Implementation by Institutions

Question 1

No activity involving animals may be conducted or supported by PHS until what has been provided?

Answer 1

A written Assurance acceptable to PHS, setting forth compliance with PHS Policy

Question 2

Who signs the Assurance?

Answer 2

IO

Question 3

To whom are Assurances submitted?

Answer 3

OLAW, Office of the Director, NIH

Question 4

For how long are Assurances approved?

Answer 4

For a specified period, no longer than five years. OLAW may limit the period or otherwise condition, restrict, or withdraw approval

Question 5

The Assurance must describe the institution’s program for the care and use of animals, using what document as a basis for developing the program?

Answer 5

The Guide

Question 6

What information must the program description include? (9)

Answer 6

1. List of every branch and major component of the institution, as well as list of every branch and major component of any other institution to be included under the Assurance
2. Lines of authority and responsibility for administering the program and ensuring compliance with PHS Policy
3. 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. Membership list of the IACUC
5. Procedures that IACUC will follow to fulfill PHS Policy requirements
6. Health program for personnel who work in lab animal facilities or have frequent contact with animals
7. Synopsis of training in human practice of animal care and use, as well as training 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. Gross square footage of each animal facility (including satellites), species housed, and average daily inventory, by species, of animals in each facility
9. Any other pertinent information requested by IACUC

Question 7

What is a Category 1 institutional status?

Answer 7

Accredited by AAALAC. All facilities have been evaluated by IACUC And will be revaluated at least once every 6 months and reports prepared in accordance with PHS Policy.

Question 8

What is a Category 2 institutional institutional status?

Answer 8

No AAALAC accreditation. IACUC has evaluated all facilities and the program and facilities will be reevaluated at least once every six months with reports prepared in accordance with PHS Policy. Most recent seminannual report of the IACUC evaluation shall be submitted to OLAW with Assurance.

Question 9

What must Category 2 institutions do that Category 1 institutions do not?

Answer 9

Submit the most recent semiannual report of the IACUC evaluation to OLAW with the Assurance.

Question 10

The HREA requires how many IACUC members? How many does PHS Policy Require?

Answer 10

HREA: 3
PHS: 5

Question 11

What must the Assurance include regarding the members of the IACUC?

Answer 11

Must include the names, position titles, and credentials of the IACUC Chairperson and members. Members other than the chairperson and veterinarian with program authority can be represented with numbers or other symbols.

Question 12

What IACUC members does PHS Policy require?

Answer 12

1. One DVM with training or experience in LAM who has direct or delegated program authority and responsibility
2. One practicing scientist experienced in research with animals
3. One member whose primary concerns are nonscientific
4. One individual who is not affiliated with the institution and is not a member of the immediate family of a person affiliated with the institution

Question 13

Can the CEO delegate responsibility to appoint the IACUC?

Answer 13

Yes, but must be specific and in writing. CEO is considered to be the highest operating official of the organization.

Question 14

Can an IACUC member fill more than one role?

Answer 14

Yes, but must be a minimum of five members.

Question 15

What must the IACUC do at least once very 6 months? What document is used as a guide?

Answer 15

Review the institution’s program for human care and use of animals and inspect all of the institution’s animal facilities (including satellite facilities). Uses the Guide as a basis for evaluation.

Question 16

How often must reports of the IACUC evaluation conducted be submitted? To who?

Answer 16

At least once every 6 months on completion of required semiannual evaluations. Submitted to IO.

Question 17

How are semiannual IACUC reports maintained?

Answer 17

Maintained by institution and made available to OLAW on request.

Question 18

What must the IACUC’s semiannual report include?

Answer 18

1. Description of the nature and extent of the institution’s adherence to the Guide and PHS Policy. Must identify specifically any departures from the provisions of the Guide and PHS Policy and state reason for departure.
2. Must distinguish significant deficiencies from minor deficiencies. If deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency.
3. If some or all facilities are accredited by AAALAC or another accrediting body recognized by PHS, report should identify those facilities as such.

Question 19

What distinguishes a significant deficiency from a minor one?

Answer 19

Significant deficiency, consistent with PHS Policy and in the judgement of IACUC and the IO, is a threat to the health or safety of animals.

Question 20

In addition to semiannual program review, inspections, and reports, what are additional functions of the IACUC?

Answer 20

1. Review concerns involving the care and use of animals
2. Make recommendations to the IO regarding any aspect of the institution’s animal program, facilities, or personnel training
3. Review and approve, require modifications to secure approval, or withhold approval or those components of PHS-conducted or supported activities
4. Review and approve, require modifications, or withhold approval of proposed sig. changes regarding the use of animals in ongoing activities
5. Be authorized to suspend an activity

Question 21

The IACUC must confirm that proposed projects or major amendments are in accordance with what regulations?

Answer 21

PHS Policy, including the Assurance, AWA, and Guide (unless acceptable justification for a departure is presented)

Question 22

IACUC shall determine that proposed research projects meet what requirements? (7)

Answer 22

1. Will avoid or minimize discomfort, distress, and pain to animals
2. Procedures that may cause more than momentary or slight pain or distress will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator
3. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end or during the procedure
4. Living conditions of animals will be appropriate for species and contribute to health and comfort. Housing, feeding, and nonmedical care will be directed by a vet or scientist trained and experienced in care, handling, and use of species.
5. Medical care will be available and provided by a qualified veterinarian
6. Personnel conducting procedures will be be qualified and trained
7. Methods of euthanasia will be consistent with AVMA recommendations, unless a deviation is justified for scientific reasons in writing by investigator

Question 23

What must IACUC members be provided prior to review?

Answer 23

A list of proposed research projects to be reviewed.

Question 24

How many IACUC members must review a protocol if FCR is not requested?

Answer 24

At least one member

Question 25

If FCR is requested, when can the project be approved?

Answer 25

Only after review at a convened meeting of a quorum of the IACUC with the approval vote of a majority of the quorum present.

Question 26

How can a member participate in the IACUC review or approval of a project in which the member has a conflicting interest?

Answer 26

Only to provide information. May not contribute to quorum.

Question 27

Can consultants review IACUC protocols?

Answer 27

Yes, but they may not approval or withhold approval or vote unless they are also members.

Question 28

How must the IACUC notify investigators and the institution of its decision to approve or withhold approval?

Answer 28

In writing. If approval is withheld, must include the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

Question 29

How often must the IACUC complete a complete review of protocols?

Answer 29

At least once every 3 years.

Question 30

Under what circumstances can the IACUC suspend an activity which it previously approved?

Answer 30

If activity is not being conducted in accordance with AWA, Guide, institution's Assurance, or PHS Policy. May suspend only after review of the matter at a convened meeting of a quorum of the IACUC and with suspension vote of a majority of the quorum present.

Question 31

What occurs if the IACUC suspends an activity involving animals?

Answer 31

IO in consultation with IACUC shall review reasons for suspension, take appropriate corrective action, and report that action with full explanation to IACUC.

Question 32

Can IACUC protocols be subject to further appropriate review and approval by officials at the institution?

Answer 32

Yes, but officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC.

Question 33

Applications and proposals for awards submitted to PHS that involve the care and use of animals must include what information? (5)

Answer 33

All institutions: 1. Identification of species and approximate number of animals to be used 2. Rationale for using animals and appropriateness of species and numbers 3. Complete description of proposed animal use 4. Description of procedures to assure that discomfort and injury to animals will be limited to that which is unavoidable in the 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 5. Description of any euthanasia methods to be used

Question 34

What is unique regarding noncompeting applications and contract proposals for other than full and open competitions?

Answer 34

Need not repeat the information is it was complete in the last application and there are no sig. changes. Application/proposal must contain a statement to that effect. If sig. changes in the info, the application/proposal must specifically address and state reasons for the changes.

Question 35

Applications/proposals from institutions that have an approved Assurance on file with OLAW shall include what?

Answer 35

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 point prior to reward unless specifically requested earlier by the funding component. If verification of IACUC approval is submitted subsequent to the submission of the application/proposal, the verification shall state the modifications required by the IACUC.

Question 36

The verification of IACUC approval required for applications/proposals submitted to PHS must be signed by who?

Answer 36

An individual authorized by the institution, but not the IO.

Question 37

Applications/proposals from institutions that do not have an approved Assurance must submit what? When?

Answer 37

Signature of the official signing for the applicant organization which constitutes a declaration that the institution will submit an Assurance when requested by OLAW. On request by OLAW, and following IACUC approval of those components, the institution will submit the Assurance to OLAW.

Question 38

What records must the awardee institution maintain?

Answer 38

1. Copy of PHS-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 sig. changes in the cause and use of animals and whether IACUC approval was given or withheld 4. Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the IO 5. Records of accrediting body determinations

Question 39

How long must records be maintained for?

Answer 39

At least three years. Records that relate directly to applications, proposals, and proposed sig. changes in ongoing activities maintained for the duration of the activity and for an additional three years after completion of the activity.

Question 40

How must records be accessible to OLAW?

Answer 40

Available for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

Question 41

How often must the IACUC, through the IO, report in writing to OLAW?

Answer 41

Every 12 months

Question 42

What information must be reported to OLAW every 12 months?

Answer 42

1. Any change in institution's program or facilities that would place the institution in a different category than specified in the Assurance (AAALAC accreditation) 2. Any change in the description of the institution's policy for animal care and use 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 IO

Question 43

What must the IACUC report, through the IO, if there are no changes to report?

Answer 43

That there are no changes and shall inform OLAW of the dates of the required IACUC evaluations and submissions to the IO

Question 44

What must the IACUC, through the IO, promptly report to OLAW? What information is included?

Answer 44

1. Any serious or continuing noncompliance with PHS Policy 2. Any serious deviation from the provisions of the Guide 3. Any suspension of an activity by the IACUC Include full explanation of the circumstances and actions taken.

Question 45

What must be included in any annual or prompt report to OLAW?

Answer 45

Any minority views filed by members of the IACUC