Institutional Animal Care and Use Committee (IACUC)- University Policies

Laws and Policies Governing The Care And Use Of Live Vertebrate Animals In Teaching, Research And Testing

  Permits Required for Wildlife Research					
  Allocating and Counting Animal Numbers for Protocols					
  AVMA Guidelines on Euthanasia
  Institutional Animal Care and Use Committee
  Use of Animals in Research
  Use of Animals in Teaching
  Use of Animals in Blood and Tissue Sampling
  Use of Animals in Breeding colonies
  Use of Animals in Special Events
  Protocol Modifications
  Protocol Renewals
  Reporting Concerns Regarding Animal Care and Use
  External Protocol Review

Veterinary Care Program

  Attending Veterinarian
  LAR Veterinary Staff
  Consultations
					

Policies on Specific Procedures

  Monoclonal Antibody Production
  Freund's Complete Adjuvant
  Orbital Sinus Blood Sampling in Rodents
  Cardiac Puncture
  Humane Euthanasia
  Experimental Procedures Conducted In Animal Facilities
  Use Of Radioisotopes In Animal Facilities
  Guidelines For Research Involving Transgenic Animals
  Guidelines For The Use Of Live Vertebrate Animals In Teaching
  Surgery
  Purchase of Dogs and Cats from USDA Class B Licensees
					

Institutional Animal Care and Use Committee

Both the Animal Welfare Act and the Public Health Service (PHS) Policy mandate the existence of an Institutional Animal Care and Use Committee. The committee answers to the institutional official responsible for the animal care and use program. At Iowa State the committee is named the Institutional Animal Care and Use Committee  (IACUC) and the institutional official (I/O) is the Vice President for Research and Economic Development (Vice Provost). The membership of the IACUC is in compliance with the Animal Welfare Act and the PHS policy, which require that the following members be appointed to the committee.

• 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.
• One practicing scientist experienced in research involving animals.
• One member who has primary concerns in a nonscientific areas (for example, ethicist, lawyer, clergy).
• One member not affiliated in any way with the institution and not a member of the immediate family of a person who is affiliated with the institution to represent general community interest in proper care and use of animals.

It is recommended that persons with expertise in the disciplines involved in institutional research and teaching programs be appointed as members.It is also recommended that individuals with expertise in specific areas pertinent to protocol and program oversight be considered (e.g., statisticians, occupational health experts, information resource specialists, animal health technicians, and scientific research staff.ISU uses a member/alternate member appointment

To be in compliance with the Animal Welfare Act and the PHS policy the IACUC must fulfill the following responsibilities:

• Review and approve, require modification in, or withhold approval of all proposed uses of live vertebrate animals in teaching, research and testing, including regular review of all ongoing projects.
• Review and approve, require modification, or withhold approval of changes in previously approved uses of animals.The principal investigators must receive approval for the changes, in writing, from the IACUC before the changes may be implemented.
• Inspect the institution's animal facilities at least once every six months. Inspection reports must be prepared which specify deadlines for correction of cited deficiencies. Special note is taken of deficiencies, which are not corrected. Under most conditions ongoing deficiencies must be reported to the USDA and the PHS.
• Review the institution's animal care and use program every six months.
• Submit semiannual reports to the Vice Provost and the Office of Laboratory Animal Welfare (OLAW) detailing results from the review of the animal care and use program and facility inspections.
• Review concerns involving the care and use of animals at the institution.
• Make recommendations to the Vice Provost regarding the animal care and use program, university animal facilities and the care and use training programs available to university personnel.

In addition the IACUC has the authority to suspend a previously approved animal related activity if the committee determines that the activity is not being conducted in compliance with the Animal Welfare Act, the PHS policy, or university policy.The IACUC’s authority to review and approve protocols is independent of the IO who may not overrule a IACUC decision to withhold approval of a protocol. The converse is not true in that if the IACUC approves a protocol, ISU is not required or obligated to allow conduct of the research activity.ISU may also subject protocols to additional institutional review (e.g., department head, scientific review committee).

Go to Top

REVIEW OF PROPOSED ANIMAL USE

Use of Animals in Research

All activities involving the use of live vertebrate animals must be approved by the IACUC. Specific examples of such activities are: research (including field studies and clinical trials), use of blood donor animals, and breeding colonies.

IACUC approval is not required when all procedures are being carried out on tissues obtained from a slaughterhouse or from animals euthanized for another purpose. However, if animals are procured and euthanized/slaughtered to obtain tissues for a particular project, that project must be approved by the IACUC. If procedures (even minimally invasive procedures) are performed for research or teaching purposes, prior to slaughter the project must be approved by the IACUC.

Faculty are expected to obtain IACUC approval for these activities regardless of where the animals are maintained and/or the project carried out. However, if the entire animal portion of the project is to be done at a site or in cooperation with an institution that has its own Institutional Animal Care and Use Committee, a copy of that committee’s approved form may be submitted to the IACUC.

To obtain IACUC approval for a research activity, a Protocol Review Form (PRF) – Research must first be submitted electronically to the IACUC at coac@iastate.edu. Protocol review forms are available on the IACUC website (Office of Research Assurances). Please use the most current version available, and do not save copies to your files; as of October 20, 2003, old versions of the research form will no longer be accepted. A completed PRF must be submitted and approved by the IACUC before any animals may be purchased or used. The original, completed (PI and Department Chair signatures are required) signature page(s) and page one of the new PRF – Research must be received by Sarah Zamzow, IACUC Administrator, 1138 Pearson Hall, before final IACUC approval can be released.

Each Wednesday at noon, PRFs submitted during the week are sent electronically to each member of the IACUC. Along with the protocols, any questions or concerns submitted by committee members are discussed at the following week’s subcommittee meeting.The subcommittee is composed of three members of the IACUC who serve on a rotational basis; it may approve a project, request additional information, request modifications, or refer the entire proposal for full committee review. Members of the IACUC may also request full committee evaluation of the project (federal regulations stipulate that one request requires that the protocol receive full committee review). If this is the case, the study will be held until the next scheduled meeting of the full IACUC. A decision not to approve a protocol must be made at a meeting of the full committee, and a majority vote of the quorum of members present is necessary to deny approval. Written notification of denial and the justification for this action will be sent to the PI.

You will receive an email from the IACUC Administrator when the IACUC has approved your project. An IACUC approval letter and copy of the IACUC approval signature will be forwarded to you via campus mail for your files. Approved protocols are assigned a log number that will be used for the entire duration of the study; you will not receive a new number when your project is renewed each year. The Office of Sponsored Programs Administration will also be notified of IACUC approval and related awards will be released.

The IACUC receives more than 15 – 20 new applications and modifications to existing protocols each week. The federal regulations also require that IACUC review of the applications and modifications be meaningful and that they ensure compliance with the applicable regulations. Due to the large number of applications that are submitted, you should allow at least four to six weeks for review of new applications and two to four weeks for review of a modification/renewal of an approved study. To avoid delays in receiving approval, you should also ensure that you have entirely completed the application form and provided all information requested.

Please remember that in order to be included in the agenda for the following week’s subcommittee meeting, Sarah Zamzow must receive your new application or renewal of an approved study before noon on Wednesday.

Because of the number of disciplines in which proposals are submitted, it is not possible for a committee such as the IACUC to have expertise in all areas. Both the Animal Welfare Act and the Public Health Service Policy recognize the need for the committee to, on occasion, refer certain questions to consultants. When this situation arises, the IACUC will contact the PI and give the PI the option of agreeing that a consultant may be contacted or withdrawing the proposal from IACUC consideration. The PI may suggest individuals who may serve as consultants. The IACUC may or may not utilize these suggestions.

Although the IACUC is not intended to conduct peer review of research proposals, the federal regulations include language such as “consistent with sound research design,” “rationale for involving animals or humans” and “scientifically valuable research,” which requires that the committees consider in their review the general scientific relevance of a research study. Proposals that do not meet these basic tests are not justifiable and cannot be approved. If the IACUC has concerns about the scientific merit of a project and the project was not competitively funded by peer review or was funded by corporate sponsors, the project may be referred to a scientific review committee. The scientific review committee will be adhoc and will consist of your ISU peers and outside experts as needed. If this situation arises, the PI will be contacted and given the option of agreeing that a consultant may be contacted or withdrawing the proposal from consideration.

Go to Top

Use of Animals in Teaching

IACUC approval for the use of live vertebrate animals must be obtained prior to the use of these animals in a scheduled course or continuing education offering. Approval is obtained by submitting a completed "Protocol Review Form - Teaching" electronically to the IACUC at coac@iastate.edu . Protocol review forms are available on the IACUC website (Office of Research Assurances). Please use the most current version available, and do not save copies to your files. The original, completed signature page (PI and Department Chair signatures are required) must be received by Sarah Zamzow, IACUC Administrator, 1138 Pearson Hall, before final IACUC approval can be released.

The procedures involved in review of Teaching protocols are identical to those described above for research activities.

You will receive an email from the IACUC Administrator when the IACUC has approved your project. An IACUC  approval letter and copy of the IACUC approval signature will be forwarded to you via campus mail for your files. Approved protocols are assigned a log number that will be used for the entire duration of the study; you will not receive a new number when your project is renewed each year.

Go to Top

Use of Animals in Blood and Tissue Sampling

All activities involving the use of live vertebrate animals must be approved by the IACUC. Approval for blood and tissue sampling is obtained by submitting a completed "Protocol Review Form – Blood and Tissue" electronically to the IACUC at coac@iastate.edu. Protocol review forms are available on the IACUC website (Office of Research Assurances). Please use the most current version available, and do not save copies to your files. The original, completed signature page (PI and Department Chair signatures are required) must be received by Sarah Zamzow, IACUC Administrator, 1138 Pearson Hall, before final IACUC approval can be released.

The procedures involved in review of Blood and Tissue protocols are identical to those described above for research activities.

You will receive an email from the IACUC Administrator when the IACUC has approved your project. An IACUC approval letter and copy of the IACUC approval signature will be forwarded to you via campus mail for your files. Approved protocols are assigned a log number that will be used for the entire duration of the study; you will not receive a new number when your project is renewed each year.

Go to Top

Use of Animals in Breeding colonies

All activities involving the use of live vertebrate animals must be approved by the IACUC. Approval for breeding colonies is obtained by submitting a completed “Protocol Review Form – Breeding Colony” electronically to the IACUC at coac@iastate.edu. Protocol review forms are available on the IACUC website (Office of Research Assurances). Please use the most current version available, and do not save copies to your files. The original, completed signature page (PI and Department Chair signatures are required) must be received by Sarah Zamzow, IACUC Administrator, 1138 Pearson Hall, before final IACUC approval can be released.

The procedures involved in review of Breeding Colony protocols activities are identical to those described above for research activities.

You will receive an email from the IACUC Administrator when the IACUC has approved your project. An IACUC approval letter and copy of the IACUC approval signature will be forwarded to you via campus mail for your files. Approved protocols are assigned a log number that will be used for the entire duration of the study; you will not receive a new number when your project is renewed each year.

Go to Top

Use of Animals in Special Events

All activities involving the use of live vertebrate animals must be approved by the IACUC. Approval for Special Events is obtained by submitting a completed “Protocol Review Form – Special Events” electronically to the IACUC at coac@iastate.edu. All requests for Special Events approval must now be submitted on this form. Protocol review forms are available on the IACUC website (Office of Research Assurances). Please use the most current version available, and do not save copies to your files. The original, completed signature page (“person responsible for the animals” and “Veterinarian responsible for providing care” signatures are required) must be received by Sarah Zamzow, IACUC Administrator, 1138 Pearson Hall, before final IACUC approval can be released.

The procedures involved in review of Special Events protocols are identical to those described above for research activities.

You will receive an email from the IACUC Administrator when the IACUC has approved your project. An IACUC approval letter and copy of the IACUC approval signature will be forwarded to you via campus mail for your files. Approved protocols are assigned a log number that will be used for the entire duration of the study; you will not receive a new number when your project is renewed each year.

Go to Top

Protocol Modifications

Major vs. minor protocol modifications

In an attempt to help Iowa State University investigators determine what course of action is necessary when making modifications to an existing animal protocol, we have generated two lists of examples. These lists are in no way complete and are shown here only as a guide to help investigators make informed decisions when modifying existing protocols.
Please note: per the Research Compliance Advisory Committee, a change in Principal Investigator (PI) is not a modification, but rather requires submission of a new Protocol Review Form (PRF).
The following is a list of modifications that the Institutional Animal Care and Use Committee (IACUC) deems as major, and as such require submission of a “Continuing Review and/or Modification” form by the PI (via email to coac@iastate.edu), and review and approval by the IACUC (please note: if the changes are considered significant enough, the IACUC may require submission of a new PRF):

1. Changing the Principal Investigator.
2. Applying the protocol to a new species [however, PRFs in which several species are already studied are exempt (i.e. survey studies)].
3. Changing the number or age of animals used on the study.
4. Changing the humane use category.
5. Changing when an intervention will be administered to an animal on trial.
6. Changing the duration, frequency or number of procedures to be performed on an animal.
7. Changing from terminal to survival or repeat surgery.
8. Changing to a different surgical approach or medical treatment.
9. Changing the dosage or dose of hazardous agent or an infectious or biohazardous material already in the protocol.
10. Addition of a new hazardous agent (e.g. betamercaptoethanol).
11. Addition of a new biohazardous material or new infection protocol (e.g. adenovirus vs. lentovirus).
12. Changing or adding objectives to the study.
13. Changing the anesthetic agent(s) or the use or withholding of analgesics. PIs should give an acceptable range so that a modification is not needed.
14. Changing the method of euthanasia.

The following is a list of modifications that the Institutional Animal Care and Use Committee deems as minor and as such require submission of a “Continuing Review and/or Modification” form by the PI (via email to coac@iastate.edu) for approval by the IACUC Chair:

1. Changes in personnel other than the principal investigator. When adding personnel, list their role/duties on the project and list their training.
2. Changing the sex of animals used on a protocol.
3. Changing the supply source of animals.
4. Changing the campus housing location.
5. Changing the disposal of animals.
6. Changing the amount of blood drawn, if within guidelines.
7. Changing the person monitoring anesthesia (if person is properly trained).

Go to Top

Protocol Renewals

The IACUC must review protocols annually. As a courtesy, ~sixty days before a log number is due to expire, the PI will receive a renewal notice by campus mail. If the project is to continue and there have been no significant changes, a “Protocol Review Form - Renewal” should be sent electronically to the IACUC at coac@iastate.edu. If significant changes have been made to the protocol, a new PRF must be submitted. Renewal forms may be submitted for 2 consecutive years. If a project is to continue beyond 3 years, a new PRF must be submitted. Protocols will keep the log number assigned with the first IACUC approval for the duration of the project

If a renewal has not been submitted and approved by the expiration date, the project is considered terminated, and the PI will be notified in writing that any animals being housed under the expired log number are not available for use. To re-establish IACUC approval, the investigator will be required to submit a new application form. The same committee ID number(s) will be maintained for these projects for tracking purposes and to eliminate possible confusion by having more than one number assigned for the same protocol. This policy will apply regardless of the reason for the lapse in approval.

The requirement for submission of a new application does not apply to applications submitted prior to the continuing review date, but lacking sufficient time for committee review and approval by the review date (e.g., 1 day before the review date). Investigators will be sent a memorandum confirming receipt of the continuing review application. The investigator will also be informed that federal regulations require that all research-related activity on the particular project must halt until the project is reviewed and approved by the respective committee

Go to Top

REPORTING CONCERNS REGARDING ANIMAL CARE AND USE

Institutional Animal Care and Use Committee: Noncompliance/Complaint Process

Upon notification to the Office of Research Assurances of noncompliance or complaint:

1. The Director of Research Assurances (DORA) and the Chair of the IACUC will determine if immediate suspension of the project in question is required, while the complaint is being addressed. The decision is made in consultation with the Attending Veterinarian, the IO and/or Associate Vice President, following discussion with the investigator. If applicable, the sponsor contract or grant award notice will be reviewed to determine requirements for notifying the sponsor. Reports to the sponsor are made by the DORA.
   The DORA will lead the investigation of the incident with the assistance from any combination of the following as appropriate: the IACUC Chair, the Attending Veterinarian, the IACUC Administrator, and members of the IACUC. Following completion of the investigation, a meeting will be called of the following individuals: the IACUC Chair, the IACUC members, the principal investigator, and the principal investigator’s department chair to discuss the nature of the situation.
   In order to make the determination of serious or continuing noncompliance it may be necessary to perform an audit of study records. The principal investigator will be required to produce: all data related to the study projects, applications for approval from the IACUC, any study-related documentation including monitoring logs, etc.
2. The DORA or IACUC Chair will present the matter to the members of the IACUC, when a quorum of the full committee is present. The IACUC will determine if: (1) suspension is not merited; or (2) suspension is merited. In order to suspend a study, a majority of the quorum of members present must vote in favor of the suspension.
   1. Suspension not merited: If suspension is not merited, the issue will be resolved between any combination of the following individuals: DORA, Chair of the IACUC, Attending Veterinarian, Principal Investigator, Principal Investigator’s Department Chair. These actions will be based on recommendations from the IACUC members and in communication with the Vice President for Research and/or the Associate Vice President. All communications will be documented.
   2. Suspension is merited: Notice of suspension effective immediately will be sent to: the principal investigator, co-principal investigators, the department chair, the Office of Sponsored Programs Administration, Sponsored Programs Accounting, the Vice President for Research, the Associate Vice President for Research, and the Office of Laboratory Animal Resources. Notification will be sent to the Office of Laboratory Animal Welfare and the United States Department of Agriculture when applicable.
      
3. The IACUC will also be asked to make a recommendation to determine if the situation merits a designation of serious or continuing non-compliance.
1. Nonserious and Noncontinuing. If the incident appears to be isolated and in essence is a miscommunication or misunderstanding of a nonserious and noncontinuing nature, a letter from the DORA to the principal investigator describing a summary of the audit will be written. The DORA in communication with the Vice President for Research and Economic Development may determine the appropriate corrective action based on recommendations made by the Chair of the IACUC, the Attending Veterinarian, and members of the IACUC, or require that the principal investigator describe corrective actions. This will be considered the final step if the incident is considered to be nonserious and noncontinuing. A copy of the letter will be sent to the principal investigator’s department chair and to the Chair of the IACUC.
2. Serious or Continuing. If the audit indicates noncompliance that is serious or continuing, corrective action will be determined by the DORA in consultation with the Vice President and the Associate Vice President for Research. The corrective action will be based on recommendations made by the Chair of the IACUC, Attending Veterinarian, and members of the IACUC. A copy of the letter will be sent to the principal investigator’s department chair, the dean of the principal investigator’s college, the Provost, and other necessary individuals as determined by the Vice Provost for Research. The IO will notify the Office of Laboratory Animal Welfare of the final outcome.

During attending care visits, the attending veterinarian and clinical veterinarians monitor research animal health and well being, husbandry, sanitation, and other pertinent aspects of animal care and use. Additionally, if appropriate, they assist personnel with animal care and use issues, procedures, and training, etc. The frequency of visits to individual animal care and use areas is based on animal use activity and need but are targeted at least once a month. LAR maintains documentation of the attending care visits. If significant issues or problems are identified during visits, the Attending Veterinarian notifies the Director of Research Assurances and the IACUC Chair for follow-up using the investigation procedures noted above. If warranted, the Attending Veterinarian refers significant concerns regarding health and well-being of animals to the IACUC or the IO, while in communication with the Director of Research Assurances, for additional consideration and/or formal action.

Go to Top

VETERINARY CARE PROGRAM

Attending Veterinarian

Both the Animal Welfare Act and the PHS Policy require the designation of an institutional attending veterinarian. At Iowa State this person has traditionally been the Director of Laboratory Animal Resources (LAR). Dr. Joan Hopper is the Attending Veterinarian and Director of the office of Laboratory Animal Resources. The attending veterinarian is a permanent member of the . This fulfills the federal requirement that one member of the IACUC must be a veterinarian with training and/or experience in laboratory animal medicine who has "direct or delegated program responsibility for activities involving animals at the institution" (PHS Policy, 1986). The stated responsibilities of the attending veterinarian are as follows. These duties may be carried out by the attending veterinarian or by his/her designee.

1. Observation of teaching and research animals to assess their health and welfare.
2. Prevention, control, diagnosis and treatment of diseases and injuries.
3. Provide guidance to animal users regarding handling, restraint, anesthesia, analgesia and euthanasia.
4. Monitor surgery programs and postsurgical care.

Go to Top

LAR Veterinary Staff

The LAR veterinary staff consists of the Director, two clinical veterinarians, and two licensed veterinary technicians. Members of the veterinary staff are available from 8:00 am to 5:00 pm, Monday through Friday and the veterinarians are on call on a rotational basis on weekends and holidays.

Animal caretakers working in each facility are expected to observe each animal under their care daily and report any illness, injury or death to the veterinary staff. In addition, the animals in each campus facility are observed at least weekly by a member of the veterinary staff.

On receiving a report of sick or injured animals the clinical veterinarian examines the animal(s) and consults with the principal investigator (PI) or the individuals the PI has indicated (PRF for Research, question #4, PRF for teaching, question #7) have the authority to approve medical care or euthanasia. If the PI, or his/her designee, cannot be reached in a timely manner, the LAR veterinarian will determine the course of action.

The clinical veterinarians oversee the quarantine and conditioning programs. Treatments are carried out by the veterinary staff or animal caretakers under the direction of the clinical veterinarian unless other arrangements have been made in advance with the PI.

Go to Top

Consultation

LAR veterinarians are available for consultation with PI's in areas such as restraint, handling, anesthesia, euthanasia and experimental procedures. Arrangements may be made in advance for a veterinarian or other qualified individual to perform, or train laboratory personnel to perform, specified experimental procedures.

Go to Top

POLICIES ON SPECIFIC PROCEDURES

Production of Monoclonal Antibodies

A number of in vitro methods have been developed to replace the mouse ascites method in production of monoclonal antibodies. Consideration of these in vitro methods is consistent with the federal mandate to avoid or minimize discomfort, pain and distress in animals and to consider alternative methods that will reduce, refine or replace the use of animals. The Public Health Service has reminded research institutions of this mandate and informed Animal Care and Use Committees of the expectation that, prior to the approval of any project in which the mouse ascites method is proposed, the committee will “determine that (i) the proposed use is scientifically justified, (ii) methods that avoid or minimize discomfort, distress, and pain (including in vitro methods) have been considered, and (iii) the latter have been found unsuitable”. (OPRR Reports, November 17, 1997).

The staff of the Cell and Hybridoma Facility is experienced in the production of monoclonal antibodies using several techniques. The Facility is located in the Molecular Biology Building. Dr. Paul Kapke is prepared to discuss in vitro techniques that can be used in the individual investigator’s laboratory. Arrangements can also be made for the staff of the Cell and Hybridoma facility to produce the required antibodies.

Go to Top

Freund's Complete Adjuvant

The IACUC encourages the use of adjuvants which typically cause less tissue damage than Freund's Complete Adjuvant (FCA). However, when FCA must be used the IACUC will approve its use for the initial inoculation only. Subsequent inoculations must be done with another adjuvant.

Whenever possible inoculation with FCA should be subcutaneous rather than intradermal, intramuscular, or intravenous. Footpad injections must be specifically justified to the IACUC. The FCA injected must not exceed 10 (g mycobacteria per injection site (5 (g per site in mice). This guideline can be met by limiting injection of a standard FCA solution (0.1 mg/ml) to 0.1 ml/site (0.05 ml/site in mice).

Use of FCA is considered a painful procedure and analgesics are to be used following inoculation. Specific justification must be provided to the IACUC in writing if analgesics can not be used. A copy of this justification will be included in the annual report to the USDA. This information is available to the public through the Freedom of Information Act.

Personnel using FCA need to be aware that humans accidentally inoculated with FCA have experienced chronic pain associated with severe inflammation. As reported in Laboratory Animal Science (391:400-404, 1989) these individuals also have an increased risk of severe allergic reactions, possible autoimmune disease, uveitis, arthritis and increased incidence of neoplasia.

Go to Top

Orbital Sinus Blood Sampling in Rodents

In the past the IACUC has approved collection of blood samples from the orbital sinus in rodents, with the requirement that the animals be anesthetized. An alternative technique is available in which blood is collected from the saphenous vein. This technique has the advantages that the animals do not have to be anesthetized, repeated samples can be taken from the same site, and the risk of injury to the animal is very small. The IACUC now strongly recommends that the saphenous vein technique be used and will require additional justification for use of the orbital sinus technique. Arrangements can be made for training on the saphenous vein technique by calling the LAR office, 4-8507.

Go to Top

Cardiac Puncture

Cardiac puncture in all species is to be performed under general anesthesia and must be a terminal procedure unless justification for survival is approved by the IACUC.

Go to Top

Humane Euthanasia

In 2000, the American Veterinary Medical Association (AVMA) published a revised and updated "AVMA Panel on Euthanasia". This report has been accepted by the USDA and the PHS as the basis for selecting an appropriate method of euthanasia. In order to obtain IACUC approval to perform euthanasia a PI must utilize a method approved by the AVMA or provide specific justification for use of a method that is not consistent with these recommendations.

Go to Top

Experimental Procedures Conducted in Animal Facilities

Experimental procedures unlikely to cause pain or distress may be carried out in the animal rooms. However, where procedure rooms are available in the animal facility, the PI is encouraged to use them whenever possible. Use of these rooms may be scheduled with the facility supervisor.

Animals may be transported to laboratories for the conduct of experimental procedures. However, they may not be kept outside the animal facility for more than 12 hours without IACUC approval.

Euthanasia, procedures requiring inhalant anesthetic, and potentially painful or stressful procedures may not be conducted in an animal unless the PI has obtained prior IACUC approval.

Go to Top

Use of Radioisotopes in Animal Facilities

If radioisotopes are to be used in animals the facility where the animals are to be housed must be inspected by personnel from the radiation safety section of Environmental Health and Safety and the caretaker assigned responsibility for the animals must complete a seminar in radiation safety before the animals are exposed to radioactive material. It is preferable for PI’s to meet with the animal care staff before animals are ordered to assure that specific animal care instructions (e.g., disposal of bedding and carcasses) are thoroughly explained.

Go to Top

Guidelines for Research Involving Transgenic Animals

Iowa State University supports responsible, well-planned research involving transgenic animals. All proposals will be carefully reviewed with respect to public safety, animal welfare, and social and economic impacts. Ongoing projects will be monitored with respect to public safety and animal welfare. These are guidelines for the review and monitoring processes.

Proposal Review

Approval of all proposals must be obtained from the Institutional Biosafety Committee (IBC) and the Institutional Animal Care and Use Committee (IACUC).

a. IBC review will determine:

• compliance with National Institutes of Health and the Animal and Plant Health Inspection Service guidelines;
• adequacy of designated laboratory facilities;
• adequacy of specified containment procedures; and
• the biosafety containment level under which the project must be conducted.

b. IACUC review will determine:

• compliance with existing animal care and use policies (alleviation of pain and distress, adequate veterinary care, adequate training of personnel, approved method of euthanasia, etc.) as outlined by the Public Health Service, the United States Department of Agriculture, the State of Iowa, and Iowa State University;
• adequacy of the method proposed to individually mark all transgenic animals and their offspring with a number from a standard university identification system maintained by the attending veterinarian;
• adequacy of methods chosen to evaluate variations from non-transgenic animals of the same species; and
• availability of housing appropriate for the biological safety level assigned by the IBC.

c. A quorum of each committee must be present for review. Consultants may be contacted as necessary. A majority vote is needed to approve/disapprove a proposal. When a proposal is not approved, it will be returned to the PI with a written explanation of the action taken.

d. A copy of the completed "IACUC New Application form" and a copy of the proposal will remain on file in the office of the Vice President for Research and Economic Development, 1138 Pearson Hall. The PI will be notified in writing of all committee actions by the chairs of the two reviewing committees and the Vice President for Research and Economic Development.

Research in Progress

1. Monitoring and Recordkeeping

• Animals must be observed daily by trained animal care personnel (existing PHS policy). Any behavioral, physiological or pathologic changes are to be recorded and a Laboratory Animal Resources (LAR) veterinarian contacted as soon as possible. Records of observations will be kept in the LAR office with copies available to the PI.
• Based on physical examination, the attending veterinarian may require modification in husbandry (different type of caging, etc.), diagnostic testing, treatment or euthanasia of individual animals.
• The PI must notify the attending veterinarian of any behavioral, physiological or pathological changes noted by the research team.
• The PI will keep detailed records of the methods used to monitor the animals (as approved during the protocol review process), and the results, particularly noting differences from control animals. These records will be available to the attending veterinarian and IACUC.
• Each animal will be permanently marked, with a number from the standard university identification system, by a means approved by the IACUC during the protocol review process. The PI must maintain individual animal records including the name of animal housing facility, location within the facility, final disposition of the animal, and specific breeding records.
• If animals are to be moved at any time, primary enclosures and any conveyances used must be structurally sound and of sufficient construction that the animals cannot escape. The animals may not be left unattended, and they must be delivered directly to the assigned location (not left in a holding area or loading dock). Male and female animals of breeding age may not be moved in the same primary enclosure.

2. Reporting of Deficiencies

Current requirements for humane animal care stipulate that any university personnel have the right to express concerns regarding the care and/or use of animals in a research or teaching project. Concerns may be reported to Diane Ament, Director of the Office of Research Assurances (DORA), who will then introduce the matter for discussion at a committee meeting. The DORA may be contacted at (515) 294-3115; dament@iastate.edu. For anonymous reporting, a help line has also been established, (866) 384-4277. Concerns may also be reported to the Chair and members of the IACUC or the Attending Veterinarian who will then forward the concern to the DORA. The concern will be investigated following the IACUC Complaint Non-Compliance Process. All reports will be kept confidential.

3. Disposition of Animals at the Termination of the Project

• Nonsurvival projects: animals must be humanely euthanized and incinerated.
• Survival projects: animals may remain in the colony/herd and be used in another project as approved by the IBC and the IACUC. Animals must retain their individual identifications. The transfer to another project/PI must be recorded on the animal's identification record and the record must be maintained by the PI of the succeeding project.

4. Suspension of an Ongoing Project

Ongoing projects may be suspended:

• at the request of the PI;
• at the request of the attending veterinarian with the concurrence of the PI;
• by majority vote of a quorum of the IACUC if it is determined that the project is no longer in compliance with the Animal Welfare Act, the PHS policy or University policy, or if it is determined that the animals involved are experiencing pain or distress beyond that expected when the protocol was reviewed; or
• by a majority vote of a quorum of the IBC if it is determined that the research team is not enforcing measures appropriate to the assigned biosafety containment level.

(The Institutional Animal Care and Use Committee or the Institutional Biosafety Committee will each submit a written statement to the Vice President for Research and Economic Development. Under current PHS policy, the IACUC must also notify the PHS of suspension if the project is funded through one of its member agencies.)

Release of Transgenic Animals

Requests to release transgenic animals or their offspring to the environment or to the food chain must be made in writing to the Institutional Biosafety Committee for recommendation to the Vice President for Research and Economic Development. The Vice Provost may also request counsel from the Institutional Animal Care and Use Committee. The Institutional Biosafety Committee will refer the PI to an appropriate federal agency. It will be the responsibility of the PI to contact the agency and to report in writing to the Vice Provost regarding this contact. The office of the Vice Provost will notify the chairs of the two reviewing committees prior to the release of any animals.

Requests to discontinue individual identification of offspring of transgenic animals will be handled in the same manner as a request to release transgenic animals into the environment.

Go to Top

Guidelines for the Use of Live Vertebrate Animals in Teaching

The study of animals is an important part of many courses at Iowa State University. Courses using animals run the gamut from those in zoology, animal production, and veterinary medicine in which the animal itself is the main subject matter to those in molecular biology, biochemistry, foods and nutrition, psychology, and others in which animals and animal cells are models for the study of mechanisms common to all animals, including humans.

Before animals are used in a course, a properly completed Teaching Protocol Review form must be submitted to the Institutional Animal Care and Use Committee (IACUC). The instructor may be asked to meet with the committee to answer in detail questions such as those below concerning the use of animals in a course.

Animal use is not to be taken lightly. Instructors should determine first whether animal use is the most effective and efficient means to accomplish instructional objectives and be able to state why alternative methods are not suitable. If a decision is made to use animals, it is critical that animals are treated humanely and respectfully and that every aspect of animal use is done responsibly. Before approval of a teaching protocol is granted, instructors must state the number and training of the laboratory instructors to be involved in the course and to specify the preparation the students will have prior to the laboratory.

The following questions should be addressed before animals are used in any aspect of the course.

• Do the instructional objectives of the course require the use of live animals?
• Are there other equally efficient and effective means, such as computer simulations or videotapes, to accomplish the learning objectives?
• If experiments or exercises are done in which results are already known or stereotypical, is it necessary to perform the experiment with live animals?
• Are instructors prepared to justify the use of animals in accomplishing their teaching objectives?
• Are alternatives available for students who are opposed to the use of animals on ethical grounds? Have students been informed that alternatives exist?
• Is the species of animal to be used appropriate for the learning objectives?
• Will use of this species negatively impact the natural environment?
• Can a species from a taxonomically lower vertebrate or invertebrate class be used meaningfully? Can fewer animals be used to accomplish the learning objectives?
• Have all precautions been taken to assure that animals will not suffer undue physiological, psychological, and/or behavioral distress in the experiment or exercise?
• Have proper handling and restraint techniques been discussed for each species to be used?
• Are students made aware of signs of illness and discomfort in the species to be used?
• Are students made aware of a readily available contact person who can assist with problems in animal use and care?
• Need every student perform the required procedure?
• Are students and instructors informed of possible zoonotic diseases?
• Have students been informed early in the course and before using animals:
  • that live animals will be used in the course?
  • which species of animals are to be used in the course?
  • the general procedures to be performed?
  • whether or not euthanasia will be performed, and if so, by what method and by whom?
  • that the use of animals in the university is monitored by the University Institutional Animal Care and Use Committee?
  • how and to whom to report problems and concerns related to animal use in the course?
• Are students, instructors, and teaching assistants properly prepared before laboratory use of animals to derive maximum meaning from the use of the animal?
• Are the users prepared to deal expediently with medical and procedural emergencies?
• What measures are taken to insure that instructors and assistants have the proper training and attitudes to use animals humanely and respectfully?
• Is adequate housing provided for the animals with respect to space, sanitation, food, water, ventilation, etc. according to appropriate guidelines?
• The following points must be addressed for all courses using anesthesia.
• In any course involving anesthesia, whether or not surgery is to be done, students must receive prior instruction on the administration and monitoring of anesthesia or the students must be provided with animals already anesthetized by experienced personnel. Induction techniques such as the anesthesia jar for rodents may be demonstrated by the instructor in a pre-lab. Students must practice techniques such as IV injections on a previously anesthetized animal before attempting the technique as part of a laboratory exercise. In all cases, students must receive prior instruction on monitoring anesthesia.
• IACUC suggests the following limits on the number of times an individual animal may be anesthetized. An animal should not be anesthetized more than twice in one week at an interval of at least 72 hours. An animal should not be anesthetized a total of more than 4 times before it is euthanized.

It is recommended that all departments using animals should evaluate required courses in undergraduate and graduate majors that involve the use of animals for the appropriateness of animal use in those courses. The appropriateness/necessity of each student of a given major, at a given level, performing the specified procedures on live animals must be evaluated.

Undergraduate, graduate, and professional courses using animals should be evaluated for similarity of content. Combining courses with similar content which are being offered in different colleges may decrease the number of animals used.

Guidelines for Courses Utilizing Surgical Procedures On Living Vertebrates

The IACUC requires that instructors adhere to NIH research guidelines when using survival surgical procedures in teaching. Deviation from the NIH guidelines must be justified in writing.

• Students should be informed during the first meeting of the course that surgical procedures will be performed on living vertebrates. The rationale for requiring these procedures to be performed in class rather than observed on film or videotape should be presented. Students should be informed whether procedures will be performed by the instructor or graduate teaching assistants only or by the students themselves.
• Prior to each laboratory exercise, a "pre-lab" should be held to review the procedures to be followed in the surgical laboratory. The "pre-lab" should include the following:
• rationale for the surgical procedure
• a film or videotape of each procedure being performed and a step by step discussion of each procedure, including presurgical, surgical, and post surgical care of the animal
• instruction in aseptic technique, gloving, gowning, and surgical site preparation
• procedures to be followed in data collection, including trouble shooting
• expected outcome(s) if known
• data analysis
• final disposition of the animal(s).

Input from students regarding adequacy of pre-lab preparation and availability and preparedness of instructors should be sought.

• During each surgical laboratory, an instructor and/or teaching assistant proficient in the procedures should remain in the laboratory at all times to assist students and answer questions.
• Whenever possible, students should work in teams rather than individually in order to reduce the number of animals used.
• In any course involving anesthesia, whether or not surgery is to be done, students should be provided with animals already anesthetized by experienced personnel, or they must receive prior instruction on the administration of anesthesia. In either case, students must receive prior instruction on monitoring anesthesia.
• Students should practice techniques such as venipuncture on a previously anesthetized animal before attempting the technique as part of a laboratory exercise.
• If animals are to be allowed to recover after surgery, each animal must be inspected by the instructor and/or teaching assistant at the end of the procedure and at regular frequent intervals thereafter until the animal is fully recovered. Written records should be maintained for the anesthesia recovery and postoperative period. Students must be able to contact an instructor as needed for operative and anesthetic emergencies.
• All animals which are deemed by the instructor or teaching assistant to be unacceptable for recovery due to poor surgical techniques or other complications must be euthanized or corrective procedures performed.
• At the termination of each course involving surgery, the instructor and students should evaluate the effectiveness of each procedure in accomplishing overall course objectives, adequacy of pre-lab preparation, and availability and preparedness of instructors.
• All surgical procedures must take place in appropriate surgical facilities as specified in the Guide for the Care and Use of Laboratory Animals. (Copies of the "Guide" are available in most departmental offices, libraries and reading rooms, and at Laboratory Animal Resources.) Surgical garb appropriate for the subject species is required.

Go to Top

Surgery

Survival surgery is a surgical procedure in which animals regain consciousness after anesthesia. A major surgery is defined as one in which a major body cavity is penetrated and exposed or substantial impairment of physical or physiologic function is produced. Federal law and university policy allow recovery from one major surgery.However, recovery from more than one major surgical procedure (multiple survival surgery) is forbidden unless it is absolutely necessary to accomplish the objective of the project. Multiple survival surgery must be justified, on a scientific basis, in writing to the IACUC. Cost is not sufficient justification.

Federal regulations require that major survival surgery on nonrodent species be performed in a separate surgical suite, which includes a surgeon’s prep area, an animal prep area, surgical support area, operating room(s) and an area for intensive care and supportive treatment. Aseptic technique must be used on nonrodent animals undergoing major survival surgery. This includes the use of sterile gloves, caps, gowns and masks, use of sterile instruments, preparation of the surgeon and aseptic preparation of the surgical site. (ILAR Guide, 1996). Minor procedures may be performed under less stringent conditions but preparation of the surgical site and the use of gloves and sterile instruments are still required.

Surgery may be performed on rodent species in a laboratory if the area being used is clean and no other procedures are being done in the area at the time of surgery. However, a separate animal prep area should be provided to prevent contamination of the surgical area by hair and dirt from clipping and prepping the animal. Sterile instruments, gloves and preparation of the surgical site should be used when performing survival surgery in rodents.

In nonsurvival surgery the animal is euthanized before recovery from anesthesia. It is not necessary to utilize all aseptic techniques for nonsurvival procedures. However, it is expected that the surgery site will be clipped, the surgeon will wear gloves and the instruments used will be clean.

Federal regulations require that animals be monitored while anesthetized and that adequate postoperative care be provided. This includes monitoring of the animal during recovery from anesthesia, administering supportive fluids, analgesics and other drugs as required, adequate care for surgical incisions and maintaining appropriate medical records. Copies of the anesthesia record and the post operative monitoring records are to be kept in the facility with the animals.

Go to Top

Purchase of Dogs and Cats from USDA Class B Licensees

As a means of assuring the public that Iowa State University does not use stolen pets in research and teaching, dogs and cats may not be purchased from USDA Class B licensees.

Go to Top