Research Office iacuc pain & Distress Policy & Guide
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- Bu səhifədəki naviqasiya:
- POLICY GUIDE: Pain Distress - Assessment and Categorization POLICY
- PI responsibilities
- Pain and Distress Definitions
- Category Definitions Examples
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POLICY & GUIDE: Pain & Distress - Assessment and Categorization POLICY: Oregon State University is committed to protecting the welfare of animals associated with the institution’s Animal Care and Use Program. It is our policy to enhance animal well-being, and eliminate or otherwise minimize any pain and/or distress to mild and momentary levels with available methods. All exceptions to this policy require scientific justification, review and approval by the IACUC. Related regulations, guidelines, & reference resource links can be found below. Please note these may be revised periodically.
The intent of the following Guideline is to assist Principal Investigators (PIs) in Animal Care & Use Protocol (ACUP) preparation, response to Pain & Distress during activities, and retrospective reporting. PI responsibilities:
The IACUC office must also be notified promptly. See also: Incident Report Form
Determination of pain, distress, or discomfort in animals can be subjective. To minimize variability, objective clinical and behavioral scoring systems should be used by trained participants whenever possible. When this is not possible, PIs must consider that any procedures that would cause pain or distress in humans may cause pain or distress in other animals. ACUP procedures designed to identify, assess, and mitigate P/D must be carried out preemptively as directed, and promptly when otherwise identified. When an animal experiences P/D that is not already described and justified within the approved ACUP, the Attending Veterinarian (or designee) must be consulted promptly. Veterinary consult measures, including euthanasia, must be implemented. Changes to the ACUP must be submitted to the IACUC when applicable. ACUP-related documents provide additional guidance, such as the Laboratory Animal Resources Center (LARC) guideline on Experimental and Humane Endpoints, and the IACUC Policy & Guidelines for Death as an Endpoint. Pain and Distress Definitions: Distress: A state in which an animal is unable to escape from, or adapt to stressors. Normal function is disrupted, and animal well-being is compromised. Pain: A noxious or aversive stimulus that would reasonably be expected to cause more than slight or momentary P/D in a human under the same conditions. While the ability of animals to experience pain is not completely understood, all animals should be considered capable of experiencing pain unless the contrary has been established. Category Definitions & Examples The categories below list the USDA-APHIS pain & distress categories required for institutional reports. The italicized definitions are copied from the required USDA form. Category B: Animals reported in Column B should be those animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes. Breeding colonies should report their breeding animals and any offspring which are not being used for research purposes in Column B. Animals actually used for research purposes during the reporting year must be reported in Column C, D, or E, as appropriate. Category B is a USDA report category, but is not used to describe pain or distress related to research or teaching. Category B is used mostly for holding protocols. Animals listed as Cat B are not subject to any research or teaching manipulations and cannot contribute to any related data collection. They may be bred with permission from the PI. Category C: Animals used in teaching, research, experiments, or tests which involve no pain, distress, or use of pain-relieving drugs. ACUP activities categorized as C include those in which animals experience no more than mild or momentary P/D, and appear to be otherwise comfortable. Examples: Observations; most AVMA-approved euthanasia methods; most peripheral injections, fluid collections, and catheter placements; most procedures associated with livestock husbandry; most live-trapping and marking; food restrictions allowing for acclimation and minimal weight loss; engineered phenotypes that are not expected to cause congenital pain/distress; mild and transient clinical signs during tumor and infection studies; etc. If animals require sedation, anesthesia, and/or analgesia to maintain comfort or reduce potential distress, then those animals should be categorized in “D”. Category D: Animals used in teaching, research, experiments, or tests which involve accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used. A painful procedure is defined as “any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being to which that procedure is applied, that is, pain in excess of that caused by injections or other minor procedures”. ACUP activities that cause more than momentary or slight P/D, and are provided remedies or treatment(s) to prevent or promptly relieve that P/D. These animals are monitored and would receive appropriate and timely administration of anesthetics, analgesics, medications, treatments, refinements, or euthanasia to eliminate or cap pain/distress to mild and transient levels. Examples: Appropriately treated major and minor surgical procedures; use of pharmacologic agents to prevent pain, distress, and/or injury to self; laparoscopy; biopsy; endpoints that avoid persistent negative effect on health and well-being; etc. Category D animals not afforded appropriate and timely treatment(s) to prevent and/or relieve pain & distress as described in the ACUP requires:
Category E: Animals used in teaching, research, experiments, or tests which involve accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. Category E includes animals that experience pain & distress related to ACUP activities that are not relieved with timely and appropriate treatments such as anesthetics, analgesics, medications, refinements, monitoring, or euthanasia. Category E also includes animals that are maintained in a morbid state without treatment or relief for a period of time in order to reach a later endpoint. Descriptions of Category E activities must include enough detail for a layperson to recognize the cause of pain or distress and understand the associated scientific justification for allowing that condition. Descriptions of Category E activities that are mandated by federal regulations must provide a full explanation as stated above, and include a reference to the agency and specific mandate that applies. Examples: Toxicological or infectious testing/research that results in persistent, moderate-to-severe clinical alterations; experience of noxious stimulation that an animal cannot avoid or escape; exposure to extreme environmental conditions; induced paralysis of a conscious animal; engineered phenotype that causes unalleviated pain/distress; prey in predator/prey studies; death as an experimental endpoint; clinical disease allowed to progress to moribundity; LD50 studies; etc. Yüklə 18,81 Kb. Dostları ilə paylaş:
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