS, the grantee has primary responsibility for ensuring that it is conducting its NIH-funded project in accordance with the approved application and budget and the terms and conditions of the award. The grantee must carry out its responsibilities with extra care where research misconduct has been found or where a research misconduct investigation has been initiated, as specified in 42 CFR 50.103 and 50.104. The grantee must report promptly to ORI any incident of alleged or apparent research misconduct that it judges as warranting investigation and must advise ORI of any decision to initiate an investigation. The regulations also require that the grantee submit an annual report (see “Administrative Requirements—Monitoring—Reporting”).

If a misconduct investigation has been initiated, the grantee must take any necessary steps, in addition to its normal and ongoing responsibilities under the grant, to protect the scientific integrity of the project, protect human subjects and animals, provide reports to ORI, and ensure the proper expenditure of funds and continuation of the project during the investigation, if appropriate. ORI staff members are available to help grantees with investigating and reporting on research misconduct, and IC staff members are available to provide technical assistance and to work with grantees to protect funded projects from the adverse effects of research misconduct.

The grantee is responsible for the actions of its employees and other research collaborators, including third parties, involved in the project. When the grantee finds research misconduct by anyone working on an NIH grant-supported project, whether at the grantee organization or at a third-party organization, the grantee must assess the effect of that finding on the ability to continue that project, as originally approved by NIH, and must promptly obtain NIH approval of any intended change of PI or other key personnel. Examples of possible sanctions by NIH are withdrawal of approval of the PI or other key personnel, debarment, disallowance of costs associated with the invalid or unreliable research, withholding of a continuation award, or suspension or termination, in whole or in part, of the current award. These actions are described in “Administrative Requirements—Enforcement Actions.”

Where research misconduct has affected data validity or reliability, ORI or NIH may require the grantee and its employee/collaborator authors to submit a correction or retraction of the data to a journal, publish the corrected data, or both. If the grantee does not comply with this requirement, NIH may invoke its rights, under 45 CFR Part 74 or 92, to access the data (including copyrightable material developed under the award), have the data reviewed, and submit the correction.

The grantee must promptly report issues involving potential criminal violations, such as misappropriation of Federal funds, to the HHS OIG (see Part III).

NIH Guidelines for Research Involving Recombinant DNA Molecules
and Human Gene Transfer Research

Scope and Applicability

The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) (April 2002 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/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm. As defined by the NIH Guidelines, recombinant DNA molecules are either (1) molecules that are constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or (2) molecules that result from the replication of those described in (1). The NIH Guidelines apply to both basic and clinical research studies. Recombinant DNA research involving select agents also is subject to pertinent CDC and USDA regulations.[7] Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidelines. Failure to comply with these requirements may result in suspension or termination of an award for recombinant DNA research at the organization, or a requirement for NIH prior approval of any or all recombinant DNA projects at the organization. Two specific requirements of the NIH Guidelines are discussed below, but the grantee should carefully review the NIH Guidelines in their entirety to ensure compliance with all of the requirements for projects involving recombinant DNA techniques.

Institutional Biosafety Committee

Each organization that conducts research involving recombinant DNA, including contractors under grants, must have policies and procedures to ensure compliance with the NIH Guidelines and must establish a standing IBC. The IBC is required to review each proposed project for recombinant DNA experiments and certify that the procedures, project, personnel, and facilities are adequate and in compliance with the NIH Guidelines. Section IV of the NIH Guidelines specifies the composition of IBCs. A roster of the IBC members must be submitted to NIH’s OBA (see Part III for address). At a minimum, the roster should include the names, addresses, occupations, and qualifications of the chairperson and members of the committee. The roster also should indicate which IBC members are serving as the chairperson, contact person, and, as applicable, experts in biosafety or plant, animal, or human experimentation. Section IV of the NIH Guidelines also specifies the roles and responsibilities of PIs and grantees in relation to IBCs and in other areas.

Safety and Annual Reporting

Appendix M-I-C-4 of the NIH Guidelines requires serious adverse events that are unexpected and are possibly associated with human gene transfer intervention to be reported to OBA and the IBC within 15 calendar days of investigator notification of the sponsor, or within 7 days if life-threatening or fatal. In addition, annually, investigators must submit to OBA certain information about protocols. Further information about the content of these reports can be found in Appendix M-I-C-3 of the NIH Guidelines.

Nondelinquency on Federal Debt

The Federal Debt Collection Procedures Act of 1990 (Act), 28 U.S.C. 3201(e), provides that an organization or individual that is indebted to the United States, and has a judgment lien filed against it, is ineligible to receive a Federal grant. NIH cannot award a grant unless the AOO of the applicant organization (or individual in the case of a Kirschstein-NRSA individual fellowship) certifies, by means of his/her signature on the application, that the organization (or individual) is not delinquent in repaying any Federal debt. If the applicant discloses delinquency on a debt owed to the Federal government, NIH may not award the grant until the debt is satisfied or satisfactory arrangements are made with the agency to which the debt is owed. In addition, once the debt is repaid or satisfactory arrangements made, NIH still will take that delinquency into account when determining whether the applicant would be responsible with respect to an NIH grant, if awarded.

Anyone who has been judged to be in default on a Federal debt and who has had a judgment lien filed against him or her should not be listed as a participant in an application for an NIH grant until the judgment is paid in full or is otherwise satisfied. No funds may be rebudgeted following an award to pay such an individual. NIH will disallow costs charged to awards that provide funds to individuals in violation of this Act.

These requirements apply to all types of organizations and awards, including foreign grants.

NIH Guidelines for Research Using Human Embryonic Stem Cells

NIH will fund research using human pluripotent stem cells derived from human embryos (technically known as human embryonic stem cells) or human fetal tissue (technically known as human embryonic germ cells). For purposes of these NIH Guidelines, human pluripotent stem cells are cells that are self-replicating, are derived from human embryos or human fetal tissue, and are known to develop into cells and tissues of the three primary germ layers. Although human pluripotent stem cells may be derived from embryos or fetal tissue, such stem cells are not in themselves embryos.

NIH research funded under these Guidelines will involve human pluripotent stem cells derived: (1) from human fetal tissue or (2) from human embryos that are the result of in vitro fertilization and meet the following Presidential criteria. On August 9, 2001 at 9:00 p.m. EDT, the President announced his decision to allow Federal funds to be used for research on existing human embryonic stem cell lines as long as prior to his announcement (1) the derivation process. (which begins with removal of the inner cell mass from the blastocyst) had already been initiated and (2) the embryo from which the stem cell line was derived no longer had the possibility of development as a human being.

In addition, the President established the following criteria that must be met:

l      The stem cells must have been derived from an embryo that was created for reproductive purposes.

l      The embryo was no longer needed for those purposes.

l      Informed consent must have been obtained for donation of the embryo.

l      No financial inducements were provided for donation of the embryo.

The complete notice explaining the President’s policy can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.

In order to facilitate research using human embryonic stem cells, the NIH Human Embryonic Stem Cell Registry lists the human embryonic stem cells that meet the eligibility criteria. The laboratories or companies that provide the cells listed on the Registry must have submitted to NIH a signed assurance. Each provider must retain for submission to NIH, if necessary, written documentation to verify the statements in the signed assurance. The Registry is accessible to investigators on the NIH home page at http://escr.nih.gov/. Requests for Federal funding must cite a human embryonic stem cell line that is listed on the NIH Registry.

Although NIH withdrew those sections of the NIH Guidelines for Research Involving Human Pluripotent Stem Cells (http://stemcells.nih.gov/policy/guidelines.asp) that pertain to research involving human pluripotent stem cells derived from human embryos, the NIH Guidelines contain important and current information regarding specific types of research that are eligible and ineligible for NIH funding.

Research use of human embryonic germ cells derived from fetal tissue with Federal funds requires review of compliance with the NIH Guidelines for Research Involving Human Pluripotent Stem Cells. The review process is described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-049.html.

Restriction on Distribution of Sterile Needles

NIH appropriated funds may not be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

Restriction on Abortion Funding

NIH funds may not be spent for an abortion.

Seat Belt Use

Pursuant to EO 13043 (April 16, 1997), Increasing the Use of Seat Belts in the United States, NIH encourages grantees 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.

Smoke-Free Workplace

NIH strongly encourages grantees to provide smoke-free workplaces and to promote the nonuse of tobacco products. NIH defines the term “workplace” to mean office space (including private offices and other workspace), conference or meeting rooms, corridors, stairways, lobbies, rest rooms, cafeterias, and other public spaces.


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