An Introduction to Conducting Animal Research: Oversight and the IACUC

1. An Introduction to Conducting Animal Research: Oversight and the IACUC Institutional Animal Care & Use Committee iacuc@tulane.edu

2. IACUC The charge of an Institutional Animal Care and Use Committee as mandated by NIH’s Office of Laboratory Animal Welfare and the USDA is to ensure the humane care and use of animals used in research and compliance with guidelines and regulations.

3. Animal Research has Oversight • All animal research at TU has official oversight provided by the Institutional Animal Care and Use Committee (IACUC) • All animal research must be approved by the IACUC • The IACUC helps investigators conduct ethical research by implementing guidelines and policies for the humane care and use of research animals and for the safety of research personnel • These guidelines are based on laws, regulations and policies from federal agencies and other accrediting organizations

4. Laws, Regulations, and Policies That Impact on the Care and Use of Animals • Animal Welfare Act (Animal Welfare Regulations and Animal Care Policies) • Public Health Service Policy on Humane Care and Use of Laboratory Animals • Association for the Assessment and Accreditation of Laboratory Animal Care – International (AAALAC-I) requirements

5. Regulations and Standards Federal Animal Welfare Act • Passed in 1966 • Administered by USDA-APHIS • Provisions include: • Handling, housing, feeding, watering, sanitation, ventilation, shelter, and adequate veterinary care • Use of tranquilizers, anesthetics, and analgesics to minimize pain or distress • Periodic, unannounced visits • IACUC • Personnel training • Detailed records • Annual reports to USDA • Penalties for violation - fines or revocation of funding

6. Regulations and Standards • PHS Institutions required to follow • Basis for AAALAC-I accreditation • Covers all aspects of animal care programs and facilities • The “Guide for the Care and Use of Laboratory Animals” was first published in 1963 under the auspices of the Animal Care Panel as the “Guide for Laboratory Animal Facilities and Care” . It provides standards for the care and use of research animals. (Laboratory Animal Medicine ACLAM series) • It has become THE reference for the operation of animal care and use programs and has undergone many revisions, the most recent in 1996. The Guide focuses on- • Institutional Policies and Responsibilities • Animal Environment, Housing, and Management • Veterinary Medical Care • Physical Plant Guide for the Care and Use of Laboratory Animals

7. Regulations and Standards Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals Applies to any institution receiving PHS funds for vertebrate animal research Institutions with an “Assurance” must: • Establish an appropriate line-of-authority • Use the “Guide” as a basis for operating their animal care program • Maintain an IACUC • Maintain records • Report annually to OLAW (Office of Laboratory Animal Welfare) • Submit to on-site visits

8. Regulations and Standards United States Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training • A set of 9 general principles adhered to by institutions receiving federal funds for animal research • Reinforced by the PHS Policy

9. Serious Non-complianceExamples of Reportable Situations • conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals; • conduct of animal-related activities without appropriate IACUC review and approval; • failure to adhere to IACUC-approved protocols; • implementation of any significant change to IACUC-approved protocols without prior IACUC approval as required by IV.B.7.; • conduct of animal-related activities beyond the expiration date established by the IACUC (note that a complete review under IV.C is required at least once every three years)

10. Serious Non-compliance • conduct of official IACUC business requiring a quorum (full Committee review of an activity in accord with IV.C.2 or suspension in accord with IV.C.6) in the absence of a quorum • conduct of official IACUC business during a period of time that the Committee is improperly constituted • failure to correct deficiencies identified during the semiannual evaluation in a timely manner; • chronic failure to provide space for animals in accordance with recommendations of the Guide unless the IACUC has approved a protocol-specific deviation from the Guide based on written scientific justification;

11. Serious Non-compliance • participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained as required by IV.C.1.f; • failure to monitor animals post-procedurally as necessary to ensure well-being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures); • failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry);

12. Serious Non-compliance • failure to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO 2); • failure of animal care and use personnel to carry out veterinary orders (e.g., treatments); or • IACUC suspension or other institutional intervention that results in the temporary or permanent interruption of an activity due to noncompliance with the Policy, Animal Welfare Act, the Guide , or the institution's Animal Welfare Assurance.

13. Penalties for Non Compliance AWR’s • Institution fined • Cease & desist order issued • Federal funding agencies requested to suspend or revoke funding PHS Policy • Revocation of assurance & loss of funding for entire institution

14. Program Accreditation AAALAC International • A non- profit corporation directed by its member organizations (educational, health and research groups concerned about animal care) • Conducts a voluntary program of accreditation of laboratory animal facilities and programs to encourage high standards for the care and use of lab animals, assure control of variables that may adversely affect research and protect the health of animal research workers • Conducts site visits for assessment and accreditation • Accreditation is strongly encouraged by many funding agencies

15. Oversight of Animal Research Conduct Provided By: • Institutional Official • Institutional Animal Care and Use Committee (IACUC) • Principal Investigator • Department of Vivarial Science and Research (DVSR) • This division has the charge of being directly responsible for the care and well-being of the animals

16. Why does TU have an IACUC? • All research institutions that are registered under the provisions of the Animal Welfare Act are required by law to establish an IACUC • All research institutions that receive federal funding are required by law to establish an IACUC

17. The IACUC Mission • Oversee and evaluate the institution’s program for animal care and use including it’s procedures and facilities • Implement regulations for the humane care and use of animals in research • Ensure researcher compliance with federal, state and local regulations and policies

18. Minimal Required IACUC Membership • A scientist experienced in animal research • A non-scientific member • A non-affiliated member • A veterinarian with training or experience in laboratory animal science A minimum of five members

19. IACUC Membership • Several faculty scientists actively involved with animal research • This group constitutes the majority of the committee • Non-affiliated member • non-scientist member • 1 or more veterinarians experienced in laboratory animal science and primate medicine

20. Specific IACUC Functions • Review and consider for approval all proposed animal research annually • Review animal care facilities and programs (report to Institutional Official) semi-annually • Ensure personnel training and safety • Make recommendations to Institutional Official regarding program and facilities • Review concerns about animal care and use • Suspend non-compliant animal care and use activities

21. Protocol Review • Procedures avoid or minimize discomfort, distress, and pain • Investigator has considered alternatives • Proposed activities are not duplicative • Procedures that may cause pain or distress will: • incorporate pain-relieving measures unless well justified • include veterinary involvement in planning • not use paralytics without anesthesia • Animal will be euthanized if pain cannot be relieved

22. Protocol Review cont. • Animal Numbers are the minimum possible to achieve statistically significant data and are well justified using the following criteria: • Citation of previous research, with sufficient information provided to indicate that the previous research is similar enough in concept and methodology to make it reasonable to use similar sample sizes in the proposed research project • Power analysis- with enough information to show ability in analyzing data and using a power analysis • State clearly why a specific amount of material is needed and why the number of animals requested is appropriate to provide that amount of material

23. Protocol Review cont. • Animal living conditions appropriate to species and meet standards • Animals housed in approved facility for approved time period • Medical care available and provided as necessary by a qualified veterinarian • Personnel appropriately qualified and trained • Surgical procedures performed aseptically, in approved facilities, and include appropriate pre-and postoperative care • Animals not used in more than one major, survival operative procedure • Acceptable methods of euthanasia

24. Researcher Responsibilities • Experimental design (appropriate species, alternative model, numbers…) • Ensure appropriate staff qualifications and training for animal care and use • Conduct all research in accordance with protocols approved by the IACUC and institutional safety committees

25. Researcher Responsibilitiescont. • Acquire nonprimate species through DVSR approved vendors • Schedule all animal activities through the DVSR • Ensure staff performing procedures understands what is outlined in the study • Wear proper personal protective equipment and follow exposure guidelines

26. Review Outcomes

27. Amendments It is Tulane’s institutional policy that no one may implement changes categorized as significant prior to IACUC review and approval Significant Changes -many times will require a new protocol 1. Changes in the objectives of a study 2. Proposals to switch from nonsurvival to survival surgery 3. Changes in the degree of invasiveness of a procedure or discomfort to an animal 4. Changes in species or in the approximate number of animals used 5. Changes in anesthetic agent(s) 6. The use or withholding of analgesics 7. Methods of euthanasia 8. Changes in the duration, frequency, or number of procedures performed on an animal

28. Amendment . Minor Changes: • Addition of another strain of the same animal species • Change in sex of animal to be used • Need to repeat an experiment • Small increase in animal numbers - review is based on approximately 10% of original number of animals and any other amendments filed for this protocol • Addition of minor surgery- this addition cannot change the USDA category to a higher one. If this addition will change the pain category you must submit a new protocol. • Change in Principal investigator-if already listed as co-investigator on the protocol • Addition of a faculty collaborator • Additional noninvasive sampling • Addition of sample collection times

29. The New Form(s) Nonhuman primate form • Updated analgesic/anesthetic information • Updated behavioral management section All other species form • Specific analgesic/anesthetic information for commonly housed species • Specific behavioral management section

30. The New Form(s) • Significant changes • Animal species • Drop down menu • Regulatory information • Only one question specific to multiple survival surgery, do not outline survival surgery in this area • Progress Report • Specifically required for all renewal protocols • Indicate animals continuing on study

31. The New Form(s) • Significant changes • Layperson’s summary is still required • Scientific summary • Area for text and chart • Alternative search • If hits are found, investigator must justify why those alternatives are not being used

32. The IACUC Office at TU Tidewater Suite 1707 504-988-6868 (office) 504-988-1445 ( fax) 504-481-9684 (cell) 985-871-6636 (TNPRC Thursday) iacuc@tulane.edu