III
Sample Objectives or Self-Assessment Statements

INTRODUCTION

The following are samples of learning objectives or self-assessment statements that coordinators may want to use or adapt for use at their institutions. Additional statements should be developed as necessary.

CORE MODULE

Laws, Regulations, and Policies That Impact on the Care and Use of Animals

State the primary sources of regulations and policies affecting the care and use of laboratory animals.

State the major provisions of the Animal Welfare Act regulations and PHS policy.

Describe the composition and functions of the IACUC.

Outline the required contents of your institution's PHS Assurance Statements and annual reports to the USDA and the PHS Office for Protection from Research Risks.

Describe the possible penalties for noncompliance with federal regulations and policies.

Describe the policies of your institution that affect research protocols.

Ethical and Scientific Issues

Compare key elements of the deontological and the utilitarian positions on the use of animals in research, education, and testing.



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Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs III Sample Objectives or Self-Assessment Statements INTRODUCTION The following are samples of learning objectives or self-assessment statements that coordinators may want to use or adapt for use at their institutions. Additional statements should be developed as necessary. CORE MODULE Laws, Regulations, and Policies That Impact on the Care and Use of Animals State the primary sources of regulations and policies affecting the care and use of laboratory animals. State the major provisions of the Animal Welfare Act regulations and PHS policy. Describe the composition and functions of the IACUC. Outline the required contents of your institution's PHS Assurance Statements and annual reports to the USDA and the PHS Office for Protection from Research Risks. Describe the possible penalties for noncompliance with federal regulations and policies. Describe the policies of your institution that affect research protocols. Ethical and Scientific Issues Compare key elements of the deontological and the utilitarian positions on the use of animals in research, education, and testing.

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Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs List six ethical principles suggested in the U.S. government's Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. Discuss what you might do differently in the future in response to concerns over use of animals in research. Alternatives Define the "3R's". Cite examples of nonanimal research methods and models that might aid you in your research goals. Discuss how regulations and policies on the use of alternatives affect your present and future projects. Cite the factors that influence animal model selection. List services that you can use to gather information on alternatives and indicate how you have access to these services. Responsibilities of the Institution, Animal Care and Use Committee, and Research and Veterinary Staffs State three major institutional responsibilities. List the mandated responsibilities of the IACUC. Discuss how delegating authority to the IACUC provides protection to the institution, individual investigators, and research animals. State six major categories of investigator responsibility and describe how these might be delegated among the principal investigator, co-investigators, and technical staff. If your institution has policies relating to the major categories of institutional responsibility, state where copies of these policies can be obtained. Pain and Distress Define pain, stress, and distress. State the principles of nonmalficence and beneficence. Describe situations in which pain can be present when reflex responses are absent and absent when reflex responses are present. Describe physiologic and behavioral signs that may indicate the presence of pain and distress. Discuss steps taken by your institution in carrying out its legal obligations to minimize and control pain in animals. Discuss the concept of adequate veterinary care as it relates to relief of pain.

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Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs Anesthetics, Analgesics, Tranquilizers, and Neuromuscular Blocking Agents Give an example of a pharmacologic agent that can produce each of the following: general anesthesia, analgesia, tranquilization, sedation, and chemical immobilization. List factors that are major determinants for calculating drug doses and drug effectiveness. List physiologic functions that should be monitored during general anesthesia. Describe how an anesthetic overdose is diagnosed, and what you would do if an overdose occurred. Describe requirements for recordkeeping associated with the use of pharmacologic agents, including special records required for procuring and storing controlled drugs. Survival Surgical and Postsurgical Care Define major, minor, survival, and nonsurvival surgeries. Describe the facility and equipment requirements for performing survival surgery on rodents and on mammals other than rodents. Describe the major considerations for aseptic surgery. List the most common complications of survival surgery, and describe the environment and care that is necessary to prevent morbidity and pain. Describe in detail the records that must be kept for an animal on which a surgical procedure is performed. Euthanasia Discuss the legal requirements for performing euthanasia on laboratory animals and cite the sources of laws, regulations, policies, and guidelines. List several examples of chemical methods of euthanasia and discuss the advantages and disadvantages of each. List several examples of nonchemical methods of euthanasia and discuss the advantages and disadvantages of each. Cite reasons for selecting the method of euthanasia that was chosen for use in your research protocol. Discuss ways in which professional and support staff may respond to the performance of euthanasia. Describe in detail your institution's protocol for disposal of animal carcasses, including any special considerations that may apply to your project. Husbandry, Care, and the Importance of the Environment Discuss benefits to animal research derived from control of environmental variables.

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Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs Describe in detail the measures you have taken to ensure that the animals used for your research, teaching, or testing program are housed and cared for at all times in conformance with USDA regulations and PHS policy. Describe the measures that will be taken to protect your animals in case of emergencies, such as a power failure. Resources Give examples of where you can find information regarding alternatives to use of animals. Describe where you can find information on earlier studies related to your work. Describe the resources available to you within your institution or community. SPECIES-SPECIFIC MODULE Selection and Procurement of Animals For your specific project(s), discuss the reasons for your choice of animal(s) to be studied. Discuss any legal requirements and institutional policies related to procurement of the animal(s) you have chosen for study. Husbandry and Care Discuss who is responsible for ensuring good husbandry practices and appropriate handling of the animals used in your project. For the animals selected, state the size and construction materials of the cages you will be using, the population density that is appropriate, and the food- and water-delivery systems that will be used. Discuss factors in the macroenvironment that are important to the particular species used in your research. Animal Health For the given species: State normal physiologic parameters. Describe physiologic and behavioral signs associated with pain and distress. List the signs of common diseases or conditions that require veterinary intervention.

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Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs Safety and Health Considerations (Zoonoses) For a given species, indicate routine precautions that should be taken to prevent transmission of disease. State recommended precautions for handling known high-risk animals. Specific Techniques Assemble all instruments and material for performing a given procedure. Indicate the structures or landmarks that will guide performance of the technique, including any structures that must be avoided. State how you will know if the procedure is progressing as planned and how to respond to an error. Euthanasia Indicate the method of euthanasia to be used in a given project, and give the reasons for selecting that method. PAIN-MANAGEMENT MODULE Definitions, Mechanisms, and Assessment Discuss the potentially painful aspects of your project and ways in which you will monitor subjects for pain and distress. Legal and Ethical Obligations Discuss what you are required to do to meet your legal and ethical obligations. Discuss how the attending veterinarian can assist you. Alleviation of Pain or Distress Suggest several ways that research staff and caregivers can reduce pain and distress in research animals without using pharmacologic agents. Give examples of situations in which you might choose to use a tranquilizer, an analgesic, or a neuromuscular blocking agent. For a specific animal and drug, calculate dosage and give details of administration. Explain "dosage to effect" for anesthetics, and list factors that influence effectiveness.

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Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs Anesthestics Write out instructions for preanesthesia, initial dose of anesthetic, and follow-up dosage, as necessary, specifying time intervals and methods of monitoring effectiveness. Describe signs of overdose, and state what interventions you would initiate. Euthanasia Discuss conditions under which you would be required to kill an animal before completion of the experiment and the procedure you would follow. SURGERY MODULE Legal Requirements for Survival Surgery Write a proposal for survival surgery on the species of your choice, providing sufficient information to demonstrate compliance with legal and institutional requirements. Aseptic Technique For a specific procedure on the species of your choice, describe in detail all areas of preparation for aseptic surgery, indicating who on the surgical team is involved in each action. Selection and Administration of Anesthetic For a specified animal and surgical protocol, write a pain-management protocol, stating dosage and assessment of effectiveness. Animal Monitoring For a specified animal, give the range of vital signs that you would consider acceptable during the surgical procedure and methods of monitoring vital signs during and immedi­ately after surgery. Surgical Techniques Describe the surgical procedure(s) you are using in your research, including equipment and instruments needed.

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Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs Describe the suture material preferred for the surgical procedure of your choice and state what precautions you would take to prevent dehiscence and infection. Postsurgical Care For a specific animal and a specific procedure, write a protocol for routine postsurgical monitoring, including indicators of when the animal can be returned to normal caging. Describe the signs of shock and state what interventions you would initiate in the presence of these signs. Medical Records List and describe all pertinent and required items that should be entered into the medical record of an animal subjected to surgery. Terminal Surgeries For a given animal, elect a method of euthanasia and indicate the exact procedure, including confirmation of death, and disposal method that you would use.

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