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 Training How to submit a Protocol Field Studies
Temporary Animal Holding Protocols
Occupational Safety and Health Semi-Annual Facility Inspections Permits to import/export animals for research Veterinary Medical Services Animal Purchase and Care Consideration of Alternatives Survival Surgical Procedures Euthanasia
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 2017-18 academic year is as follows:
The IACUC will meet in: Protocols must be submitted to ORPC no later than:July 13, 2018 June 13, 2018 October 12, 2018 September 12, 2018 January 11, 2019 December 11, 2018 April 12, 2019 March 12, 2019 July 12, 2019 June 13, 2019
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 (repeat every three (3) years) and occupational safety and health (repeat annually). Training must be completed or updated prior to submitting an animal use application for review. The certificate of training completion must be submitted to the ORPC.
The IACUC reviews all animal research carried out in university facilities, as well as fieldwork, that is supported by the PHS, HHS, and/or NSF and is conducted by a UMBC principal investigators. 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.
Who can be a principal investigator
UMBC personnel who carry out activities involving animals fall under the auspices of UMBC’s Animal Welfare Assurance Statement of Compliance with the Office of Laboratory Animal Welfare (OLAW). The individual who has the primary responsibility for a project that includes the design and implementation of research or teaching involving animals is known as the Principal Investigator (PI). The PI ensures that students, technicians and research staff be made aware and understand their individual and collective responsibilities for research related tasks including monitoring animal care and use, record keeping, appropriate environment and housing of animals, personnel training, etc. In terms of an IACUC application, at PI is a full time faculty member in a department where animal research activities are conducted and may also be defined by UMBC’s Policy on Principal Investigator Eligibility.
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. 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. In general, protocols undergo full committee review at the next scheduled IACUC meeting. Designated member review may be requested by the principal investigator in the event that an expedited review is desired before the next scheduled IACUC meeting. 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 an Animal Research Protocol Form and any accompanying documents to email@example.com. Please be sure to include all supporting documents with the submission. 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 or NSF funds are strongly encouraged to follow OLAW’s examples to prepare the animal use section of proposals; using the Worksheet for the Review of the Vertebrate Animal Section when developing protocol applications for review by the IACUC may benefit. Procedures proposed in applications must comply with the provisions in the PHS Assurance for Institutional Commitment (UMBC’s assurance # is D16-00462) and the Guide for the Care and Use of Laboratory Animals; taxon‐specific guidelines such as the Guidelines to the Use of Wild Birds in Research or Guidelines for the Use of Fishes in Research may be used as supplemental references.
As an additional resource, use these Java Applets for Power and Sample Size to help justify in your protocol the use of animals. 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 UM,B Veterinary Resources. 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 approval. 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 source
The ORPC will review this information with the IACUC Chair to determine if additional action is required.
Field research on warm blooded, vertebrate wildlife species is often overseen and evaluated by an IACUC to insure that the protocols employed are consistent with humane care and use of animals. Unlike many other on-site research projects, however, field studies present logistical and other challenges to IACUC evaluation. It’s important to note that studies conducted on free-living wild animals in their natural habitat do not require IACUC and approval as long as the activity does not alter or influence the activity of the animals that are being studied (for example observation, photography, collection of feces). However, if the research alters the environment, behavior or influences activities of the animals, such as direct interaction (e.g. trapping), invasive procedures (e.g. tissue sampling) causing pain or distress, or if there is potential for harm to animals or impacts the health or safety of research personnel, this activity must be reviewed and approved by the IACUC
UMBC investigators are required to submit a protocol for field studies to the IACUC for review and be approved prior to the actual use of animals. Annual review as well as other post approval administration activities apply as well. No work with animals may be done without or before IACUC approval.
The ORPC has created the below proposal development recommendations to assist investigators in the creation of a protocol.
What are examples of research activities that may alter or influence the activity of the animals?
- Capturing or restraining animals (tagging or banding)
- Peripheral blood sampling, swabbing, or the insertion of subcutaneous RFID chips
- Invasive procedures, such as entry into a body cavity or organ, or removal of a body part
Note that “pain or distress” is generally considered any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being to which that procedure is applied (e.g. pain in excess of that caused by injections, brief food or water restriction, etc.).
How can the Veterinarian assist in the development of a protocol application?
The veterinarian can provide advice on experimental animal models, occupational health, hazard containment, and zoonosis control.
How does the occupational health and safety program apply to field research?
The IACUC recognizes that the hazards and risks of field work are different from those in the laboratory setting. As such, UMBC’s Occupational Health and Safety Program addresses training requirements risk assessment to address the broad range of unique and unusual risks in working with wildlife. Risks and mitigation processes, as well as the type of personal protective equipment and specific training, are documented in an IACUC protocol application.
Is IACUC approval required for research on wildlife species if collaborating outside of UMBC?
If a UMBC investigator is directing or funding collaborative activities involving wildlife animals, UMBC IACUC submission and approval procedures apply. Wherever possible and appropriate, UMBC’s IACUC will accept the review and approval of the offsite institution’s IACUC upon submission to ORPC of that institution’s approval documentation. View the Collaborative Research page for more information.
What information is required to describe procedures for capturing wild animals? What happens if animals are captured that are not described in an IACUC protocol?
Common activities in the capture and release of wild animals involves marking, banding or sampling. The IACUC evaluates potential distress, pain and injury of the target animals resulting from the capture method, risks to project personnel, and management of potential by-catch. Steps to minimize risk to project personnel are also reviewed with the recognition that field work has different inherent and unavoidable risks than laboratory activities. If capturing non-target animals is likely, management plans should minimize potential distress and injury to animals and personnel.
What permits and other regulations relate to wildlife research?
The IACUC ensures that wildlife research complies with Animal Welfare Act and Public Health Services regulations. Depending on the field research site, specific local, state, national, or international wildlife collection or trapping permits would be required.
The Ornithological Council recommends that all permit applications be submitted to permitting agencies at least 90 calendar days prior to the date you intend to start work/import/export but in the case of endangered species permits, allow up to six months. The IACUC recommends investigators obtaining the appropriate permits as soon as possible in order to conduct the field research in a timely manner. IACUC approval is not required to obtain federal and state permits; however, the UMBC IACUC will not give approval until the required permits are obtained.
The IACUC also recommends investigators read the Ornithological Council’s article on permit “application best practices.”
Can captured wildlife species be brought back to a UMBC lab for research?
If appropriate permits have been obtained wildlife species can be brought from the field for research and education activities. Once live specimens are brought to institutional facilities, they are treated as laboratory animals rather than wildlife. Quarantine procedures, housing, animal care and veterinary care requirements must be consistent with the Guide unless the IACUC approves a deviation for scientific or medical reasons. The IACUC may also require that enrichment and housing of social animals are applied as appropriate.
What are acceptable methods for euthanasia in the field?
When wildlife activities reviewed by the IACUC, approval of research includes the overall goal of benefit for wild species by scientists interested in understanding and preserving wildlife. Field studies should conform with best available methods to minimize any necessary pain and distress to the species being studied. Methods of euthanasia must be described in an IACUC application and approved by the attending veterinarian and the IACUC. Unless the IACUC approves a deviation for scientific or medical reasons, methods should be consistent with the most recent edition of the AVMA Guidelines on Euthanasia.
How do the 3 R’s apply to field research and why are alternative searches required for wildlife research?
The IACUC recognizes that applying the 3 R’s in wildlife studies is challenging because research goals in the field are certainly different from those encountered in the laboratory; these goals may prioritize the collection of data from many animals over the welfare of individual animals.
The IACUC does expect wildlife investigators to conduct an alternatives search; strategies to obtain this information would be different from what a laboratory investigator. For more information, consult the Canadian Council on Animal Care (CCAC) website for suggestions in developing these strategies to include in an IACUC application.
Investigators from other institutions who plan to perform animal research at UMBC, or who enter into a consortium (subaward) or subcontract agreements with 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 Holding Protocol Request 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 responsibilities and training.
Semi-Annual Facility Inspections
The IACUC will inspect at least every six months the Institutions’s program for humane care and use of animals, and all of the Institution’s animal facilities using the Guide as a basis for evaluation. Semi-annual facility inspections include, but are not limited to inspection of: a. animal housing areas, b. feed and bedding storage areas, c. cage wash areas, d. surgery areas, e. animal procedure areas, f. other animal care and use areas and support areas, and g. any equipment used for transporting of animals.
If deficiencies are noted during the inspection, they will be categorized as significant or minor. A significant deficiency is one that is or may be a threat to the health and safety of the animals or personnel. Following inspection the Committee will develop a reasonable and specific plan, and schedule for correcting each deficiency.
Any concerns involving the care and use of animals may be reported by any individual to the IO, IACUC Chair, Institutional Veterinarian, or any member of the IACUC. Notices are located in the animal facilities and state how and where to report animal welfare concerns. Any individual who in good faith reports an animal welfare concern will be protected against reprisal. All reported concerns will be bought to the attention of the full Committee to discuss, investigate, and address. Reported concerns and associated actions will be reported to the IO and, as warranted to OLAW.
Reports or concerns may also be made to the ORPC.
Permits are required to enable investigators to engage in legitimate scientific research activities involving protected species that would 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. Permits are also required to document the transfer of animals to and from UMBC involving collaborators for the attending veterinarian to assess the health reports of animals, the strains and animal numbers (if different from IACUC approved use) and to determine if a protocol amendment is required. The IACUC will require evidence of an approved permit in the protocol review process.
UMBC Veterinarian Import/Export Permits
Animal Import Form – to receive animals for housing and use in UMBC animal facilities
Animal Export Form – to ship animals for housing and use in non-UMBC animal facilities
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
Investigators are required to conduct a search of at least two databases when a protocol involves working with lab animals and conducting research on animals. This search must find suitable alternatives to the use of animals, to prevent unintended and unnecessary duplication of research, and to substitute procedures that may cause more than momentary, slight pain or distress to the animals. This is an AWA requirement and is specified in the government principles for use and care of animals in the PHS policy. The results of the search are documented in the Animal Research Protocol Form that is submitted for IACUC review. Alternatives can include non-animal models, procedures that cause less pain or distress, or non-mammalian models. At least two (2) databases must be consulted that address the “3 R’s” – Replacement – substitute animal models with non-animal techniques or lower organisms; Reduction – minimized the number of animals used; and Refinement – use of techniques and procedures that reduce pain and distress.
The IACUC requires a literature search for “refinement” only if protocol procedures fall within USDA pain and stress categories E. Examples include potentially painful or stressful procedures that are not relieved with anesthetics, analgesics and/or tranquilizer drugs. Withholding anesthesia/analgesia must be scientifically justified in writing and approved by the IACUC. Replacement and reduction search results must accompany all IACUC submissions. .
Investigators conducting wildlife/field research may find that using traditional databases for searching for alternatives may not produce results to satisfy the alternatives requirement. Several taxon-specific guidelines include species-specific references to provide references to include with an IACUC submission. These include:
- American Society of Mammalogists Animal Care and Use Guidelines
- Ornithological Council Guidelines to the Use of Wild Birds in Research
- American Fisheries Society, American Institute of Fishery Research Biologists, and American Society of Ichthyologists and Herpetologists Guidelines to the Use of Fishes in Research
- American Society of Ichthyologists and Herpetologists Guidelines to the Use of Amphibians and Reptiles in Research
Reference: Sample Wildlife Protocol – OLAW – NIH
Contact the ORPC at the time of protocol submission with questions about these requirement
ORPC has created a Literature Search for Alternatives worksheet to assist investigators with this process A variety of resources to complete the database search are on the UMBC Library site as well as the Animal Welfare Information Center. Please note that Medline, PubMed & Current Contents extract from the same database and should NOT be considered as two separate searches. A search must be completed within three (3) months of a protocol submission.
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.