IACUC Frequently Asked Questions

TABLE OF CONTENTS

ABOUT THE IACUC


PROPOSALS AND AMENDMENTS



CONTINUING REVIEWS


PROTOCOL EXPIRATION/RENEWAL


FACILITY INSPECTIONS

TRAINING

HAZARDS


MISCELLANEOUS


ABOUT THE IACUC

What is an 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.




What are the responsibilities of the IACUC?

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.



What regulations/guidelines are used by the IACUC to establish and improve Central Michigan University's Program of Animal Care and Use?

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.




Why is it necessary to have IACUC approval for animal use?

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.



Why do the regulations and policies keep changing?

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

What must be reviewed and approved by the IACUC?

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.




Who may serve as the principal investigator (PI) on a project?

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.




The animals I will be using are not covered by the Animal Welfare Act (AWA). Do I need IACUC approval?

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.




Do I need IACUC approval to observe wildlife in their natural habitat?

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, transpertation, 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.




I would like to breed animals for research puposes. Do I need IACUC approval?

The use of breeding stock is a part of the institutional animal care and use program and directly supports research acitivities. Consequently, IACUC approval of protocols and SOP's that involve animals for such purposes is necessary.



Do I need IACUC approval to use dead animals or animal tissues?

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:

  • Purchsed 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. 



How do I initiate IACUC review?

The process is the same for all submissioins 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. 



How long does the review process take?

The average time from initial submission to approval for new proposals and non-personnel amendment requests is 5 weeks. 




Is there anything I can do to speed up the review process?

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 protcol.



Can review of my protcol/amendment request be expedited?

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 alloted 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). 



What factors are considered by the IACUC when reviewing my project?

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. 



May non-pharmaceutical-grade compounds be used in my work with animals ?

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




May expired pharmaceuticals, biologics, and supplies be used in my work with animals?

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




Besides the protocol/amendment form(s), should I submit anything else?

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 reseach will be conducted. 

If you are collaborating with a researcher at another institution that has an Animal Care and Use Committe, 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. 



Besides the protocol form, should I submit anything else?

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.




Why is the IACUC questioning the scientific merit of my research?

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).




Is it possible that the IACUC will deny approval of my research proposal?

Yes.

However, when the PI and the IACUC work together, a mutually agreeable resolution can usually be reached and an approval issued. 




May I acquire (purchse, transfer, collect) animals before I recieve IACUC approval?

No.




I have done this work for quite some time and have similar protocols already approved by the IACUC. Why is the committee so concerned about the details of my most recent application?

Each protocol submitted is regarded as a stand alone document. Referencing proceedures 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.




I have received word that my proposal has been approved. When can I start my project?

Work with animals can begin once you have received written IACUC approval. 




How long will my IACUC approval last?

The maximum for IACUC approval is three years.




Can I house animals in my lab?

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 reveiw of the written request and inspection of the proposed housing area.




Do I always need to submit an amendment request to make changes to my project?

Any change to a project involving animals requires additional reveiw 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.




Does the approval of my amendment extend the approval date?

No.

The original expiration date will remain the same. 




What happens if my project expires before the renewel request I submitted is approved?

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. 



I've done this work quite often and have similar protocols with the IACUC. Why is the committee so concerned about the details of my most recent application?

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.




How do I add personnel to an approved AUA?

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

I have received a continuing review form. What is the purpose of continuing review?

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

I have been notified that my protocol is due to expire. I am very busy and do not have time to submit a new protocol. Can my approval be extended?

No.

Protocol approval is good for the period requested by the PI up to a maximum of three years. PI's will recieved 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 Instituational Official (IO) and were applicable to federal and/or funding agencies. 



To renew a project having no major changes over the previous approval period, is there a short form I can use were I would only have to provide new or modified procedures instead of the full animal use application?

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. 




For the three-year protocol renewal, if there are no major protocol changes over the previous approval period, can a short form be used that would only detail new or modified procedures instead of the full protocol form?

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.




Will my protocol number change after my proposal has been renewed?

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. 


What happens if my project expires before the renewal request I submitted for review is approved?

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

What is the purpose of facility inspections conducted by the IACUC?

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. 




How does the inspection process work?

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 resonable and specific plan for correcting each deficiency, regardless of designation of minor or significant, and a schedule for resolving the issues. 


Why is the IACUC inspecting my lab?

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

What training is required to work with or care for animals?

A working knowledge of the regulations relevent 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. 




Is it a serious matter that someone is taking part in a project utilizing  live animals and they are not listed on the approved protocol?

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 Labortatory Field and Safety.
  • Enrionmental Health and Safety.
  • Institutional Biosafety Committee



MISCELLANEOUS

What should I do if I find a sick/injured animal?

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/veterniary staff immediately. 

Examples of issues that should be reported are lethargy, constant circling, self-mutilation, sevre 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 responbile 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. 




How do I report a concern related to animal care and/or use?

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 10/5/2017

Report a Research Concern