INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)

Mission, Purpose, and Goals
The mission of the Institutional Animal Care and Use Committee (IACUC) is to promote and safeguard activities that involve animals within the academic community. The IACUC is a University committee composed of faculty members who are appointed by the institution, a veterinarian, and a community representative. The Committee is responsible for reviewing all activities involving the use of vertebrate animals, regardless of the source of funding for the activity. The following are the goals of the IACUC:

1. To promote quality research and scholarship
2. To evaluate and review all activities involving the use of vertebrate animals and make recommendations regarding these studies
3. To offer assistance in educating the campus on requirements of the University's animal care and use program

2009-2010 IACUC Committee Members
Nicholas Santangelo, Chair, Department of Biological Sciences Faculty
Pradeep Bose, Director of Student Health Services
Harry Hebert, Community Member
Kenneth Dickey, Attending Veterinarian
Linda Frost, Director of Honors Program
Don Llewellyn, Department of Agriculture Faculty
Robert Mitchell, Department of Psychology Faculty
John Thomas, Community Member
Timothy Weckman, Animal Facility Manager

Gus Benson, Director, Sponsored Programs (ex-officio)
Jerry Pogatshnik, Associate Vice President for Research (Institutional Official)

Application Procedures
All research and teaching projects involving the use of animals must be reviewed and approved by the IACUC prior to the beginning of the activity. Applications for IACUC approval must be submitted for review using the current EKU Animal Care and Use Application form (linked below). The original signed and completed application and required documentation must be submitted to Sponsored Programs, Jones 414, Coates CPO 20. Please note that the pre-review submission is by email and should include editable Microsoft Word files.

The EKU IACUC does not automatically require that all applications be reviewed during a convened meeting, but a convened meeting is necessary if either of the following two events occur during the review of the application: (1) any one member requests a review by the full committee during a convened meeting; or (2) the application is not approved unanimously and without qualifications by committee members assigned as designated reviewers. Applicants may be contacted for additional information during the review process, asked to make changes to their applications for compliance reasons, or asked to attend an IACUC meeting during which their protocols will be discussed.

The IACUC’s goal is to review applications as expeditiously as possible while still maintaining compliance with federal regulations and review requirements.

Steps in the Submission and Review Process

1. The investigator, students, and other personnel complete the CITI online training course, “Working with the IACUC.”
2. All personnel complete the Occupational Health Questionnaire.
3. The investigator completes the application form and all applicable attachments, including applying for required licenses or permits.
4. The investigator sends an electronic copy of all application materials Sponsored Programs by email (Dustin.McClain@eku.edu) for pre-review by the IACUC Attending Veterinarian.
5. Sponsored Programs assigns a protocol number and forwards the application to the attending veterinarian for pre-review. The attending veterinarian sends comments and recommended changes to the investigator by email.
6. The investigator finalizes the application by addressing comments from the pre-review. The investigator signs the application, secures the signature approval of the department chair, and submits one original of all applicable materials to Sponsored Programs.
7. Sponsored Programs forwards the application materials to all IACUC members and identifies the designated reviewers assigned to the application.
8. All committee members have 5 days to request a convened meeting of the IACUC to review the application or express concerns about the protocol. If a committee member wishes to request a convened meeting for the review of the application, he or she should notify all committee members by reply email and provide the reasons for the decision. If a committee member has concerns about the application but does not wish to request a convened meeting, he or she should notify the IACUC Chair of the concerns. A lack of response will be interpreted to mean that the IACUC member does not wish to request a convened meeting, and the review of the application will continue. Any concerns noted by committee members will be addressed during the review by the designated reviewers.
9. Each designated reviewer reviews the application and provides comments to the IACUC Chair within 7 days based on the following options:

   Approve the protocol

   Request additional information : Reviewers will send comments or concerns in writing or by email to the IACUC Chair. The IACUC Chair will collate comments from all designated reviewers and send to the investigator with a request for the investigator to respond to each comment by reply email within 3 business days. The IACUC Chair will forward the investigator’s response to the designated reviewers assigned to the application along with a copy of the comments provided to the investigator. If the concerns have been satisfied, the designated reviewers will approve the application in writing or by email to the IACUC Chair. The attending veterinarian will forward a copy of all correspondence that occurred during the designated review process to Sponsored Programs and the IACUC Chair, including responses from the investigator and evidence that each designated reviewer has approved the protocol. If concerns expressed by the committee members are not addressed satisfactorily, the application may then be referred for review during a convened meeting of the IACUC.

   Request a convened meeting of the full IACUC to discuss the application : If any committee member wishes to request that a particular application be discussed during a convened meeting of the IACUC, he or she may do so by reply email to all committee members. The application will be added to the agenda of the next scheduled IACUC meeting. Committee members will send a list of their questions or concerns by email to the IACUC Chair. The IACUC Chair will forward the committee’s questions and concerns to the investigator and request that the items be addressed within 3 business days. Responses and/or revised application materials will be forwarded to all committee members prior to the meeting at which the application will be discussed. The IACUC may exercise one of the following options with a majority vote of a convened quorum:

   • Approve the protocol
   • Approve the protocol pending receipt of additional specified information
   • Table the protocol pending additional comments to and discussion with the investigator. The protocol would then be reconsidered at the next convened IACUC meeting
   • Reject the protocol (with appropriate rationale provided to the investigator). The investigator may submit a new application for consideration at the next convened IACUC meeting if the reasons for rejecting the application have been addressed

10. Following the receipt of either (1) documentation of approval from all committee members assigned as designated reviewers or (2) documentation of approval by a majority of a quorum of voting members during a convened meeting, Sponsored Programs will prepare the Notification of IACUC Approval for the application and send to the IACUC Chair for signature. The notification will include compliance and reporting requirements for the investigator.
11. The IACUC Chair will sign the approval notification letter and return to Sponsored Programs, and Sponsored Programs will provide a copy to the investigator.

Application/Reporting Forms
The IACUC application forms are available as Microsoft Word files. The application form, the animal worker questionnaire, all applicable attachments, and evidence of the completion of the CITI Lab Animal Welfare course ("Working with the IACUC") are required components of an application package.

• IACUC Application Form
  • Form W: Animal Worker Questionnaire (required attachment for each individual involved in the project)
  • Form E: Euthanasia (required attachment if activity will involve euthanasia)
  • Form H: Use of Hazardous Agents (required attachment if activity will involve the use of hazardous agents)
  • Form P: Physical Restraint or Induction of Stress (required attachment if activity will involve physical restraint or the induction of stress)
  • Form S: Surgical Procedures (required attachment if activity will involve surgical procedures)
• Required CITI Lab Animal Welfare online training - Working with the IACUC
• Form C: IACUC Continuation Review Form (must be approved by the IACUC prior to the anniversary date of initial approval to continue an approved activity beyond one year)
• Form A: Protocol Amendment Form (must be approved by the IACUC prior to the implementation of any changes from the original approved protocol)
• Form F: Final Report (must be filed within 30 days of project's completion)

Online Training
All investigators and personnel engaged in activities involving animals must be trained in the appropriate care and use of animals. EKU subscribes to the Collaborative Institutional Training Initiative (CITI) Lab Animal Welfare online training program, and all individuals involved in animal activities are required to complete the "Working with the IACUC" module. Instructions for registering and using the CITI training modules are available here. CITI Completion Reports for all engaged individuals must be included as attachments to the IACUC application. This training is valid for a period of three years, after which time individuals are required to be recertified through the CITI training program. The initial certification can take several hours to complete and may be completed in multiple sessions.

Resources
The following links provide guidance on federal regulations governing the use of animals in research and teaching activities:

• The Animal Welfare Act
• The Guide for the Care and Use of Laboratory Animals
• Office of Laboratory Animal Welfare (OLAW)
• United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
• United States Department of Agriculture’s Animal Welfare Information Center
• Report of the AVMA Panel on Euthanasia (2000)
• Report of the American College of Laboratory Animal Medicine on Rodent Euthanasia (2005)
• Guidelines for Use of Live Amphibians and Reptiles in Field and Laboratory Research (2004)
• Guidelines for the use of Fishes in Research (2004) 

Current animal care and use guidelines for studies involving specific animal groups are available for review in the office of the Department of Biological Sciences (Moore 235) and in the following publications:

• American Ornithologists' Union: Guidelines to the Use of Wild Birds in Research
• American Society of Mammalogists: Guidelines for the Capture, Handling, and Care of Mammals
• Pough, F.H. 1991. Recommendations for the care of amphibians and reptiles in academic institutions. Institute of Laboratory Animal Resources. 33 (4):S5-S21.