Animal welfare requirements, PHS Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare (OLAW), U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training. Institutional Animal Care and Use Committee, IACUC, vertebrate animals, USDA, animal policy, consortiums, verification of IACUC approval, Animal welfare assurance requirements, foreign recipients and foreign performance cites, reporting to OLAW

4.1.1 Animal Welfare Requirements

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) requires that an approved Animal Welfare Assurance be on file with the Office of Laboratory Animal Welfare (OLAW) at the time of award for all organizations involved in PHS-conducted or supported activities involving live vertebrate animals. This requirement includes organizations that are award recipients and organizations that serve as performance sites where animal activities will be conducted. Recipient organizations must establish appropriate policies and procedures to ensure the humane care and use of animals and bear ultimate responsibility for compliance with the PHS Policy in all PHS supported activities.

The PHS Policy incorporates the U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training, and requires the recipient to maintain an animal care and use program based on the Guide for the Care and Use of Laboratory Animals. An Institutional Animal Care and Use Committee (IACUC) appointed by the Chief Executive Officer or designee, is federally mandated to oversee the organization's animal program, facilities, and procedures (Public Law 99-158, Sec. 495). Organizations in foreign countries must also comply with the PHS Policy on Humane Care and Use of Laboratory Animals or may provide evidence to the PHS (i.e. NIH) that acceptable standards for the humane care and use of the animals in PHS-conducted or supported activities will be met per Section II of the PHS Policy.

The PHS Policy defines "animal" as any live, vertebrate animal used or intended for use in research, research training, experimentation, biological testing or related purposes.

Applications from organizations proposing the use of animals are incomplete if they do not thoroughly address the use of vertebrate animals required in the Research Plan of the application. If the involvement of animals isnot yet known and cannot be described in the application at the time of application, the applicant should provide an explanation and indicate when it is anticipated that animals will be used. If an award is made, prior to conducting any animal activities the recipient must submit to the NIH awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. for prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). the detailed information about the use of animals as required in the Research Plan of the application and meet the Assurance and IACUC approval requirements of the PHS Policy.

Noncompeting and competing awards are prohibited from using NIH funds to procure cats from USDA Class B dealers. The procurement of cats may only be from USDA Class A dealers or other approved legal sources.

NIH funds may not be used to procure or support the use of dogs from Class B dealers. Dogs used in NIH-supported research may only be from USDA Class A dealers or other approved legal sources. Any costs incurred in violation of this policy are unallowable and will be subject to a cost disallowance.

No activities with live vertebrate animals may begin and no costs for activities with live vertebrate animals may be charged to NIH if there is not a valid Animal Welfare Assurance and IACUC approval of the activity.

The PHS Policy does not supersede applicable State or local laws or regulations that impose more stringent standards for the care and use of animals in research. All recipient organizations are required to comply, as applicable, with the regulations (9 CFR, Subpart A) issued by the U.S. Department of Agriculture under the Animal Welfare Act, as amended, 7 U.S.C. 2131 et seq., and other Federal statutes and regulations relating to animals.

4.1.1.1 Animal Welfare Assurance Requirements

An Animal Welfare Assurance is the document submitted by an institution assuring institutional compliance with the PHS Policy. OLAW is responsible for requesting, negotiating, approving or disapproving, and, as necessary, restricting or withdrawing approval of Assurances.

When an applicant institution does not have an Animal Welfare Assurance, the Authorized Organization Representative The individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. This individual is equivalent to the signing official in the eRA Commons, i.e., holds the SO Role.'s signature on the application constitutes declaration that the institution will submit an Assurance when requested by OLAW. Upon such request, the institution shall prepare the Assurance as instructed by OLAW and in accordance with the PHS Policy, and the authorized IACUC shall review those components of the application related to the care and use of animals. Except in certain circumstances, the Assurance must be submitted to and approved by OLAW in order for the IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. to award the grant. No activities with live vertebrate animals may be conducted and no costs for activities with live vertebrate animals may be charged to NIH grants in the absence of a valid Assurance on file with OLAW.

Organizations where live, vertebrate animal work is performed onsite (i.e., serve as an animal performance site) must have an approved Domestic or Foreign Assurance. If the pass-through entity does not have an approved Domestic or Foreign Assurance and the animal activities will be conducted at an Assured institution named as a performance site, the recipient must obtain an Interinstitutional Assurance from OLAW. Under the Interinstitutional Assurance, the recipient and performance site agree that the research will be conducted under the auspices and program of animal care and use of the performance site's Assurance.

4.1.1.2 Verification of IACUC Approval

NIH will delay an award for research involving live vertebrate animals until the recipient organization and all performance sites are operating in accordance with approved Animal Welfare Assurances and the recipient has provided verification of IACUC approval of those sections of the application that involve use of vertebrate animals. IACUC approval must have been granted not more than three years prior to the budget period start date to be valid; however, IACUCs may determine that continuing review on a more frequent basis is appropriate.

Verification of IACUC approval may be filed at any time before award in accord with Just-in-Time NIH policy allows the submission of certain elements of a competing application to be deferred until later in the application process, after review when the application is under consideration for funding. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. procedures, unless required earlier by the IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.. Therefore, following peer review and notification of impact score/percentile, applicant organizations with approved Assurances may wish to proceed with IACUC review for those applications that have not yet received IACUC approval and that appear to be in a fundable range.

It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC. The applicant verifies that there is congruence between the application and the IACUC-approved protocol when it provides the IACUC approval date.

No costs for activities with live vertebrate animals may be charged to NIH grants if there is not a valid IACUC approval.

4.1.1.3 Consortiums

Under consortium (subaward) agreements in which the recipient collaborates with one or more other organizations, the recipient, as the direct and primary recipient of NIH grant funds, is accountable for the performance of the project, the appropriate expenditure of grant funds by all parties, and all other obligations of the recipient as specified in the NIHGPS (see Consortium Agreements chapter in IIB). The animal welfare requirements that apply to recipients also apply to consortium participants and subprojects.

The primary recipient is responsible for including these requirements in its agreements with collaborating organizations, and for ensuring that all sites engaged in research involving the use of live vertebrate animals have an approved Animal Welfare Assurance and that the activity has valid IACUC approval. The approval of more than one IACUC is not required if the recipient and performance site(s) have Assurances; the institutions may exercise discretion in determining which IACUC reviews research protocols and under which institutional program the research will be conducted.

The recipient is further responsible for complying with NIH prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). requirements related to the addition of sites not included in the approved application (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements).

The list of domestic and foreign organizations with a PHS approved animal welfare assurance is available on OLAW's website. The list of organizations with approved assurances is available at The OLAW web site posts a list of domestic institutions and foreign institutions with approved assurances.

4.1.1.4 Foreign Recipients and Foreign Performance Sites

Foreign recipients that will perform live, vertebrate animal activity onsite must provide OLAW with an Animal Welfare Assurance for Foreign Institutions. This constitutes institutional assurance and certification of compliance with the applicable laws, regulations, and policies of the jurisdiction in which the research will be conducted, and a commitment to follow the International Guiding Principles for Biomedical Research Involving Animals. IACUC approval is not required of foreign recipients; however, OLAW encourages foreign recipients to use the standards in the Guide for the Care and Use of Laboratory Animals.

When the recipient is a domestic institution and animal performance sites are foreign (i.e., domestic grant with a foreign component), the IACUC approval requirement applies. Accordingly, the recipient remains responsible for animal activities conducted at the foreign site and must provide verification of IACUC approval (i.e., certification that the activities as conducted at the foreign performance site are acceptable to the recipient). The recipient IACUC may accept, as its own, the approval of a foreign organization's animal welfare committee or oversight body;; however, the recipient IACUC remains responsible for the review. Additionally, the foreign animal performance site must obtain an Animal Welfare Assurance for Foreign Institutions as described in the preceding paragraph.

4.1.1.5 Reporting to OLAW

Reporting requirements under the PHS Policy include an annual report to OLAW describing any change in the institution's program for animal care and use as described in the Assurance, changes in IACUC membership, and the dates the IACUC conducted its semiannual evaluations of the institution's program and facilities. The IACUC, through the institutional official signing the Assurance, must promptly report any serious or continuing noncompliance with the PHS Policy, serious deviations from the Guide for the Care and Use of Laboratory Animals, and any IACUC suspensions.

Charges to NIH grant awards for the conduct of live vertebrate animal activities during periods of time that the terms and conditions of the grant award are not upheld are not allowable. Specific situations under which charges are not allowable are:

1. The conduct of animal activities in the absence of a valid Animal Welfare Assurance on file with OLAW.
2. The conduct of animal activities in the absence of a valid IACUC approval of the activities. Absence of IACUC approval includes failure to obtain IACUC approval, expiration, or suspension of IACUC approval.

Instances of serious noncompliance with section IV.F.3. of the PHS Policy, such as those mentioned above, are to be reported to OLAW and the IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. supporting the grant award. In cases where charges have been made for unauthorized animal activities, appropriate adjustments must be made to the grant to remove those charges. NIH requires that reports contain a certification that no unallowable costs were charged to NIH grant funds during a period of noncompliance. If such a certification cannot be made, a detailed accounting of unallowable charges made to each affected grant should be included with the report. If a detailed accounting has not been completed at the time of reporting, a date when it will be provided should be included.

NIH expects recipients to continue to maintain and care for animals during periods when animal activities are conducted in the absence of a valid Animal Welfare Assurance and/or IACUC approval. ICs may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis. Consultation with the IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. is encouraged regarding questions concerning allowable costs.

Information about the PHS Policy, Animal Welfare Assurances, and other relevant topics is available on the OLAW website.