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Following is a list of categories providing possible examples of procedures which are representative of each category.
Type A: Studies which cause little or no pain or distress.
Examples include housing and brief restraint of animals for observation or examination; single blood sampling; single injections of non–toxic materials; standard approved methods of euthanasia that induce rapid unconsciousness; short periods (a few hours) of food and water deprivation; and behavioral observations.
Type B: Studies which may involve minor pain or distress of short duration.
These include surgical procedures and other studies on anesthetized animals where the animals do not regain consciousness (eg non–survival surgery). Also included are cannulation of vessels or body cavities performed under anesthesia; minor surgical procedures such as biopsies and others where post–surgical pain and distress are minimal; overnight or longer food or water deprivation; behavioral studies on awake animals that involve short–term restraint; studies using noxious stimuli from which escape is possible; using tumor implants or hybridomas under guidelines as outlined by the IACUC; and the use of Freund’s complete adjuvant injected intramuscularly.
Comment: During and after Type B studies animals are not expected to show anorexia, dehydration, abnormal discharges, hyperactivity, increased recumbency or dormancy, increased vocalization, self–mutilation, aggressive–defensive behavior or demonstrate social withdrawal and self–isolation.
Type C: Studies which may involve moderate to severe pain or distress.
These include major surgical procedures performed under anesthesia, permitting recovery, with adherence to acceptable veterinary practices including postoperative analgesia, fluid therapy and veterinary nursing care; prolonged periods (several hours or more) of physical restraint or deprivation of the animals’ environmental necessities, such as maternal deprivation, aggression, predatory–prey interactions; procedures which alter perceptual or motor functions, such as the induction of paralysis or seizures; and induction of infectious diseases or toxicities, and when severe clinical symptoms begin to appear the animals are treated or euthanized.
Comment: Involvement of trained technicians, scientists and veterinarians is critical if this pain is to be minimized or avoided. Animals used in Type C studies should not show signs of prolonged clinical distress, such as behavioral abnormalities, lack of grooming, dehydration, anemia, abnormal vocalization, prolonged anorexia, self-mutilation, increased signs of infectious processes (peritonitis, pneumonia, diarrhea, encephalitis, etc.). If these clinical abnormalities develop, the necessary treatments to alleviate the symptoms must be available and provided. If the symptoms cannot be alleviated, the animals must be euthanized with minimal delay.
Type D: Projects that may involve moderate to severe pain or distress without the benefit of pain–relieving drugs or other appropriate therapy.
Such studies include application of noxious stimuli from which escape is impossible; exposure to noxious stimuli or agents whose effects are unknown; completely new experiments which have a high degree of invasiveness; induction of aggressive behavior leading to self–mutilation or fighting; and induction of infectious diseases or toxicities where death is an end point and animals are not treated or euthanized when severe clinical abnormalities develop.
Comment: Type D projects present an explicit responsibility on the faculty to explore alternative methods before proceeding with the study. Type D projects are considered by some to be highly questionable or unacceptable, irrespective of the significance of the anticipated results. Before our Committee can review and approve these projects, the justification statements and the veterinary involvement must be clearly presentable and understandable.
Federal law (Animal Welfare Act, 7 U.S.C. 2121, et seq.) requires written investigator assurance “. . . that alternatives to procedures that may cause more than momentary or slight pain or distress have been considered and written description of the methods and sources used to determine that alternatives are not available.”
Therefore, protocols must include this assurance and written description of the methods and sources consulted prior to approval by the IACUC. A search for alternatives to potentially painful procedures must be conducted. Searches should be conducted using databases such as Medline, AWIC, CRIS, Index Medicus, etc. The minimal written narrative should include: the databases searched or other sources consulted, the date of the search and the years covered by the search. At least two databases must be searched, although databases containing multiple sub–databases (e.g. Ovid search) are also acceptable. A protocol will not be approved without this information.
The IACUC requires the original signature of the principal investigator for the protocol to be approved. The principal investigator must be a USC faculty member. Signatures of coinvestigators and other staff will not be accepted. The signature indicates the person with overall responsibility for the protocol and animals used on the protocol. If a coinvestigator will assume this responsibility, the entire protocol should be in their name with their signature.