IACUC Protocol Development

The below information will assist investigators in the planning, development and submission of animal use protocols for review and approval by the IACUC.

Investigator Responsibilities 

The IRB requires that all investigators (faculty members, staff members, graduate students or undergraduate students) comply with both internal and federal regulations regarding the care and use animal in research and the appropriate administration of protocol activities. Additionally, investigators have the responsibility of staying abreast of policies to remain within compliance.  Failure to do so will result in the investigator losing their capability to perform as the individual responsible the administration of the research protocol. The IACUC Policy and Procedure Guidebook, the UMBC investigator’s manual for conducting animal research, provides complete information about these responsibilites.

Schedule of Meetings               

The UMBC IACUC meets four (4) times a year. In order to allow for sufficient review and placement on the meeting agenda, new or renewal protocol applications must be submitted at least 45 days before the scheduled meeting. Applications not received by that deadline date will be automatically placed on the agenda for the next scheduled meeting.

The meeting schedule for the 2009-10 academic year is as follows:

                                                                Protocols must be submitted to

The IACUC will meet in:                             HARPO no later than:

      October, 2009                                           August 15, 2009 

      January, 2010                                           November 15, 2009

      April, 2010                                                 February 15, 2010

      July, 2010                                                  May 15, 2010

How to submit a Protocol 

Please review the requirement for animal care and use training. The IACUC requires that all animal care staff and research personnel, including faculty, graduate students and undergraduate students, using animals in any research or teaching project complete the on-line education module. Training must be completed before submitting an application. The certificate of training completion must be submitted to the Human and Animal Research Protections Office.

Using the above schedule for protocol submissions, electronically submit the protocol and any accompanying documents to iacucsubmissions@umbc.edu. The Human and Animal Protections Research Office prefer applications submitted in MS Word format, but Adobe Acrobat versions will be accepted also. Please do not submit “hard-copy” or paper documents.

Please be sure to include the applicable pages with the signature of the investigators. A scanned version as a PDF document is acceptable. If that's not possible, fax that page (and that page only) to the Human and Animal Protections Research Office at (410) 455-3868. Protocol applications will not be processed until this face page is received.

Click to download a Animal Research Protocol Form

Sufficient lead-time is necessary for the Committee to review each protocol; this should be taken into consideration in planning start dates or need for approval for funding agencies.  Investigators will be provided opportunity to respond to Committee reviewer questions prior to full review and approval at each scheduled meeting.

Types of Approval

Approval

Approval is granted if all reviewing members provide approval.

Additional Information Requested

If additional information is requested by any member(s), then a letter is sent to the principal investigator detailing the information requested.   Copies of the letter and the investigator’s response are forwarded to all members on the committee.  Approval is granted if all reviewing members provide approval.

Disapproval

If disapproval is recommended by the committee, a letter detailing the reason(s) for the disapproval is sent to the principal investigator and the protocol is officially closed.  The principal investigator must resubmit a new protocol that is reviewed as a new submission.

Veterinary Medical Services

The staff of Veterinary Resources, in the Comparative Medicine Program at UM,B, provides technical training such as blood withdrawal, administration of anesthetics, animal transportation, etc. to support investigators in their research activities.  Training may also be provided for surgery, pathology and radiology.

Pre-research consultation is also available for the following topics:

• Special caging or experimental techniques
• Selection of appropriate animal species to carry out specific animal techniques
• Animal models of human diseases
• Anatomical and physiological peculiarities of animals used in research
• Techniques of anesthesia, analgesia, chemical restraint, and dosages
• Techniques of blood and other sampling and drug or chemical administration
• Pathological and clinical effects of intercurrent animal disease
• Estimates of animal purchase prices

Animal Purchase and Care

Animals used at UMBC are purchased from pre-approved commercial suppliers and dealers. Approval of sources is based on the health status, genetic quality, costs, vendor reputation and reliability. A pre-approved list of vendors can be obtained from the Human and Animal Research Protections Office. Investigators with specific requests for animals from commercial sources not currently approved must contact the IACUC Chair who will ensure that a proper investigation of the source is obtained.  No animals may be brought onto UMBC property without prior consultation and approval of the IACUC. When dealing with commercial suppliers, who have multiple production colonies, it is often best to try to obtain animals from the same colony to prevent differences in biological response. All procurements for UMBC research animals, under approved protocols must be placed in accordance with UMBC Department Procurement Manual.

Animals from other sources, such as other universities, have a great potential for carrying pathogens.  The current health status of animals requested from these sources, must be reviewed by the VR staff and the animals must be quarantined and tested by UM,B Veterinary Resources before they are placed in the UMBC colonies to ensure that they are pathogen free.

No animal may be housed in UMBC facilities unless a protocol is approved and the animal ordering procedures are followed. The introduction of animals without authorization by the IACUC places the facility and the research of other investigators at great risk for loss of animals and data, which could jeopardize the results of research endeavors, publication and funding. 

Consideration of Alternatives

Animal research protocol applications should indicate that alternatives have been thought of and that a review of database searches been performed. A good faith effort must be made on the part of the researcher to consider the use of alternatives. This is an AWA requirement and is specified in the government principles for use and care of animals in the PHS policy. Alternatives can include non-animal models, procedures that cause less pain or distress, or non-mammalian models.  The protocol narrative must include the databases searched, any consultation with experts, and the date of the search, the years covered by the search, and the key words utilized.

The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. Researchers may use the variety of resources to complete the database search, found at Animal Welfare Information Center http://www.nal.usda.gov/awic/databases/database.htm

Survival Surgical Procedures

The Institutional Animal Care and Use Committee have set minimum standards for animal operating rooms and laboratories in which surgery is performed.  The standards are based on the NIH Guide for the Care and Use of Laboratory Animals. The standards are meant to ensure that surgical procedures are performed in an appropriate environment using good surgical techniques. Aseptic technique (e.g., surgical gloves, mask and sterile instruments) should be used for surgical procedures on rodents such as rats and mice; however, the standards for the surgical facility are not as rigid.  Rodent surgical areas may be a separate room or portion of a room.  The area should be clean and orderly and should not be used for any other purpose during the time of the surgical activity.  Animal housing areas may not be used for surgical procedures. 

Non-survival surgical procedures may be performed in general purpose laboratories provided the rules outlined below are followed:

The surgical site should be clipped, the surgeon should wear gloves, and the instruments and surrounding area should be clean.

The use of a survival surgical area for non-survival surgery is satisfactory provided the rules regarding survival surgery are followed, and the room is properly sanitized following the procedure.  Any other laboratory outside of those designated for survival surgery CANNOT be used for survival surgical procedures in animals other than rodents.

Euthanasia

The “Public Health Service Policy on Humane Care and Use of Laboratory Animals”, “Animal Welfare Act” and the Guide for the Care and Use of Laboratory Animals require the IACUC to review and approve the proposed methods of euthanasia. The proposed methods must be consistent with the recommendations of the AVMA Guidelines on Euthanasia (formerly Report of the AVMA Panel on Euthanasia), published in June 2007, unless there are scientific justifications for alternative methods. The AVMA  categorizes each method of euthanasia as acceptable (methods which consistently produce a humane death when used as the sole means of euthanasia), conditionally acceptable (methods which by the nature of the technique or because of greater potential for operator error or safety hazards might not consistently produce humane death or are methods not well documented in the scientific literature) and unacceptable (methods deemed inhumane under any conditions or that the panel found posed a substantial risk to the human applying the technique). The Office of Laboratory Animal Welfare (OLAW) has issued policy guidance clarifying current requirements regarding the use of carbon dioxide (CO2) as a euthanasia agent for small laboratory animals. Protocol applications should reflect the methods and guidance provided by the AVMA and OLAW.

Euthanasia is the act of humanely killing animals by methods that induce rapid unconsciousness and death without pain or distress. In evaluating the appropriateness of methods, some of the criteria that should be considered are ability to induce loss of consciousness and death while minimizing animal pain, distress, or anxiety; reliability; irreversibility; time required to induce unconsciousness; species and age limitations; compatibility with research objectives; and safety of and emotional effect on personnel.

Euthanasia should be carried out in a manner that avoids animal distress. Depending on the species involved, some animals being euthanized may vocalize, release pheromones or behave in a manner which may be distressing to other animals. For those reasons, animals should not be euthanized while crowded or in the presence of animals not being euthanized.

It is essential that euthanasia be performed by personnel who are skilled in methods for the species in question and that it be performed in a professional and compassionate manner. It is imperative that death be verified after euthanasia and before disposal of the animal. Animals in deep narcosis following exposure to euthanasia agents may appear dead, but may eventually recover. Death must be confirmed by examining the animal for cessation of vital signs with consideration given to the animal species and method of euthanasia when determining the criteria for confirming death.

Principal Investigators are responsible for ensuring all personnel performing animal euthanasia have been properly trained to consistently apply the techniques in a humane and effective manner. See the Recommended Methods of Euthanasia and the American College of Laboratory Animal Medicine (ACLAM) Task Force Report on Rodent Euthanasia in the Appendices of the Policy for species specific information.

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