The below information will assist investigators in the planning, development and submission of animal use protocols for review and approval by the IACUC.Animal Care and Use Federal Assurance
Schedule of Meetings
How to submit a Protocol
Temporary Animal Holding Protocols
Occupational Safety and Health
Permits to obtain animals for research
Veterinary Medical Services
Animal Purchase and Care
Consideration of Alternatives
Survival Surgical Procedures
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 30 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 2014-15 academic year is as follows:
The IACUC will meet in: Protocols must be submitted to ORPC no later than:
October, 2014 August 15, 2014 January, 2015 November 15, 2014 April, 2015 February 15, 2015 July, 2015 May 15, 2015
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 in both animal care and use and animal occupational safety and health. Training must be completed or updateds prior to submitting an animal use application for review. The certificate of training completion must be submitted to the ORPC.
Regulations require that the IACUC review all animal use carried out in university facilities, as well as fieldwork conducted by UMBC personnel. All projects are to be approved prior to the actual use of animals, whether it involves research/teaching or warm/cold blooded vertebrates. The approval of animal use will be granted for a three-year period. The IACUC is required to review activities annually, even though it may be a multiple-year project.
IACUC Application Pre-review Consultation
The ORPC staff is available to answer any questions regarding the IACUC submission process and IACUC review of research studies. We also provide pre-review consultation to discuss all aspects of IACUC review, from preparing the submission to completion of the study. We also offer in person review sessions on twice a month on Wednesdays between 12:00 pm and 1:00 pm during the academic year. Please visit our registration page to arrange a time. Please contact the office staff for more information.
When will I hear from the IACUC about my study?The length of time a study will take to be approved and an approval letter received depends on the type or level of review required. . The ORPC staff, working in concert with the IACUC, will make every effort to work with investigators to process proposals promptly. If additional changes are needed, it can take longer depending on reviewer questions or protocol load.
Using the above schedule for protocol submissions, electronically submit the Animal Research Protocol Form and any accompanying documents to email@example.com. 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 Office for Research Protections and Compliance (ORPC) at (410) 455-3868. Protocol applications will not be processed until this face page is received. Use these Java Applets for Power and Sample Size to help justify in your protocol the use of animals
The protocol form is designed to help provide the IACUC sufficient information to allow a meaningful review of your proposed animal use. Investigators applying for PHS funds are strongly encouraged to follow OLAW's examples to prepare the VAS as well as use the Worksheet for the Review of the Vertebrate Animal Section when developing protocol applications for review by the IACUC. This will ensure that what is being proposed for funding is consistent in description the IACUC reviews and approves.
If you and your technical staff require assistance for animal procedures (i.e., you are not qualified in performing certain techniques, including surgery) help is available, at no cost to your project, from the UMB Veterinary Resources at 410-706-3540. In addition, assistance in the planning of anesthetic/ analgesic procedures and methods of euthanasia is available.
What kinds of projects are exempt from IACUC review?
Several types of projects would not require prior IACUC review or aprpoval. Examples include:
- research involving invertebrates
- the use of tissues, organs or other parts of dead animals if received as such, for example, from colleagues
- tissues obtained from commercial vendors or salvaged animals (found dead)
- noninvasive observation of wild animals in their natural habitat
A IACUC protocol is required if tissues are obtained if animals were euthanized specifically to obtain tissues or there was a project-specific "pre-death" procedure used to obtain the animals tissues prior to euthanizing them.
If there is question as to whether or not IACUC approval is required for a proposed animal activity, please contact the ORPC with the information before you commence with the project at firstname.lastname@example.org.
- a brief description of the project
- where noninvasive observations will take place or from where and from whom tissues or other animal parts will be obtained
- the applicable teaching course number and title or internally/externally funded title and funding soruce
The ORPC will review this information with the IACUC Chair to determine if additonal action is required.
Investigators from other institutions who plan to perform animal research at UMBC must follow their home-institution’s policies, procedures and guidelines as well as those of the UMBC. Wherever possible and appropriate, UMBC’s IACUC will accept the review and approval of the offsite institution’s IACUC upon submission to ORPC of approval documentation (IACUC approval letter and copy of an Animal Welfare Assurance (domestic institutions) or a Statement of Compliance [foreign institutions] with the Office of Laboratory Animal Welfare [OLAW]), indicating compliance with federal regulations governing the ethical care and use of animals. The institution that owns the animals will maintain primary oversight responsibility. The collaborating institution does not have a PHS approved Assurance of Compliance for animal welfare on file with OLAW the investigator must contact the ORPC.
All animals at UMBC must be connected to an active IACUC approved animal protocol. Occasionally, situations occur where protocols become inactive (e.g., protocol approval expires, protocol is suspended), but animals remain in the animal facilities. In order to avoid euthanasia of valuable research animals, and to remain in compliance with regulatory requirements, the IACUC will allow principal investigators (PI) to transfer animals to the holding protocol for a maximum of 90 days. During this time, investigators are asked to take the necessary actions to gain re-approval of their animal use protocol in order to avoid forfeiture of their animals.
This procedure may also be used for:
- animals arriving prior to the arrival of a new faculty member, but an IACUC protocol has not yet been approved
- principal investigators who have left UMBC but whose animals cannot be immediately transferred to the new institution
Requests to place animals on the Animal Holding Protocol will be generated by the PI, the Attending Veterinarian (AV), or the IACUC Chair. Should the AV be contacted first by a PI, her office will inform the IACUC. PIs requesting a holding protocol will submit a Use of Holding Protocol Request Form for Principal Investigators to the ORPC. Upon receipt the ORPC will forward the request to the AV for review and authorization of the transfer of animals to a holding protocol. All actions will be reported to the IACUC at the next regularly scheduled meeting.
The ORPC will notify animal care staff in writing that the transfer has been approved and, when applicable, the animal care staff will verify that the transfer has been completed and that no animals are being housed under the expired protocol. The maximum approval period of a holding is 90 days. Animals that remain on a holding protocol will be euthanized after the 90 day period.
Animals placed on a holding protocol will receive conventional husbandry, housing and care. Breeding to maintain viability of specific lines may occur under this protocol but the expansion of colony breeding is not authorized. Feeding and sanitation will be performed as expected for the species. Standard institutional environmental enrichment will be provided to all animals under this protocol.No surgery, research, teaching or experimental procedures are allowed.
The PI and animal care staff must notify the AV of any significant pre-existing health conditions prior to the transfer of animals to the holding protocol. Examples of important information include but are not limited to: existing surgical implants, zoonotic disease, special dietary needs, past surgical history, viral vectors, poor fecundity. Medical treatment and/or euthanasia will be performed by, and at the discretion of, attending veterinarian.
Animal care staff will be responsible for identifying the animals; this can be done at the cage level, on the animal room door, or both. Any costs or fees associated with maintaining animals on a holding protocol will be charged to the investigator (or department) while their animals are on the holding protocol.
*NOTE: Federal grant funds may NOT be used for support of any animals in a holding protocol status due to non-compliance or failure to obtain IACUC approval for a 3-year replacement protocol.
Upon IACUC approval of the PI's protocol, the removal of a protocol suspension or the receiving institution where the former UMBC PI is currently employed is ready to accept animals will be removed from the Holding Protocol. The cage cards reflecting the approved and active UMBC IACUC protocol number will then be used.
The Guide for the Care and Use of Laboratory Animals requires that “an occupational health program must be part of the overall animal care and use program.” The Occupational Health and Safety Program (OHSP) is an important component of the University of Maryland, Baltimore County’s institutional animal care and use program. The goal of the occupational health and safety program is to prevent occupational injury and illness by avoiding, controlling or eliminating hazards in the workplace, as well as to provide for early diagnosis and treatment when necessary.
Please click on this link or more information about animal care personnel responsibilites and training.
Permits are issued by governmental agenices that enable investigators to engage in legitimate scientific research activities involving protected species thatwould otherwise be prohibited by law. These permits ensure activities are carried out to safeguards wildlife as well as promote local, national and international conservation efforts. The IACUC will require evidence of an approval permit in the protocol review process.
US Fish & Wildlife Service, US Department of the Interior (CITES, ESA, etc.)
· National Marine Fisheries Service, National Oceanic & Atmospheric Association
- Pre-Application Guide Information on All Permits
- General Permit Information
- Marine Mammal Protection Act (MMPA) Permits
- Endangered Species Act (ESA) Permits
· Animal & Plant Health Inspection Service, US Department of Agriculture
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
Animals must be purchased or otherwise acquired from an approved commercial supplier (as listed below). No animals may be purchased without an IACUC approved animal use protocol. Investigators with specific requests for animals from non-approved sources must submit a justification for their use in the animal use protocol submission, or via a minor modification form for already approved protocols. All animal acquisitions and associated costs (i.e., shipping) should be coordinated with your unit's administrative representative, and must correspond to the applicable IACUC approved protocol.
Animals from non-approved vendors or other sources have a great potential for carrying pathogens. 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. 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 UMB Veterinary Resources before they are placed in the UMBC colonies to ensure that they are pathogen free.Harlan - http://www.harlan.com
Charles River - http://www.criver.com
Taconic - http://www.taconic.com
Jackson Labs - http://www.jax.org
NCI Mouse Repository - http://mouse.ncifcrf.gov/
Carolina Biological - http://www.carolina.com/
Charles Sullivan Co. - http://www.researchamphibians.com/
Zebrafish International Resource Center - http://zebrafish.org/zirc/home/guide.php
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
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 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.
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 unless there are scientific justifications for alternative methods.
The UMBC IACUC requires investigators to incorporate the AVMA guidelines in proposed protocol applications and follows recommendations from University of Maryland School of Medicine Animal Care and Use Program on acceptable methods of euthanasia for species used in research. Additional information about recommended methods are described in the Animal Research Protocol Form.
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. The Attending Veterinarian as well as the University of Maryland School of Medicine Animal Care and Use Program offer education and training.