Policy Author:
Chair and Committee Members: IACUC

Responsible Office-Department:
Office of the Provost

Effective Date of Policy:
Spring 2024

Purpose of this Policy

The mission of the Institutional Animal Care and Use Committee (IACUC) is to ensure the humane husbandry and use of live, non-human, vertebrate animals in research and teaching, through compliance with federal and state guidelines and regulations. The IACUC’s responsibilities and procedures follow those outlined in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals.

Definitions

Research

Research is defined as a systematic investigation, including research testing, and evaluation, designed to develop or contribute to generalizable knowledge. Faculty are required to obtain IACUC approval for these activities, regardless of where the animals are maintained and/or the project is physically carried out. However, if a project is to be conducted at a facility that has its own Animal Care and Use Committee, a copy of that committee’s approval should be submitted to the IACUC, in lieu of an institutional review at Daemen University.

Teaching

This constitutes any type of procedure that is done with live animals in a credit-bearing setting. Specifically, this refers to any procedures that would perturb the animal / its behavior.

Animal subject

The PHS policy defines animals as any life, vertebrate animal used in research, research training, or related purposes. As the recognition of pain in invertebrate species has been recognized in recent years, the Daemen University IACUC will follow guidance from the broader scientific community with regards to the species for which approval for use is deemed necessary. As such, these following guidance is subject to review.

The IACUC will not require an animal use protocol for activities involving lower level invertebrate species (e.g., brine shrimp, fruit flies, etc.). Any activities involving higher level invertebrates in the Class Cephalopoda will require an approved animal use protocol.

Many species of invertebrates are non-native and obtained from the wild. All federal, state, and local laws must be followed when obtaining and maintaining invertebrate animals on campus. All appropriate permits must be obtained prior to obtaining animals from wild sources.

IACUC approval

IACUC approval means that the IACUC  has reviewed the proposed research protocol and determined that the proposed research protocol may be conducted within the constraints set forth by the IACUC and by other institutional and federal requirements. Specifically, the research has been deemed appropriate in terms of minimizing animal risk, distress, & pain, and includes a plan for mitigating adverse events associated with the research.

Once approval has been granted, the investigator may proceed with conducting the research exactly as indicated in the approved protocol. The IACUC is responsible for assessing the proposed research in terms of institutional policy, federal and state government regulations, applicable law, and standards of ethical treatment of animal subjects.

Membership

The IACUC must consist of at least five members, who fulfill the following roles:

1. a Chairperson (‘Chair’)
2. an attending veterinarian – a Doctor of Veterinary Medicine either certified (e.g., by ACLAM, ECLAM, JCLAM, KCLAM) or with training and experience in laboratory animal science and medicine or in the use of the species at the institution (‘AV’)
3. at least one practicing scientist experienced in research involving animals (‘Scientist’)
4. at least one member from a nonscientific background, drawn from inside or outside the institution (‘Lay Member’)
5. at least one public member to represent general community interests in the proper care and use of animals (‘Nonaffiliated Member’)

Individuals who meet the requirement of more than one of these categories may fulfill more than one requirement. It is not recommended that the AV be the IACUC Chair due to real or perceived conflicts of interest. No more than three voting members shall be from the same department. The institution size and the nature & extent of the Program will determine the number of committee members & terms of appointment. For broad research Programs, multiple Scientist members from a wide range of disciplines and experience may be needed to properly evaluate animal use protocols.

Specific roles of the members

Chair: The Chair is responsible for overseeing the coordination and implementation of effective and efficient systems for protocol and program review by the IACUC in accordance with PHS policy. The Chair must be an effective leader and be knowledgeable on relevant animal care and research practices. The Chair must have the full support of the Institutional Official (“IO”) and is preferably tenured so that they may perform the functions of the position without jeopardy to career or position. The Chair should:

• Serve as a spokesperson for the IACUC
• Educate and support IACUC members, Primary Investigators (PIs), and others regarding the IACUC process
• Have regular interaction with other institutional committees, occupational health and safety, physical plant, human resources
• Stay informed of the most recent regulatory trends and interpretations
• Report any activities which have been suspended by the IACUC for non-compliance to the IO, in accordance with PHS policy.

AV: The Attending Veterinarian shall be a Doctor of Veterinary Medicine either certified (e.g., by ACLAM, ECLAM, JCLAM, KCLAM) or with training and experience in laboratory animal science and medicine. The AV should:

• Ensure that research proposals include the safe and ethical treatment of animals, that seeks to limit or eliminate discomfort and pain
• Ensure safe housing of animals (done on an at least semi-annual basis).
• Assist researchers with any questions about safety concerns or animal welfare

Scientist: The Scientist is defined as an individual who uses animals in their teaching or research activities. The scientist member should have adequate training/experience with animal models related to the IACUC protocols that will be reviewed. As such, it is advisable for scientists across a range of departments within the institution to sit on the IACUC so that a wider range of animal models can be evaluated.

Lay Member: The non-scientific, Lay Member, of the IACUC shall be an individual whose primary concerns are in a nonscientific area (for example, ethicist, lawyer, member of the clergy). This ensures the IACUC will have a diversity of perspectives, and that membership will have an individual with a neutral attitude with regard to science and scientific activities.

Nonaffiliated Member: The non-affiliated member (also referred to as the Public Member) shall be an individual who is not otherwise affiliated with the University, and who is not part of the immediate family of a person affiliated with the University. Immediate family includes parent, partner, child, and sibling. The person chosen should provide representation for general community interests in the proper care and treatment of animals.

Voting Members

Voting members of the IACUC will include the Chair, AV, Scientist, Lay Member, and Nonaffiliate members. Regular members shall have voting rights on the IACUC; if a voting member is unable to attend an IACUC meeting, site inspection, or some other duty, an alternate may attend in their stead (see below for qualifications and restrictions on alternate members).

Alternate Members

An alternate may be appointed to the IACUC for the AV, Scientist, Lay Member or Non-affiliate members, as long as they are appointed by the IO or other official with authority to appoint members, and there is a specific one-to-one designation of IACUC members and alternates.  An alternate member does not have voting rights, but is welcome and encouraged to attend IACUC meetings. In the event that a voting member is unable to attend a meeting or some other duty, the alternate member may represent that role in the voting member’s stead. In this capacity, the alternate member would have voting rights (if needed).  An IACUC member and their alternate may not count toward a quorum at the same time or act in an official member capacity at the same time. Alternates should receive training similar or identical to the training provided to regular IACUC members. Notes regarding the appointment of alternate members:

• the alternate member must fulfill all of the requirements of the role for which they are an alternate.
• once appointed an alternate, the alternate member must be designated as 1-1 for a specific voting member. It is however possible for an alternate to be a designated alternate for two voting members (e.g., two voting Scientist members). In this case, if both voting members are absent, then the alternate may only take the place of one of the voting members.
• more than one alternate member may be appointed to a voting member. It would follow the following scenario: Dr A is a voting member for the Scientist role. Dr B has been appointed an alternate to Dr A. Dr C is also an alternate; they will be an alternate to Dr B. This alleviates any concerns in designating an appropriate alternate in the event of an absence by a voting member.

Meetings

The full IACUC shall meet once per month during the Fall and Spring semesters to review new animal protocols, protocol renewals, and other pertinent business.

Following the semiannual Program Reviews and Facility Inspections, a written report shall be compiled and provided to the IO about the status of the Research Program. Shortly thereafter (no later than 1-month following the written report was provided to the IO), the AV, IACUC Chair, and the IO shall meet to review the status of the Research Program, and any recommendations.

Meetings may be held in person, virtual, or hybrid, depending on the needs of the members & institution. Meeting dates will be scheduled prior to the start of the relevant semester; that is, Fall semester meeting schedules would be created in the summer & Spring semester meetings would be created in the winter term. Prior to creating the schedule, committee members will be queried by email for schedule conflicts. Final schedules will be posted to the Daemen IACUC website. Emergency meetings may be scheduled as needed.

Criteria for approval

The animal use protocol is a detailed description of the proposed use of laboratory animals. The following topics should be considered in the preparation of the protocol by the primary investigator/course instructor, and its review by the IACUC:

• rationale and purpose of the proposed use of animals
• a clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee
• availability or appropriateness of the use of less invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation
• justification of the species and number of animals proposed; whenever possible, the number of animals and experimental group sizes should be statistically justified (e.g., provision of a power analysis)
• unnecessary duplication of experiments
• nonstandard housing and husbandry requirements
• impact of the proposed procedures on the animals’ well-being
• appropriate sedation, analgesia, and anesthesia (indices of pain or invasiveness might aid in the preparation and review of protocols)
• conduct of surgical procedures, including multiple operative procedures
• postprocedural care and observation (e.g., inclusion of post-treatment or postsurgical animal assessment forms)
• description and rationale for anticipated or selected endpoints
• criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated
• method of euthanasia or disposition of animals, including planning for care of long-lived species after study completion
• adequacy of training and experience of personnel in the procedures used, and roles and responsibilities of the personnel involved
• use of hazardous materials and provision of a safe working environment.

Scope and Applicability of this Policy: Members of the Daemen community (e.g., faculty, staff, students) using vertebrate animals in teaching and/or research.

Proposed Procedures for Policy Implementation:

Procedures

Types of review

The IACUC oversees the specific use of animals by formally reviewing animal use protocols and granting approval prior to the work commencing. The two valid methods of protocol review are either full committee review (FCR) or designated member review (DMR).

Full committee review

FCR may only be conducted at a convened meeting with a quorum (simple majority) of members present. A majority vote of the quorum present is needed to approve, require modifications in (to secure approval), or withhold approval of a protocol. When substantive modifications are required in a protocol to secure approval, the resubmitted protocol must be reviewed using either FCR or DMR.

Designated member review

DMR may occur only after all IACUC members have been provided with a list of the protocols to be reviewed and have an opportunity to call for FCR. If FCR is not requested, at least one member of the IACUC qualified to conduct the review is designated by the Chair. DMR may result in approval, require modifications in (to secure approval), or request FCR. DMR may not result in disapproval.

Modifications to previously approved protocols

In some cases, research that is approved by the IACUC may require some additional modifications by the researcher/instructor.

Minor modifications / changes

If the modifications are substantial, the amendment must be reviewed by the IACUC for approval. Such situations may include but are not limited to:

• increasing the number of animals used
• adding new procedures (including surgical & non-surgical procedures)
• adding new personnel to the protocol
• the use of new chemical or biological agents with live animals
• a change to animal husbandry (including housing & feeding)

If the PI is unsure as to whether the changes require an amendment, they are advised to speak with the IACUC Chair for further clarification.

Significant modifications / changes

If the modifications go beyond a minor modification, such as changing the objective of the project, it is recommended that a new protocol proposal be submitted.

Disapproval

If the IACUC decides to disapprove a proposal, written notification and an explanation of the reasons for the decision will be provided to the investigator/instructor along with an opportunity to respond in writing or in-person at the next scheduled IACUC meeting. They may also make changes to the protocol and resubmit for a new review.

Ongoing research & monitoring

Approved protocols expire 3-years after the approval date. The use of animals after the expiration date is strictly forbidden. If an investigator / instructor wishes to continue their work with animals, they may submit a protocol renewal application, which also includes a summary of the research project’s progress & plans. The protocol renewal serves as an opportunity for the IACUC to review the procedures and data produced within the previous 3-year span.

The protocol renewal should be submitted no later than 3-months prior to the anticipated expiration date, to allow adequate time for the IACUC to review the application and for the PI to provide any required modifications to the protocol.  Protocol renewals are effective for 3-years beginning on the renewal date.

Monitoring of animal care and use is required by the PHS Policy. The IACUC will conduct semi-annual reviews of animal housing/use facilities to ensure safe & humane use. Methods for continuing review include:

• laboratory inspections (conducted either during regular facilities inspections or separately);
• veterinary or IACUC observation of selected procedures;
• observation of animals by animal care, veterinary, and IACUC staff and members;
• external regulatory inspections and assessments.

Animal procurement & husbandry

All animals must be acquired lawfully and appropriate paperwork should be provided to the IACUC. Prior to acquisition there should be adequate housing facilities and appropriately trained animal caretakers. Every effort should be made to acquire purpose-bred animals for consistency for research and teaching. Generally, animals meant for scientific use should not be obtained from pet stores or pet distributors due to unknown health status and potential for introduction of health risks to personnel and other facility animals.

Animal Housing

All animals used in research or teaching on the main Amherst campus of Daemen University are expected to be housed in appropriate facilities. Housing is defined as anytime an animal is kept in a location more than 12 consecutive hours. Appropriate facilities have enough space for the animals to make normal postural adjustments (e.g. the animal should be able to completely rotate without touching the sides of the enclosure), and maintain ambient conditions (temperature, day-night cycles, etc.) suitable for the species in question. All animal housing facilities must be set up under the supervision of the PI, as close to the research/teaching location as is practically possible, and must be approved by the Attending Veterinarian before use.

For aquatic organisms, standards for acceptable water quality, appropriate parameters to test, and testing frequency, should be developed by the PI and approved by the Attending Veterinarian based on species-specifications . A biofilter of sufficient size should be used to process nitrogenous waste entering the system, with a flow rate that minimally turns over the water volume twice per hour. A written record of water testing, as approved by the Attending Veterinarian, should be maintained and made available to the IACUC upon request.

Exceptions to these housing requirements will be considered by the IACUC on a case-by-case basis.

Acclimation

All research animals housed at Daemen University will have a minimum acclimation period of 72 hours, prior to use in research or teaching. PI’s need to build this time into their experiments and as they order laboratory animals to be shipped. If the animals are received for a terminal procedure, there is no requirement for an acclimation period. If researchers require an exemption to this standard 72 hour acclimation period, they may request it in their initial protocol, giving a valid reason for the exemption.  The Attending Veterinarian may grant an exemption after a protocol is approved on an individual emergency basis.

Environmental Enrichment

The provision of environmental enrichment to all species of animals used in research and teaching at Daemen is suggested, and  is required by the Animal Welfare Act for some species. PI’s housing laboratory animals should consult with the Attending Veterinarian to determine the most appropriate form of enrichment for the species with which they are working. Common enrichments for various species can be found at www.nal.usda.gov/awic/environmental-enrichment

Environmental enrichment includes additions to an animal’s environment that enhance its wellbeing, by allowing it to express species-typical behaviors. Environmental enrichment should provide appropriate housing, care, activities, and social interaction to promote the well-being of research animals, while not compromising personnel safety, animal health and safety, or the goals of the research. Because animals may become accustomed and indifferent to the enrichments provided, enrichment devices should be rotated to encourage curiosity and discourage negative behaviors. The following criteria should be considered when evaluating items to be used for environmental enrichment:

• Species of animal and its needs, abilities, and habits 
• Type of enrichment device (treat, toy, or exercise)
• Ability of device to stimulate the animal 
• Safety of the device (likelihood of injuring the animal) 
• Ability to clean and sanitize the device 
• Nature of the research being done (the enrichment does not hinder or alter research findings)

The PI must justify an exception from use of standard environmental enrichment in their IACUC protocol. The exception must be approved by the IACUC prior to withholding enrichment from animals on the protocol.

Animal Husbandry

To avoid damage to the protective mucous layers and/or skin, handling of animals should be kept to the minimum required, and appropriate handling techniques should be identified by the PI.  

Records should be kept concerning feeding regimes to ensure sustenance of nutritional profile. Food should be stored in a type-appropriate manner to preserve nutritional content, minimize contamination, and prevent entry of pests. Storage time of commercial diets should be based on manufacturer recommendations or commonly accepted practices; in general, the researcher should know the date of manufacture and be aware of factors that impact the food’s shelf life, to avoid using expired food.

Some semi-aquatic animals may need bowls or containers of water for soaking and drinking, and water quality should be species appropriate.

Appropriate emergency response plans should be developed to address major system failures (e.g. loss of power), and must be submitted to the IACUC to be kept on file. 

Euthanasia of sick/injured animals; planned euthanasia

Euthanasia is the act of humanely killing animals by methods that induce rapid unconsciousness and death without pain or distress. The AVMA Guidelines for the euthanasia of animals (2020 edition or most up to date version) should be consulted for species-specific information. Planned euthanasia and methods of euthanasia will need to be reviewed by the IACUC and AV. A protocol for emergency euthanasia for sick/injured animals should be a part of every protocol submitted to the IACUC for review. 

Policy violations and consequences

Reporting procedures:

Any individual who is concerned about animal use in a specific class or research project should first discuss their concerns with the designated animal caretaker, or Principal Investigator (PI) in charge of the animals.

If the concern is not addressed adequately, or there is fear of retribution for expressing a concern directly to the caretaker or PI, the individual is encouraged to report through one of the following routes:

Attending Veterinarian, iacuc@daemen.edu

IACUC Chair, iacuc@daemen.edu, or 716-839-7327

Office of Academic Affairs, (716) 839-8227 

Signs containing the mechanism for reporting concerns must be posted in all animal housing facilities, and all procedure locations.

Any individual who, in good faith, reports an animal welfare concern will be protected against reprisals.

How concerns are handled / Suspension of Animal Activities

Concerns must be handled in a confidential or anonymous manner if requested by the reporting individual. The IACUC Chair and the Attending Veterinarian (AV) will investigate each reported concern, as soon as possible; if the report concerns a project with which the IACUC Chair is involved, an alternative IACUC member must replace the Chair for these investigations.

The Chair and the AV, in consultation with any individual(s) they deem necessary, will investigate all concerns that were raised, and evaluate the need for action on each concern. The Chair and AV are authorized to take immediate action to improve the welfare of the animals, should their investigation suggest that such action is needed; if remedial action is needed, but not immediately, The Chair and AV must specify both action(s) required, and a timeline, to the PI.

Upon conclusion of the investigations, a written report must be prepared by the IACUC Chair and submitted to the IACUC, the PI responsible for the animals, the Office of Academic Affairs, and the individual who initially reported the concern(s); this report must specifically address the validity of all reported concerns, and details of any remedial action that was required.

If any reported concerns were validated by the investigation, the PI will receive a written warning  from the IACUC, valid for 3 years. Should a PI receive 2 or more such warnings over the same 3 year period, all protocols involving that person, in any capacity, must cease any current use of animals in research and teaching. Additionally,  no further use of animals in research and teaching involving that person (new protocols or renewals) will be approved by the IACUC until 3 years after the second written warning.