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ARCHIVED - NIH Grants Policy Statement (03/01)

Part II: Terms and Conditions of NIH Grant Awards
Subpart A: General -- Part 1 of 7


Part II: Terms and Conditions of NIH Grant Awards

Subpart A: General

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, review of the project budget, assessment of the applicant's management systems, and determination of applicant eligibility and compliance with public policy requirements. The applicant may be asked to submit additional information or to undertake certain activities (such as negotiation of a facilities and administrative (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 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 also has 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 by submitting documentation or by a certification accomplished by the authorized organizational official's signature on the application (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 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).

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."

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 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, 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 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

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 awards. Subpart A includes those terms and conditions that apply, in general, to NIH awards, and Subpart B includes 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 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 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 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.

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, if there is a perceived conflict between or among these three categories of requirements, i.e., statutory and regulatory requirements, the terms and conditions in 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 designated 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 specified in the NGA.

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, 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 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 in this section set many of those standards. The signature of the authorized organizational official on the application certifies that the organization is in compliance with, or intends to comply with, all applicable certifications and assurances referenced (and, in some cases, included) in the application package. These include the following as discussed in this section:

  • Debarment and Suspension (specific certification language included in application package)
  • Drug-Free Workplace
  • Lobbying (specific certification language included in application package)
  • Financial Conflict of Interest
  • Research Misconduct and Instruction in the Responsible Conduct of Research
  • Delinquent Federal Debt
  • Human Pluripotent Stem Cell Research
  • Human Subjects
  • Research on Transplantation of Fetal Tissue
  • Vertebrate Animals
  • Inclusion of Women, Children, and Minorities in Clinical Research
  • Age Discrimination
  • Civil Rights
  • Sex Discrimination
  • Handicapped Individuals

As noted in this section, some certifications and assurances may require submission of a separate document (e.g., human subjects assurance, Institutional Review Board certification, and 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.

Table II-1 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 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 designated GMO if there is any question concerning the applicability of a particular public policy requirement or objective.

The listing in Table II-1 indicates where, in this policy statement, the individual public policy requirements and objectives are covered in more detail. However, the governing statute, regulations, or other cited policies or documents should be consulted for complete information.

TABLE II-1
PUBLIC POLICY REQUIREMENTS AND OBJECTIVES

Requirement
or
Objective


Grantee


Consortium
Participant

Contractor under Grant (Routine Goods/Services)*


GPS Section for
Additional Information

Acknowledgment of Federal Funding

X

X

N/A

Availability of Information

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

Civil Rights

National Research Service Awards

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

Animal Welfare

X

X

X

Animal Welfare

National Research Service Awards

Awards to Foreign Institutions

Ban on Human
Embryo Research and Cloning

X

X

X

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)

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)

Civil Rights

National Research Service Awards

Awards to Foreign Institutions

Confidentiality of
Patient Records

X

X

X

Requirements Affecting the Rights and Welfare of Individuals

Controlled Substances

X

X

X

Requirements Affecting the Rights and Welfare of Individuals

Data and Safety Monitoring

X

X

X

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)

Ethical and Safe Conduct in Science and Organizational Operations

Awards to Foreign Institutions

Drug-Free Workplace

X

N/A

N/A

Ethical and Safe Conduct in Science and Organizational Operations

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)

Civil Rights

National Research Service Awards

Awards to Foreign Institutions

Elimination of
Architectural Barriers to the Handicapped

X

N/A

X

Construction Grants

Financial Conflict of Interest

X
(N/A to Phase I of the SBIR/STTR programs and to Federal
institutions)

X

N/A

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

X

N/A

NA

Construction Grants

The Freedom of
Information Act

X
(Applies to certain research data produced by specified types of
grantees; N/A to commercial organizations)

X
(Applies to certain research data produced by specified types of
grantees; N/A to commercial organizations)

X
Applies to certain research data
produced by specified types of entities; N/A to commercial organizations)

Availability of Information

Health and Safety Guidelines

X

X

Applies as required by Federal, State or local regulations

Ethical and Safe Conduct in Science and Organizational Operations

Historic Properties/
Archeological Sites

X

N/A

X

Construction Grants

Human Pluripotent Stem Cell Research

X

X

X

Ethical and Safe Conduct in Science and Organizational Operations

Human Subjects

X

X

X

Requirements Affecting the Rights and Welfare of Individuals

National Research Service Awards

Awards to Foreign Institutions

Inclusion of Children as Subjects in Clinical Research

X

X

N/A

Requirements for Inclusiveness in Research Design

National Research Service Awards

Awards to Foreign Institutions

Inclusion of Women/Minorities as Subjects in Clinical Research

X

X

N/A

Requirements for Inclusiveness in Research Design

National Research Service Awards

Awards to Foreign Institutions

Intergovernmental Review under EO 12372

X

N/A

N/A

Construction Grants

Investigational New Drug Applications/
Investigational Device Exceptions

X

X

X

Requirements Affecting the Rights and Welfare of Individuals

Labor Standards
under Federally
Assisted Construction

X

N/A

X

Construction Grants

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

X

X

X

Ethical and Safe Conduct in Science and Organizational Operations

Lobbying

X
Certification required if total costs expected to exceed $100,000

X
Certification
required if greater than $100,000 only

X
Certification
required on
contracts greater than $100,000 only

Ethical and Safe Conduct in Science and Organizational Operations

Metric System

X

X

X

Other Public Policy Requirements and Objectives

Construction Grants

Military Recruiting and ROTC Program Access to Institutions of Higher Education

X

X

X

Other Public Policy Requirements and Objectives

National
Environmental Policy Act of 1969

X

N/A

N/A

Construction Grants

Nondelinquency on Federal Debt

X

X

N/A

Ethical and Safe Conduct in Science and Organizational Operations

Awards to Foreign Institutions

The Privacy Act

X
Applies to
covered
material in
NIH's
possession

X
Applies to
covered
material in NIH's possession

X
Applies to covered material in NIH's possession

Availability of Information

Pro-Children Act of 1994

X

X

X

Requirements Affecting the Rights and Welfare of Individuals

Program Fraud and Civil Remedies and False Claims Acts

X

X

N/A

Application and Review Processes—Legal Implication of Application

Protection of
Research Subjects' Identity

X

X

X

Requirements Affecting the Rights and Welfare of Individuals

Public Disclosure

X

N/A

N/A

Construction Grants

Recombinant DNA Molecules

X

X

X

Ethical and Safe Conduct in Science and Organizational Operations

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)

Civil Rights

National Research Service Awards

Awards to Foreign Institutions

Relocation Assistance and Real Property
Acquisition

X

N/A

N/A

Construction Grants

Research Misconduct

X

X

N/A

Ethical and Safe Conduct in Science and Organizational Operations

Awards to Foreign Institutions

Research on
Transplantation of Fetal Tissue

X

X

X

Requirements Affecting the Rights and Welfare of Individuals

Restriction on
Distribution of Sterile Needles

X

X

X

Ethical and Safe Conduct in Science and Organizational Operations

Seat Belt Use

X

N/A

N/A

Ethical and Safe Conduct in Science and Organizational Operations

Smoke-Free
Workplace

X

N/A

N/A

Ethical and Safe Conduct in Science and Organizational Operations

Standards of Conduct

X

N/A

N/A

Ethical and Safe Conduct in Science and Organizational Operations

*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.

Ethical and Safe Conduct in Science and Organizational Operations

NIH grants are subject to requirements intended to ensure that recipient organizations are responsible in their handling of Federal awards. Grantees are required to adopt and enforce policies that minimize the opportunity for improper financial gain on the part of the organization, their 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.

Standards of Conduct

Grantees must 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:

  • Address the conditions under which outside activities, relationships, or financial interests are proper or improper;
  • Provide for advance notification of outside activities, relationships, or financial interests to a responsible organizational official;
  • Include a process for notification and review by the responsible official of potential or actual violations of the standards; and
  • Specify the nature of penalties that the grantee may impose. These penalties would be in addition to any penalties that may be imposed by NIH or a cognizant Federal agency for infractions that also violate the terms or conditions of award.

(Note: The following paragraph has been revised in accordance with the 03/20/2001 NIH Guide Notice)
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 officer of the grantee, 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 informing the IC Chief Grants Management Officer (CGMO) if the infraction is related to an NIH award. If a suspension or separation action is taken by a grantee against a PI or other key personnel under an NIH grant, the designated GMO must be notified as specified in "Administrative Requirements—Changes in Project and Budget."

Financial Conflict of Interest

NIH also 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 there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will 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 authorized organizational official on the face page of the application serves as certification of compliance with the requirements of 42 CFR Part 50, Subpart F, including that:

(Note: The following bullets were revised in accordance with the 03/20/2001 NIH Guide Notice)
  • There is in effect, at that organization, 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;
  • Prior to the expenditure of any NIH funds awarded under a new award, the organization will inform the CGMO the existence of any conflicting financial interests of the type covered by 42 CFR 50.605 identified by the organization;
  • When informing the CGMO that a financial conflict of interest has been identified, the organization will assure that the interest has been addressed in accordance with the regulations by indicating whether the conflict has either been managed, reduced, or eliminated;
  • The organization will continue to make similar reports on subsequently identified conflicts; and
  • The organization will make additional information available to NIH, upon request, as to how identified conflicting interests have been handled in accordance with the regulations.

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

  • Public disclosure of significant financial interests;
  • Monitoring of research by independent reviewers;
  • Modification of the research plan;
  • Disqualification from participation in all or a portion of the research funded by PHS;
  • Divestiture of significant financial interests; or
  • 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 collaborating organization or to those of the grantee (see "Consortium Agreements").

The protection of human subjects requires objectivity in communicating risks, selecting subjects, promoting informed consent, and gathering, analyzing, and reporting data. Although there is no regulatory requirement for Institutional Review Boards (IRBs) to consider investigator financial conflict of interest, in some cases IRBs are incorporating conflict of interest issues in their deliberations (see "Public Policy Requirements and Objectives—Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Human Subjects.")

Some strategies used by IRBs to consider investigator conflict of interest include the following:

  • Make IRBs aware of the organization's conflict of interest policies and procedures and elect to include a statement in the informed consent form that all clinical investigators comply with the organizational guidelines.
  • Ask investigators to complete a short questionnaire in which they are asked whether they or any person responsible for the design, conduct, or reporting of research have an economic interest in, or acts as an officer or a director of any outside entity whose financial interest could reasonably appear to be affected by, the research.
  • Provide instruction to IRB members during their orientation on how to identify and respond to a perceived financial, academic, or other conflict of interest.

Debarment and Suspension

HHS regulations published at 45 CFR Part 76 implement the government-wide debarment and suspension system for HHS' non-procurement transactions. "Nonprocurement transactions" include grants, cooperative agreements, scholarships, fellowships, and loans. Accordingly, applicants for NIH grants ("primary covered transactions"), including applicants for individual National Research Service Awards (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):

  • Are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from covered transactions by any Federal department or agency;
  • Have not, within the 3-year period preceding the application, been convicted of, or had a civil judgment rendered against them for, commission of 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; for violation of a Federal or State antitrust statute; for commission of embezzlement, theft, forgery, bribery, falsification or destruction of records; or for making false statements or receiving stolen property;
  • 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
  • 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. The full text of the instructions and the certification are included in Appendix A to 45 CFR Part 76.

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 an institutional National Research Service Award prior to 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.

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 authorized organizational official agrees that the grantee will provide a drug-free workplace and will comply with requirements to notify NIH in the event that 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, "Government-wide Debarment and Suspension (Nonprocurement) and Government-wide Requirements for Drug-Free Workplace (Grants)."

Health and Safety 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. The following standards and guidelines are recommended for use in developing and implementing health and safety operating procedures and practices for both personnel and facilities, and they serve to supplement prevailing Federal, State, and local laws and regulations:

  • Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, and the National Institutes of Health. HHS Publication No. (CDC) 93-8395. This publication is available at http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm.
  • 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.
  • Prudent Practices for Safety in Laboratories (1995), National Research Council. National Academy Press, 2101 Constitution Avenue, NW, Lockbox 285, Washington, DC 20418; telephone: 1-800-624-6242; or on-line at http://books.nap.edu/catalog/4911.html (ISBN)-309-05229-7).
  • 42 CFR Part 72, Interstate Shipment of Etiological Agents, and, in particular, 42 CFR 72.2, Additional Requirements for Facilities Transferring or Receiving Select Agents. Copies of these regulations are available from the Office of Health and Safety, Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30333; telephone: (404) 639-2453.
  • Procedures for Domestic Handling and Transport of Diagnostic Specimens and Etiologic Agents, 1994 (3rd ed.), H5a3doc.75, National Committee for Clinical Laboratory Standards. Copies may be obtained from NCCLS Ordering Department, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898; telephone: (610) 688-6400.
  • 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.

Grantee organizations are not required to submit documented assurance of their compliance with or implementation of the above standards. However, if so requested by the IC, 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, as appropriate.

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 it is made known to the Federal official having authority to obligate funds, in this case 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 Federal (appropriated) 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 (1) they have not made, and will not make, such a prohibited payment, (2) they will be responsible for reporting the use of non-appropriated funds for such purposes, and (3) they 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 authorized organizational official 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/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. Regulations at 42 CFR Part 50, Subpart A, "Responsibilities for PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science," specify grantee responsibilities in dealing with and reporting possible research misconduct. The signature of the authorized organizational official on the application 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 Office of Research Integrity (ORI) on its home page (http://www.ori.dhhs.gov) and, in hard copy, at the address shown in Part III.

As stated throughout this NIH GPS, the primary responsibility for ensuring that an NIH-funded project is being conducted in accordance with the approved application and budget and the terms and conditions of the award rests with the grantee. These responsibilities must be carried out 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 shall 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(s), protect human subjects and animals, provide reports to ORI, and ensure the proper expenditure of funds and continuation of the project during the conduct of the investigation, if appropriate. ORI staff are available to assist grantees with respect to research misconduct investigations and reporting, and IC staff are available to provide technical assistance and to work jointly 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 a finding of research misconduct has been made regarding conduct by an individual(s) 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. A finding of research misconduct may result in a range of possible sanctions by NIH, including, but not limited to, withdrawal of approval of the PI or other key personnel, debarment, disallowance of costs associated with the invalid or unreliable research, withholding of all or part of a continuation award, and/or suspension or termination, in whole or in part, of the current award. These actions are described in "Administrative Requirements—Enforcement Actions."

Where the validity or reliability of data has been affected by research misconduct, the grantee and its employee/collaborator authors are responsible for submitting a correction or retraction of the data to a journal, as appropriate, and/or publishing the corrected data, if required. ORI or NIH may require corrections or retractions. 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.

Issues involving potential criminal violations, such as misappropriation of Federal funds, must be promptly reported to the HHS Office of the Inspector General (see Part III).

Nondelinquency on Federal Debt

The Federal Debt Collection Procedure 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 authorized organizational official of the applicant organization (or individual in the case of an Individual National Research Service Award) certifies, by means of his/her signature on the application, that the organization 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 will still 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 NIH support 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.

Recombinant DNA Molecules

Scope and Applicability

The NIH Guidelines for Research Involving Recombinant DNA Molecules (the NIH Guidelines) (65 FR 60328, October 10, 2000 or latest revision) apply to all NIH-funded and non-NIH funded gene transfer projects that 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://www4.od.nih.gov/oba/rac/guidelines/guidelines.html. 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) DNA molecules that result from the replication of those described in (1). The NIH Guidelines apply to both basic and clinical research studies. 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, limitation, or termination of NIH funds 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 NIH Guidelines should be carefully reviewed, in their entirety, to ensure compliance with all of the requirements for the conduct of 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 Institutional Biosafety Committee (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. The composition requirements of IBCs are specified in section IV of the Guidelines. A roster of the members of the IBC must be submitted to the Office Biotechnology Activities (OBA), NIH (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. Section IV of the NIH Guidelines specifies the roles and responsibilities of PIs and grantees in relation to IBCs and in other areas.

Serious Adverse Event Reporting

The NIH Guidelines currently require the immediate reporting of serious adverse events that occur in human gene transfer clinical studies. As specified in Appendix M-I-C-4, investigators that have received authorization from the Food and Drug Administration (FDA) to initiate a human gene transfer research protocol must report any serious adverse event immediately to the local IRB (see "Public Policy Requirements and Objectives—Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Human Subjects—Assurance Requirements and Institutional Review Boards"), the IBC, the Office for Human Research Protections (OHRP) (if applicable), and OBA (at the address specified in Part III of this policy statement), followed by the filing of a written report with each office/group[7]. The Guidelines, available from OBA, should be consulted for complete requirements for the conduct of projects involving recombinant DNA techniques.

Human Pluripotent Stem Cell Research

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). NIH published final NIH Guidelines for Research Using Human Pluripotent Stem Cells (Guidelines) that were effective on August 25, 2000. Because the Guidelines contained a few incorrect citations and other minor errors, they were corrected on November 21, 2000 (http://stemcells.nih.gov/policy/guidelines.asp). The Guidelines establish procedures to help ensure that NIH-funded research in this area is conducted in an ethical and legal manner. Such research also is subject to the informed consent requirements of section 498A of the PHS Act.

NIH Guidelines for Research Using Human Pluripotent Stem Cells

For purposes of the 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, are in excess of clinical need, and have not reached the stage at which the mesoderm is formed. NIH funds may not be used to derive human pluripotent stem cells from human embryos. The Guidelines designate certain areas of human pluripotent stem cell research as ineligible for NIH funding.

Human Pluripotent Stem Cell Review Group

The approval process for NIH research proposed for support under grants and cooperative agreements is described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-050.html. In addition to the peer review process described in Part I of this policy statement, research that proposes to use human pluripotent stem cells will undergo a formal review of documentation of compliance with the Guidelines. This latter review will be conducted by the Human Pluripotent Stem Cell Review Group (HPSCRG), which is a working group of the Center for Scientific Review Advisory Council (CSRAC). The process for documenting compliance with the Guidelines is separate from the grant and cooperative agreement scientific review process. The two processes will take place in parallel in order to ensure that all aspects of scientific review and review of compliance are considered in a timely manner. Organizations and investigators proposing research using human pluripotent stem cells must be mindful of the requirements and deadlines for both processes in order to avoid delays in the potential funding of proposed research. NIH will not provide funds or allow existing funds to be used for research involving human pluripotent stem cells derived from human embryos or human fetal tissue until appropriate approvals have been obtained. Evidence of compliance with the Guidelines does not affect the peer review of the application nor does it ensure a favorable funding decision by NIH. The documentation requirements and approval process also apply to requests to conduct research using human pluripotent stem cells that are not part of a competitive process, i.e., that are part of an administrative supplemental request or a prior approval request for a change in scope.

When the HPSCRG receives compliance documentation in support of a request that proposes use of a the line of human pluripotent stem cells that has not been previously reviewed by the HPSCRG and recommended to, and approved by, the CSRAC, the HPSCRG review will take place in a public meeting. Thus, although the HPSCRG will review all requests for funds, the review of compliance documentation for the use of a cell line previously approved by NIH will not take place in a public meeting of the HPSCRG. The final approval of documentation of compliance always will take place in a public meeting of the CSRAC. Meetings of the CSRAC are open to the public. Following meetings of the CSRAC, the NIH Office of Science Policy will convey the results of the human pluripotent stem cell compliance review to the principal investigator, the organization, and the potential funding IC.

Restriction on Distribution of Sterile Needles

NIH appropriated funds may not be used to carry out any program involving distribution of sterile needles or syringes for the hypodermic injection of any illegal drug unless the Secretary, HHS, determines that (1) exchange projects are effective in preventing the spread of HIV and do not encourage the use of illegal drugs, and (2) the project is operated in accordance with criteria established by the Secretary for preventing the spread of HIV and ensuring that the project does not encourage the use of illegal drugs.

Seat Belt Use

Pursuant to Executive Order 13043 (April 16, 1997), Increasing the Use of Seat Belts in the U.S., NIH encourages grantees to adopt and enforce on-the-job seat belt policies and programs for their employees when operating organizationally owned or rented, or personally owned vehicles.

Smoke-Free Workplace

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




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