Ethical Scenario #1 – What do You Do?

Scenario Setup

You are a first year post-doc working in Dr. Eric McGarrity’s laboratory who is doing some ground-breaking work in immunology. You felt honored to get a position in the laboratory- it was very competitive. The research protocol you are working with involves cats and innovative work.

The Situation

It is early on a Saturday (8 a.m.) when you come in to do your work. Dr. McGarrity walks into the laboratory and says that the cats have to have timed blood draws (10 ml each) at 2 and 4 p.m. and make to sure this happens because all the work for the past 6 months “will be worthless” if it doesn’t happen. You start getting everything ready to perform the blood work on the cats.

The Problem

You are reviewing the protocol and realize that the protocol doesn’t have approval to draw the blood from the cats. You find Dr. McGarrity in his office and explain this and he states that this isn’t a problem; because he has this approval on other protocols, it is a minor oversight at worst. He tells you to just do the blood draws.

What do you do?

As a twist…

You are the attending veterinarian and happen to be in the facility because of another issue and hear your vet techs discussing the blood draws (they found it out somehow). You go up and talk with Dr. McGarrity about this issue. As you review all of his current, IACUC-approved protocols, it is clear that he does not have approval to perform 2 10-ml timed blood draws on cats.

What do you do?

As a twist…

You are the chair of the IACUC and the PI called you to inform you that he needed to take the timed blood samples in order to not waste these animals and 6 months worth of work and “just realized” that he does not have approval to perform this procedure on his cats.

What do you do?

 

Ethical Scenario #2 – Reduction vs. Refinement

Scenario Setup

The regulations state that you must use the 3Rs of Research: Reduction, Refinement and Replacement. What if reduction and refinement are at odds with each other? For example, say you are working with non-human primates. These are highly intelligent creatures, so you feel the need to use the least amount of animals possible in your research project. However, what you are doing to the animals may cause pain and distress. You have two choices: reduce the animal numbers and cause more pain to fewer animals or increase the animal numbers and cause less pain to more animals.

What do you do?

Specism is the act of placing higher moral or ethical value on one species over others. It is done in the laboratory animal field all the time. In fact, it is a requirement to view animal work in this way. Federal law requires that researchers consider the concept of refinement when using laboratory animals: one aspect of refinement is using animals lower on the phylogenetic scale (e.g., using mice instead of rabbits, rabbits instead of cats, cats instead of non-human primates).

How would we define the issue of animals and ethics and the use of animals- whether in biomedical use, exhibition, or as pets? Does common sense play a role in this? Is it a philosophical issue or a moral debate? Is it a personal choice or a societal dilemma? These questions are not easily answered- we can only say that it is a deeply divided issue and a long-standing subject for debate.

Using animals in research requires that some conditions be met. The procedures involving animals must be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. And the proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. The view that we, as human beings, have the right to make these decisions, is based on various philosophical arguments.

Scientific Justification

For research based on an animal model, the validity of the science is the model. It is dependent upon the extent that the experimental findings in the animal model can be generalized to other species, in particular, human beings.

Ethical Justification

Ethical justification of animal research is, in some ways, more difficult than the scientific justification as an individual’s personal beliefs can affect the way they may view the research. It can converge with the scientific justification and can, in some ways, depend on it. It boils down to the following: is the ethical cost of the research (the pain of the animals, the ultimate death of the animals) either balanced or outweighed by the potential value of the research to human or animal health, the advancement of knowledge, or the good of society?

In 2012, the Office of Clinical and Translational Research (OCTR) instituted the OCTR policy that requires budget initiation meetings for all clinical trials before or at the time that the trial opens for accrual.

For all studies which required a Budget Workbook, a budget initiation meeting is scheduled when final IRB approval is issued. The meeting should occur prior to the enrollment of the first study participant, but may occur due to scheduling conflicts within two weeks of the opening of the study.

It is strongly recommended that the study coordinator, department administrator and/or billing coordinator, and the PI attend the budget initiation meeting. The purpose of the meeting is as follows:

• To review the Medicare Coverage Analysis prepared by OCTR personnel
• To review and confirm accuracy of procedure codes and time and effort (T&E) allocations in the Budget Workbook
• To amend the workbook with any new charges or changes to charges in the original Budget Workbook
• To review process for opening and maintaining Banner account
• To review payment procedures and research rates to be paid for UMG and JDH protocol induced charges
• To review the sponsor’s budget, if applicable, and clarify what may be charged to insurance and what is being paid by research
• To identify charges to be invoiced to a research sponsor
• To review coding procedures for RC and PIC medical services

The IACUC Connection is designed to help researchers who work with laboratory animals at UConn Health.

 

Update:  The IACUC Connection is coming back!  First one out will be in April, 2025.

Release Date	Topics
Spring (April) 2025	Semi-annual inspections

The purpose of an occupational health program is to help to provide a safe and healthy work environment. Working with laboratory animals presents potential hazards or problems: some are inherent in all animal-care related activities and others result from the nature and design of the experimental protocol.

Physical hazards include scratches, bites, injuries from lifting or carrying heavy objects, needle-sticks or injuries from other sharp objects, and falling injuries.

Chemical hazards include flammable agents, cleaning, disinfecting, and sanitizing compounds, carcinogens, mutagens, teratogens, and radioactive compounds.

Zoonotic hazards include infectious agents (biohazards) individuals may be exposed to when working with laboratory animals. Though fairly uncommon, they represent potentially serious and fatal hazards to those working with laboratory animals.

Laboratory animal allergies is one of the most wide-spread and serious hazard faced by individuals working with laboratory animals. Many individuals (40 to 75 percent) experience allergic reactions of some type when working with laboratory animals- many of these can ultimately develop asthma.

Standards and Guidelines

For many years, NIH and other federal funding bodies have required that research facilities provide an occupational health program for those who work with research animals. In 1997, the National Research Council (NRC) published Occupational Health and Safety in the Care and Use of Research Animals, which established the standards for Occupational Health Programs in research facilities. The objective was to promote occupational health and safety by recognizing and considering hazards and health risks associated with the care and use of research animals. The report differed from previous reports, though it affirmed prudent practices developed in previous reports.

Are the standards new?

The biggest difference between the 1997 guideline and older guidelines is the concept of increased risk. It is not the number of hours an individual works with animals (e.g., determining if individuals meet “substantial animal contact” definitions) that determines their participation in the program anymore. The recommendation was “that every institution initiate a concerted effort to address the health and safety hazards associated with the care and use of research animals and broaden its occupational health and safety program as necessary to reduce the risks to an acceptable level.” Substantial contact with research animals was deemed not to be a sufficient indicator of the need for health surveillance but based on the hazards associated with the care and use of research animals.

It was also recommended that every institution develop a multidisciplinary approach to occupational health and safety that permits the continuing evaluation of potential workplace hazards and the risks to the employees who work with animals. This risk assessment should include frequency of contact, intensity of exposures, hazards associated with the animals being handled, hazardous properties of the agents being used in the research being conducted, the susceptibility of the individual employee, the hazard-control measures that are in place, and the occupational history of each individual employee.

Who is at increased risk?

An employee or student is at “increased risk” if they are exposed to live, vertebrate animals in a way that gives them an increased risk of an occupational illness, such as a zoonotic diseases, physical injury, or allergies. Most people who work with animals are at increased risk of animal related illness. The recommendations of the NRC is that participation in the occupational health surveillance program not be limited to full-time employees who are involved in the care and use of animals but to all personnel involved in the care and use of research animals based upon the basis of risks encountered.

Who must enroll in the program?

All employees who work with laboratory animals must enroll in the occupational health program. This includes Principal Investigators, post-docs, research assistants, graduate students, part-time employees, volunteers, summer students, and special payroll employees.

Who is responsible for the Occupational Health Program for individuals who work with laboratory animals?

The Institution

UConn Health Center, represented by its Institutional Official (IO), has ultimate responsibility for providing a healthful and safe work environment. The IO must have an adequate understanding of all the issues in the Occupational Health Program. Institutional management is the key element required for developing and sustaining any useful occupational health and safety program.

Principal Investigators

An effective program relies on the involvement and commitment of managers at all levels. They should disseminate knowledge about the program to all personnel who work in their laboratories. PIs sign an assurance that they will make sure that all their personnel will enroll in the occupational health surveillance program.

Employees

All employees must take responsibility for their own health and safety and for the safety of others around them. This requires that employees should follow standard procedures, all applicable policies, and be knowledgeable about the risks they are working with. A truly successful program will ultimately depend on the participation of all employees.

Institutional Animal Care and Use Committee

It is the responsibility of the IACUC to ensure that there is a program at the institution. It is also charged with keeping a record of all individuals enrolled in the occupational health surveillance program.

Employee Health Service

It is the responsibility of EHS to enroll individuals into the occupational health program. Employees are encouraged to discuss surveillance with a health care professional at EHS who will be able to advise each individual, in the context of their particular health status, about the risks associated with working with laboratory animals and other risks identified in the IACUC protocol.

What is the ideal program?

There is no such thing as the “ideal” occupational health and safety program. But you can say that protecting the health and safety of employees engaged in the care and use of research animals is a cooperative undertaking that requires the active participation of institutional officials, scientists who plan and carry out research involving experimental animals, individuals responsible for the management of animal care and use programs, health and safety professionals, and the individual employees who share the responsibility for their own health and safety and for the health and safety of those they work with.

What are the components of an effective occupational health program?

The Guide for the Care and Use of Laboratory Animals identifies the following components as necessary to an effective occupational health program:

Hazard Identification and Risk Assessment

There should be an individual involved with the program who is qualified to assess dangers associated with the use of animals and to select safeguards appropriate to the risks. Health and safety specialists with knowledge in the appropriate disciplines should be involved in the assessment of risks associated with hazardous activities and in the development of procedures to manage those risks. Though the IACUC website provides an initial risk assessment that can be done privately, UConn Health encourages individuals to speak with the Biosafety Officer and Employee Health Service.

Personnel Training

Personnel should be trained regarding zoonoses, chemical safety, microbiologic and physical hazards, handling of waste materials, and other considerations.

Personal Hygiene

It is essential that all personnel maintain a high standard of personal cleanliness. Suitable and/or dedicated clothing for the animal facility and animal use laboratories should be used. Personnel should not eat, drink, smoke, or apply cosmetics in animal rooms.

Personal Protective Equipment

PPE should be provided to include dedicated clothing (where appropriate), bonnets, masks, gloves, and shoe covers. Face shields and arm protectors should be available for individuals working with nonhuman primates. Protective clothing should not be worn outside the immediate animal area (e.g., cafeteria, rest room).

Adequate Facilities, Procedures, and Monitoring

Facilities and supplies for washing should be provided- the facilities should be appropriate to the animal care and use program. Facilities, equipment, and procedures should be designed, selected, and developed to provide for ergonomically sound operations.

Medical Evaluation and Preventive Medicine for Personnel

Development and implementation of a program of medical evaluation and preventative medicine should be available. The evaluations and preventive medicine program should be tailored to each individual enrolled in the occupational health program.

Animal Experimentation Involving Hazards

Careful consideration should be given to animal protocols involving hazards to include housing considerations, waste and carcass disposal, and safe handling of the hazards involved. Formal safety programs should be established to assess hazards, determine safeguards needed for their control, ensure that the staff has the necessary training and skills, and ensure that the facilities are adequate for the safe conduct of the research being performed

In order to be compliant with both PHS Policy on the Humane Care and Use of Laboratory Animals and the UConn Health Policy on Occupational Health Surveillance Program for Principal Investigators, Researchers, Technicians, Center for Comparative Medicine Staff, and Students Utilizing Animals in Research or Educational Programs, the Principal Investigator and everyone listed on a protocol as an animal user must enroll in the UConn Health Occupational Health Surveillance Program for Animal Users on an annual basis.

It would be helpful for all animal users to perform a preliminary risk assessment prior to filling out the MACE form (see below). Click on the species that will be used to see associated risks. Prior to consulting with each person listed on the protocol, the PI is advised to come to a consensus with the Biological Safety Officer (BSO) about what will be considered hazards in the IACUC protocol.

IMPORTANT INFORMATION:  You cannot enroll in the OHS program until you have completed an initial animal user registration form and that form has been processed by the IACUC office.  DO NOT TRY to enroll in the OHS program until you receive an email informing you that your animal user training registration form has been processed.  You must have a UConn Health network account; if you do not, you will not be able to enroll in the OHS program.  You will need to speak with your department administrator to have one set up.  This includes people from UConn Storrs or other branches – you still will require a UConn Health network account.

PLEASE NOTE:  There has been some confusion between the OHS program and the medical clearance for animal use requirement.  Enrollment in the OHS program is done when you complete the MACE form and submit it.  The medical clearance is an appointment with Employee Health Service (EHS) where they ensure that you are medically fit to use animals, as using laboratory animals is a hazard.  To complete this requirement, you need to call EHS at x2893 and say you need an appointment to be cleared for laboratory animal use.

To enroll:

Complete the Mandatory Annual Certification of Enrollment (MACE) enrollment form

(You MUST be on campus or connected to the UConn Health VPN, and otherwise signed in to the UConn Health network through some other means, i.e. remote.uchc.edu, to complete this form and submit it to the IACUC and Employee Health Services offices via the “submit” button at the top of the form. If you are off campus and can’t gain access through VPN, contact the UConn Health IT department (860-679-4400) for any questions or accessing this form from off campus.  Please DO NOT contact the IACUC office. )

Protecting yourself with Personal Protective Equipment (PPE), including respirators is HIGHLY RECOMMENDED. Respirators may be helpful in preventing allergies to laboratory animals.  Unless directed by Environmental Health & Safety (EH&S) that a respirator is required for a specific task, your choice to wear a respirator will be considered voluntary.  If you choose to protect yourself with a respirator, you will need to review the OSHA document regarding the use of respirators.

You will also need to consult with EH&S, or with the Biological Safety Officer (BSO), about how to do this. For respirators, medical clearance and fit testing will be required.  Medical clearance for respirators is obtained through Employee Health Service (EHS).  Medical clearance is separate from the OHS program and involves filling out a separate questionnaire – call EH&S at 860-679-2723 to get a copy of the Respirator Questionnaire and then send the Respirator Questionnaire directly to EHS (MC-6210).  Respirator fit testing and training is performed by EH&S and must be done after written medical clearance is received from EHS.

Please note that no new protocols or modified protocols will be approved until all personnel associated with these protocols are enrolled in the Occupational Health Surveillance Program for Animal Users; therefore, please make this a priority in your laboratory.

Thank you for your cooperation in this matter.

Occupational/Environmental Medicine
Environmental Health and Safety
Institutional Animal Care and Use Committee

What Is Leptospirosis?

Leptospira species are bacteria found in many animals but are most commonly associated with livestock and dogs. Transmission from laboratory rodents to people has been reported. It causes an acute febrile illness with fever, headache, nausea, and vomiting. Leptospirosis in animals is often subclinical- an infected animal may appear healthy even as it sheds the bacteria in its urine.

Routes of Infection

Humans become infected with Leptospires after exposure to fresh urine. The bacterial infect humans by invasion across mucosal surfaces or non-intact skin. Infection may occur via direct contact with urine or through contact with contaminated water and soil. In favorable conditions, leptospires can survive in fresh water for as many as 16 days and in soil for as many as 24 days.

Risks

In 10 percent of cases, leptospirosis presentation is dramatic and reaches mortality rates of 10 percent.

Prevention

Leptospira infection can be prevented by taking the appropriate precautions when handling rodents of unknown lymphochoriomeningitis virus (LCMV) status. Keeping wild rodents out of the animal facility is an important step to prevention of leptospirosis in the laboratory rodent population.

What Is Hantavirus?

Hantavirus Pulmonary Syndrome (HPS) is a respiratory disease caused by a virus known as Sin Nombre Virus. The virus is carried by wild rodents, especially deer mice. The virus produces no clinical symptoms in the deer mice, but can produce a deadly infection in man – over 50 percent of human cases have been fatal.

Routes of Infection

Humans become infected with the hantavirus when they inhale dust which has been contaminated with rodent urine. Most individuals who have become infected have lived or worked in areas that were heavily contaminated with rodent droppings. Campgrounds, abandoned cabins, and other areas that have become infested with high populations of wild rodents should be considered risky. Digging up a rodent nest, trapping wild rodents, or performing necropsies on wild rodents would also be considered risky activities.

If a human being becomes infected, signs of illness usually appear about two weeks after exposure, although the time can range from a few days to as long as six weeks. The first signs are fever, headache, and pain in the abdomen, joints, and back. Afterwards, the patient’s lungs begin to fill with fluid and breathing becomes extremely difficult. A high proportion of the patients die, but early treatment offers the best chance of survival. If you develop symptoms that are suspicious of HPS, and you have worked with or been around wild rodents within the last six weeks, report this information to your physician immediately.

Risks

Most individuals who have contracted HPS have acquired the disease by living and sleeping in areas where there are large populations of rodents and copious quantities of dust contaminated with their feces. In a research setting, there is also risk associated with individuals that work with wild rodents.