VAPHS

Institutional Animal Care and Use Committee (IACUC)

Policies and Procedures

The VAPHS IACUC is structured and functions under the directives in VA Handbook 1200.7, USE OF ANIMALS IN RESEARCH Section 8: INSTITUTIONAL ANIMAL CARE AND USE COMMITTEES. Reference to specific parts of Section 8 will be made throughout this description.

“According to the USDA Animal Welfare Act Regulations and Standards (see Section 2.37), each VA medical center with a program of research involving use of live vertebrate animals must establish an Institutional Animal Care and Use Committee (IACUC). It is the responsibility of the Medical Center Director to provide adequate administrative support for the IACUC, including space sufficient to provide privacy for conducting sensitive duties related to animal subjects involved in research, and personnel to support the review and record-keeping functions of the IACUC, to include timely preparation of minutes and timely preparation of investigator correspondence and other documents.”

Definition 3.j: “The Institutional Official (IO) is the VA official responsible for ensuring that the animal research program has the resources and support necessary to comply with all federal regulations and guidelines that govern the use of laboratory animals. The IO is the point of contact for correspondence addressing animal care and use issues with the United States Department of Agriculture (USDA), the Public Health Service (PHS), AAALAC, VA ORD, and VA ORO. As mandated by Handbook 1200.7, the Medical Center Director must fulfill the role of IO for VA research programs.”

IACUC Membership (refer to 8.a)

The members of the Institutional Animal Care and Use Committee (IACUC), which is designated as the "Subcommittee on Animal Research" (SAR) at this VA Medical Center, are recommended by the Associate Chief of Staff for Research and Development (ACOS/R&D), confirmed by the R&D Committee, and appointed by the IO/Medical Center Director.

The VAPHS IACUC is constituted to fulfill the requirements defined in Handbook 1200.7 and is currently composed of the following individuals:

Chandrashekhar R. Gandhi, Ph.D. (Chairperson)	VA Research Scientist, Investigator with experience in animal research
Patricia A. Eagon, Ph.D.	VA Research Scientist, Investigator with experience in animal research
Jie Fan, Ph.D. (Alt Chair)	Investigator with experience in animal research
William R. Langbauer, Jr., PhD Director of Science: Conservation PA Zoo & Aquarium	Community Representative, non-scientist and non-affiliated member
Gene Bingham, D.V.M.	Consulting Veterinarian
Roger Sembrat, V.M.D.	Clinical Veterinarian
Pamela Matey, AALAT	VAPHS Animal Research Facility (ARF) Supervisor
Marie Rose, B.A.	Senior Research Specialist
Diana Whaley, B.A.	Biological Science; Experienced Animal/Lab Technician
Kenneth Patrene, BS	Research Specialist; Experienced Animal/Lab Technician
Alan Smith	Community Representative/ Non-Scientific
Stephen Baker (Ex-officio W/O vote)	VAPHS Industrial Hygienist
Nicholas L Squeglia (Ex-officio W/O vote)	AO/ACOS/R&D
Ali F. Sonel, MD (Ex-officio W/O vote)	ACOS/R&D
Elizabeth Toth (Staff)	Program Support Clerk

Committee members agree to serve for 3 years; the term of the IACUC Chair is one year. Members and Chair may be re-appointed without lapse in service to the IACUC.

IACUC members should be familiar with Handbook 1200.7, and are required to complete and pass the exam covering the "Essentials for IACUC Members" web course found at http://www.researchtraining.org.

No member may participate in IACUC review or approval of a research protocol in which the member has a Conflict of Interest (e.g., is personally involved in the protocol, or has a financial conflict related to the project), except to provide information requested by the IACUC; nor may a member who has a conflict of interest contribute to the constitution of a quorum for the review of that protocol.

Frequency of Meetings

The VA IACUC or SAR of the Research & Development Committee meets on the third Thursday every month except when there is no business that requires a meeting.

Responsibilities of the IACUC

The IACUC is responsible for reviewing all animal study protocols, all amendments to these protocols and all renewals of these protocols and either approves them as submitted, approves with changes or disapproves them. The IACUC is responsible for assuring that the animal facilities, the operation of the facility and the animal research carried out is in compliance with all applicable guidelines, policies and regulations.

Frequency of IACUC Review of Program

It is the IACUC’s responsibility to keep the VAPHS Animals Research Program Description updated. At each meeting of the IACUC, during the review of new protocols, the following sections of the Program Description are updated as required.

IIA1c Physical restraint

IIA1d1 Multiple major surgical procedures

IIA1e Food or fluid deprivation

IIA4e5 List of approved hazardous substances

IIC3h-i Survival procedures performed

IIC4c Analgesic and Anesthetic agents used

IIC5a Procedures used for euthanasia

Animal usage chart

The entire Program Description is reviewed and updated semi-annually (January and July). At these times, the IACUC completes semi-annual inspection of the animal facility and laboratories in which animal procedures are carried out. A report is prepared from the IACUC by R&D Support staff using the prescribed VA form. The same form is used for reporting on the Program Review and the inspection. The report of the inspection indicates the nature of deficiencies found, the seriousness of each deficiency, the steps to be taken to resolve the deficiency and the timetable for correcting each deficiency. In addition, the report notes whether deficiencies noted in the previous inspection have been corrected. The report is signed by a majority of the IACUC and submitted to the Medical Director of this VA station. There is an opportunity for minority views to be expressed on the form. A copy of the report is sent to VA Central Office.

The IACUC Chairperson is responsible for reporting to the committee when deficiencies in the Program are corrected. The Animal Research Facility (ARF) supervisor reports to the subcommittee when deficiencies in the ARF are corrected. These reports are included in the minutes of the monthly meeting of the IACUC.

Recording and Reporting Requirements.

Preparation of IACUC Minutes. IACUC minutes, formatted to comply with 8.f.1.a-j shall be written and published within 3 weeks of the meeting date. Protocols that have received expedited review since the last meeting are included in the minutes of the next meeting. Once IACUC minutes are approved at the following meeting, the IACUC Chair should sign and date them at the bottom.

Mandated Reporting of Deficiencies. Continuous monitoring of animal use by the ARF supervisor facilitates early identification and correction of any problems. The Animal Facility supervisor makes daily rounds of all animal rooms to ensure that the investigators are in compliance with their protocols. If non-compliance exists, a report is submitted by the facility supervisor to the IACUC chairperson who decides in consultation with the veterinarian whether further Subcommittee review is needed.

The main categories of deficiencies to be reported to outside authorities include:

Any serious or continuing noncompliance with PHS Policy;
Suspensions of protocols previously approved or suspensions of procedures or studies never given approval;
Failure to correct a significant deficiency (identified during a semi-annual IACUC program or facilities self-review) according to the schedule approved by the IACUC;
Any ORD veterinary holds.

The time frame and the officials to which these reports are sent are detailed in 8.g.4.

Suspension of Projects. The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the PI and approved by the IACUC. It may also suspend any animal procedures not approved by the IACUC. However, the IACUC may suspend an activity only after review of the matter at a properly convened meeting of the IACUC and with the suspension vote of a majority of a quorum.

Investigation of Allegations of Improper Animal Care or Use. All internal and external allegations of improper animal care and use will be investigated promptly by the IACUC. A written report of the investigation should be approved by a majority of a convened IACUC quorum and sent to the Medical Center Director through the ACOS/R&D. If preliminary findings suggest that an allegation does represent a reportable deficiency as defined in above , the agencies/groups listed in paragraph 8.g.(1) must be contacted as indicated in paragraph 8.g.(3).

Calendar For Program Review, Facility Inspection and Reports. The VA Medical Center Animal Facility is part of a "Federal Government" Research Institution and as such is not inspected by the USDA. However, this facility complies with the USDA regulations under the Animal Welfare Act (AWA) and files annual animal usage reports with that department.

The R&D office prepares and submits the annual reports required by the US Department of Agriculture, AAALAC and OLAW with the assistance of the animal facility supervisor and the records of the IACUC.

Jan.: Inspection of animal facility and research laboratories, and Program Review is done during Jan meeting; the resulting report forwarded to the CVMO’s office through the ACOS/R&D and the Medical Center Director.

Submission of annual OLAW report.

Annual VA ARF (VMU) Report for the previous fiscal year

(CVMO’s office by January 15^th)

July: Inspection of animal facility and research laboratories,

Program Review; reporting as in Jan.

Sept.: Submission of annual AAALAC report [a copy and all correspondence to and from AAALAC (minus the triennial Program Description) will be submitted to the CVMO and ORO within 30 days after submission to AAALAC, or receipt from AAALAC]

Nov.: Submission of USDA report to ORD by Nov 15.

VA Animal Research carried out at non-VA Facilities:

The only "contract" facilities used are those of the School of Medicine, University of Pittsburgh which are AAALAC accredited. VA staff members who choose to do their animal research at the University Facilities have faculty appointments at the School of Medicine, University of Pittsburgh. The Memorandum of Understanding (MOU) for Collaborative Research executed between the University of Pittsburgh and VAPHS describes in detail the structure for the coordination of oversight of VA-funded research carried out in University facilities (implemented, February, 2004). Briefly, the VA IACUC reviews all animal study protocols involving research at VAPHS and VA funded research at the University of Pittsburgh. The VA IACUC receives copies of the semi-annual program review and facility reviews and the annual USDA report from the animal facility at the University of Pittsburgh. The VA ICAUC Chair, who presents any significant findings or the lack thereof at the next IACUC meeting, reviews these reports.

The IACUC ACORP Review and Approval Process :

1. Principal Investigators new to the Pittsburgh VA should arrange for a pre-submission meeting with Dr Bingham. This can occur in the afternoon of any IACUC meeting date, that is the 3rd Thursday of the month. Contact Elizabeth Toth at 412-365-4290 or ext 83-4290. Investigators with a current approved animal protocol from the University of Pittsburgh should follow the guidance in the "Addendum for Investigators with an Approved University of Pittsburgh Protocol" found under Resources.

2. New PIs, or those proposing a significant change/increase in use of the ARF should meet with Pam Matey, VA Animal Research Facility Manager, 412-688-6107 or ext 81-6107, to evaluate availability of space and facility accommodation of any special needs of their projects.

3. “Investigators and research staff who utilize laboratory animals must pass the exam covering the "Working with the VA IACUC" web course plus the exam for any species-specific web course that covers the species proposed for use [8.k.(2)(a) ]”. The VA IACUC currently recognizes the University of Pittsburgh Animal training for staff working with animals, however anyone involved in the preparation and submission of an ACORP to the VA IACUC MUST present certification of completion of the VA Training found at Research Training.Org.

4. Submit completed ACORP and Certificates of Training electronically to Elizabeth Toth in the Research Office at Elizabeth.Toth2@va.gov.

5. VA Pittsburgh Healthcare System IACUC Review Process

a) When a Principal Investigator (PI) submits an ACORP to the Research Office it will be electronically forwarded to the Chair to determine whether the ACORP qualifies for designated review or full committee review.

b) The Chair will assign a member from the Institutional Animal Care and Use Committee (IACUC) and the Veterinary Medical Consultant (VMC) as the reviewers of the ACORP.

c) The Program Clerk will electronically mail the submission to the reviewers to review the ACORP for completeness of the application and compliance with information requirements.

d) Their written comments/recommendations will be requested within 10 calendar days and electronically mailed to the Research Office.

e) The Program Clerk will assemble all of the comments/recommendations into one word document and forward it to the PI.

f) The PI should respond to the Program Clerk within 10 calendar days of receiving the comments by addressing each item with a written response and by highlighting the recommended changes on the revised ACORP and attachments as applicable.

g) The Program Clerk will electronically mail the revised ACORP and the PI’s response to the reviewer and the VMC for verification that the comments/recommendations have been adequately addressed and notify the Program Clerk within 5 business days.

h) Any additional comments/recommendations from the reviewers will be sent to the Program Clerk to forward to the PI to make additional changes (highlighting changes) and if the PI has any other modifications to the ACORP they should be italicized, this revised ACORP should be resubmitted to the Program Clerk within 5 business days.

i) The reviewer and the VMC must be satisfied with the PI’s response and revised ACORP in order to recommend approval.

j) A reviewer can request a full committee review and/or discussion of the ACORP at a regularly scheduled meeting.

k) Before final approval can be granted each member of the IACUC must have the opportunity to review the ACORP and the opportunity to request a full committee review.

l) A copy of the revised ACORP will be provided to the IACUC members as part of the monthly meeting’s agenda and each member’s decision with regard to the ACORP will be recorded at the meeting.

m) If this revised version is approved by the IACUC, it may be finalized with the signatures of the IACUC chair and the VMC.

6. Review of ACORPs by the IACUC is performed in parallel with review by the Subcommittee on Research Safety/Biosafety.

7. Keys to timely approval of ACORPs include:

a) Attention to instructions contained in the ACORP;

b) Clear communication with the IACUC (call for clarification if there is any question about the meaning of comments/contingencies! Face to face or phone conversations with the reviewers can be arranged);

c) Prompt revision of the ACORP in response to the initial and IACUC review of the protocol.

Annual Review of ACORPs:

A checklist is computer generated annually and each investigator is required to review and update his or her protocol. If a study is no longer active the investigator uses this form to notify the IACUC. Every 3 years, all ACORPs must be completely updated and resubmitted to the committee for approval.

The IACUC has the responsibility of informing the ARF supervisor when animal protocols have been approved and when they have expired. In order to facilitate this, the animal usage table in the Program Description includes the date that each protocol was approved. The supervisor of the ARF is a member of the IACUC and therefore is kept up to date on which protocols are about to expire so that she will not approve animal orders until the ACORP is renewed.

All research protocols that involve the use of animals are peer reviewed for scientific merit by the Research and Development Committee at this VA station. VA Central Office established review committees also review those research protocols that are funded by the VA for scientific merit and the VA Chief Veterinary Medical Officer or designee reviews the animal protocols.

Monitoring of Animal Use:

The ARF supervisor reviews the daily observation report by the animal caretakers and personally observes any animals that are suspected of having pain or distress. The supervisor consults with one of the veterinarians for a plan of action that includes contacting the principal investigator. Research investigators and their technicians are instructed in how to detect signs of pain and/or distress in their experimental animal subjects and to notify the facility supervisor when these signs are observed.

Resources:

The VAPHS IACUC from time to time establishes SOP to guide PI development of ACORPs consistent with current Guidelines. These can be found on the VAPHS Research Web site at

and currently includes:

Addendum for Investigators with an Approved University of Pittsburgh protocol

Standard Operating Procedures for Employee Animal Bite or Scratch Incidence

Policy on Tail snips

Policy for Transporting Rodents from the VA ARF to Off Site Facilities

Predetermined Criteria for Expedited Review

Policy on Multiple Major Surgeries

Policy on Analgesics and Anesthetics

Use of Controlled Substances in Animal Research

VAPHS IACUC Review Process

Also see resources (Not just for IACUC members) at: www.vaphs.research.med.va.gov

http://www.iacuc.pitt.edu/Guidelines.asp - Guidelines for animal procedures (anesthesia, euthanasia, etc.) at the University of Pittsburgh IACUC site.