PHS Policy

This Policy is applicable to all PHS-conducted or supported activities involving animals, whether the activities are performed at a PHS agency, an awardee institution, or any other institution and conducted in the United States, the Commonwealth of Puerto Rico, or any territory or possession of the United States. Institutions in foreign countries receiving PHS support for activities involving animals shall comply with this Policy, or provide evidence to the PHS that acceptable standards for the humane care and use of the animals in PHS-conducted or supported activities will be met. No PHS support for an activity involving animals will be provided to an individual unless that individual is affiliated with or sponsored by an institution which can and does assume responsibility for compliance with this Policy, unless the individual makes other arrangements with the PHS. This Policy does not affect applicable state or local laws or regulations which impose more stringent standards for the care and use of laboratory animals. All institutions are required to comply, as applicable, with the Animal Welfare Act, and other Federal statutes and regulations relating to animals.

• Animal: Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.
• Animal Facility: Any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation. A satellite facility is any containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 24 hours.
• Animal Welfare Act: Public Law 89-544, 1966, as amended (P.L. 91-579, P.L. 94-279, and P.L. 99-198), 7 U.S.C. 2131 et seq. Implementing regulations are published in the Code of Federal Regulations (CFR), Title 9, Chapter 1, Subchapter A, Parts 1, 2, and 3, and are administered by the U.S. Department of Agriculture.
• Animal Welfare Assurance or Assurance: The documentation from an institution assuring institutional compliance with this Policy.
• Guide: Guide for the Care and Use of Laboratory Animals: Eighth Edition, National Academy Press, 2011, Washington, D.C., or succeeding revised editions.
• Institution: Any public or private organization, business, or agency (including components of Federal, state, and local governments).
• Institutional Official: An individual who signs, and has the authority to sign the institution's Assurance, making a commitment on behalf of the institution that the requirements of this Policy will be met.
• Public Health Service: The Public Health Service, or the PHS, includes the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Health Resources and Services Administration, the Indian Health Service, the National Institutes of Health, and the Substance Abuse and Mental Health Services Administration.
• Quorum: A majority of the members of the Institutional Animal Care and Use Committee (IACUC).

A. Animal Welfare Assurance

No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with this Policy. Assurances shall be submitted to the Office of Laboratory Animal Welfare (OLAW), Office of the Director, National Institutes of Health (NIH).¹ The Assurance shall be signed by the Institutional Official. OLAW will provide the institution with necessary instructions and an example of an acceptable Assurance. All Assurances submitted to the PHS in accordance with this Policy will be evaluated by OLAW to determine the adequacy of the institution's proposed program for the care and use of animals in PHS-conducted or supported activities. On the basis of this evaluation, OLAW may approve or disapprove the Assurance, or negotiate an approvable Assurance with the institution. Approval of an Assurance will be for a specified period of time (no longer than five years) after which time the institution must submit a new Assurance to OLAW. OLAW may limit the period during which any particular approved Assurance shall remain effective or otherwise condition, restrict, or withdraw approval. Without an applicable PHS-approved Assurance, no PHS-conducted or supported activity involving animals at the institution will be permitted to continue.

• 1. Institutional Program for Animal Care and Use

  The Assurance shall fully describe the institution's program for the care and use of animals in PHS-conducted or supported activities. The PHS requires institutions to use the Guide for the Care and Use of Laboratory Animals(Guide) as a basis for developing and implementing an institutional program for activities involving animals.² The program description must include the following:

  1. a list of every branch and major component of the institution, as well as a list of every branch and major component of any other institution, which is to be included under the Assurance;
  2. the lines of authority and responsibility for administering the program and ensuring compliance with this Policy;
  3. the qualifications, authority, and responsibility of the veterinarian(s) who will participate in the program and the percent of time each will contribute to the program;
  4. the membership list of the Institutional Animal Care and Use Committee(s) (IACUC) established in accordance with the requirements set forth in IV.A.3. of this Policy;³
  5. the procedures that the IACUC will follow to fulfill the requirements set forth in this Policy;
  6. the health program for personnel who work in laboratory animal facilities or have frequent contact with animals;
  7. a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment, or use;
  8. the gross square footage of each animal facility (including satellite facilities), the species housed therein, and the average daily inventory, by species, of animals in each facility; and
  9. any other pertinent information requested by OLAW. 

• 2. Institutional Status

  Each institution must assure that its program and facilities are in one of the following categories:

  Category 1 - Accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated and accredited by AAALAC, or another accrediting body recognized by the PHS.⁴ All of the institution's programs and facilities (including satellite facilities) for activities involving animals have also been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months, in accordance with IV.B.1. and 2. of this Policy, and reports prepared in accordance with IV.B.3.of this Policy.

  Category 2 - Evaluated by the Institution. All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC. These programs and facilities will be reevaluated by the IACUC at least once every six months, in accordance with IV.B.1. and 2. of this Policy, and reports will be prepared in accordance with IV.B.3. of this Policy. The most recent semiannual report of the IACUC evaluation shall be submitted to OLAW with the Assurance.​ 

• 3. Institutional Animal Care and Use Committee (IACUC)

  • a. The Chief Executive Officer shall appoint an IACUC, qualified through the experience and expertise of its members to oversee the institution's animal program, facilities, and procedures.⁵
  • b. The Assurance must include the names,⁶ position titles, and credentials of the IACUC chairperson and the members. The committee shall consist of no fewer than five members, and shall include at least:
    • (1) one Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program authority and responsibility for activities involving animals at the institution (see IV.A.1.c.);
    • (2) one practicing scientist experienced in research involving animals;
    • (3) one member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, and member of the clergy); and
    • (4) one individual who is not affiliated with the institution in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with the institution.
  • c. An individual who meets the requirements of more than one of the categories detailed in IV.A.3.b.(1)-(4) of this policy may fulfill more than one requirement. However, no committee may consist of fewer than five members. 

B. Functions of the Institutional Animal Care and Use Committee

As an agent of the institution, the IACUC shall with respect to PHS-conducted or supported activities:

• 1. review at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation;⁷
• 2. inspect at least once every six months all of the institution's animal facilities (including satellite facilities) using the Guide as a basis for evaluation;
• 3. prepare reports of the IACUC evaluations conducted as required by IV.B.1. and 2. of this Policy, and submit the reports to the Institutional Official;⁸ 
      (The reports must meet the following criteria:
  1. The reports shall be updated at least once every six months upon completion of the required semiannual evaluations.
  2. The reports shall be maintained by the institution and made available to OLAW upon request.
  3. The reports must contain a description of the nature and extent of the institution's adherence to the Guide and this Policy and must identify specifically any departures from the provisions of the Guide and this Policy, and must state the reasons for each departure.
  4. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one that, consistent with this Policy, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency.
  5. If some or all of the institution's facilities are accredited by AAALAC or another accrediting body recognized by the PHS, the report should identify those facilities as such.)
• 4. review concerns involving the care and use of animals at the institution;
• 5. make recommendations to the Institutional Official regarding any aspect of the institution's animal program, facilities, or personnel training;
• 6. review and approve, require modifications in (to secure approval), or withhold approval of those components of PHS-conducted or supported activities related to the care and use of animals as specified in IV.C. of this Policy;
• 7. review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and
• 8. be authorized to suspend an activity involving animals in accordance with the specifications set forth in IV.C.6. of this Policy.

C. Review of PHS-Conducted or Supported Research Projects

• 1. In order to approve proposed research projects or proposed significant changes in ongoing research projects, the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed research projects are in accordance with this Policy. In making this determination, the IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the Guide unless acceptable justification for a departure is presented.⁹ Further, the IACUC shall determine that the research project conforms with the institution's Assurance and meets the following requirements:
  • a. Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.
  • b. Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator.
  • c. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
  • d. The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.
  • e. Medical care for animals will be available and provided as necessary by a qualified veterinarian.
  • f. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
  • g. Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.^10​
• 2. Prior to the review, each IACUC member shall be provided with a list of proposed research projects to be reviewed. Written descriptions of research projects that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full committee review of those research projects. If full committee review is not requested, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval), or request full committee review of those research projects. If full committee review is requested, approval of those research projects may be granted only after review at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present. No member may participate in the IACUC review or approval of a research project in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.
• 3. The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC.
• 4. The IACUC shall notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
• 5. The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C.1.-4. at least once every three years.
• 6. The IACUC may suspend an activity which it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, the institution's Assurance, or IV.C.1.a.-g. of this Policy.¹¹ The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present.
• 7. If the IACUC suspends an activity involving animals, the Institutional Official in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW.
• 8. Applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the institution. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC.

D. Information Required in Applications and Proposals for Awards Submitted to the PHS

• 1. All Institutions

  Applications and proposals (competing and noncompeting) for awards submitted to the PHS that involve the care and use of animals shall contain the following information:

  a. identification of the species and approximate number of animals to be used;

  b. rationale for involving animals, and for the appropriateness of the species and numbers used;

  c. a complete description of the proposed use of the animals;

  d. a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and

  e. a description of any euthanasia method to be used.

  Noncompeting applications and contract proposals for other than full and open competitions need not repeat the information required by IV.D.1.a.-e. if the information was complete in the last competing application or proposal and there are no significant changes to that information. However, the application or proposal must contain a statement to that effect. If there are significant changes in the information, then the application or proposal must specifically identify them and state the reasons for the changes.

• 2. Institutions That Have an Approved Assurance

  Applications or proposals (competing and noncompeting) covered by this Policy from institutions that have an approved Assurance on file with OLAW shall include verification of approval (including the date of the most recent approval) by the IACUC of those components related to the care and use of animals. For competing applications or proposals only, such verification may be filed at any time prior to award unless specifically required earlier by the funding component. If verification of IACUC approval is submitted subsequent to the submission of the application or proposal, the verification shall state the modifications, if any, required by the IACUC. The verification shall be signed by an individual authorized by the institution, but need not be signed by the Institutional Official.

• 3. Institutions That Do Not Have an Approved Assurance

  For applications and proposals covered by this Policy from institutions that do not have an approved Assurance on file with OLAW, the signature of the official signing for the applicant organization shall constitute a 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 IV.A. of this Policy. The authorized IACUC shall review those components of the application or proposal as required by IV.C. of this Policy. Upon IACUC approval of those components of the application or proposal, the institution shall submit the Assurance to OLAW.

E. Recordkeeping Requirements

• 1. The awardee institution shall maintain:
  • a. a copy of the Assurance which has been approved by the PHS;
  • b. minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations;
  • c. records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld;
  • d. records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official; and
  • e. records of accrediting body determinations.
• 2. All records shall be maintained for at least three years; records that relate directly to applications, proposals, and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

F. Reporting Requirements

• 1. At least once every 12 months, the IACUC, through the Institutional Official, shall report in writing to OLAW:
  • a. any change in the institution's program or facilities that would place the institution in a different category than specified in its Assurance (see IV.A.2.of this Policy);
  • b. any change in the description of the institution's program for animal care and use as required by IV.A.1.a.-i. of this Policy;
  • c. any changes in the IACUC membership;¹² and
  • d. notice of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities and submitted the evaluations to the Institutional Official.
• 2. At least once every 12 months, the IACUC, at an institution which has no changes to report as specified in IV.F.1.a.-c. of this Policy, shall report to OLAW in writing, through the Institutional Official, that there are no changes and shall inform OLAW of the dates of the required IACUC evaluations and submissions to the Institutional Official.
• 3. The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:
  • a. any serious or continuing noncompliance with this Policy;
  • b. any serious deviation from the provisions of the Guide;¹³ or
  • c. any suspension of an activity by the IACUC.
• 4. Reports filed under IV.F. of this Policy shall include any minority views filed by members of the IACUC.
   

1. Responsibilities of the Office of Laboratory Animal Welfare
   OLAW is responsible for the general administration and coordination of this Policy and will:
   1. request and negotiate, approve or disapprove, and, as necessary, restrict or withdraw approval of Assurances;
   2. distribute to Scientific Review Administrators of initial review and technical evaluation groups, and to PHS awarding units, lists of institutions [domestic and foreign] that have an approved Assurance;
   3. advise awarding units and awardee institutions concerning the implementation of this Policy;
   4. evaluate allegations of noncompliance with this Policy;
   5. have the authority to review and approve or disapprove waivers to this Policy (see V.D. of this Policy); and
   6. conduct site visits to selected institutions.
2. Responsibilities of PHS Awarding Units
   PHS awarding units may not make an award for an activity involving animals unless the prospective awardee institution and all other participating institutions have approved Assurances on file with OLAW, and unless the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals. If any one of these institutions does not have an approved Assurance on file with OLAW, the awarding unit will ask OLAW to negotiate an Assurance with the institution or institutions before an award is made. No award shall be made until all required Assurances have been submitted by the institution or institutions and approved by OLAW, and the institution or institutions have provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals.
3. Conduct of Special Reviews/Site Visits
   Each awardee institution is subject to review at any time by PHS staff and advisors, which may include a site visit, to assess the adequacy or accuracy of the institution's compliance or expressed compliance with this Policy.
4. Waiver
   Institutions may request a waiver of a provision or provisions of this Policy by submitting a request to OLAW. No waiver will be granted unless sufficient justification is provided and the waiver is approved in writing by OLAW.