TABLE OF CONTENTS
ABOUT THE IACUC
PROPOSALS AND AMENDMENTS
CONTINUING REVIEWS
PROTOCOL EXPIRATION/RENEWAL
FACILITY INSPECTIONS
TRAINING
HAZARDS
MISCELLANEOUS
ABOUT THE IACUC
The Institutional Animal Care and Use Committee (IACUC) is a self-regulating entity that, according to U.S. federal law, must be established by institutions using vertebrate animals in research, instructional, training, outreach and display projects. The overall role of the IACUC is to ensure the humane and sensitive care and use of animals.
The IACUC is responsible for assuring that live vertebrate animals used in research, teaching, training, outreach projects are used and cared for in an ethical and humane manner and to ensure compliance with federally mandated rules and regulations. Below is an abbreviated list of committee responsibilities.
- Review, at least semiannually, the institution's program for the humane care and use of animals;
- Inspect, at least semiannually, the institution's animal facilities (including satellite facilities);
-
Prepare reports to the Institutional Official (IO) of the IACUC evaluations;
- Review animal welfare concerns;
- Make recommendations to the IO on any aspect of the animal program, facilities, or personnel training;
- Review and approve, those components of PHS conducted or supported activities related to the care and use of animals;
- Review and approve, proposed significant changes to the use of animals in ongoing activities; and
- Be authorized to suspend an activity involving animals.
All research, teaching, training, outreach projects and animal husbandry procedures must conform to the statutes described in:
All PHS-assured institutions are required to comply, as applicable, with the Animal Welfare Act and other Federal statutes and regulations relating to animals.
The IACUC is charged with ensuring that the university adheres to the highest standards of ethical treatment of animals and that the university complies with federal regulations regarding the care and use of animals.
The truth is that the federal regulations and policies have not changed in decades. However, publications such as the
Guide and the
Guide for the Care and Use of Agricultural Animals in Research and Teaching
[also known as the Federation of Animal Science Societies (FASS) Guide] are periodically revised and updated. Furthermore, interpretation by representatives of the
PHS Office of Laboratory Animal Welfare (OLAW)
and the
United States Department of Agriculture (USDA)
of regulations and their guidance regarding them change over time as government officials come and go.
The IACUC is here to help the members of CMU's research and teaching community understand these regulations and policies. Additionally, institutional awareness of federal regulations has increased over the years. Please contact the IACUC Coordinator whenever you have questions.
PROPOSALS AND AMENDMENTS
All research, instructional, training, and outreach projects that involve the use of live vertebrate animals as well as any changes to previously approved projects, including the addition of new personnel, regardless of funding source or lack thereof.
A member of CMU's faculty or staff must be listed as the PI, however graduate and undergraduate students may be designated as a Co-PI.
In compliance with the PHS policy, CMU's IACUC oversees the use of all live vertebrate animal species regardless of inclusion or exclusion from the AWA and as a such, IACUC review and approval is required prior to initiation of all animal use activities.
Field studies on free-living, wild, vertebrate animals in their natural environment
may be exempt from IACUC approval if the study does not:
- Involve an invasive procedure, harm, or materially alter the behavior of an animal under study (9 CFR 1.1-Animal Welfare Regulations).
- Involve the capture, handling, housing, transportation, treatment, or euthanasia of animals.
- Cause excessive disturbance of target and non-target animals due to study activities.
If all of the above conditions are met, and there are no other requirements for IACUC approval (such as by a funding agency), exemption from IACUC approval may be requested. Contact the IACUC Coordinator for more information.
The use of breeding stock is a part of the institutional animal care and use program and directly supports research activities. Consequently, IACUC approval of protocols and SOP's that involve animals for such purposes is necessary.
Use of materials such as these in a research or teaching activity does not require IACUC approval if the material is obtained in one of the following ways:
- Purchased from a commercial source.
- Obtained from animals sacrificed following an IACUC-approved project at CMU or another institution, or a governmental agency.
- Samples remaining from diagnostic tests preformed by private laboratory facilities.
However, IACUC approval is required if an animal is both procured and sacrificed solely and specifically for a research or teaching purpose.
The process is the same for all submissions to the committee. All IACUC forms can be found on IRBNet.org, a web-based submission website, under the forms and templates tab.
A link to IRBNet.org, as well as guidance materials on navigating the sight, is available on the Office of Research Compliance website.
The average time from initial submission to approval for new proposals and non-personnel amendment requests is 5 weeks.
Yes.
Examples include:
- Reaching out to the Attending Veterinarian (AV) while drafting your proposal rather than waiting until it is submitted for review by the committee.
Regulations require consultation with the AV for studies involving more than momentary pain and distress (Category D or E studies).
- Review each page of the application to make certain each response is clear and complete.
- Provide a thorough justification when requesting changes to a previously approved protocol.
The IACUC, taking its cue from the PHS Policy, does not recognize the term "expedited" review. As per the PHS Policy, the full committee must be allowed the opportunity to review a proposal and are allotted 7 business days to do so. During this time, any member may request full committee review (FCR). If such a request is not made, the Chair will assign two committee members to review the proposal by designated member review (DMR).
Of foremost concern, will any part of the project cause, or have the potential to cause, harm to the animals involved. Harm includes, but is not limited to, physical pain and/or injury, death, and psychological distress. If animals may be harmed, documentation is necessary to show that alternative methods have been considered but are not appropriate, and why, that steps have been taking to minimize the harm, and that the scientific merit of the project outways the harm to the animals.
Other elements include, but are not limited to:
- A clear rationale for using animals.
- Suitability of the species chosen and the number of animals requested.
- Training and/or experience of all project personnel.
- Euthanasia methods consistent with AVMA recommendations.
Pharmaceutical-grade chemicals and other substances, when available, must be used. Please refer to the OLAW FAQ via this link:
http://grants.nih.gov/grants/olaw/faqs.htm#useandmgmt_4
The use of expired materials is not consistent with acceptable veterinary practice, even in terminal procedures. Please refer to the OLAW FAQ via this link:
http://grants.nih.gov/grants/olaw/faqs.htm#663
If your project involves collecting animals in the field, you must furnish a copy of your scientific collector permit issued by the state in which collecting will take place, if one is required. Threatened or endangered species or species of concern are not covered under a scientific collector permit. If the species you will be working with falls into one of these categories, you must obtain a threatened/endangered species permit and furnish a copy to the IACUC.
For more information on permits, visit the Michigan Department of Natural Resources website, or the DNR website for the state in which the research will be conducted.
If you are collaborating with a researcher at another institution that has an Animal Care and Use Committee, you will be required to furnish a copy of the project approval letter from that institution.
If you will be utilizing hazardous materials, you are responsible for obtaining approval, if required, from other campus divisions such as the Institutional Biosafety Committee, Office of Laboratory and Field Safety Committee or Risk Management, Environmental Health and Safety.
Failure to provide any additional materials required by the committee could delay the IACUC review process or receipt of the written IACUC approval necessary to begin work on your project.
Yes.
If you are performing any animal use activities involving a threatened or endangered species or specimen collection, you will be required to submit a copy of any required permits with your AUA.
If you are working in cooperation with another institution that has an Animal Care and Use Committee, you will be required to furnish a copy of the project approval letter from that institution.
If you will be utilizing hazardous materials, you will need to determine if approval is required from another campus compliance committee. Approval documentation of this type must be provided to the IACUC at the time of AUA submission.
The IACUC is required to ensure that all animal use is the best use of animals to achieve the expected result. The IACUC does not question the merit of your research, but the use of animals within it. The IACUC is charged with making certain all research utilizing animals complies with the 3 R's (reduction, replacement, and refinement).
Yes.
However, when the PI and the IACUC work together, a mutually agreeable resolution can usually be reached and an approval issued.
No.
Each protocol submitted is regarded as a stand alone document. Referencing procedures from other protocols, or from publications, makes the assumption that they are so generally used that everyone will know what you will be doing. References can not take the place of procedure descriptions.
The IACUC encourages the use of Standard Operating Procedure (SOP) documents in instances like this. Once an SOP is approved by the committee a PI may reference the SOP in the protocol form. SOP's should be reviewed by the author at least every three years.
Work with animals can begin once you have received written IACUC approval.
The maximum for IACUC approval is three years.
Housing animals anywhere but in an approved animal housing area for greater than 12 hours (USDA regulated species) and 24 hours for all other vertebrate animals (PHS Policy) requires prior approval by the IACUC. The PI must provide justification for the requested housing site. Housing exceptions must be requested in writing either as part of the initial protocol submission or as an amendment to a pre-existing protocol. Each housing exception is examined on an individual basis and approval is contingent upon review of the written request and inspection of the proposed housing area.
Any change to a project involving animals requires additional review by the IACUC and may not be initiated until approval has been granted. Changes may included, but are not limited to the following:
- Personnel additions.
- Species and/or strain.
- Increase in animal numbers.
- Adding or modifying procedures.
- Adding or changing anesthetics or other agents.
- Euthanasia method.
The original expiration date will remain the same.
At the time a project expires, all work involving the use of live animals must cease. Any work conducted after the expiration date is considered noncompliant and must be reported to regulatory and funding agencies.
Any animals that remain housed in one of the institutions facilities may be transferred to another IACUC approved study, or be humanely euthanized. Animals transferred to another study may only be used for the research study covered by that protocol.
Remember that the protocol you submit is a "stand alone" document and you cannot refer to procedures in other protocols or publications, or assume that they are so generally used that everyone will know what you will do. References cannot take the place of procedure descriptions.
Complete and submit a
Personnel Amendment Form to
IRBNet. New personnel must have completed all required training and be a participant in the Occupational Health Program. Amendment requests that involve
only the addition of personnel are reviewed and approved administratively.
CONTINUING REVIEWS
Continuing review is both a regulatory requirement and a component of our post approval monitoring (PAM) program. The procedures purpose is three fold:
- It provides a project progress report to the IACUC.
- It demonstrates the projects continued compliance with PHS, USDA, and institutional requirements.
- It allows the committee and PI to determine whether the 3 R's can be applied further to the project.
PROTOCOL EXPIRATION/RENEWAL
No.
Protocol approval is good for the period requested by the PI up to a maximum of three years. PI's will received a minimum of one notice prior to the expiration date. However, it is the responsibility of the PI to know when a protocol will expire and submit a renewal request, if they intend to continue the project.
Once IACUC approval is allowed to expire, any work involving live vertebrate animals is considered a matter of non-compliance and must be reported to the IACUC, the Institutional Official (IO) and were applicable to federal and/or funding agencies.
No.
PHS Policy requires that minimally that every three years all protocols undergo de novo review by the IACUC. Using a short form that focuses only on changes does not satisfy this requirement.
No.
PHS policy requires that every three years, all protocols be reviewed by the IACUC as if they were new (de novo). Using a short form that focuses only on changes does not satisfy this Federal requirement. In this context, "de novo" means that the criteria and procedures for review of projects specified in IV.C. of the PHS Policy must be applied not less than once every three years. The IACUC must make the determination that the project conforms to the criteria in IV.C.1.a-g. of the PHS Policy. These criteria address such factors as pain and distress, pain relief, animal husbandry, veterinary care, personnel qualifications and methods of euthanasia. In addition to confirmation that projects are in compliance with the PHS Policy, the IACUC must also determine that the project is being conducted in a manner consistent with the
Guide, unless departure is justified.
Yes.
PHS Policy requires a complete de novo review and the protocol is regarded as an entirely new project by the IACUC.
I closed my project before its expiration date. Can't the IACUC just reactive the protocol?
While you can not reactivate a closed protocol you may clone it and submit it for IACUC review. Before submission ensure that all information is current and correct.
At the time a project expires, all work involving the use of live animals must cease. Any work conducted after the expiration date is considered, non-compliant and must be reported to regulatory and funding agencies.
Any animals that remain housed in one of the institution's facilities may be transferred to another appropriate and IACUC-approved study or be humanely euthanized. Animals transferred to another study may only be used for the research covered by that protocol.
Back to Table of Contents: PROTOCOL EXPIRATION/RENEWAL
FACILITY INSPECTIONS
Per regulations the IACUC is required to inspect at least twice a year any area where live animals are housed or used. This includes all buildings, rooms, enclosures and vehicles.
Using a checklist based on the Guide, the committee categorizes items as acceptable, a minor deficiency, or a significant deficiency. A significant deficiency is defined as something that is or may be a threat to the health or safety of animals. Inspection reports are reviewed at a convened meeting where the committee is tasked with providing facility managers with a reasonable and specific plan for correcting each deficiency, regardless of designation of minor or significant, and a schedule for resolving the issues.
Institutions are responsible for the oversight of all animal related activities regardless of where the activity occurs.
Do I need to be present for the semiannual inspection?
Not necessarily. Anyone who is knowledgeable of the animal care and use activities occurring in the facility/lab may accompany the inspection team. If an experienced personnel member will not be present, contact the IACUC Coordinator to arrange a more suitable date and time.
What documents may be requested by the inspection team?
The IACUC may want to see protocols and amendments, review animal identification and health records, staff training logs, sanitation records, Standard Operating Procedures, controlled substance logs, environmental control and/or husbandry records. Essentially the IACUC may request to see any documentation related to the use of animals.
What if I disagree with the inspection results reported to the committee and the Institutional Official (IO)?
Deficiencies identified by the inspection team are shared with the facility manager who is then required to provide the committee with a letter describing what steps will be, or have already been taken to correct the issue. This letter presents the facility manager with an opportunity to share their point of view with the committee.
TRAINING
A working knowledge of the regulations relevant to the use of animals is necessary. The committee currently provides this information through the online program Collaborative Institutional Training Initiative (CITI). Everyone involved in the care and use of animals must complete the courses, Working with the IACUC and Post-Approval Monitoring. CITI also offers species-specific and procedural courses which may also be required. The training to perform specialized procedures must be provided by someone with sufficient training/experience. Documentation of that training must be made available upon request by the IACUC.
Yes.
Federal guidelines state "participation in animal related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained" is a reportable offense.
HAZARDS
What types of hazards might the IACUC be concerned with in relation to my animal use?
Radioisotopes, carcinogens, toxins, recombinant DNA, chemicals, radiation, and lasers, just to name a few.
What does the IACUC require when a project involves a known or potential hazard?
When developing the protocol, provide as much information as possible relating to the hazard(s).
The committee may also request that copies of personnel training records, signage to be posted, verification of approval from the Institutional Biosafety Committee, or other relevant committee be submitted at the same time as your proposal. When in doubt contact the IACUC Coordinator.
Guidance may also be obtained from:
- Office of Laboratory Field and Safety.
- Environmental Health and Safety.
- Institutional Biosafety Committee
MISCELLANEOUS
If the animal is a part of an IACUC approved project (laboratory, classroom or field work), the illness/injury/unusual behavior must be reported to the animal care/veterinary staff immediately.
Examples of issues that should be reported are lethargy, constant circling, self-mutilation, severe weight loss and appearance of a lump, wound or lesion. When in doubt error on the side of caution.
If you are in the field and observe an animal that is injured or exhibiting abnormal behavior, and the animal has not been handle as part of an IACUC approved study, you are not responsible for providing treatment or care. CMU researchers are encouraged to report their observations to local authorities such as the DNR or local law enforcement when appropriate.
The IACUC must review and resolve any reported concerns related to the use of animals in research, instructional and outreach activities to ensure that animals are treated humanely and in accordance with federal, state, and local laws and Central Michigan University policies.
Instructions for reporting a concern are posted in all areas where animals are housed or utilized.
Additional methods for reporting a concern include:
- By use of one of the many Report a Research Concern links on the Office of Research Compliance website.
- By phone.
Office of Research Compliance (989) 774 - 1152
IACUC Office (989) 774 - 7313
- By email: IACUC_ADMIN@cmich.edu
Updated 9/9/2019
Report a Research Concern