What are the roles of the Institutional Animal Care and Use Committee and the Institutional Review Board?

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The Institutional Animal Care and Use Committee (IACUC) is a compliance committee established by federal requirements by the U.S. Department of Agriculture and the United States Public Health Service. Public and private institutions utilizing animals are subject to these regulations, and an IACUC operating at each such institution is the mechanism by which such animal-related activity is regulated and monitored. The committee is comprised of scientists knowledgeable in the use of animals, a veterinarian with training in animal laboratory science, and at least one non-scientist lay member.

Novelution Online Protocol Submission System

Effective December 1, 2021, use of the online protocol submission system is required for all new and 3-year renewal protocol submissions. System demonstrations took place for faculty and students in April 2021. If you were unable to attend a demonstration, you will find it helpful to watch the video demonstration before interacting with the system:

How to Submit an IACUC Protocol in Novelution

Objectives

1. Enhance collaborative and multidisciplinary research endeavors across the colleges and schools.
2. Keep the colleges and schools apprised of emerging and ongoing initiatives sponsored by federal, state and local municipal agencies as well as private entities that support research.
3. Discuss current issues that bear on University research administration.
4. Discuss roadblocks and other issues that the colleges and schools experience in meeting their ongoing research efforts and aspirations.

Mandated Responsibilities

1. Review at least every six months the institution's program for humane care and use of animals, using the Guide for the Care and Use of Laboratory Animals as a basis for evaluation.
2. Inspect at least every six months the institution's animal facilities (including satellite facilities), using the Guide for the Care and Use of Laboratory Animals as a basis for evaluation.
3. Prepare reports of the IACUC evaluations as set forth in the PHS policy at IV.B.3 and submit the reports to the responsible Institutional Official.
4. Review concerns involving the care and use of animals at the institution.
5. Make written recommendations to the Institutional Official regarding any aspect of the institution's animal care program, facilities, or personnel training.
6. Review and approve, require modifications in (to secure approval), or withhold approval of those activities related to the care and use of animals as set forth in the PHS Policy at IV.C.
7. Review and approve, require modifications in (to secure approval), or withhold approval of those activities related to the care and use of animals in ongoing activities as set forth in the PHS Policy at IV.C.
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 as set forth in the PHS Policy at IV.C.4.
9. Conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS policy at IV.C.4 at least once every three years.
10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6.

Review Process

1. The review process begins with the submission of a proposal for an activity involving animals. This may encompass research grants, educational projects or demonstrations, or other types of testing.
2. Projects involving other institutions (educational institutions, commercial firms, etc.) or individuals at those institutions require an approval process at each institution and involved individuals at each site bear joint responsibility for the appropriate conduct at the other site(s).
3. Investigators should review University of Minnesota guidelines on performing procedures on laboratory animals and incorporate this information into their protocol.
4. An animal protocol must be submitted in the online protocol submission system. If the project involves a grant submission, a copy of the grant application should be linked to the IACUC protocol in the system.
5. The application to IACUC will be reviewed for compliance with issues and practices defined by legislation and current accepted laboratory veterinary practice. These include (but are not necessarily limited to):
   1. The justification for the species chosen and the number of animals being used.
   2. The rationale for the use of animals for the proposed procedures versus the availability of less invasive procedures, tissue culture, computer simulation, etc.
   3. Criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated.
   4. The proper use of euthanasia.
   5. Training and experience in appropriate techniques of the researchers and co-workers performing the project.
   6. That the activities do not unnecessarily duplicate previous work.
   7. The safety of the working environment for personnel.
6. The IACUC may approve the application as submitted, required modifications in order to receive approval, or reject the application. Application must be granted prior to the procurement of animals and their use in the project.
7. Approved projects must undergo full review at least every three years.

IACUC Animal Protocol Forms

For new and 3-year renewal animal protocols, the Novelution online protocol submission system is required beginning December 1, 2021. For protocols approved on paper forms before then, amendments should be submitted using the Protocol Amendment Form below.

• Protocol Amendment Form
• Protocol Annual Review Form (To be used only for research involving animals under the oversight of USDA's Animal Welfare Act)

Investigators must include quantifiable criteria for euthanasia of animals on their Animal Protocol Review Form. The IACUC has created guidance to assist investigators with determination of appropriate criteria for euthanasia.

Investigators are strongly encouraged to review University of Minnesota guidelines regarding performing procedures on laboratory animals, and incorporate this information into the animal protocol.

For Animal Care & Housing Forms, visit the Center for Biomedical Research website.

Investigator Training

The humane care and treatment of animals in research is of critical importance to the Institutional Animal Care and Use Committee (IACUC). In order to ensure the well-being of animals used in research, the IACUC has implemented mandatory training for all individuals working with animals. This includes faculty researchers, technicians, graduate and undergraduate students, visiting scientists, and any other individual working with laboratory animals.

UND's animal welfare training program is conducted through the CITI Program. For information on training requirements and how to register for training, visit the Center for Biomedical Research training webpage.

Policies

• Occupational Health Plan
• Respiratory Protection Program
• Biological Safety Cabinet Policy
• Transport of Hazardous Materials Policy
• Use of Controlled Substances in Research Policy

Standard Operating Procedures

• Analgesia Guidelines for Laboratory Animals
• Anesthesia Surgery Post-Procedural Recordkeeping
• Animal Procurement
• Euthanasia of Animals
• Humane Endpoints
• Training and Recertification Requirements
• Whistle-blower Policy & Procedures
• Post-Approval Monitoring Policy & Checklist
• Social Housing
• Use of Non-Pharmaceutical Grade Compounds in Animals
• Use of Neuromuscular Blocking Agents in Animals
• Veterinary Care

Animal Care

Research animals are housed at the Center for Biomedical Research, a state-of-the-art research facility located on the northwest side of the School of Medicine and Health Sciences at the University of North Dakota. In addition to housing research animals, the Center for Biomedical Research is also responsible for ordering animals used in research and providing medical care to ensure the health and well-being of the animals.

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