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ARCHIVED - NIH Grants Policy Statement (10/98)

Part II: Terms and Conditions of NIH Grant Awards-Part 2 of 7

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NIH grants are subject to requirements intended to ensure that organizations are responsible in their handling of Federal awards, and to minimize the opportunity for improper financial gain on the part of grantees and their employees and 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.

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 must also:

  • 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 institutional 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.

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, the NIH awarding office. The grantee is responsible for enforcing its standards of conduct, taking appropriate action on individual infractions, and informing NIH 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 IC GMO must be notified as specified in "Administrative Requirements     Changes in Project and Budget".

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 NIH Funding is Sought," pertaining to investigators' actual or potential financial conflicts of interests. These requirements do not apply to grants under 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:

  • 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 NIH of the existence of any conflicting financial interests of the type covered by 42 CFR 50.605 it identified and assure that the interest has been managed, reduced, or eliminated in accordance with the regulations;
  • It will continue to make similar reports on subsequently identified conflicts; and
  • It will make information available to NIH, upon request, as to how identified conflicting interests have been handled.

HHS regulations published at 45 CFR Part 76 implement the government-wide debarment and suspension system for HHS's nonprocurement transactions. "Nonprocurement transactions" include grants, cooperative agreements, scholarships, fellowships, and loans. Accordingly, applicants for NIH grants ("primary covered transactions") are required to certify1 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.

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 neither they nor their principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any Federal agency, and, if unable to certify, the grantee must attach an explanation to the application or provide the information to the GMO prior to awarding the contract or entering into the agreement.

The Drug-Free Workplace Act of 1988 (Public Law 100-690, Title V, Subtitle D, as amended) requires that all grantees receiving grants from any Federal agency agree that they will maintain a drug-free workplace. By signing the application, the authorized institutional 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)."

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. Copies of these regulations may be obtained from OSHA Office of Publications, U.S. Department of Labor, Room N3101, 200 Constitution Avenue, NW, Washington DC 20210; telephone: (202) 219-4667.
  • 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.
  • 42 CFR Part 72, Interstate Shipment of Etiological Agents, and, in particular, 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 appropriate Federal, State, and local health and safety standards have been considered and have been put into practice, as appropriate.

NIH officials 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" in this section).

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, that are not subject to this prohibition.

Applicants for NIH awards with total costs expected to exceed $100,000 are required to certify that they have not made, and will not make, such a prohibited payment, they will be responsible for reporting the use of non-appropriated funds for such purposes, and 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 institutional official on the application serves as the required certification of compliance. 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 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. See also "Cost Considerations     Allowability of Costs/Activities     Selected Items of Cost".

The grantee will inquire into and, if necessary, investigate and resolve promptly and fairly all instances of alleged or apparent misconduct in science. 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 misconduct in science. Organizations applying for or receiving NIH research grants are required to certify in their applications that they have 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 and, in hard copy, at the address shown in Part IV.

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 misconduct in science has been found or where a misconduct in science 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 misconduct in science 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").

Where 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 misconduct in science 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 misconduct in science.

When a finding of misconduct in science has been made regarding conduct by an individual(s) working on an NIH grant-supported project, the grantee must assess the effect of that finding on the ability to continue that project, as originally approved by NIH, and promptly obtain NIH approval of any intended change of PI or other key personnel. A finding of misconduct in science 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".

The grantee is responsible for the actions of its employees and other research collaborators involved in the project. Where the validity or reliability of data has been affected by misconduct in science, 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. Corrections or retractions may be required by ORI or NIH. 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 IV).

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. Before a grant can be awarded, the applicant organization must certify that neither it nor any person to be paid from grant funds is 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.

All research involving recombinant DNA techniques that is supported by NIH must meet the requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules (the Guidelines) (59 FR 34496, July 5, 1994 or latest revision). As defined by the 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).

Each institution that conducts (or will conduct) research involving recombinant DNA technology, including contractors under grants, must establish a standing Institutional Biosafety Committee. The composition requirements of these committees are specified in section IV of the Guidelines, which also discusses the roles and responsibilities of PIs and grantees. The committee is required to review each proposed nonexempt project for recombinant DNA experiments and certify that it has found the procedures, project, personnel, and facilities adequate and in compliance with the Guidelines. A roster of the members of the Institutional Biosafety Committee must be submitted to the Office of Recombinant DNA Activities (see Part IV for address). At a minimum, the roster should include the names, addresses, occupations, and qualifications of the chairperson and members of the committee.

The Guidelines, available from the Office of Recombinant DNA Activities, should be consulted for complete requirements for the conduct of projects involving recombinant DNA technology, including requirements for submission of information to other Federal agencies, such as the Food and Drug Administration.

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 exchange projects are effective in preventing the spread of HIV and do not encourage the use of illegal drugs, and 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.

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.

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.

NIH appropriated funds may not be used to support human embryo research under any extramural award instrument. NIH funds may not be used for the creation of a human embryo(s) for research purposes or for research in which a human embryo(s) is destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and section 498(b) of the PHS Act. The term "human embryo(s)" includes any organism not protected as a human subject under 45 CFR 46, as of the date of enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

In addition to the statutory restrictions on human fetal research under section 498(b) of the PHS Act, by Presidential memorandum of March 4, 1997, NIH is prohibited from using Federal funds for cloning of human beings.

Section 543 of the PHS Act requires that records of substance abuse patients be kept confidential except under specified circumstances and purposes. The covered records are those that include the identity, diagnosis, prognosis, or treatment of any patient maintained in connection with any program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research that is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States. This requirement is implemented at 42 CFR Parts 2 and 2a.

If controlled substances are proposed to be administered as part of a research protocol or if research is to be conducted on the drugs themselves, applicants/grantees must ensure that the requirements of the Drug Enforcement Administration (DEA), including registration, inspection, and certification, as applicable, are met. Regional DEA offices can supply forms and information concerning the type of registration required for a particular substance for research use. The main registration office in Washington, DC may be reached at (202) 254-8255. Information is also available from the National Institute on Drug Abuse at (301) 443-6300.

HHS regulations for the protection of human subjects, at 45 CFR Part 46, implement section 491(a) of the PHS Act and provide a systematic means, based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by NIH or other HHS components. They stipulate that the applicant/grantee, whether domestic or foreign, is responsible for safeguarding the rights and welfare of human subjects involved in NIH grant-supported research activities. Subpart A of the HHS regulations constitutes the Federal policy (common rule) for the protection of human subjects.

Applicant organizations proposing to involve human subjects in nonexempt research must file (or have previously filed) a written Assurance of Compliance with the Office for Protection from Research Risks (OPRR) setting forth the commitment of the organization to establish appropriate policies and procedures for the protection of human subjects. Affiliated organizations or organizations that will serve as other performance sites for the grant-supported research must also file an Assurance. OPRR is responsible for approving the Assurance, which may be a Multiple Project Assurance (MPA), a Single Project Assurance (SPA), or other type of Assurance, as appropriate. OPRR may also negotiate an Inter-Institutional Amendment if employees of an organization with an MPA routinely conduct their grant-supported research at an affiliated institution, thereby avoiding the need for an SPA for each separate project performed at such sites.

NIH will not award any grant for nonexempt research involving human subjects unless the organization is operating under an approved Assurance and, if operating under an MPA, provides certification, as part of its application, that an appropriate Institutional Review Board (IRB) has, within 12 months of the budget period start date, reviewed and approved the proposed activity in accordance with the regulatory requirements. SPA organizations must provide certification of IRB approval to OPRR as part of the SPA. In addition, no human subjects may be involved in research at an affiliated institution prior to approval by OPRR of an applicable Assurance for that organization. If an MPA organization submits an application with the knowledge that human subjects may be involved within the project period, but definite plans are not set forth in the application, the research activity must be reviewed and approved by an IRB and a certification submitted to NIH before human subjects may be involved in covered research activities supported by the award.

As specified in 45 CFR 46.111, the IRB review must include a determination that, for research covered by the regulations:

  • The procedures to be used will minimize risks to subjects;
  • Risks to subjects are reasonable in relation to expected benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result;
  • Selection of subjects is equitable;
  • Informed consent is sought from each prospective subject or the subject's legally authorized representative and is appropriately documented in accordance with, and to the extent required by, the regulation;
  • Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects, the protection of privacy, and the confidentiality of data; and
  • Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness or persons who are economically or educationally disadvantaged, appropriate additional safeguards are included in the study to protect the rights and welfare of these subjects.

The regulations specify additional protections for research involving fetuses, pregnant women, and human in vitro fertilization (Subpart B); prisoners (Subpart C); and children (Subpart D).

No individual may receive NIH grant funds for covered research involving human subjects unless the individual is affiliated with or sponsored by an organization that assumes responsibility for the research under an applicable written Assurance or the individual makes other arrangements with OPRR.

For purposes of this public policy requirement, the definitions at 45 CFR 46.102 apply. A "human subject" is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. The regulations extend to the use of human organs, tissues, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable State and local law and is not directly regulated by 45 CFR 46.

"Research" is defined as "systematic investigation designed to develop or contribute to generalizable knowledge." Unless an activity is "exempt" (see 45 CFR 46.101), any activity meeting the regulatory definition of "research" constitutes research for purposes of applying the regulations, even if supported by a grant that might have as its overall purpose an activity that is not primarily research. (For example, some training programs may include research activities.) OPRR should also be consulted if there is any question concerning the classification of research as exempt or nonexempt.

Information concerning the preparation and negotiation of Assurances, as well as copies of the regulation, may be obtained from OPRR at the address shown in Part IV or from its home page. OPRR has also produced a publication available through the Government Printing Office2 and an instructional videotape.

All clinical research involving investigational new drugs (IND), drugs approved for a different indication, or experimental combinations of drugs, must meet the Food and Drug Administration's (FDA) IND regulations, FDA's human subjects protection requirements, and the HHS human subjects' requirements (as described above) to be eligible for funding.

The official sponsor of the IND, whether NIH, a grantee, or a third party, is legally responsible for meeting the FDA IND requirements. If a third party, such as a pharmaceutical company or research organization under contract to a grantee or to a pharmaceutical company, is the IND sponsor, the legal responsibility for monitoring the clinical trial and reporting to FDA rests with the IND sponsor rather than the grantee, which will generally be the case for larger, multi-site clinical trials. If the grantee is the IND holder, commonly referred to as an "investigator-initiated IND," the grantee or the investigator serves as the IND sponsor and assumes the legal responsibility. In any case, the grantee is ultimately responsible to NIH for ensuring compliance with the requirements for protection of human subjects, including compliance with FDA's IND requirements.

Following the filing of an IND, FDA has a 30-day period in which to review the IND. FDA may allow the IND to proceed or may defer approval of the IND until changes it deems acceptable are made. FDA may also order a clinical trial to be suspended or terminated, at any time, based on information it receives about that clinical trial. The FDA regulations are published at 21 CFR Parts 50 and 312.

Public Law 103-227, Title X, Part C-Environmental Tobacco Smoke, also known as the Pro-Children Act of 1994 (Act), imposes restrictions on smoking in facilities where federally funded children's services are provided. NIH grants are subject to these requirements only if they meet the Act's specified coverage. The Act specifies that smoking is prohibited in any indoor facility owned, leased, or contracted for and used for the routine or regular provision of kindergarten, elementary, or secondary education or library services to children under the age of 18. In addition, smoking is prohibited in any indoor facility or portion of a facility owned, leased, or contracted for and used for the routine or regular provision of federally funded health care, day care, or early childhood development (Head Start) services to children under the age of 18. The statutory prohibition also applies if such facilities are constructed, operated, or maintained with Federal funds. The statute does not apply to children's services provided in private residences, facilities funded solely by Medicare or Medicaid funds, portions of facilities used for inpatient drug or alcohol treatment, or facilities where Women, Infants, and Children (WIC) coupons are redeemed. Failure to comply with the provisions of the law may result in the imposition of a civil monetary penalty of up to $1,000 per violation and/or the imposition of an administrative compliance order on the responsible entity.

Because of the nature of NIH programs and funding, individual transactions, rather than entire programs, may be subject to these requirements. Therefore, NIH does not require a separate certification of intent to comply with the Act. The signature of the applicant's authorized official will indicate the intent to comply. Any questions concerning the applicability of these provisions to an NIH grant should be directed to the IC GMO.

Section 301(d) of the PHS Act provides that the Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research activities to protect the privacy of research subjects by withholding the names and other identifying characteristics of those subjects from individuals not engaged in the research. Authorized persons may not be compelled to disclose subjects' identities in any Federal, State, or local civil, criminal, administrative, legislative or other proceeding. An applicant may request a certificate of confidentiality to protect research subjects' identities under a specific research project. The request should be submitted to the IC GMO, and, subject to IC review and approval, a certificate may be issued pursuant to 42 CFR 2a.

In submitting an application to NIH, the authorized institutional official that signs the application is certifying that, if research on the transplantation of human fetal tissue is conducted under the grant-supported project, the organization will make available for audit by the Secretary, HHS, or designee, the physician statements and informed consents required by subsections 498A(b)(2) and (c) of the PHS Act or will ensure HHS access to those records, if maintained by an entity other than the grantee. This requirement is in addition to the human subjects in research requirements specified above.

The PHS Policy on Humane Care and Use of Laboratory (the Policy) requires that applicant organizations proposing to use vertebrate animals in NIH-supported activities file a written Animal Welfare Assurance with the Office for Protection from Research Risks (OPRR), NIH. The Policy, which defines "animal" as "any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes," stipulates that the applicant/grantee bears responsibility for the humane care and use of animals in NIH-supported research activities. The Policy implements and supplements the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and requires the applicant to establish appropriate policies and procedures for humane care and use of animals, based on the NIH Guide for the Care and Use of Laboratory Animals, and to comply with the Animal Welfare Act and its implementing regulations. This includes appointment of an Institutional Animal Care and Use Committee (IACUC) with specified responsibilities.

No NIH award for research involving live vertebrate animals will be made unless the applicant organization and all performance sites are operating in accordance with an approved Animal Welfare Assurance and provide verification that the IACUC has reviewed and approved those sections of the application that involve use of vertebrate animals, in accordance with the requirements of the Policy. Applications from organizations with approved Assurances will be considered incomplete if they do not include verification of IACUC review or do not contain the information concerning the use of vertebrate animals required as part of the application's research plan (see instructions for completion of the PHS-398 for the five specific points that need to be addressed). In the case of apparent or potential violations of the Policy, NIH may refer applications back to the applicant for further IACUC review.

Foreign organizations proposing activities involving vertebrate animals are required to comply with the Policy or provide evidence that acceptable standards for the humane care and use of animals will be met. NIH will not make an award for research involving live vertebrate animals to an individual unless that individual is affiliated with an organization that accepts responsibility for compliance with the Policy and has filed the necessary assurance with OPRR.

The Policy does not affect applicable State or local laws or regulations that impose more stringent standards for the care and use of laboratory animals. All organizations are required to comply, as applicable, with the Animal Welfare Act, as amended, 7 U.S.C. 2131 et seq., and other Federal statutes and regulations relating to animals.

Information concerning the preparation and submission of Animal Welfare Assurances as well as copies of the Policy and other relevant materials are available from the Division of Animal Welfare, OPRR.

NIH has adopted policies requiring grant-supported research projects to be as inclusive in design as possible in order to extend the validity of research findings and allow for enhancement of the health status of all population groups.

Research involving human subjects of any age must comply with the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, and Federal Register, 59 FR 14508-14513, March 28, 1994), implementing section 492B of the PHS Act. These guidelines require that women and members of minority groups and their subpopulations be included in any NIH-supported research project involving human subjects, unless a clear and compelling rationale and justification establishes, to the satisfaction of the IC Director, that inclusion is inappropriate with respect to the health of the subjects, the purpose of the research, or other circumstances. Cost is not an acceptable reason for exclusion, except when the research would duplicate data already available from other sources. Women of child-bearing potential should not be routinely excluded from participation in clinical research; i.e., any biomedical or behavioral research involving human subjects. The guidelines should be reviewed for policy concerning inclusion of these groups in Phase III clinical trials.

Peer reviewers will evaluate proposed plans for inclusion of members of minority groups and both genders, the design of clinical trials, and recruitment and outreach as part of the scientific assessment. Failure to comply with this policy may result in NIH not making an award. Grantees are required to report annually on the enrollment of individuals by gender and racial or ethnic minority group as part of the noncompeting continuation request or other annual progress reporting (see "Administrative Requirements     Monitoring     Reporting").

NIH has developed a separate policy on inclusion of children as subjects in clinical research that is similar to the policy regarding inclusion of women and minorities (see above). Any new application involving human subjects research submitted for a receipt date after October 1, 1998 must include children (i.e., individuals under the age of 21) in the research design unless there are scientific or ethical reasons not to include them. If children will be excluded from the research, the application must present an acceptable justification for the exclusion. This policy applies to both exempt and nonexempt research activities (see "Human Subjects" in this section). The inclusion of children as subjects in research must comply with all applicable provisions of 45 CFR part 46 and other pertinent Federal laws and regulations. This policy is not mandatory for awards made prior to October 1, 1998 and for new applications submitted for earlier receipt dates.

Before an NIH IC may make an award to any domestic applicant organization, the organization must affirm that it has an Assurance of Compliance with the statutes described below on file with the Office of Civil Rights (OCR), Office of the Secretary, HHS. The Assurance, Form HHS-690, is filed on an institutional basis and is not required for each application; however, the certification is required with each application. If the application has been recommended for funding and the applicant organization does not have an Assurance on file, it will receive, from the responsible IC, the required form and instructions for completion and submission. The Form HHS-690 is also available from grantsinfo@nih.gov or by telephone at (301) 435-0714.

Domestic organizations that receive funding from grantees rather than directly from NIH, including contractors under grants, are also required to file this Assurance, and the applicant/grantee is responsible for determining whether those organizations have the required Assurance on file or, if not, ensuring that it is filed with OCR.

The Age Discrimination Act of 1975 prohibits discrimination on the basis of age in any program or activity receiving Federal financial assistance. The HHS implementing regulations are codified at 45 CFR Part 91.

Title VI of the Civil Rights Act of 1964 provides that no person in the U.S. shall, on the grounds of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. The HHS implementing regulations are codified at 45 CFR Part 80.

Title IX of the Education Amendments of 1972 provides that no person in the U.S. shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any educational program or activity receiving Federal financial assistance. The HHS implementing regulations are codified at 45 CFR Part 86.

Section 504 of the Rehabilitation Act of 1973, as amended, provides that no otherwise qualified handicapped individual in the United States shall, solely by reason of the handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. These requirements pertain to the provision of benefits or services as well as to employment. The HHS implementing regulations are codified at 45 CFR Parts 84 and 85.

Public policy requirements that apply to "construction activities" are described in "Construction Grants" in Part III. However, they may also apply to alteration and renovation (A&R) activities. A grantee undertaking an A&R project under a non-construction award should consult the GMO concerning potential applicability.

With the exception of certain types of information that may be considered proprietary or private information that cannot be released, after the grant is funded, most grant-related information submitted to NIH by the applicant or grantee in the application or postaward phase is considered public information and is subject to possible release to individuals or organizations outside NIH. The statutes and policies that require this information to be made public are intended to foster an open system of Government and accountability for governmental programs and expenditures, and, in the case of research, to provide information about federally funded activities.

NIH routinely makes information about awarded grants, including project title, the name of the PI, and the amount of the award, available to the public through the NIH Computer Retrieval of Information on Scientific Projects (CRISP) system. The project description provided by an applicant for a funded research grant application is sent to the National Technical Information Service (NTIS), U.S. Department of Commerce, where the information is used for dissemination of scientific information and scientific classification and program analysis purposes. The public may request these descriptions from NTIS. Other information may be released on a case-by-case basis as provided below.

Several policies require acknowledgment of support and a disclaimer for publications, inventions, and other research products, as provided in "Administrative Requirements     Availability of Research Results: Publications and Intellectual Property Rights, Including Unique Research Resources" and elsewhere in this policy statement. The disclosure requirement stated below ("Acknowledgment of Federal Funding") is included in HHS appropriations statutes and applies government-wide.

All grantees must acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money. Grantees are required to state (1) the percentage and dollar amounts of the total program or project costs financed with Federal money, and (2) the percentage and dollar amount of the total costs financed by nongovernmental sources.

The Freedom of Information Act (FOIA), 5 U.S.C. 552, and implementing HHS regulations (45 CFR Part 5) require NIH to release certain grant documents and records requested by members of the public, regardless of the intended use of the information. These policies and regulations apply to information in the possession of NIH and do not require grantees or contractors under grants to permit public access to their records. The regulations also indicate types of information that are generally exempt from release.

The following types of material will generally be released:

  • Funded applications;
  • Pending and funded noncompeting continuations;
  • Grant progress reports; and
  • Final reports of any audit, survey, review, or evaluation of grantee performance that have been transmitted to the grantee.

This includes information of this type maintained in electronic format.

The following types of records or information will generally be withheld in response to an FOIA request:

  • Pending competing grant applications;
  • Unfunded new and competing continuations and competing supplemental applications;
  • Financial information regarding a person, such as salary information pertaining to project personnel;
  • Information pertaining to an individual, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
  • Predecisional opinions in interagency or intra-agency memoranda or letters expressed by Government officers, employees, or consultants;
  • Evaluative portions of site visit reports and peer review summary statements, including priority scores;
  • Trade secrets and commercial, financial, and otherwise intrinsically valuable items of information that are obtained from a person or organization and are privileged or confidential;
  • Information which, if released, would adversely affect the competitive position of the person or organization; and
  • Patent or other valuable commercial rights of the person or organization.

If NIH has substantial reason to believe that information in its records could reasonably be considered exempt, before the information is released in response to an FOIA request, the applicant or grantee will be notified of the request by the appropriate NIH FOIA office, through the PI, and will be given an opportunity to identify potentially patentable or commercially valuable information that should not be disclosed. After NIH consideration of the grantee's response, if any, the grantee will be informed of the agency's decision as to what documents will be released and to whom. If a document contains both disclosable and nondisclosable information, the nondisclosable information will be deleted by a designated NIH or HHS FOIA Officer, and the balance of the document will be disclosed.

The Privacy Act of 1974, 5 U.S.C. 552a, and its implementing regulations (45 CFR Part 5b) provide certain safeguards for information about individuals maintained in a system of records, as identified by the Act (i.e., information may be retrieved by the individual's name or other identifying information). These safeguards include the rights of individuals to determine what information about them is maintained in Federal agencies' files (hard copy or electronic) and how it is used, to have access to such records, and to correct, amend, or request deletion of information in their records that is inaccurate, irrelevant, or outdated.

Records maintained by NIH with respect to grant applications, grant awards, and the administration of grants are subject to the provisions of the Privacy Act. NIH has two Privacy Act systems of records that cover NIH grant records:

  • 09-25-0036, Extramural Awards and Chartered Advisory Committees: IMPAC (Grant/Contract/Cooperative Agreement Information/Chartered Advisory Committee Information), HHS/NIH/OER and HHS/NIH/CMO.
  • 09-25-0112, Grants and Cooperative Agreements: Research, Research Training, Fellowship and Construction Applications and Related Awards, HHS/NIH/OD.

These two systems provide guidance on requirements for the management of grant records in the possession of NIH and include appropriate routine uses of such information. They also include requirements for safeguarding the records and for record retention and disposal.

In considering a request for information concerning an individual made by a party other than that individual, NIH must take into account both the requester's right to know under FOIA and the individual's right to privacy under the Privacy Act.

Records maintained by grantees ordinarily are not subject to the requirements of 45 CFR Part 5b.

Consistent with Executive Order 12770 (July 25, 1991), Metric Usage in Federal Government Programs, measurement values in applications and grantee-prepared reports, publications, and other grant-related documents should be in metric. See "Construction Grants" in Part III for requirements for metric usage in construction activities.

NIH is subject to section 588 of the National Defense Authorization Act of 1995, as implemented in 32 CFR Parts 23 and 216, that precludes grant awards to schools that the Department of Defense (DOD) determines have an anti-ROTC (Reserve Officer Training Corps) policy or practice (regardless of when implemented) that either prohibits or, in effect, prevents, the Secretary of Defense from gaining entry to campuses or access to students or information for military recruiting purposes. DOD publishes each determination of ineligibility in the Federal Register as well as publishing, once every 6 months, a list of all currently ineligible schools. If DOD makes its determination of ineligibility during an ongoing project period, NIH may either continue the award or take an action to end the award as provided in "Administrative Requirements     Enforcement Actions     Suspension, Termination, and Withholding of Support". Funding eligibility may be restored on the basis of new information provided to DOD.

As part of their responsibilities for the scientific, administrative, and financial aspects of the grant-supported activity, grantees are responsible for taking all steps necessary to anticipate and mitigate potential problems that might be caused by the advent of the Year 2000. NIH grantees are expected to ensure that the NIH activity being supported is not adversely affected by the Year 2000 problem, including any applicable computer systems, software applications, databases, and equipment.

All electronic data submitted to NIH by grantee organizations must be Year 2000 compliant. Data that is noncompliant will not be accepted. Organizations exchanging electronic data with NIH will also need to be able to interface with the systems being developed by NIH under its Electronic Research Administration (ERA) initiative. Further information may be obtained from the Inventions and Extramural Reporting Branch, the designated focal point in OPERA (see Part IV), and at http://grants.nih.gov/grants/oer.htm.


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