2.22 Assurance of Compliance with Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals

Ithaca College, hereinafter referred to as Institution, hereby gives assurance that it will comply with the NIH Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as "PHS Policy."

2.22.1 Applicability of Assurance

This Assurance applies whenever this Institution conducts the following activities: all research, research training, experimentation, biological testing, and related activities involving live vertebrate animals supported by the PHS, NSF and/or NASA. This Assurance covers only those facilities and components listed below.

A. The following are branches and components over which this Institution has legal authority, included are those that operate under a different name: Ithaca College.

B. The following are other institution(s), or branches and components of another institution: Not applicable

2.22.2 Institutional Commitment

A. This Institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.

B. This Institution is guided by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training.”

C. This Institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance. As partial fulfillment of this responsibility, this Institution will ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance, and other applicable laws and regulations pertaining to animal care and use.

D. This institution has established and will maintain a program for activities involving animals in accordance with the “Guide for the Care and Use of Laboratory Animals” (Guide).

E. This Institution agrees to ensure that all performance sites engaged in activities involving live vertebrate animals under consortium (subaward) or subcontract agreements have an Animal Welfare Assurance and that the activities have Institutional Animal Care and Use Committee (IACUC) approval.

2.22.3 Institutional Program for Animal Care and Use

A. The lines of authority and responsibility for administering the program and ensuring compliance with the PHS Policy are as follows:

The Provost of the College is our Institutional Official. The Provost appoints the IACUC Chair. The Director of Sponsored Research in the Provost's Office, who reports to the Provost, is delegated to oversee the routine administration supporting IACUC activities. The Veterinarian is contracted through Sponsored Research. Both IACUC Chair and the Veterinarian have direct access to the Provost. If they feel it is necessary, any member of the IACUC can communicate directly to the Provost, but typically the IACUC Chair reports to the Provost on the committee's behalf.

B. The qualifications, authority, and percent of time contributed by veterinarian(s) who will participate in the program are as follows:

Name: Glenn Jackson, DVM, PhD
- Qualifications:
  - Degrees: BS, Animal Science, 2002, Brigham Young University
  - DVM, 2006, University of California, Davis, with focus laboratory animal medicine
  - PhD, Veterinary Pathobiology, 2012, University of Missouri, Columbia
  - Additional certification: ACLAM diplomat
- Training and Expertise: Dr. Jackson completed a comparative medicine residency, and has spent 1 year of general practice in a mixed animal clinic. For 3 years at a veterinary technician school he provided technical training in procedural techniques of large, small, and exotic animal medicine. He has provided clinical care, regulatory oversight, and staff training for animal research at a large research university for 3.5 years.
- Authority: Dr. Jackson has direct program authority and responsibility for the Institution's animal care and use program including access to all animals.

Dr. Jackson provides expert direction for the overall supervision of the laboratory animals at Ithaca College. He has delegated the normal day-to-day maintenance of the animals to the animal caretaker, who is regularly supervised by the IACUC chair. Ms. Laura Bechtler, Animal Care Technician, has assigned responsibility for the daily animal care and use and facility management in the absence of the veterinarian.

Dr. Jackson conducts regularly scheduled visits (at least 2 per year) and unscheduled visits (at least 2 per year) to the animal facilities in addition to serving as a member of IACUC. Dr. Jackson notifies the IACUC chair in the event of any discrepancies from normal policy of animal husbandry and care. It is the chair's responsibility to assure expeditious remedy of the situation. Dr. Jackson retains the prerogative of ordering or personally undertaking the necessary actions to ensure that no animal undergoes inhumane treatment or suffering. It is estimated that he devotes 2% of his time to these tasks.

The animal facilities are inspected at least once a year by a veterinary professional employed by New York State. These are unannounced visits. Copies of the results of these inspections are provided for the IACUC chair and Dr. Jackson.

In the case where veterinary assistance is needed and Dr. Jackson is unavailable, back up veterinary care will be provided by the Cornell University Animal Hospital. This hospital is equipped to handle emergencies for a wide array of species and is staffed 24 hrs. a day by a team of licensed veterinarians covering a broad array of medical specialties. The veterinarian team at Cornell University Hospital is led by Dr. Lorin Warnick, DVM, PhD. Dr. Warnick has been a faculty member at Cornell since 1996, having worked as a large animal clinical epidemiologist, as Associate Dean for Veterinary Education, and is now Dean of Veterinary Medicine. He received his veterinary degree from Colorado State University in 1988, a PhD from Cornell University in 1994 and is board certified by the American College of Veterinary Preventive Medicine.

In addition, the services of the Diagnostic Center at the Cornell University Veterinary School are readily available. This service can be utilized for necropsy interpretation and advice on special problems.

C. The IACUC at this Institution is properly appointed according to PHS Policy IV.A.3.a and is qualified through the experience and expertise of its members to oversee the Institution’s animal care and use program and facilities. The IACUC consists of at least 5 members, and its membership meets the composition requirements of PHS Policy, Section IV.A.3.b

D. The IACUC will:

(1) Review at least once every 6 months the Institution's program for humane care and use of animals, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual program reviews are as follows:

The IACUC meets and reviews the college's program three times a year at routine intervals to ensure that review occurs inside every six months. Facility inspection is also conducted at each of these times. The IACUC reviews the college’s program using the “Semiannual Program Review Checklist” https://olaw.nih.gov/resources/documents/cheklist.htm  This checklist will be included in the semiannual report signed by all present IACUC members.
Any changes or modifications to the existing Occupational Health and Safety protocols, Veterinary Care Program, Assurance, Training programs or changes to The Guide will also be discussed and approved by all present IACUC members, with details included in the semiannual report.
The list of ongoing animal research protocols with their summary information will be reviewed as part of the program review. The principal investigator or a designated representative will answer any questions regarding these activities.
At this meeting, the chair, veterinarian, or IACUC members might bring up additional animal welfare or safety issues that might need to be addressed.
All IACUC members are invited to attend the meeting and inspection.

(2) Inspect at least once every 6 months all of the Institution's animal facilities, including satellite facilities and animal surgical sites, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual facility inspections are as follows:

In addition to its program evaluation, in conjunction with regular meetings at least three times a year, the IACUC includes an announced facility inspection of all rooms in which animals are housed. These three inspections are spaced to ensure that facilities are inspected within every six months. As we do not have extensive facilities, all facilities are inspected together.
All committee members are invited to inspect all animal housing facilities, including USDA covered species. The animal care staff and at least two voting members of the IACUC participate in inspections. Under the Program of Veterinary Care, the veterinarian inspects the facilities more often than the semi-annual requirement, and may participate in the semi-annual inspection as a subset of their visits. Any concerns during the inspection are noted and corrected under the guidance of the chair. The members will use the Facility Review Checklist (https://olaw.nih.gov/resources/documents/cheklist.htm) to guide the inspection.

(3) Prepare reports of the IACUC evaluations according to PHS Policy IV.B.3. and submit the reports to the Institutional Official. The IACUC procedures for developing reports and submitting them to the Institutional Official are as follows:

Minutes of the IACUC meetings and inspections are submitted semi-annually, including any minority opinions. A list of all approved protocols is also included and submitted by the IACUC chair to the Institutional Official.
The semiannual report to the IO will include a description of the nature and extent of this Institution’s adherence to the Guide, and any departures from the Guide will be identified specifically and reasons for each departure will be stated and reported to the IO for each six month reporting period during which the IACUC approved departure is in place.
Deficiencies noted will be distinguished as minor (not directly affecting animal health or safety) or significant (directly affecting animal health or safety). In consultation with the IACUC chair and veterinarian, the IACUC will create a reasonable plan and schedule for correcting each deficiency (using the Semiannual Program Review and Facility Inspection Report). The IACUC will then determine if the deficiency has been corrected by the set deadline and will pass this information on to the chair. The chair will report this information (as a memorandum or at the next meeting) to the committee and to the Institutional Officer.
Any minority views will be included with the report. If there are no minority views, that fact will be stated.
The report will be signed by a majority of the IACUC members.

(4) Review concerns involving the care and use of animals at the Institution. The IACUC procedures for reviewing concerns are as follows:

Individual concerns about animal care can be submitted to any member of the IACUC committee. All concerns are presented to the chair, who discusses them with the veterinarian, if necessary, the animal caretakers, and the principal investigator using the animals. Should the IACUC chair be the principal investigator whose research is of concern, the Institutional Official will designate an alternative person to lead investigation and IACUC oversight of the matter. If deemed necessary by the chair, a meeting of the IACUC can be called to discuss the concerns. Any necessary changes in animal care or use can be mandated by the IACUC, with no reprisals to the reporting individual. The IACUC shall provide every animal facility manager and principal investigators with a notice describing how to report concerns regarding animal care. This information shall also be posted in a visible location and will be maintained on the website. In addition, the Ithaca College Whistle Blower Policy (Section 2.34 – Ethics and Integrity) states that complaints may be made anonymously. Complaints shall be dealt with confidentially to the extent reasonably possible. No member of the College is subject to any reprisal for reporting any suspected violations. The chair will report the concerns and the actions chosen by the IACUC to address these concerns to the Institutional Official.

(5) Make written recommendations to the Institutional Official regarding any aspect of the Institution's animal program, facilities, or personnel training. The procedures for making recommendations to the Institutional Official are as follows:

The IACUC chair will submit written recommendations, as approved by the IACUC, to the Institutional Official regarding changes in the animal care procedures, facilities, or personnel training.

(6) Review and approve, require modifications in (to secure approval), or withhold approval of those PHS-supported activities related to the care and use of animals according to PHS Policy IV.C.1-3. The IACUC procedures for protocol review are as follows: Externally funded protocols, unfunded research protocols and protocols for teaching laboratories will be reviewed by the full committee at least once every 3 years according to PHS Policy IV.C. 1.-5

Animal protocols involving live vertebrate animals are submitted electronically by the principal investigator to the chair of the IACUC at least 2 weeks prior to the scheduled IACUC review. These protocols include a project description (suitable for non-scientists), a statement of the purpose of the project, a rationale for the use of animals and the number of animals used, an explanation of why a non-living model is not appropriate, certification that this project does not duplicate previous studies, a description of how the animals will be used and cared for and what means are taken to insure a minimum of discomfort and suffering of the animals, and how the animals will be disposed of at the end of the study. Protocols also include precautions for human safety. All IACUC committee members have access to the protocols online at a shared secure site at least five (5) business days prior to the full committee review.
Full committee review occurs during a convened meeting of a quorum of the IACUC members, and with a formal vote. The meeting may be convened in person or virtually. The Committee then votes on protocol approval at the meeting, with result determined by a majority vote of the present quorum. Full IACUC review may result in: (1) approval, (2) require modifications to secure approval, or (3) rejection. Any minority opinions are recorded in the minutes and included in report to the Institutional Official. IACUC decisions are made in writing to the principal investigator. For protocols requiring revision, principal investigators are given two (2) weeks to make the necessary changes.
When a protocol has been approved, the IACUC chair will notify the principal investigator in writing. Animal work will not be permitted to begin or resume until final approval is granted. All approval letters also inform the principal investigator that they must inform the IACUC and receive approval of any changes in protocol from that approved by the committee.
No member may participate in the IACUC review or approval of a protocol in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum. When a member has a conflicting interest, quorum must be maintained at the convened meeting. If quorum is not maintained, the protocol will be reviewed at the next convened meeting where quorum is maintained. Members unable to attend will submit their comments in writing to the chair prior to the meeting.
The IACUC has a written policy, which is reviewed and agreed to by all members whenever IACUC membership changes, on the use of Designated Member Review for both subsequent to FCR (for revisions) and as an alternative to FCR (for off-cycle new or significant changes). The policy is as follows.
For protocols requiring revisions, the Committee may vote to allow the revised protocol to be reviewed, and approved, using the Designated Member Review process. Approval of the change from FCR to DMR must be unanimous of the present quorum and is recorded in the minutes. Committee members are given the opportunity to require that the requested modification(s) be brought before the next committee meeting.
Designated Member Review may also be used as an alternative to Full Committee Review if a new protocol or proposed significant changes to a protocol are requested off-cycle to scheduled IACUC meetings. In this case, each IACUC member must be provided with a copy of the protocol and are given a five (5)-business day member consideration period to review the protocol document and respond either allowing the DMR to review the protocol or to hold the protocol for the next FCR. Members are reminded that failure to respond within the member consideration period is considered as approval to use DMR for review. These responses are sent to the IACUC coordinator via email. The IACUC coordinator tallies the votes to ensure that more than half of the voting members respond, then at the end of the member consideration period, the IACUC coordinator sends the protocol to DMR for review. If any one member votes to hold the protocol until the next IACUC meeting, then the protocol is placed on the agenda for the next IACUC meeting. If all members vote to allow the DMR to review the protocol before the end of the member consideration period, then the IACUC coordinator sends the protocol to DMR for review.
In DMR, the IACUC Chair designates one or more qualified members to review the proposal (or proposed amendment or renewal). These designated member(s) have authority to approve, require modifications in (to secure approval), or request full committee review. A designated reviewer may not withhold approval; this action may only be taken if the review is conducted using the full committee method of review.
For designated review three outcomes are possible: 1) The protocol is unanimously approved by the designated reviewers. 2) The protocol requires additional modifications that are unanimously agreed upon by the designated reviewers. If the designated reviewers require additional modifications, the concerns will be relayed in writing to the principal investigator who may then make the protocol adjustments and submit the amended protocol for the designated reviewers’ unanimous approval. All IACUC members are informed of such modification requests. At this time, any IACUC member may request a full review. 3) The protocol is referred to full committee review. If referred to full committee, a convened meeting will be called to review and approve as described above.

(7) Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities according to PHS Policy IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are as follows:

Proposed changes to ongoing activities are submitted electronically to the IACUC by the principal investigator. All committee members have the opportunity to review the proposed changes, but unless any member calls for full review, designated review will be used following the procedures outlined previously. If full committee review is requested then that would also follow the procedures outlined previously.

(8) Notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval according to PHS Policy IV.C.4. The IACUC procedures to notify investigators and the Institution of its decisions regarding protocol review are as follows:

The chair of the IACUC informs all investigators of the decisions regarding submitted protocols in writing immediately after the IACUC meeting. All investigators with protocols not approved by the IACUC are notified in writing as to the reasons for rejections. The investigator may either resubmit a revised protocol for consideration or petition (either the IACUC chair or IO) to meet with the full committee if the proposed changes would seriously impact the research goals. A summary of all protocol decisions is forwarded to the Institutional Official.

(9) Conduct continuing review of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review at least once every 3 years according to PHS Policy IV.C.1.-5. The IACUC procedures for conducting continuing reviews are as follows:

At each meeting (at least 3 times annually), IACUC members will be provided the list of active protocols, and they are free to ask questions of the principal investigators (or a designated representative). A complete review of each existing animal protocol by the IACUC will be required on a three-year basis. This review requires a formal protocol renewal of the original approved protocol. This protocol will undergo the same evaluation as a new or revised proposal as previously described; it may be submitted to Full Committee Review at a regular IACUC meeting or if submitted off-cycle it may be sent to Designated Member Review following the DMR policy described above. Renewal protocols may be submitted by the Principal Investigator prior to the expiration of the existing protocol, or after the expiration of the existing protocol. If the existing protocol expires, the PI cannot continue activities until after a renewal has been approved.

(10) Be authorized to suspend an activity involving animals according to PHS Policy at IV.C.6. The IACUC procedure for suspending an ongoing activity is as follows:

If necessary, the IACUC can suspend an ongoing activity. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present. If the IACUC suspends a previously approved activity, the Institutional Official (IO) in consultation with the IACUC shall review the reasons for the suspension, take appropriate corrective action, and report that action with a full explanation to OLAW. The investigator, all members of the IACUC, the Institutional Official, and the OLAW are notified of the suspension. The animal use cannot be resumed until 1) the IACUC agrees by majority vote of present quorum that there is satisfactory evidence that the corrective actions recommended by the IO and the IACUC have been implemented and 2) the protocol is re-reviewed and approved by Full Committee Review. Suspended protocols are not eligible for Designated Member Review.

E. The risk-based occupational health and safety program for personnel working in laboratory animal facilities and personnel who have frequent contact with animals is as follows:

The Ithaca College Office of Environmental Health and Safety (EHS) is responsible for planning and monitoring the occupational health and safety program. An EHS officer sits on the IACUC committee to help coordinate between these entities as well as with the Institutional BioSafety Committee.

Each research project involving animals will have a Hazard and Risk Assessment completed identifying applicable hazards (inherent danger) and risk (likelihood and seriousness). The Hazard and Risk Assessment will be submitted with the IACUC protocol proposal. The protocols are evaluated by the IACUC with input from the veterinarian, as well as physician consultation if needed. In addition, the IACUC looks to identify hazards (actual and potential) during the program reviews and facility inspections. Hazards include:

Physical hazards (Bites, sprains, scratches, sharps, machinery, slips, falls)
Chemical Hazards (Burns, skin irritations, inhalation, ingestion, absorption)
Zoonosis (Human diseases acquired from animals)
Allergens (Allergies to animals including urine, contaminated litter, dander, hair)
Ergonomics (Heavy lifting, repetitive motion, body mechanics, posture)
Infectious Agents (Bacteria, fungi, parasites, protozoa, rickettsia, viruses, blood-borne pathogens, etc.)

Some research programs have specific hazards and risks above those generally associated with laboratory animal care and use, and increased evaluation and oversight are established for these. Additional safety protocols, including training and potential requirements (for example, negative TB tests required for field research on primates) are established in the associated IACUC protocols and project Hazard and Risk Assessment. Project Hazard and Risk Assessments are then used to inform medical professionals as they screen personnel for individual evaluation.

All faculty, staff, and students involved in animal care or use have a screening via a Medical Health Questionnaire before their work with animals may begin. At the time of the screening, they are provided with information on hazards, risks, and prevention (personal hygiene and accident prevention) associated with animal care and use. The health screening questionnaire helps identify additional risks of an individual basis.

The questionnaire is reviewed by medical professionals in the Ithaca College Hammond Health Center. They will either approve the person for work, or indicate that a follow-up physical examination is needed. The individual may choose to then visit their own personal health care provider. Faculty or full-time staff may alternatively be referred to a local clinic such as Guthrie Clinic, and students may visit the Hammond Health Center. The consulted professional will submit a written evaluation either that the person is cleared for animal work, the person is cleared for animal work with specific restrictions (for example, mask required during animal work), or that the person is not cleared at this time. Required accommodations will be arranged by Environmental Health and Safety (e.g. provision of additional PPE) or coordinated between EHS and the Office of Human Resources as needed.

Completion of the health history risk assessment and clearance by the health professional are required for participation in animal care and use, and cannot be declined. Faculty or student researchers who are not cleared will have to seek alternative research opportunities; staff (full-time or student part-time) who are not cleared will not be hired to this responsibility. If necessary, Office of Human Resources will work with an employee for alternative job responsibilities.

Individuals are advised that should their relevant personal health circumstances change they are responsible for re-evaluation. They are particularly advised to seek medical advice if they are working with animals and are (or planning to become) pregnant, have an illness, are immunosuppressed, or experience changes in their allergies. If the animal research programs change to create new hazards (for example a colony of a new species with different zoonoses is established), all affected personnel will be asked to submit an updated health history screen. \

Further, the college recommends for all students and employees to have routine physicals and keep up-to-date tetanus vaccination. The college will facilitate tetanus vaccination for all animal care and use personnel. Students can obtain the vaccination through the Hammond Health Center, and the college will help connect faculty and staff to vaccine access either through their personal health care provider, another local health care provider, or a local pharmacy.

The facilities are secure and no other personnel normally enter the area; housekeeping is done by the animal care staff. Other college staff who may need to enter the area, such as maintenance and public safety, receive hazard training from EHS at the time of employment.

Ithaca College Office of Environmental Health and Safety also holds programs on laboratory safety, fire safety and hazardous materials safety, which all personnel are required to attend yearly. The program is based on hazard identification, risk assessment, and developing and implementing measures to minimize identified hazards and risks. Protective equipment (lab coats, gloves, masks, etc.) is provided as needed by Environmental Health and Safety. The principal investigators and full-time care staff will work individually with EHS to be trained in any additional specific safety measures associated with a specific research project. The project investigators will then provide this training to student researchers on the project, and the full-time animal care staff will train student animal care workers. Resources on occupational health and safety are kept in CNS 131 and regular review is required of animal care staff. Safety Data Sheets (SDS’s) are available through Velocity EHS at the link on the EHS webpage, or at the following link

https://chemmanagement.ehs.com/9/ddabfa32-f76c-425e-95dd-639931b9ab67

or for mobile devices using the QR code in each lab. The Ithaca College Biosafety Committee is responsible for overseeing research with biohazardous agents, working with principal investigators to identify and train in appropriate safety protocols.

Injuries or illness requiring more than first-aid procedures may require immediate response by Campus Safety officers and are cared for by the Cayuga Medical Center Emergency Room or the employee’s primary health care provider. Any injurious accident or any disease suspected of being employment related is to be reported in writing, within 24 hours, to the Ithaca College Office of Human Resources and the IACUC Chair.

F. The total gross number of square feet in each animal facility (including each satellite facility):

Center for Natural Sciences Suites Total Sq.Ft 2178

Williams Lab Total Sq. Ft 100

G. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is as follows:

All personnel involved in animal care and use must undergo training with the animal caretaker or a trained principal investigator or provide certification of previous training prior to animal use.

Principal investigators, student researchers, full-time animal care staff, and student animal care workers in the animal care facility are all required to complete the CITI Training course on Working with the IACUC. This course includes the module "Planning Research and Completing the Protocol Form" which covers the "3 Rs", minimizing the number of animals required to obtain valid results, and minimizing animal pain and distress. CITI training must be renewed every three years. Faculty and student researchers are also required to complete CITI courses on working with their relevant species. The full-time animal care staff complete CITI courses on working with all species under their care, and are responsible for training student part-time workers in the animal care facility on recognition of species-specific signs of pain and distress.

In addition, principal investigators must provide sufficient proof of qualifications for animal use to the chair of the IACUC and the veterinarian (for invasive procedures) prior to beginning animal use. Any investigator lacking sufficient qualifications will be provided with appropriate training from the animal caretaker and/or veterinarian as needed. When necessary, faculty and the IACUC chair can consult with experts at nearby Cornell Veterinary Medical School, or arrange training from other expert colleagues. The principal investigator then gives hands-on training to their student researchers after the students have completed their CITI modules.

The full-time animal care technician sits on the IACUC committee and also receives additional materials and CITI training described below. Should they not have appropriate qualifications for care and handling of species that are to be brought under their care, they will receive training from the principal investigator, the veterinarian, or experts at nearby Cornell Veterinary Medical School. Animal care staff are eligible for professional development grant support from the college for relevant additional training opportunities (such as workshops, courses, or conferences) on animal care. The full-time animal care technician gives hands-on training to student workers in the care and handling of the animals.

Documentation of all individuals certified for animal use will be maintained with the IACUC records.

IACUC Member Training includes:

IACUC members are provided with the following materials: the PHS Policy on Humane Care and Use of Laboratory Animals, 2015; the Guide for the Care and Use of Laboratory Animals, 8th Edition; the ARENA/OLAW IACUC Guidebook, 2nd Edition; and the brochure titled What Investigators Need to Know About the Use of Animals. They are particularly expected to review the IACUC Guidebook section C2 on Protocol Review Criteria which discusses the three Rs, minimizing the number of animals required to obtain valid results, and minimizing animal pain and distress.

They are also notified of training opportunities (such as IACUC 101 courses) by the IACUC chair and are required to take the following training:

Initial Training – All IACUC members must complete CITI training on the Essentials of IACUC. Training includes an overview of applicable federal government regulations.

Continuing Education – For members who have previously completed the Essentials of IACUC training from CITI, training will need to be renewed every three years.

2.22.4 Institutional Program Evaluation and Accreditation

All of this Institution’s programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC within the past 6 months and will be re-evaluated by the IACUC at least once every 6 months according to PHS Policy IV.B.1-2. Reports have been and will continue to be prepared according to PHS Policy IV.B.3. All IACUC semiannual reports will include a description of the nature and extent of this Institution’s adherence to the PHS Policy and the Guide. Any departures from the Guide will be identified specifically and reasons for each departure will be stated. Reports will distinguish significant deficiencies from minor deficiencies. Where program or facility deficiencies are noted, reports will contain a reasonable and specific plan and schedule for correcting each deficiency. Semiannual reports of the IACUC’s evaluations will be submitted to the Institutional Official. Semiannual reports of the IACUC’s evaluations will be maintained by this Institution and made available to OLAW upon request.

This Institution is Category Two (2) – not accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC). As noted above, reports of the IACUC’s semiannual evaluations (program reviews and facility inspections) will be made available upon request.

2.22.5 Recordkeeping Requirements

A. This Institution will maintain for at least 3 years:

A copy of this Assurance and any modifications thereto, as approved by the PHS
Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations
Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld
Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official, the Provost and Senior Vice President for Academic Affairs.
Records of accrediting body determinations

B. This Institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional 3 years after completion of the activity.

C. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

2.22.6 Reporting Requirements

A. The institutional reporting period is the federal fiscal year (October 1 – September 30). The IACUC, through the Institutional Official, will submit an annual report to OLAW after September 30, but on or before December 1 of each year. The annual report will include:

Any change in the accreditation status of the institution (e.g., if the Institution becomes accredited by AAALAC or AAALAC accreditation is revoked)
Any change in the description of the Institution’s program for animal care and use as described in this Assurance
Any change in IACUC membership
Notification of the dates that the IACUC conducted its semiannual evaluations of the Institution’s program and facilities (including satellite facilities) and submitted the evaluations to Institutional Official, the Provost and Senior Vice President for Academic Affairs.
Any minority view filed by members of the IACUC

B. The IACUC, through the Institutional Official, will provide the OLAW with a full explanation of the circumstances and actions taken with respect to:

Any serious or continuing noncompliance with the PHS Policy.
Any serious deviations from the provisions of the Guide.
Any suspension of an activity by the IACUC.

C. Reports filed under VI.A.2. and VI.B. above should include any minority views filed by members in the IACUC.

Last Updated: August 1, 2022