Animal Research Handbook

Access essential documents, forms, and training materials to ensure your animal research meets all compliance and ethical standards.

Conducting animal research requires meticulous attention

Having all the necessary forms, training materials, and guidance in one place helps streamline your process and ensures that your work adheres to the highest standards. This handbook is designed to support researchers by providing quick access to the tools you need to plan, initiate, and carry out your research responsibly.

Looking for where to submit your application? Visit the Animal Research page for submission details and meeting dates.

Forms

New personnel process for animal research

New animal research personnel and new Principal Investigators who will be working with live vertebrate animals must complete the following steps.

  1. For adding new personnel to a previously approved protocol, begin at step 2. For adding new personnel to a new protocol, start at step 3. All personnel listed on new protocols must complete all onboarding requirements before the committee review. Protocols with personnel who have incomplete training will not be included on the monthly agenda.
  2. The Principal Investigator must submit a New Personnel Amendment form through the IACUC submission portal.
  3. Complete IACUC-required CITI training
    1. Working with the IACUC, and
    2. Species specific or Wildlife, as relevant to the work you will do, and
    3. Laboratory Chemical Safety, and
    4. Animal Biosafety.
    5. If applicable: Aseptic Surgery, for anyone performing surgical techniques
    6. If applicable: Minimizing Pain and Distress, for anyone performing procedures that fall into Pain and Distress Category D and/or E.
  4. Complete other applicable Safety training (biological, bloodborne pathogens, carcinogen, radiation, etc. as needed).
  5. Read Asthma and Allergy materials (This is in our Safety and Training section below)
  6. Complete the Risk Assessment form to the best of your knowledge and with input from your supervisor, then submit through the New Personnel Portal.
  7. The Attending Veterinarian, Dr. Fyke, will email you after you submit your form to schedule a meeting with you to review, print, and sign your Risk Inventory Assessment. This must be complete before being seen at Health Services (Step 9).
  8. Complete Part I and Part II of the Occupational Health Evaluation form.
  9. Contact University Health Services for an appointment to be seen by a UM healthcare provider. Be sure to take a printout of both the Occupational Health Evaluation and your Risk Assessment, that was signed by Dr. Fyke in step 7, to your appointment.
    1. Students: Call 662-915-7274 to see Dr. Coon
    2. Employees: Call 662-915-6550 to see Dr. Spears
  10. After the healthcare provider signs Part III of the Occupational Health Evaluation form, email only that page to the IACUC office at iacuc@olemiss.edu. This can also be placed in the IACUC mailbox on the first floor of Barr Hall.
  11. The IACUC office will notify you when you have met all the requirements.
  12. After receiving IACUC approval, personnel who will perform surgery and/or procedures with more than momentary pain and distress much obtain a Anesthesia and Surgery proficiency certification from Dr. Fyke prior to performing any procedure unsupervised. PIs must contact Dr. Fyke at hfyke@olemiss.edu to schedule evaluations for all personnel that require certification.

Be sure to have all personnel review the UM Occupational Health and Safety Policy.

IACUC Occupational Health Program

UM Occupational Health Program for Personnel Working with Animals

Institutional Animal Care and Use Committee

100 Barr Hall

University MS 38677

662-915-5062

662-915-7577 fax

The most common health problems encountered in an animal facility are usually not directly related to animals. They are injuries resulting from falling on slippery floors, lifting items improperly, burns from heated materials or steam, exposure to toxic substances, and cuts from needles, wires, knives or other sharp instruments.

Zoonoses (diseases of animals that may be transmitted to man) are infrequently documented in animal facilities and laboratories housing primarily rodents. However, some zoonotic diseases, especially those associated with wild-caught animals in field studies can be very serious and even fatal. Therefore persons working with animals should be familiar with zoonotic diseases in their particular species. Diseases can pass not only from an animal to a person, but from a person to an animal and from an animal to an animal by way of a person, especially if the person does not take reasonable precautions in proper hygiene. For these reasons, as well as ensuring compliance with the mandate of NIH’s Guide for the Care and Use of Laboratory Animals (Guide), the University of Mississippi requires persons having contact with laboratory animals to abide by the following guidelines.

Visitors:*

All visitors are required to wear provided Personal Protective Equipment (PPE). Visitors will be advised of the risks posed by animal allergens before entering the vivarium.

*Visitors are persons who are not UM faculty, staff, or students and will have transient contact with animals or animal or human tissue. All others must complete the Occupational Health Evaluation form.

Employees, Investigators, Technicians, Students, and All Others Exposed to Laboratory Animals:

These persons are all required to complete the UM OHSP Risk Inventory and Occupational Health Evaluation forms.

The risk of contracting an illness associated with animal care and research using animals depends on several factors such as: species used, infectious agents, toxic chemicals, carcinogens and radiation used, as well as the length and closeness of animal contact.

Initial Physical Examination:

All personnel employed in animal caretaker positions will be required to undergo a physical examination at the beginning of employment. Other personnel (including students) whose work involves special health risks (due to the nature or extent of animal contact) may be required, at the discretion of the Attending Veterinarian or the Institutional Animal Care and Use Committee (IACUC) to have the physical. This examination will routinely involve a medical history. It is important that the applicant honestly answer all questions, especially those regarding drugs, pregnancy, back problems which prevent lifting, and any known zoonotic disease such as tuberculosis. Persons who have allergies to animals should make this known during the pre-employment interview. Persons who are pregnant or plan on becoming pregnant should provide this information to the health personnel.

The physical will include physical measurements, chest auscultation, ear scope, mouth and throat examination, and laboratory tests. A tetanus shot is required unless the person has a current inoculation.

Follow-Up of Physical Examinations:

Employees who work with animals may be required, at the discretion of the Attending Veterinarian, the IACUC, or a medical health professional, to undergo follow-up physical examinations where indicated. Specific guidelines for categories of workers are as follows:

Laboratory Animals:

Personnel working with laboratory animals are at a low risk of contracting diseases of a zoonotic nature. Although uncommon, some of these diseases can be serious. For these personnel, an initial physical may be required and follow-up physicals may be requested at 2-5 year intervals. Injuries received while working with any animal species should be promptly reported to an immediate supervisor and documented. When a question of the severity of the injuries exists, medical attention must be sought.

Allergies:

It is estimated that 10-44% of persons having direct contact with animals develop allergies to them. Up to 73% of persons with pre-existing allergies will develop allergies to laboratory animals. Evidence also suggests that persons with a prior history of allergies are more likely to develop severe symptoms (asthma) from animal exposure. Early signs may include mild upper respiratory difficulties such as sneezing, rhinitis (runny nose), and conjunctivitis (swollen eyelids, watery eyes). The symptoms may progress to more serious respiratory problems such as asthma or anaphylaxis. Hives or skin rash can also occur. Persons developing allergies after having worked with animals should contact their supervisor and through him or her seek medical help for control and/or treatment of this condition. Proper use of recommended apparel (gloves, masks, and laboratory clothing) will greatly reduce the development of animal-related allergies, and therefore should be provided and used. Due to the wide range of severity involving animal related allergies, each case will be handled as an individual case involving appropriate medical recommendations.

Recommended Reading:

Cutaneous Infections:

Personnel with cutaneous bacterial infections who have direct contact with animals should be relieved of work upon recommendation of Student/Employee Health Service. This is particularly true of employees with open or draining skin lesions, such as those caused by Staphylococcus. These employees are likely to be infectious and should not be in contact with animals until the skin lesions are adequately treated and healed. There is normally no benefit in obtaining routine nasal cultures for staphylococci since the carrier rate is so high among the general population. However, in persistent staphylococcal infections, it might be important to attempt to determine the nasal colonization status and treat this, if possible. Dermatomycosis (ringworm) is another skin disease that may be transmitted by animals. It is characterized by pruritic (itchy), circular, red scaled lesions.

Rabbits and Rodents:

The majority of rabbits and rodents used at UM are acquired from vendors having breeding colonies free of human and animal pathogens. This further decreases the chance of contracting an infectious disease from these animals. The most significant hazards associated with these animals are the possibility of developing or exacerbating an allergy, and being bitten or scratched. Nevertheless, precautions should be taken to prevent exposure to diseases such as toxoplasmosis, lymphocytic choriomeningitis (LCM), salmonellosis, rat bite fever, and tapeworm infection. Wild rodents can carry those diseases as well as hanta virus, leptosporosis, and bubonic plague. Wild rabbits can also carry tularemia.

Other infectious diseases and health concerns with possible zoonoses transmission should be reviewed by the Student/Employee Health Service in consultation with the Attending Veterinarian. You should always inform your health care provider that you work with animals so they will be aware of the potential for zoonotic diseases.

General Injuries/Accidents:

All injuries and/or health related incidents should be reported immediately to the employee’s/student’s supervisor.

Animal Bites:

Employees/students should report animal bites to their supervisor immediately and scrub the wound well with soap and water. Necessary medical attention should be sought and Student/Employee Health Service should be consulted. It is the responsibility of the supervisor to follow up on the injured person’s status at weekly intervals for one month.

Scratches (other species):

Scratches from rats, rabbits, and dirty caging have serious potential for infection. The scratch should be scrubbed thoroughly with soap and water (betadine solution) and the incident immediately reported to the supervisor.

Needle Sticks:

All needle stick injuries will be immediately reported to the supervisor. The site of injury should be scrubbed thoroughly with soap and water. The supervisor will ascertain the substance associated with the needle stick or autoinoculation. Student/Employee Health Service will be consulted for the course of action and Enviromental Health and Safety should be notifed.

Work-Related Incidents:

  1. It is the responsibility of the employee/student to report a work-related injury to the immediate supervisor as soon as possible (no later than 5 days) after occurrence. Accident reports will be filed for any job-related injury even though the incident may seem minor or trivial at the time. An accident report will be initiated but should not delay the accomplishment of medical intervention as warranted. Employee and supervisor will complete the designated portions, and sign and date the reports. All completed forms will be forwarded to the UM Worker’s Compensation Office. A copy of all completed forms will be forwarded to Student/Employee Health Service. Forms can be found here.
  2. On request from the employee/student or when considered warranted by the supervisor, persons with non-emergency injuries will be seen in Student/Employee Health Service, between the hours of 8:00 am and 5:00 pm, Monday through Friday. Referral, if appropriate, will be the responsibility of Student/Employee Health Service.
  3. Between the hours of 5:00 PM and 8:00 am, Monday through Friday, and on Weekends and holidays, the employee will go to Baptist Memorial Hospital—North Mississippi or another appropriate source. Student/Employee Health Service will be notified by the employee/supervisor on the next working day.
  4. In the event of a serious or life-threatening injury, supervisors or co-workers will see that the employee is transported to the nearest emergency care facility or will call an ambulance for transportation. Emergency room personnel should be notified that the injured person is a UM employee and that the injury is job-related.
  5. Employees who have been absent from work due to a job-related injury or incident must provide a Student/Employee Health Service Physician’s statement upon return to work.

Non-Work-Related Incidents:

Employees who become ill or injured while at work from non-work related causes will contact their own physicians and make their own arrangements for care. Any costs and sick leave needed/associated with the incident will be the responsibility of the employee.

Visitors, Volunteers, and Invitees Incidents:

  1. If, while on the animal facilities premises, a visitor, volunteer, or invitee (the latter is defined as any person on the premises performing a function at the request of the institution), is involved in an incident which requires medical assistance, the same response plan will be followed as indicated above.
  2. Bills for treatment of injury or illnesses for visitors, volunteers, or invitees will be sent directly to them.

  • Fire or Medical Emergency 911
  • UM Student Health Services 662-915-8100
  • Hazardous Materials Response Team 662-915-5433
  • Enviromental Health and Safety 662-915-5433
  • University Police Non-Emergency 662-915-7234
  • Attending Veterinarian 662-915-5324
  • Attending Veterinarian Alternate 662-234-2928

Rodent or Rabbit Bites and Scratches, Injuries from Dirty Animal Cages

Most rodent/rabbit bites and scratches will be to the hand, fingers, or forearm. Bite wounds may bleed profusely and can be acutely painful. Some personnel may experience allergic reactions (itching, inflammation, and/or swelling) to saliva or scratches. If these do not subside rapidly or become more intense after repeated exposure to animals, the procedure outlined in Section III.A of the Occupational Health Program for Personnel working with Animals should be followed.

Immediate First Aid

  1. Massage area around wound to encourage bleeding.
  2. Wash the area with a povidone iodine scrub for 3 to 5 minutes, rinsing periodically.
  3. Dry using sterile gauze pad.
  4. Apply first aid antibiotic cream and bandage.
  5. Report injury to at least one co-worker

Needle Stick Injuries

Needle stick injuries can range in severity from merely pricking a fingertip with a sterile needle to accidental puncture by a non-sterile needle or auto-injection with a controlled substance or infectious agent. Any needle stick injury should be reported to a superior as soon as possible. Decisions about after care will be based on the agent injected.

Immediate First Aid

Follow procedure outlined for rodent bites.

Animal research guidance

Guidance on animal activities requiring IACUC oversight

Purpose: To describe what activities require IACUC oversight and/or an IACUC-approved animal use protocol

Background: The IACUC must review and approve all research and teaching proposals (protocols) involving vertebrate animals in compliance with PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy II) and the Animal Welfare Act Regulations (AWAR §1.1 and §2.31).

Determination of activities requiring IACUC oversight:

The IACUC has established the following guidelines to determine whether an activity involving animals requires IACUC oversight and/or an IACUC-approved animal use protocol:

Requires oversight:

  • Any research, research training, experimentation, biological testing, and related activities involving live vertebrate animals and conducted at this Institution, or at another institution as a consequence of the subgranting or subcontracting of a Public Health Service (PHS) conducted or supported activity by this Institution.
  • A course using vertebrate animals in teaching. See IACUC Policy on Classroom Use of Live Animals for more information.
  • A researcher’s involvement with animal research at another institution that does or does not have its own IACUC.

May require oversight (contact iacuc@olemiss.edu prior to conducting these activities):

  • Live animal demonstrations or exhibits involving more than minimal interactions with the participants.
  • Activities in which the animal is under the control of its owner (e.g., pets).
  • Observation-only field studies, as defined in the Animal Welfare Act regulations (“…any study conducted on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study.”). See IACUC Form on Determination of Exemption for Observation Only Studies.
  • Activities involving invertebrate animals.

No one – veterinarians, faculty, staff, students, or visitors – is exempt from providing animals with humane care while on the University of Mississippi campus.

For questions related to animal activities, please contact the IACUC Office at iacuc@olemiss.edu.

Other Contacts:

The Animal Welfare Act Regulations (§2.31, d, 1) state that studies “...that are conducted on free-living wild animals in their natural habitat and do not involve an invasive procedure, any harm to the animal, or any material alteration of the behavior of an animal under study” do not require an IACUC approved protocol. Therefore, a UM IACUC approved protocol is not required if the study involves unobtrusive observation of free-living wild animals in their natural habitat. All other studies involving the use and care of live vertebrate animals require an IACUC approved protocol.

Checklist:

Could your study:

  1. Affect the behavior of an animal under study?
  2. Involve an invasive procedure?
  3. Cause any harm to an animal?

Examples of behavior effects or invasive procedures include: supplemental feeding; nest checks; playback of recorded vocalizations that might result in territory desertion or infanticide in some cases/species, etc.

Passive observation can easily transition into disruption; the Principal Investigator (PI) must recognize when this point is reached, stop work, and apply for IACUC approval.

If you answered "no" to all 3 questions above and your study will ONLY involve observation of free-living wild animals in their natural habitat, an IACUC-approved protocol is not required. Please contact IACUC staff if you are unsure that your study is observation-only, or if anything in your observation-only study changes that would result in contact or behavioral changes of the animal under study.

UM Investigators must still comply with the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals, provisions of the USDA Animal Welfare Act and Regulations, and UM Policies.

Guidance

The categories below reflect the potential levels of pain, discomfort, and/or distress in common lab procedures. The examples are not exhaustive and are only to guide PIs and the IACUC. They cannot cover the range of severity and duration of P & D in specific study procedures, which must be considered in assigning categories.

Where appropriate, PIs should assign research groups undergoing different procedures to separate categories. The IACUC determines the final pain category. PIs’ Annual Updates should include any category changes that occurred during the course of the study.

Definitions

Pain

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. ‘Momentary or slight pain’ is no greater than the severity and duration of common injection pain.

Distress

Distress is the state associated with conditions which significantly compromise the welfare of an animal, which may or may not be associated with pain, and where the animal must devote substantial effort or resources to the adaptive response to environmental challenges.

Discomfort

Discomfort is viewed as a mild form of distress.

Categories

B - Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes.

C - The research involves procedures that cause no more than momentary or slight pain or discomfort and do not require pain-relieving drugs.

  • Injection
  • Venipuncture (blood sampling)
  • Collection of tissues preceded by approved methods of euthanasia
  • Behavioral testing with no more than momentary stress
  • Toxicity testing in which no pain is expected
  • Naturalistic observations
  • Short-term physical restraint of animals
  • Animal identification procedures that do not require anesthesia
  • Chemical restraint
  • Live trapping studies where animals are not in traps longer than 12 hours
  • Chronic maintenance of animals with a disease or functional deficit that involves no more than slight pain or distress

D - The research involves procedures that involve pain or distress which will be treated with appropriate anesthetics/analgesics.

  • Major and minor surgical procedures with anesthesia (both survival and terminal)
  • Inducement of a functional deficit (e.g., inflammation, infection, and tumor disease states)
  • Toxicological, microbiological, or infectious disease research that requires continuation until significant clinical signs are evident and death is not the endpoint
  • Prolonged physical restraint of animals with appropriate conditioning
  • Prolonged food or water restriction with appropriate monitoring to ensure animal well being
  • Induction of more than minor behavioral stress
  • Terminal perfusion, cardiac blood collection, exsanguination under anesthesia
  • Ocular blood collection in mice
  • Implantation of devices

E - The research involves procedures that involve pain or distress which cannot or will not be alleviated through the administration of appropriate anesthetic, analgesic, or tranquilizer drugs.

  • Toxicity testing – infectious agent challenge where death is the endpoint
  • Chronic maintenance of a disease or functional deficit where death is the endpoint
  • Studies causing inflammation, tissue damage, or neoplasia that result in morbidity or mortality which is not the result of euthanasia
  • Application of noxious stimuli from which escape is impossible

Category E protocols require consultation with the AV and written justification (which goes in the annual report to USDA).

In trying to justify precluding analgesics (because of their real or perceived potential effects they may have on the animal's immune system), the researcher should consider the effects that unalleviated pain may have on the animal and the experimental results. The investigator should consider that pain itself affects the animal's overall physiology and immune system. Such effects can in many cases be more significant than the effect that analgesics themselves may have on the research results. Some of the effects of unalleviated pain may include:

  1. Activation of the sympathetic nervous system
  2. Increased cardiac output
  3. Increased systemic vascular resistance
  4. Increased blood pressure
  5. Increased oxygen demand
  6. Vasoconstriction of coronary arteries
  7. Spleen ischemia
  8. Adverse renal effects
  9. Increased aldosterone output
  10. Increased sodium and water retention
  11. Release of endogenous glucocorticoids, which may be immunosuppressive
  12. Higher rate of metastasis
  13. Self-mutilation
  14. Stop grooming
  15. Anorexia
  16. Weight loss
  17. Catabolic state
  18. Increased clotting
  19. Increased blood viscosity
  20. Increased platelet aggregation
  21. Altered mental status (anxiety)
  22. Interference with normal activity
  23. Lastly, pain itself constitutes an uncontrollable research variable

Guidance for PIs on Animal Number Justification

Purpose: To help PIs better understand how to justify their requested number of animals. Sample size calculation plays an important role at the planning stage of research projects to ensure sufficient subjects for answering the question(s) of interest. If sample size is too large, study will waste resources. If sample size is too small, study does not have enough power to detect treatment effects; if the study has to be repeated, it will waste resources. While sample size calculation is important, going through the analytical process is useful on its own!

Background:

  • Sample size selected for animals should be “the minimum number required to obtain valid results.” (PHS Policy US Government Principle III)
  • The Guide for the Care and Use of Laboratory Animals states that the requested number of animals be justified statistically whenever possible.
  • If conducting a study where statistical justification for animals is inappropriate (e.g., pilot studies, breeding protocols, teaching protocols, etc.), PIs must at a minimum provide information on how they arrived at the number of animals requested for the proposed activity.
  • 3 Rs (Reduce, Replace, Refine)

Determining Sample Size:

  • Use of Power Analysis: When doing hypothesis testing, a sample size is calculated to achieve desired power (often .8 or .9) for detecting meaningful differences at a fixed Type 1 error rate.
  • The Power Analysis should match with the planned Statistical Analysis to be used in the study.
  • Estimates needed to determine sample size:
    • Target Power
    • Significance Level
    • Clinically important difference that we wish to detect
    • Additional nuisance parameters
  • Sample size estimates are approximate; parameters used in calculations are educated guesses. Be conservative but realistic.
  • Guessing means and SDs is often the hardest part of power analysis. Use of pilot studies, estimates from related studies, theoretical knowledge, or a range of minimum and maximum possible values can help. A standardized effect size could also be used instead.
  • Statistical Justification on Protocol:
    • Hypothesis driven outline of the experimental design should be included in the protocol.
    • Number of animals proposed should include information on how many groups will be utilized, the number of animals in each group, and a statement on how the proposed research is related to any previous or published research when important to the justification of the number of animals proposed.
    • When appropriate, additional animals requested to account for potential experimental losses should be considered.
There are many statistical programs available to help PIs estimate sample sizes. A free program called G*Power is available at http://www.psycho.uni-duesseldorf.de/abteilungen/aap/gpower3/.

Reduce, Refine, Replace

Reduce the number of experimental animals per experiment by:

  • choosing appropriate species/strains
  • using quantitative rather than qualitative endpoints
  • careful consideration of a research strategy, i.e. pilot studies
  • improving experimental design with particular attention to statistical methods

Refine experiments on animals by minimizing animal discomfort:

  • developing suitable measurements of animal pain
  • using analgesia
  • minimizing pain and distress by allowing animals to acclimate to new surroundings, using suitable restraining techniques, and ensuring competency in techniques such as injections, surgery, euthanasia, etc.
  • disseminating and encouraging refinement techniques

Replace animal experiments by methods not requiring experimental animals:

  • using in vitro methods
  • using physical and chemical techniques
  • using lower organisms
  • using mathematical and computer models, videos, etc.

DO's [Requirements]

  1. Submit an Animal Study Protocol Application form for all research and teaching using living vertebrates.
  2. Answer all questions, clearly describe procedures and experimental design, complete applicable appendices, contact the Attending Veterinarian, submit signed application ASAP, and plan for processing times.
  3. Submit the appropriate form (Preserved Animal Form) to the IACUC Coordinator if you use dead vertebrate animals for teaching or research.
  4. Submit protocols regardless of funding source and location of research.
  5. Submit protocols in the name of the faculty member.
  6. Complete species specific, safety and animal care training for PI/students/technical staff as part of the protocol submission process.
  7. Submit Occupational Health Evaluation and OHSP Risk Inventory forms for review and preventive health recommendations.
  8. Submit ANY protocol changes to the IACUC. Minor changes may only require documentation and approval while significant changes may require IACUC review.
  9. Submit annual progress reports.
  10. Submit a new application after three years have elapsed.
  11. Post whistle-blower information in your laboratory in the event that students, technicians, or other personnel have concerns regarding animal welfare.
  12. Post emergency contact information for research study.
  13. Post emergency procedures flyer in your laboratory in case of an unexpected occurrence that may threaten the safety of your laboratory animals.
  14. Post SOP for animal care in your laboratory.
  15. Post protocol approval letter.
  16. Remember to check the website for the most current forms.
DON’T's
  1. Don’t begin research before receiving an e-mailed approval letter.
  2. Don’t conduct surgery until mandatory training is completed in performance of surgical techniques in the procedure(s) and species indicated and observed by the Attending Veterinarian to receive a surgery proficiency certification.
  3. Don't order animals before the protocol is approved.
  4. Don't use jargon in your application.
Please contact the IACUC Research Compliance Specialist (RCS), Attending Veterinarian, or IACUC Chair with any questions —
  • IACUC Office: Brittney Casey 662-915-5062, iacuc@olemiss.edu
  • IACUC Chair: Dr. Bill Gurley bjgurley@olemiss.edu
  • Attending Veterinarian: Dr. Harry Fyke, Animal Facility 662-915-5324, hfyke@olemiss.edu
  • Executive Director of Research Integrity and Compliance: Mandy King, MS, CIP, CPIA, 215 Barr Hall; 662-915-5458; mlking9@olemiss.edu
  • In Case of Emergency: Dr. Harry Fyke ~ (work) 662-915-5324, (clinic) 662-234-2928

Submitting an Animal Study Application / Non-Personnel Protocol Amendment

  1. DON’T USE JARGON. Help all IACUC members, including community members, comprehend your application. Define abbreviations. Avoid technical language that only specialists in your field would understand.
  2. ANSWER ALL QUESTIONS. If a question does not apply to your study, mark “no” or “not applicable (n/a).”
  3. CLEARLY DESCRIBE PROCEDURES. Descriptions of procedures should stand alone and, other than an SOP, should not refer to another document, such as a grant application. List all possible anesthetics.
  4. MAKE THE EXPERIMENT DESIGN CLEAR. For more complex experiments, provide a flow chart or a simple outline to help guide reviewers.
  5. COMPLETE AND ATTACH APPLICABLE APPENDICES. The online forms are listed separately, allowing you to pick only those that apply to your study.
  6. CONTACT ATTENDING VETERINARIAN. Dr. Fyke is available to guide you. He must be consulted for all protocols having animals in Pain and Distress Category E.
    1. E-mail him at hfyke@olemiss.edu,
    2. Visit him at TCRC Room B-104.
    3. Call him at 662-915-5324
  7. COMPLETE ALL REQUIRED TRAINING. Incomplete training delays processing.
  8. IF CONDUCTING SURGERY. Complete mandatory training and obtain surgery proficiency certification from the Attending Veterinarian, Dr. Fyke.
  9. COMPLETE OCCUPATIONAL HEALTH AND SAFETY ENROLLMENT. The OHSP Risk Inventory and Occupational Health Evaluation forms must be submitted for all personnel listed on/added to a protocol and reviewed/signed by the occupational health physician.
  10. PLAN FOR PROCESSING TIME. Approval of protocol applications and/or significant change amendments take a minimum of three weeks and depend on submitting all required forms, office processing time, and time for PI responses to IACUC comments.
  11. SUBMIT APPLICATION AS SOON AS POSSIBLE. Submit protocols and amendments via e-mail to iacuc@olemiss.edu No research may begin until written final approval is received.
  12. ALWAYS CHECK THE WEBSITE FOR THE MOST CURRENT FORMS. Use the online forms to avoid delay in processing and/or review. The Animal Research pages of the ORSP website can be found at www.research.olemiss.edu/iacuc.
  13. CONTACT THE IACUC OFFICE. IACUC Office staff want to help and answer your questions.
    1. E-mail them at iacuc@olemiss.edu
    2. Call them at 662-915-5006

Submitting a Personnel Change Amendment to an Animal Study Protocol

  1. ENSURE PERSONNEL ADDED TO A PROTOCOL:
    1. get the required species specific training, health and safety training, surgery training/certification, etc.;
    2. read the asthma and allergy materials;
    3. submit health forms;
    4. obtain recommended vaccines (tetaus).
    5. Amendment approval will be delayed until these are done.
  2. NOTIFY VIVARIUM SUPERVISOR WHEN PERSONNEL/STUDENTS NO LONGER NEED ACCESS TO THE VIVARIUM. Personnel who are no longer working on an animal study protocol should be deleted from the protocol using the Protocol Amendment for Personnel Changes Only.

Submitting Animal Orders

  1. CHECK WITH VIVARIUM SUPERVISOR (662-915-5324 or pboltonl@olemiss.edu):
    1. about space, caging, feed and bedding availability before ordering animals;
    2. if ordering a large number of animals or a species that has not been housed in a while to make arrangements and before placing order.

Maintaining Animal Logs (i.e., surgery weight logs, use and disposition logs, daily care logs, etc.)

This is a regulatory requirement. Animal facility inspectors will cite PIs if animal logs are not maintained and will report repeat noncompliances to the NIH Office of Laboratory Animal Welfare (OLAW).

Safety and training

Mandatory Training Components for Research Animal Anesthesia and Surgery

All research personnel must receive training, demonstrate proficiency, and be certified by the Attending Veterinarian (AV) before performing anesthesia and surgery unsupervised. Training components may include:

  1. Complete Required CITI training;
  2. Observe and assist AV or experienced, qualified personnel perform anesthesia and surgery;
  3. Perform anesthesia and surgery, including pre-operative procedure, under direct supervision of AV until competent;
  4. Demonstrate proficiency and thorough post-operative observational skills to the AV (not applicable for non-survival surgery certification).

The Proficiency Criteria for Research Animal Surgery form contains proficiency criteria.

Regulatory References:

USDA AWA Regulations (9 CFR 2.32)

PHS Policy (IV.C.1.f.)

Guideline for Reporting of Adverse Events and Unexpected Outcomes and Injuries

Animals involved in research may be subject to events that have the potential to adversely impact their health or welfare. These events must be reported promptly to the Animal Care and Use Committee (IACUC) for assessment.

If you have concerns regarding the welfare and care of research animals, please see our guidance regarding Reporting Concerns.

Definitions

  • Adverse Event - An unexpected incident that negatively affects the health or welfare of animals.
  • Unexpected Outcome - An unexpected result of IACUC-approved animal activities. Examples of IACUC reportable unexpected outcomes may include, and are not limited to:
    • Animal morbidity or mortality occuring at a higher frequency than expected.
    • Unanticipated debilitating defects discovered after created or breeding genetically modified animals.
  • Injury - Unexpected injuries that results from accidents or IACUC-approved activities.
  • Expected Outcome - An anticipated result of IACUC-approved animal activities. For example, a certain percentage of morbidity or mortality may be expected with a particular procedure, such as a surgery or disease model. These outcomes do not need to be reported to the IACUC if they fall within the anticipated frequency of occurrance and the procedures are conducted as approved in the Animal Use Protocol (AUP).
  • Minor concerns – the animal is in distress, but not in a life-threatening situation. Examples might be: an animal which has been unable to obtain food or water for a short period of time, minor wounds, a suture or staple missing from an incision but the incision remains closed.
  • Extreme emergency – the animal needs immediate intervention/euthanasia. Examples might be: uncontrollable bleeding, continuous seizures, fractures, extreme dehydration, and severe self-mutilation resulting in open wounds.

Guidance

In the event of an unanticipated animal injury, illness, or research outcome that impacts animal welfare, Animal Care staff will attempt to contact the Principal Investigator (PI). The PI must post emergency contact information in his/her lab(s), updating it as changes in personnel occur.

PIs or research personnel should immediately notify the veterinarian or animal care staff of any unanticipated animal injury, illness, or research outcome that impacts animal welfare. Prompt notification is essential to prevent unnecessary pain or distress as well as to prevent the spread of any disease.

Euthanasia decisions will typically be made by the Pricipal Investigator in consultation with the Attending Veterinarian however, some events may require immediate action by the Animal Care Staff or the Attending Veterinarian to protect animal heath and welfare.

Procedures For Animal Care Staff

  • During normal working hours (8:00 a.m.–5:00 p.m.), Animal Care staff will contact the PI via all available contact numbers and email address provided by the PI.
  • If after 30 minutes there is no response by phone or email, Animal Care staff will contact the Attending Veterinarian or Alternate Veterinarian. The Veterinarian will take appropriate action.
  • If this is an extreme emergency, Animal Care staff will contact the Attending or Alternate Veterinarian and then call the PI. The Attending or Alternate Veterinarian or their representative will take appropriate action. Animal Care staff will notify the PI by email of action taken by the Veterinarian.

Procedures For PI or Research Personnel

  • Contact a member of the animal care staff or the veterinarian in the vivarium or call one of the emergency numbers posted on the vivarium office door.
  • The PI may wish to treat or euthanize the animal based on the severity of the situation and its effect on the research. The veterinarian or the animal care staff should be notified of this decision as soon as possible.
  • As soon as possible after resolution, the event must be reported, in writing, to the IACUC at iacuc@olemiss.edu. Please include the relevant protocol number, a brief description of the event, and how it was handled.

Procedures for the IACUC

  • Once an adverse event or unexpected outcome has been reported to the IACUC office, the IACUC Research Compliance Specialist notifies the IACUC Executive Committee (IEC). The IEC consists of the IACUC Chair, the AV, the Executive Director for Research Integrity, and Compliance, and one additional IACUC voting member.
  • The IEC reviews the reports and determines if the event/outcome constitutes an animal welfare concern. If the event/outcome is not an animal welfare concern, the event/outcome and resolution are reported at the next convened IACUC meeting.
The Attending or Alternate Veterinarian or their representative will take immediate action, irrespective of the above procedures, when he/she feels that the life of the animal is in jeopardy or if the animal appears to be experiencing undue pain or distress.

References:
The Guide, pg. 46
AWAR §2.31,d,vi; §2.31,d vii

Asthma and Allergy in Animal Handlers

Significance

Some people develop allergies to the animals they work with or to their own pets. The incidence is quite high — some estimate that as many as 15% of a human population is allergic to some animal species. If you're allergic to a species that you work with in your job, it can be quite debilitating. If you suffer from asthma, working with a species to which you are allergic can be a significant health risk.

Symptoms

Allergic individuals may display any of a number of symptoms; allergic rhinitis (a condition characterized by runny nose and sneezing similar to hay fever); by allergic conjunctivitis (irritation and tearing of the eyes); by asthma (characterized by wheezing and shortness of breath); or by contact dermatitis (a red, bumpy rash that may appear where your skin touches the animal). If you have a stuffy nose or other respiratory signs, and if it seems to last longer than a common cold (weeks instead of days) then you may very well be suffering from an allergy. If you develop suspicious symptoms whenever you're exposed to a certain species, then you're very likely to have an animal allergy.

Biology

Workers may be allergic to any animal species. The allergens are proteins that are excreted in the animals' saliva, urine, and from various glands associated with the skin. The proteins tend to be sticky and become associated with the animal's hair and with particles of dander. The allergens are unique to each species of animal, so it's possible to be allergic to mice and not to rats and vice versa. It's also possible to be allergic to multiple species; in fact a person who is already allergic to one allergen (animal or otherwise) has a greater chance of becoming allergic to a new allergen that a person that has no allergies at all.

The animals most commonly associated with workplace allergies are mice and rats; perhaps these are the most common laboratory animals. Other animals to which allergies are seen include rabbits, cats, guinea pigs, dogs, horses, and even cattle and pigs. An individual could potentially be allergic to almost any animal.

Relative Risk

Exposure to animals is only one of many risk factors associated with asthma and allergy. Various studies have shown that the incidence of animal allergies among animal handlers may be as low as 10% or as high as 30%. While this means that the majority of animal handlers don't suffer from allergies to the animals under their care, it also means that animal handlers have an incidence of allergy and asthma about three times as high as that seen in workers who do not work with animals. Allergy is clearly an important risk associated with animals.

Prevention and Treatment

Those who work with animals should be aware of the signs and symptoms of animal allergies. If you work with animals, and feel you may suffer from allergy to the animals you work with, you should discuss this with your private physician. If you're a supervisor, you should be aware of the possibility of allergy in your workers, and you should be aware of factors in the workplace that can increase or decrease the exposure of your workers to animal allergens.

Allergy can often be managed by a combination of medical management and workplace strategies. It's important to consult with a physician to determine the cause of your allergy in order to manage it effectively.

The most effective way to control and prevent allergies is to minimize exposure to the allergens. If you work in an animal facility, or if you work with animals in a laboratory setting, the following practices may help reduce your exposure to animal allergens:

  • When possible, perform animal manipulations in a ventilated hood or a biosafety cabinet.
  • When you're not working in a hood or cabinet, make sure that the animal room or other work area is adequately ventilated and that all the air handling equipment in the room is in good order. If there is doubt, your supervisor can ask Facilities to measure the number of air changes in the room. Animal rooms should deliver at least 10 air changes per hour.
  • Don't wear your street clothes when working with animals. Wear dedicated, protective clothing.
  • Launder your protective clothing at work, or have it cleaned by a professional service. Don't take your protective clothing home with you.
  • Wash your hands frequently. Avoid touching your hands to your face while working in the vivarium.
  • Keep cages and your work area clean.
  • Use beddings that are not dusty. Most commercial beddings are not dusty. Wood shavings may be dusty or not depending on their source and quality.
  • Reduce your skin contact with animals by wearing gloves and long-sleeved lab coats.
  • If you suffer from allergies to a species you must work with, consider wearing an approved, NIOSH certified N95 respirator when in the animal facility. Respirators are, in general, less effective than the other methods shown above and should not be used as a substitute for good workplace hygiene.

If your job requires you to be exposed to something to which you are allergic, you should discuss with your physician what effect the allergy may have on your future health. Some workers are so severely affected that only a change in career will control their allergies.

References

Preventing Asthma in Animal Handlers, January, 1998. DHHS (NIOSH) Publication No. 97-116. Available on the Web at http://www.cdc.gov/niosh/docs/97-116/ 

Vivarium information

DO's

  1. Update all emergency contact information with current names and numbers.
  2. Update protocol information labels on doors.
  3. Keep all animal and procedure rooms clean, routinely disinfected, uncluttered (i.e., wipe up water and feed spills, as well as urine/feces).
  4. Store all equipment after use.
    Keep floors unobstructed and sanitized (i.e. power cords, boxes, computers; furniture should not rest on the floor).
  5. Wear appropriate protective clothing (i.e. lab coats or scrubs and footwear) and eye protection.
  6. Pre-schedule tours and or visits to the UM Vivarium or satellite facilities through the Office of Research.
  7. Learn exit routes and pre-designate a gathering area outside the Vivarium or satellite facility for your research group.
  8. Check animals on active studies on a daily basis.
  9. Alert Vivarium (or satellite facility) personnel to any animal health or equipment problems (i.e. low feed, low water, flooded or dirty cage).
  10. Maintain up-to-date account numbers on cage tags.
  11. Keep conversation to a minimum.
  12. Wash hands frequently and especially when moving from one animal room to another.
  13. Learn when cage changeouts and room sanitation is scheduled, and, if possible, plan projects around these times. Please inform animal care staff at least 24 hours in advance if this is not possible.
  14. Hang “Experiment in Progress” signs on doors when procedures are in progress. Take them down when rooms are not in use.
  15. Clearly label lab coats with name and research group.
  16. Keep animal colony room doors closed.
  17. Use sign-up boards for surgery and necropsy rooms.
  18. Clearly label bags with euthanized animals with the protocol number, investigator name and date before placing in the freezer.
  19. Notify Vivarium supervisor when personnel/students no longer need access to the Vivarium.
  20. Maintain animal logs (i.e., surgery weight logs for animals on active studies, and use and disposition logs, especially important for guinea pigs, rabbits, hamsters).
  21. Properly dispose of syringes, glassware, needles and sharps.

DON'T's

  1. Do not bring food into the UM Vivarium or satellite facilities (exception: offices and tech carrels).
  2. Do not wear perfumes or colognes.
  3. Do not bring cellphones, pdas, non-university-owned laptops, cameras, or mp3/cd players into the Vivarium or satellite facilities.
  4. Do not bring outerwear (i.e. coats, raincoats, etc), back packs, or brief cases into the Vivarium or satellite facilities.
  5. Do not wear shorts, dresses or skirts in the Vivarium or satellite facilities
  6. Do not wear facility-dedicated lab coats/shoes and personal protective equipment outside of the Vivarium or satellite facilities.
  7. Do not let unauthorized personnel (visitors or children) into restricted areas.
  8. Do not tape or glue posters, notices, etc. to walls or doors.
  9. Do not use cardboard boxes for storage within the Vivarium or satellite facilities
  10. Do not take Vivarium/satellite facility- specific clothing/shoes home to clean.
  11. Do not obstruct air return ducts.
  12. Do not leave dirty glassware in sinks.
  13. Do not remove carts or tables from cagewash without asking.
  14. Do not hang items on, over, or from heat, light and humidity sensors in testing rooms.

PURPOSE

Provides a mechanism for holding research animals not assigned to current UM protocols.

BACKGROUND

Protocols must meet all federal regulations. The Institutional Animal Care and Use Committee ( IACUC ) have the responsibility to ensure that all animal use activity meets federal law, Public Health Service policy, and accreditation standards. All animals maintained by The University of Mississippi (UM) must be covered by an active, IACUC-approved protocol. This policy addresses holding animals on a global animal holding protocol.

RESPONSIBILITIES

Researcher – The PI should work with the IACUC to ensure that protocols are active and current for any anticipated or ongoing animal use.

IACUC – The IACUC provides a mechanism for rapid transfer of animals in cases where necessary to protect the wellbeing, welfare, or prevent the waste of the animals.

Attending Veterinarian or Designee – The AV maintains a Holding Protocol to receive and maintain animals that would otherwise be euthanized for lack of an existing active protocol.

POLICY AND PROCEDURES

Use of the Holding Protocol (HP) is intended to be temporary. Situations which may result in the use of this protocol might include:

  1. Animals ordered without an approved protocol (noncompliance situation).
  2. Animals originating from inactive (or terminated) protocols.
  3. Animals on a protocol under investigation for potential issues of noncompliance where the welfare or wellbeing of the animals is in question.
  4. New investigators without an IACUC-approved protocol having animals that may require immediate housing at UM.
  5. Investigators that are leaving UM and do not have approval for transfer to the new institution.
  6. Animal Care staff is only authorized to transfer animals on a holding protocol to another PI after consultation with the original PI.
  7. Request forms to place animals on the UMHP will be completed by the PI, the IACUC Chair, or the Attending Veterinarian (AV). PIs will submit the form to the AV, the IACUC chair, or the IACUC Executive Committee, any of whom can authorize the transfer of animals from an active protocol to the holding protocol. All actions will be reported to the IACUC at the next regularly scheduled meeting.
  8. Fees: Per diems for animals will be charged to the investigator (or department) while animals are on the holding protocol. No animal related costs may be charged to federal funding sources until the three-year renewal is approved by the IACUC.
  9. Management of Animals on the UMHP:
    1. No experimental procedures are allowed on animals maintained on the HP. Any use of animals on the HP will be treated as serious regulatory noncompliance.
    2. Breeding may be performed to maintain viability of specific lines occurring under this protocol. Expansion colony breeding is not authorized.
    3. Feeding, sanitation and environmental enrichment will be performed as expected for the species. Husbandry duties may be performed by the Animal Care staff, the PI or previously approved personnel depending on the circumstances.
    4. No tissues may be utilized from animals euthanized without specific IACUC approval.
    5. Animals may not be euthanized for research purposes.
    6. Other than animals already on the UMHP, no additional animals may be ordered in anticipation of IACUC approval of a new or renewal study.
  10. Animal Care staff must be notified of all significant pre-existing conditions prior to transfer of animals onto the holding protocol. Examples include but are not limited to:
    1. Existing surgical implants.
    2. Zoonotic disease or other hazard.
    3. Special dietary needs.
    4. Past surgical history.
    5. Viral vectors.
    6. Poor fecundity.
    7. If any of these situations exist for animals on the holding protocol, Animal Care staff may place a surcharge with the Vice Chancellor’s approval.
  11. In the case of an expired protocol, the animals may remain on the HP for no more than one month from the expiration date of the prior protocol unless a renewal protocol is submitted during that month, at which time the animals may remain on the UMHP for a total of two months from the expiration date of the prior protocol.
  12. If holding protocol timelines elapse or if the renewal protocol is not approved, animals on the HP may be transferred or euthanized by the AV or the animal care staff. In the case of wildlife studies, it may not be appropriate to euthanize the animals. In such cases, the investigator may release the animals in accordance with any applicable guidelines and regulations.
  13. Timelines for other situations will be established by the Attending Veterinarian on a case by case basis.

Background

We strongly encourage investigators to share research animals in order to reduce research animal numbers. Transfer of animals already used in protocols (i.e., non-“surplus” animals) depends on the following conditions:

  1. Multiple major survival surgeries are not allowed;
  2. Animals subjected to a major surgery or other procedure with the potential for more than momentary or slight pain or distress will not be approved for transfer to another protocol unless scientific justification is provided, and the transfer is reviewed and approved by both the University Veterinarian and the IACUC.

How do I transfer animals to another investigator?

Once the receiving and donating PIs agree on the transfer, the following must occur:

  • Principal Investigators
    • The donating PI informs the Animal Facility Supervisor about the agreement.
    • The donating PI completes Part 1 of the Request for Intra-University Transfer of Live Animals form, and the receiving PI
      completes Part 2.
    • One of the PIs faxes (x5324) or hand delivers the signed original to the UM Vivarium, B103 NCNPR.
      (Facility preparations will take longer if biohazards, infectious agents or radioactivity are involved.)
  • Animal Facility Supervisor (once notified by the donating PI of the agreement to transfer animals):
    • Notes the transfer.
    • Changes the per diem billing account to the receiving PI.

What happens to the form after it is submitted?

  • Animal Facility Supervisor notifies IACUC staff and Attending Veterinarian.
  • Attending Veterinarian reviews the form.
  • IACUC Staff ensures proper animal numbers tracking for animal use is within regulations.
  • Final disposition rests with the Attending Veterinarian or Animal Facility Supervisor, who must approve the transfer.
  • The IACUC will review cases where “Background” bullet #2 above applies.

What happens once the animal transfer is approved?

  • Animal Facility Staff:
    • Contacts the PI to arrange for the transfer once the application is approved.
    • Ensures that animals are housed properly and that all census sheets are revised.
    • Faxes (x7577) a copy to the IACUC office.
  • IACUC Staff:
    • Notifies both PIs of the approval via email; if the animal transfer was denied, the PIs will be provided the reason for the denial.
    • Faxes a copy of the approved form to both PIs.
    • Files the original approved form in the Animal Transfer folder and a copy each in the respective protocol folders for the donating and receiving PIs

Information for per diem, animal tracking, and accounting:

  • Donating PI:
    • Will have transferred animals subtracted from their protocol only if they were not used in protocol procedures. Control animals are counted as animals used in the protocol.
    • Must report the transfer on their next Protocol Annual Update form.
  • Receiving PI:
    • Will be charged per diems.
    • Will have the number of animals transferred counted against their protocol.
    • Is responsible for new cage cards for the animals containing all necessary information (for animals housed in the Animal Facility, these may be obtained from the Animal Facility office).
    • Must report the transfer on the next Protocol Annual Update form.
Contact us with questions:
Division of Research Integrity and Compliance at x7482 (iacuc@olemiss.edu)

References:
AWAR § 2.31,d,1,x,A
Guide, page 12