PHS Policy / NIH / OLAW

Question 1

PHS Continuing Review

Answer 1

Complete re-review of the project at least once every three years

[PHS IV.C.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.

Question 2

PHS Policy on Scientific Value

Answer 2

1. Procedures… consistent w/ sound research design (IVC1a)
2. Animals selected… should be… the minimum number…to obtain valid results (USGP III)
3. Procedures… should be designed… with… relevance to human or animal health, the advancement of knowledge or the good of society (USGP II)
4. Procedures… for the conduct of scientifically valid research (IVD1d)
5. Not unnecessarily duplicative (the Guide)

Question 3

PHS IACUC Composition Rules

Answer 3

At least five individuals

Must contain:
Veterinarian with program authority
Non-affiliated member
Practicing scientist
Non-scientist

Individuals who meet the requirements of more than one of the categories may fulfill more than one requirement, without dipping below fewer than five members.

Question 4

Inspection Requirements from the PHS Policy

Answer 4

You can use “agents” of the IACUC (contractors, other individuals, etc.)

Question 5

PHS Policy on Delivering Annual Report to IO

Answer 5

No mention of the means by which this is done

Question 6

How often must you renew your NIH/PHS Assurance

Answer 6

Every 4 years

Question 7

What species of animals are covered by the PHS Policy?

Answer 7

Any live (warm blooded or cold blooded) vertebrate animal to be used in research, research training, and biological testing “activities” which are:

PHS conducted, or
PHS supported, or
Subject to the requirements of the PHS Policy and the Institution’s Animal Welfare Assurance

Question 8

Is the IACUC required to notify the investigator and the institution in writing of its decisions?

Answer 8

YES
[PHS Policy IV.C.4; USDA 9 CFR 2.31(d)(4)

The IACUC shall notify investigators in writing of its decision to approve or withhold approval of those activities… 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 9

When are Semiannual Reports submitted to OLAW?

Answer 9

1. If an institution is not accredited by AAALAC, a copy of the most recent semiannual report must be submitted to OLAW with a new or renewal Assurance.
2. Upon request by OLAW or other PHS representatives.

Question 10

PHS Policy requirements to inspect specific locations on semi-annual inspections

Answer 10

Must inspect anywhere animals are held for more than 24 hours and areas where surgical manipulations are performed

Question 11

What document is the basis for semi-annual review from the PHS standpoint?

Answer 11

The Guide for the Care and Use of Laboratory Animals

Question 12

Which regulations (PHS or USDA) require you to comply with the AVMA Panel on Euthanasia?

Answer 12

PHS Policy

It is not mentioned in The Guide

Question 13

What constitutes a satellite facility according to PHS Policy?

Answer 13

Any containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 24 hours

Question 14

What does the PHS encompass?

Answer 14

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 15

Maximum length an Animal Welfare Assurance can be approved for?

Answer 15

5 years

Question 16

Mandatory components of the Animal Welfare Assurance

Answer 16

1. List of every branch and major component of the institution, as well as a list of every branch in 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 veterinarians who will participate in the program and the percent of time each will contribute to the program.
4. Membership list of the institutional Animal Care and Use committees established in accordance with the requirements of this policy.
5. The procedures that the IACUC will follow to fulfill the requirements set forth in this policy
6. 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 and 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 growth 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 17

What are the two categories of institutional status according to the PHS policy?

Answer 17

Category 1 - accredited by AAALAC, as well as being evaluated by IACUC at least once every 6 months

Category 2 - evaluated by the institution, using the IACUC to evaluate the program at least once every 6 months. The most recent semi-annual report of the IACUC evaluation shall be submitted to OLAW with the assurance.

Question 18

Functions of the IACUC according to PHS policy?

Answer 18

1. Review at least once every 6 months the institutions program for humane care and use of animals
2. Inspect at least once every 6 months all of the institutions animal facilities, including satellite facilities.
3. Prepare reports of the IACUC evaluations conducted as required by the Policy, and submit the reports to the institutional official (IO)
4. Review concerns involving the care and use of animals at the institution.
5. Make recommendations to the IO regarding any aspect of the institutions 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.
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.
8. Be authorized to suspend an activity involving animals in accordance with the specifications set forth in this policy

Question 19

Important components of semi-annual reports?

Answer 19

1. Shall be updated at least once every 6 months upon completion of the required semi-annual evaluations.
2. Reports shall be maintained by the institution and made available to OLAW upon request.
3. Reports must contain a description of the nature and extent of the institutions adherence to the guide and this policy unless 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 maybe 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 institutions facilities are accredited by AAALAC or another accrediting body recognized by the PHS the report should identify those facilities as such.

Question 20

Items to consider when reviewing PHS conducted or supported research projects, according to the PHS policy

Answer 20

1. Confirm that the research project will be conducted in accordance with the Animal Welfare Act in so far as it applies to the research project.
2. Make sure that the research project is consistent with the Guide unless acceptable justification for a departure is presented.
3. The research project conforms with the institutions Assurance
4. Procedures minimize or avoid discomfort, distress, and pain to the animals in accordance with sound research design
5. Procedures that may cause more than momentary or slight painter distress will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing.
6. 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.
7. Living conditions will be appropriate for the species, and contribute to their health and comfort. Housing, feeding, and non-medical care will be directed by a veterinarian or other scientist trained and experienced in the proper care of said species.
8. Medical care for animals will be available and provided as necessary by a qualified veterinarian.
9. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
10. Methods of euthanasia will be consistent with the AVMA guidelines

Question 21

Information required in applications and proposals for awards submitted to the PHS

Answer 21

For all institutions:
Applications must contain:
1. Identification of species and approximate number of animals to be used.
2. Rationale for involving animals, and appropriateness of species and animal numbers
3. Complete description of the proposed use of animals
4. 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 were indicated and appropriate to minimize discomfort and pain
5. The description of any euthanasia method to be used.

Institutions with approved Assurance:
1. Applications must include verification of approval by the IACUC of those components related to the care and use of animals.
2. 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.
3. If such 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.
4. The verification shall be signed by an individual authorized by the institution, but need not be signed by the institutional official

Institutions without an approved assurance:
1. The signature of the official signing for the applicant organization shall constitute a declaration that the institution will submit an insurance when requested by OLAW.
2. Upon the request for an assurance, the institution shall prepare the assurance as instructed by OLAW and accordance with the policy.
3. The authorized IACUC shall review those components of the application or proposal as required by the policy.
4. Upon IACU see approval of those components of the application or proposal, the institution shall submit the assurance to OLAW.

Question 22

PHS Recordkeeping Requirements

Answer 22

Awardee institutions shall maintain:
1. A copy of the approved Assurance
2. Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations
3. Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.
4. Records of semi-annual IACUC reports and recommendations, including minority views, as forwarded to the IO.
5. Records of accrediting body determinations.

• Records shall be maintained for at least 3 years.
• Records pertaining directly to applications, proposals, and proposed significant changes in ongoing activities shall maintained for the duration of the activity and for an additional 3 years after completion.
• All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

Question 23

Reporting Requirements from the PHS Policy

Answer 23

1. At least once every 12 months, the IACUC, through the IO, shall report in writing to OLAW:
   - any change in the institutions program or facilities that would place the institution in a different category than specified in its assurance
   - any change in the description of the institutions program for Animal Care and Use required by the policy
   - any changes in the IACUC membership
   - notice of the dates that the IACUC conducted is semi-annual evaluations of the institutions program and facilities and submitted the evaluations to the IO
2. At least once every 12 months the IACUC at an institution which has no changes to report as specified in this policy, shall report to OLAW in writing, through the IO, that there are no changes and shall inform OLAW of the dates of the required IACUC evaluations and submissions to the IO.
3. The IACUC, through the IO, shall promptly provide OLAW with full explanation of the circumstances and actions taken with respect to:
   - any serious or continuing non-compliance with this policy
   - any serious deviation from the provisions of the Guide
   - any suspension of an activity by the IACUC
4. All reports filed under this policy shall include any minority views filed by members of the IACUC.

Question 24

Responsibilities of the OLAW

Answer 24

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 non-compliance 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 25

Responsibilities of PHS Awarding Units

Answer 25

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 the 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.

Question 26

Conduct of special reviews/site visits according to the PHS policy

Answer 26

Each authority institution is subject to review at any time by the PHS staff and advisors, which may include a site visit, to assess the adequacy or accuracy of the institutions compliance or expressed compliance with this policy

Question 27

Waivers for the PHS policy

Answer 27

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.