PHS Policy on Humane Care and Use of Laboratory Animals

Question 1

PHS: Animal Facility

Answer 1

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.

Question 1

PHS: Animal

Answer 1

Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.

Question 2

PHS: Public Health Service

Answer 2

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.

Question 3

PHS: Animal Welfare Assurance

Answer 3

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.

Question 4

PHS: Who does the written Animal Welfare Assurance go to?

Answer 4

OLAW, Office of the Director, National Institutes of Health (NIH)

Question 5

PHS: Who at the institution signs the written Animal Welfare Assurance?

Answer 5

The IO

Question 6

PHS: What is the approval of an assurance period?

Answer 6

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.

Question 7

PHS: What happens without an applicable PHS-approved Assurance?

Answer 7

No PHS-conducted or supported activity involving animals at the institution will be permitted to continue.

Question 8

PHS: What must the Assurance describe?

Answer 8

The Assurance shall fully describe the institution’s program for the care and use of animals in PHS-conducted or supported activities.

Question 9

PHS: What is used as a basis for developing and implementing an institutional program?

Answer 9

The Guide

Question 10

PHS: What must the program description include? (9)

Answer 10

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.
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.
9. Any other pertinent information requested by OLAW.

Question 11

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

Answer 11

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.​

Question 12

PHS: How many members must be in the IACUC?

Answer 12

No fewer than five members, and shall include at least:

(1) one Doctor of Veterinary Medicine.

(2) one practicing scientist experienced in research involving animals.

(3) one member whose primary concerns are in a nonscientific area.

(4) one individual who is not affiliated with the institution.

An individual who meets the requirements of more than one of the categories may fulfill more than one requirement. However, no committee may consist of fewer than five members.

Question 13

PHS: IACUC Requirements

Answer 13

1. review at least once every six months the institution’s program.
2. inspect at least once every six months all of the institution’s animal facilities (including satellite facilities).
3. prepare reports of the IACUC evaluations and submit the reports to the Institutional Official.
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 or withhold approval of those components of PHS-conducted or supported activities related to the care and use of animals.
7. review and approve, require modifications in or withhold approval of proposed significant changes regarding the use of animals in ongoing activities.
8. be authorized to suspend an activity involving animals.

Question 14

PHS: What must be in the report to the Institutional Official?

Answer 14

The reports shall be updated at least once every six months upon completion of the required semiannual evaluations.

The reports shall be maintained by the institution and made available to OLAW upon request.

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.

The reports must distinguish significant deficiencies from minor deficiencies.

Question 15

PHS: What is a significant deficiency?

Answer 15

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.
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.)

Question 16

PHS: In order to approve proposed research projects or significant changes the IACUC shall conduct a review of those components in accordance with the Policy, the components are?

Answer 16

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

Question 17

PHS: Prior to review what should each IACUC member be provided with?

Answer 17

A list of proposed research projects to be reviewed with written descriptions of research projects that involve the care and use of animals.

Question 18

PHS: FCR Requested- now what?

Answer 18

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.

Question 19

PHS: FCR not requested- now what?

Answer 19

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.

Question 20

PHS: When can an IACUC member NOT participate in a review or approval?

Answer 20

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.

Question 21

PHS: Consultants- when to invite to IACUC meetings? Can they approve?

Answer 21

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.

Question 22

PHS: Notifying investigators of approvals or withhold of approvals.

Answer 22

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.

Question 23

PHS: How often must the IACUC conduct a continuing review of each approved activity?

Answer 23

At least once every three years.

Question 24

PHS: When can an IACUC suspend an activity which it previously approved?

Answer 24

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 PHS Policy.

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.

Question 25

PHS: IF the IACUC suspends an activity- what is needed by the IACUC?

Answer 25

The IACUC and Institutional Official shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW.

Question 26

PHS: Officials of the institution- can they approve before the IACUC?

Answer 26

No, they can further appropriate review and approval. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC.

Question 27

PHS: 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:

Answer 27

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.

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.

Question 28

PHS: Institutions That Have an Approved Assurance

Answer 28

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.

Question 29

PHS: Institutions That Do Not Have an Approved Assurance

Answer 29

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.

Question 30

PHS: Record keeping requirements

Answer 30

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.

e. records of accrediting body determinations.

Question 31

PHS: How long should records be maintained for?

Answer 31

The duration of the activity and at least three years after the completion of the activity.

Question 32

PHS: At least once every 12 months, the IACUC, through the Institutional Official, shall report in writing to OLAW the following:

Answer 32

1. Any change in the institution’s program or facilities that would place the institution in a different category than specified in its Assurance.
2. Any change in the description of the institution’s program for animal care and use as required by PHS.
3. Any changes in the IACUC membership.
4. 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.

Question 33

PHS: The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to the following:

Answer 33

1. Any serious or continuing noncompliance with this Policy.
2. Any serious deviation from the provisions of the Guide.
3. Any suspension of an activity by the IACUC.

Question 34

PHS: OLAW is responsible for the general administration and coordination of the PHS Policy and will:

Answer 34

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 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.
6. Conduct site visits to selected institutions.

Question 35

PHS: PHS awarding units may not make an award for an activity involving animals unless:

Answer 35

1. the prospective awardee institution and all other participating institutions have approved Assurances on file with OLAW.
2. 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

Question 36

PHS: Each awardee institution is subject to review at any time by PHS staff and advisors, which may include:

Answer 36

A site visit, to assess the adequacy or accuracy of the institution’s compliance and expressed compliance with the PHS Policy.

Question 37

PHS: Waiver

Answer 37

Institutions may request a waiver of a provision or provisions of the PHS 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.