UNIVERSITY of WISCONSIN – STEVENS POINT Policy on the Care and Use of Animals in Research and Teaching updated November 29, 2011 POLICY STATEMENT The University of Wisconsin-Stevens Point (UWSP) follows the University of Wisconsin System Board of Regents Policy (1984) <www.uwsa.edu/bor/policies/index.htm> 84-2: CRITERIA FOR USE OF ANIMALS FOR RESEARCH History: Res. 3024 adopted 4/6/84. The criteria as stated within the Guide for the Care and Use of Laboratory Animals, DHEW (NIH) 78-23 revised 1987 or succeeding additions, shall be the criteria for researchers to follow regarding the humane treatment of animals for scientific research purposes in accordance with section 36.40, Wis. Stats., (created by 1983 Wisconsin Act 27, sec. 908t). REASON FOR POLICY The university is committed to the highest ethical standards of animal care and use. This policy has been prepared as a resource for anyone at the university who works with animals in research, teaching, or testing. It outlines policies and procedures that must be followed in the humane conduct of animal-based studies, and provides resources to obtain additional information. ENTITIES AFFECTED BY THIS POLICY This policy applies to all faculty, postdoctoral fellows, graduate and undergraduate students, research personnel, and staff members involved in the care and use of animals; heads of units where animals are used in research, teaching, or testing; and Institutional Animal Care and Use Committee members, including the Institutional Officer. ANIMALS REGULATED BY THIS POLICY Animals covered by this policy include all live mammals, birds, reptiles, amphibians, and fishes, either wild or domestic. Bird, amphibian, and reptile eggs are not regulated by this policy, although post-hatching animals are regulated. This policy does not supercede federal, state, or local regulations. In all cases, animal care and use must comply with all applicable federal, state, and local regulations. ANIMAL USE REGULATED BY THIS POLICY This policy regulates the use of mammals, birds, reptiles, amphibians and fish in research and teaching by UWSP faculty, staff, postdoctoral fellows, graduate and undergraduate students engaged in any Universityrelated activities. This policy applies to all mammals, birds, reptiles and amphibians captive-housed on University property and those housed on private property used in University-related research or teaching activities. This policy does not apply to the use of wild animals for purely observational purposes when such observation is not expected to significantly affect animal behavior or well-being. This policy does not apply to animals kept solely as pets by members of the University community. COPIES OF THIS POLICY This policy can be found at the website: http://www4.uwsp.edu/special/acuc/ INSITUTIONAL ANIMAL CARE and USE COMMITTEE (IACUC) "Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society." -- U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training (1984) The members of the IACUC are responsible for overseeing UWSP compliance with federal, state, and local animal care and use policies. The Committee includes a minimum of five members, including a professional 106737150 1 scientist, a veterinarian, and a member of the Stevens Point community not associated with UWSP or conducting animal research. IACUC members are volunteers and are not paid for their service. IACUC membership is approved by the Institutional Officer (IO). An IACUC member may be removed from the committee if he/she is regularly unable to attend protocol review meetings or is unable to fulfill his/her responsibilities. It is the responsibility of the IACUC to: Review UWSP’s program for animal care and use at least once every six months, using the AWAR, the Guide, and the Ag Guide as a basis for evaluation Inspect, at least once every 6 months, all UWSP animal facilities, including primary and secondary housing locations, satellite facilities, and field sites for captive animals (free-living, wild animals in their natural habitat) using the Animal Welfare Act Regulations (AWAR), the Guide for the Care and Use of Laboratory Animals (The Guide), the Guide for the Care and Use of Agricultural Animals in Agriculture Research and Teaching (Ag Guide), and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) as a basis for evaluation. Submit to the Institutional Officer (IO) reports of the above evaluations that distinguish significant deficiencies from minor deficiencies; contain a reasonable and specific plan and schedule for correcting each deficiency; describe and justify any departures from the Guide, Ag Guide, and PHS Policy, which are signed by a majority of the IACUC members; and include any minority views Review and investigate concerns involving the care and use of animals at the university resulting from public complaints or fro reports of noncompliance received from university personnel Make recommendations to the IO regarding any aspect for the institution’s animal program, facilities, or personnel training Review and approve, require modifications to secure approval, or withhold approval of those components of proposed activities related to the care and use of animals Review and approve; require modifications to secure approval; or withhold approval of proposed, significant changes regarding the care and use of animals in ongoing activities CURRENT IACUC MEMBERSHIP [August 2006] The IACUC serves the scientific, teaching, and animal communities and welcomes opportunities to help develop research and teaching plans, implement protocols, and train users. Any member of the IACUC may be contacted for assistance. Name Vic Akemann Dr. Shelli Dubay Dr. Karin Bodensteiner Emily Starke Dr. Todd Huspeni Dr. Tom Kelble, DVM Sandra LaVake Dr. Heather Molenda-Figueira Dr. Brian Sloss Dr. Chris Diehm email work phone sdubay@uwsp.edu kbodenst@uwsp.edu estarke@uwsp.edu thuspeni@uwsp.edu 715-346-4178 715-346-3994 715-346-4823 715-346-4250 hmolenda@uwsp.edu bsloss@uwsp.edu cdiehm@uwsp.edu 715-346-3690 715-346-3522 715-346-4948 expertise Biology education Wildlife health Animal reproduction UWSP animal care facility Parasitology Veterinary medicine Nutrition, pharmaceuticals Rodent hormones and reproduction Fisheries Environmental ethics IACUC VETERINARIAN The attending veterinarian is a member of the IACUC and has the unique responsibility and authority to assure that handling, restraint, anesthesia, analgesia, and euthanasia are administered as required to relieve pain and suffering in research and teaching animals, provided such intervention is not specifically precluded in 106737150 2 protocols reviewed and approved by the IACUC. The attending veterinarian has the authority and responsibility for making determinations concerning animal well-being and assuring that animal well-being is adequately monitored and promoted. The attending veterinarian participates in the review of animal care and use protocols. He/she has the authority to remove an animal from an experiment, test, or teaching activity that is adversely affecting its well-being beyond a level reviewed and approved by the IACUC. The veterinarian can advise principal investigators on the design and performance of experiments using animals as related to model selection, collection, and analysis of samples and data from animals, and methods and techniques proposed or in use. PRINCIPAL INVESTIGATORS Faculty and academic staff members may serve as principal investigators. Post-doctoral researchers and graduate students may serve as co-investigators with a faculty or academic staff member. Undergraduate students may not serve as principal investigators but can participate extensively in the preparation and implementation of an animal use proposal. Undergraduate students must be supervised by a faculty or staff member serving as the principal investigator. For the care and use of animals in the classroom, the faculty or staff instructor, or the laboratory personnel, may serve as the principal investigator. Faculty and staff teaching in multi-section courses together may file a single animal use protocol for a procedure or use in common. All involved in the project must be trained via: http://www4.uwsp.edu/special/acuc/. The principal investigator has the responsibility to submit animal use protocols to the IACUC in a timely manner that allows for thorough review and possible revision prior to initiation of the study. The principal investigator is responsible for understanding and complying with all relevant federal, state and local regulations, and for securing all required federal, state, and local licenses or permits (e.g. a Drug Enforcement Agency registration number for the use of scheduled drugs). The principal investigator is responsible for ensuring compliance with an approved IACUC animal use protocol for himself/herself and researchers, staff, and students under his/her supervision. The principal investigator shares with the IACUC the responsibility for providing adequate training for students and staff to ensure their own safety, the well-being of the animals, and compliance with the approved protocol. The IACUC can provide hands-on, online, and text-based instruction on the care and handling of many wild and domestic animals. Contact the IACUC chair for help. The principal investigator is responsible for maintaining written records documenting this compliance and for reporting departures from approved protocols. Each year, he/she should report to the IACUC on the status of each protocol and provide assurance that ongoing activities are conducted in accordance with the approved protocol. The principal investigator must request approval from the IACUC for changes to approved studies through a protocol amendment. PROTOCOL PREPARATION for IACUC REVIEW An animal use protocol approved by the IACUC is required for use of mammals, birds, reptiles and amphibians in research and teaching by UWSP faculty, staff, postdoctoral fellows, graduate or undergraduate students. IACUC approval of a protocol is required before animal use begins. Animals cannot be obtained nor studies initiated prior to IACUC approval of appropriate protocols. The principal investigator should prepare an animal use protocol using the current form obtained from the website http://www4.uwsp.edu/special/acuc/ or from the IACUC chair. An exact paper copy signed by the principal investigator and appropriate department or division head should be given to the Grant Support Office at least three days prior to a scheduled review meeting. As part of the protocol, the principal investigator must provide details about the source, number, species, and condition of animals used. For captive animals, the protocol must demonstrate compliance with the guidelines outlined in The Guide and PHS Policy, including provisions for adequate husbandry, veterinary care, and environmental enrichment. Deviations from recommendations in The Guide or PHS policy should be explained and justified. 106737150 3 Standard operating procedures (SOP) for laboratory mice, laboratory rats, fishes, and leopard frogs (Lithobates pipiens) are included in this policy and may be cited in lieu of detailed descriptions. Deviations from the SOP should be noted in the protocol. In addition to a detailed methodology, the principal investigator must also provide a justification for the use of animals. He/she must provide evidence that alternatives to animal use have been considered, including potential use of non-animal or in vitro systems, refinement of research techniques designed to decrease or eliminate pain and distress, and reduction in the number of animals required to obtain scientifically valid data or to reach desired teaching goals through improved experimental design. IACUC REVIEW OF PROTOCOLS The IACUC will meet at least twice per year for review of protocols, usually in mid-April and mid-October. The exact dates, times, and location of meetings will be communicated via email from the IACUC Chair to department heads four weeks prior to meetings. IACUC members will be provided with paper or electronic copies of protocols to review at least two weeks in advance of a review meeting. Protocols for animal use in the fall semester should be submitted in time for the spring review meeting; protocols for spring semester and early summer studies should be submitted in the fall. DEADLINES for protocol submission March 31 for IACUC review in mid-April October 31 for IACUC review in November At least five IACUC members must be present (in person) to conduct protocol reviews. Written or verbal comments from members unable to attend in person will be considered, but as committee discussion is central to the functioning of the IACUC, determinations made by the full committee may supercede those of individuals not in attendance. Non-voting guests, colleagues, and principal investigators or their representatives may be invited to attend in order to provide additional information or expertise. Principal investigators submitting protocols are welcome to participate in the portion of the meeting relevant to their study. The IACUC will endeavor to complete protocols reviews in a timely manner. Principal investigators will be notified of the IACUC decision within two weeks of the review meeting and will receive a written summary of comments and suggestions from the committee. A majority of IACUC committee members must approve, require modifications, or withhold protocols by formal vote. A submitted protocol may be tabled or postponed by the Chair if the committee requires additional information or expertise to conduct a review, or by the Principal Investigator prior to review. Scientific Merit Review In addition to considering the technical aspects of proposed animal use, the IACUC is charged with determining whether a project demonstrates scientific merit in accordance with the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, Principle II, which states, “Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.” In cases where projects involving the use of animals have been selected to receive funding from a sponsoring agency that utilizes an external, scientific peer review process, the IACUC will generally consider that the scientific merit criteria have been met. When reviewing a protocol, the IACUC has the following options: a. Provide approval or provide approval with minor changes b. Require modification(s) to secure approval c. Withhold approval d. Table or postpone approval a. If the IACUC votes to provide approval, the approved protocol will be valid for a one-year period (12 months) beginning from the date of the protocol review. Comments and suggestions from the IACUC may 106737150 4 be offered on a “good-faith” assumption that the principal investigator will incorporate suggested improvements as possible. Any minor changes, edits, or corrections requested by the IACUC should be made in a timely manner and an updated copy should be provided to the IACUC Chair. However, work under an approved protocol may begin immediately following the review and will not be delayed. Protocol approval may be renewed for two additional one-year periods with the submission of a brief request for renewal; thus an approved protocol has an “operating life” of three years. b. If the IACUC recommends substantial changes or additions to the protocol or requires additional information critical to the evaluation of the protocol, the committee may outline modifications required to secure approval. In these cases, work under the protocol may not begin until the required modifications are approved. If the committee is able to outline specific modifications required, the IACUC may vote that a full committee review of changes is not necessary. The Chair may review any resubmitted protocol to determine if IACUC-requested modifications have been made and extend approval if modifications are satisfactory. If the IACUC is unable to outline specific modifications, or its members need to consider additional information provided by the principal investigator or outside experts, a full committee review of a resubmitted protocol will be conducted. A resubmission will be given priority of review at the next review meeting, and if possible, a special meeting may be scheduled to consider a rapidly resubmitted protocol. c. If the IACUC finds that no modifications of a protocol would bring it into compliance with federal, state, or local regulations, or finds that the proposed use of animals is not scientifically justified, it will withhold approval. The principal investigator will be given opportunities to understand the components of the IACUC decision and may respond in person or in writing. The principal investigator may submit a new protocol for review at a subsequent meeting. The IACUC will consider the new protocol without prejudice. d. The principal investigator may withdraw a submitted protocol by written request prior to review by the IACUC. The IACUC may table a protocol, or postpone its review, if additional information or action is required in order to evaluate the protocol. PROTOCOL RENEWAL - years 2 & 3 of an ongoing study For IACUC-approved studies continuing for more than one year, the principal investigator must submit a brief narrative describing the outcome of the approved protocol and request renewal of approval for a second year. This request for renewal may be repeated for a third year of study. Renewal requests may be submitted electronically or in paper copy to the Chair by the appropriate deadline (March 31 or Sept 30). Renewal requests do not require the signature of the department or division chair. PROTOCOL RESUBMISSION - for work beyond the 3rd year Every three years or 36 months (that is, prior to the fourth year of study), the principal investigator in an IACUC-approved and renewed study must submit a full protocol using the most current form for de novo review. Although not specified in the regulations set forth in the Animal Welfare Act, a de novo review every three years for ongoing work is required by the National Institutes of Health, and adherence to NIH policy is a condition of many federal grant programs. Protocols submitted for fourth year of an ongoing study should follow the format for new protocols as above. The IACUC will review these triennial submissions as new and adhering to the most current regulations. Previous approval of a protocol does not guarantee its approval in subsequent de novo triennial reviews; however, the IACUC will recognize the importance of continuation in ongoing and funded studies. Approval of a protocol submitted for de novo review is for a one-year period (12 months) and renewals proceed as above. PROTOCOL AMENDMENTS If substantial changes to an approved protocol are made, the principal investigator must submit an amended protocol for review. The original protocol may be modified to highlight the proposed changes to expedite the process. The IACUC members may authorize the Chair to approve amendments without requiring a full review. Work under the amended protocol may not begin until changes have been approved: the principal investigator must follow the original protocol until approval for amendments has been offered. Amendment 106737150 5 approval does not extend the tenure of an approved protocol. An amended protocol remains on its original renewal and resubmission schedule. Examples requiring a protocol amendment: principal investigator is changed or a co-investigator is added project title is changed species used is changed to a biologically and legislatively similar species degree of invasiveness of a procedure or discomfort to an animal is changed number of animals used is increased housing or procedure location is changed husbandry techniques are changed anesthetic or analgesic agent(s), dosage, or delivery method is modified method of euthanasia is changed Some changes require the submission of a new protocol. Examples include: objectives of or justification for the study changes species of animal used changes to an unrelated species (in different genus) species of animal used changes to one under increased regulation (threatened or endangered) an invasive or painful procedure is added surgical procedures are changed from non-survival to survival, or vice-versa APPEALS IACUC decisions to withhold approval may not be overturned by higher authorities or by any UWSP administrative officials. Principal Investigators may appeal an IACUC decision in writing by providing his/her rationale for appeal. The IACUC may invite an outside expert to serve as a “hearing officer” in mediating an appeal. COMPLAINTS Complaints or concerns about the use of animals should be communicated to a member of the IACUC in any number of ways: a written note or letter, telephone call, email, anonymous tip, or conversation via a colleague or teaching staff. The person receiving a non-written complaint should document it in an email to the IACUC chair as quickly as possible. The IACUC chair will review, and if warranted, investigate concerns involving the care and use of animals at UWSP resulting from complaints received or from reports of non-compliance. If an investigation is warranted, the IACUC chair will gather the available evidence and appropriate documents and contact the necessary staff to evaluate fully the allegation. He/she may use other IACUC members or other necessary professionals as needed to help in the investigation. The IACUC chair will discuss his/her findings with the Committee to determine if the situation merits a decision from a convened IACUC meeting. The Committee may recommend that no corrective action is necessary, may direct the responsible animal user to take corrective actions, or may suspend animal use. All actions will be documented in a written report. CONFLICT OF INTEREST To avoid potential conflicts of interest, a member of the IACUC will abstain from voting on his/her protocol. An alternate member will assume duties of the IACUC chair for review of protocols submitted by the chair. If requested by any IACUC member, the committee member submitting a protocol may be excluded from that portion of the meeting involving discussion of or vote on his/her protocol. SUSPENSION OF ACTIVITY The IACUC has the obligation to suspend an activity involving animals if it does not comply with the AWAR, The Guide, PHS Policy, or the UWSP Animal Care and Use Policy. 106737150 6