Request for Ethics Approval
Application Form II: Research Involving Animal Subjects
(All Applications Must be Typed)
Often filled applications forms are sent back to researchers for additional information. If care is taken to provide sufficient detail in the original application, then delays in their approval can be avoided.
For QU-IRB Use Only:
Research No: Click here to enter text. Received on:Click here to enter text.
Title of Project:Click here to enter text.
Key Words(see attached document on Animal Care Key Word List):
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Principal Investigator: Click here to enter text.Position: Click here to enter text.
Authorized Investigators/Faculty/Staff:Click here to enter text.
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Authorized Investigators/Graduate Student(s): Click here to enter text.
Authorized Investigators/Undergraduate Student(s): Click here to enter text.
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Faculty/Department: Click here to enter text.E-mail Address:Click here to enter text.
Phone No.(Work):Click here to enter text.(Home): Click here to enter text.
Emergency No. Click here to enter text.
PLEASE DESCRIBE Training and Qualifications of Persons Handling Animals:
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PLEASE COMPLETE SECTIONS ON RESEARCH & TEACHING
RESEARCH: Funding applied for: Choose an item. Funding Approved: Choose an item.
Name of Funding Agency: Choose an item. Grant No.: Click here to enter text.
Peer Review*: Choose an item.
*(refer to page 8 for information on Peer Review)
If Yesor Pending- Peer Review by: Click here to enter text.
TEACHING:Choose an item. Nature of Teaching:Choose an item.
If animal use is part of Classroom Teaching, please specify the course #: Click here to enter text.
If Classroom teaching, please state the pedagogical merit (teaching benefit) of the use of animals:
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SURGERY:
Acute(i.e. surgery under anaesthesia with NO recovery, or euthanasia prior to a procedure): Choose an item.
Chronic(i.e. all other procedures with or without euthanasia at the end) : Choose an item.If yes, how long Click here to enter text.
First SubmissionChoose an item.Continuing Submission Choose an item.
Start Date: Click here to enter text. *End Date:Click here to enter text.
*maximum one year after start date
Species to be used:Click here to enter text.
Quantity required (of each type of animal per year): Click here to enter text.
Source of Animals: Click here to enter text.
Facility Required:Click here to enter text.
REGULATORY CONCERNS
*Government Regulations: Choose an item.
*Importing animals or biological specimens refers to any procedures requiring special permits or permission, such as wildlife collecting, transport, use of restricted drug(s).
Possible Hazards to Staff or Animal Population:Choose an item.
**Give details and/or precautions in your description of procedure.
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The QU-IRB may request Permits for any combination of regulatory considerations and concerns such as:
1- Government Regulations
2- Hazards
3- Biohazard
4- Radiation
Approved by Biohazard Committee: Choose an item.
Approved by Radiation Safety Officer:Choose an item.
(a)Lay Summary
State in ‘lay terms’ what specific research problem(s) or instructional principle(s) this project addresses. Attach additional page(s) if necessary. (This should be accessible to a non-scientist who is a member of the Institutional Animal Care Committee).
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(b)Detailed Description of Procedures Involving Animals:
With special emphasis on details of the procedure(s) where pain or distress to the animals could occur. If pain or distress are anticipated, please specify steps taken to minimize pain or distress. Attach additional page(s) if necessary.
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(c)Justify the Species Used:
Please explain why the indicated species is going to be used. Keep in mind the three ‘R’ concept: “Replacement, Reduction, and Refinement.” Please consider using less sentient animal species and/or tissue culture whenever possible.
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(d)Justify the Numbers of Animals to be Used:
(e.g. groups, number per group, etc., please consider providing tables).
If the animals are genetically modified, please provide the required “Genetically modified animal protocol”.
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Method of:
1. Anesthesia (Specify dose and route of administration).
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- Analgesia (Specify dose and route of administration).
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- Restraint (method of).
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- Justifynot using anesthesia or analgesia, if relevant.
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- A Description of the endpoint(s) of the experimentation.
When and how euthanasia will be provided. Please provide Standard Operating Procedures (SOPS) for monitoring health and well-being of experimental subjects which should include criteria for humane removal of animals from the experimental protocol if you anticipate that the health/well-being of the animal may be compromised during the study.
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6.Type of euthanasia:
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7.If physical methods are used please use anesthetic prior to euthanising animal.
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8.If you cannot use anesthetic prior to physical method of euthanasia, explain why.
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9.a)How are animals disposed if euthanised?
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b)How are animals disposed if not euthanised?
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10.A description of the method of capture, restraint, transportation and/or housing if animals are used in field studies (as well as any other information pertinent to field studies, such as the potential for capture of non-target species and potential injuries or mortality during capture or transportation, if relevant. Also provide information on response of released wildlife after capture and manipulation).
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Please answer the following:
Anticipated Level of pain:Choose an item.
Anticipated Level of stress:Choose an item.
Category of Invasiveness**: (check all that are appropriate): Choose an item.
**See attached an example of the description of categories. If more than one category is checked, specify in the text of the description of the methods to which methods the categories apply.
PLEASE SIGN DECLARATION BELOW
I confirm that all information reported in this application form is true and accurate.I agree to report ANY DEVIATIONS from the reported procedures and methodologies to the QUIRB. I agree to maintain adequate records of all procedures. I agree to become informed and comply with the principles outlined in the "Handbook for ethical rules and regulations" as published by Qatar University and comply with all Acts and Regulations in the state of Qatar pertaining to the use of animals in research.
Signature of Principal Investigator
OFFICE USE ONLY
Approval of the above procedures for a period notexceedingoneyear is hereby given:
Chairperson, QU-IRB ______Date ______
Member of IACC ______Date ______
Previous Protocol ID ______
Approval Date ______Renewal Date ______
C:\HMYounes\QUIRB\EthicsAnimal(ver1).doc
Categories of Invasiveness in Animal Experiments
Investigators and teachers who consider it essential to use vertebrates or invertebrates in their research, teaching or testing in the laboratory or in the field, must adhere to humane principles, and take cognizance of the Canadian Council on Animal Care's (CCAC) Ethics of Animal Investigation and other CCAC documentation in assigning a category. Protocols must be submitted to an appropriate review committee for all studies and courses which involve the use of vertebrates and some invertebrates in Categories B through E. Cephalopods and some other higher invertebrates have nervous systems as well developed as in some vertebrates, and may therefore warrant inclusion in Category B, C, D, or E.
The following list of categories provides possible examples of experimental procedures which are considered to be representative of each category:
- Experiments on most invertebrates or on live isolates
Possible examples: the use of tissue culture and tissues obtained at necropsy or from the slaughterhouse; the use of eggs, protozoa or other single-celled organisms; experiments involving containment, incision or other invasive procedures on metazoa. - Experiments which cause little or no discomfort or stress
Possible examples: domestic flocks or herds being maintained in simulated or actual commercial production management systems; the short-term and skilful restraint of animals for purposes of observation or physical examination; blood sampling; injection of material in amounts that will not cause adverse reactions by the following routes: intravenous, subcutaneous, intramuscular, intraperitoneal, or oral, but not intrathoracic or intracardiac (Category C); acute non-survival studies in which the animals are completely anesthetized and do not regain consciousness; approved methods of euthanasia following rapid unconsciousness, such as anesthetic overdose, or decapitation preceded by sedation or light anesthesia; short periods of food and/or water deprivation equivalent to periods of abstinence in nature. - Experiments which cause minor stress or pain of short duration
Possible examples: cannulation or catheterization of blood vessels or body cavities under anesthesia; minor surgical procedures under anesthesia, such as biopsies, laparoscopy; short periods of restraint beyond that for simple observation or examination, but consistent with minimal distress; short periods of food and/or water deprivation which exceed periods of abstinence in nature; behavioral experiments on conscious animals that involve short-term, stressful restraint; exposure to non-lethal levels of drugs or chemicals. Such procedures should not cause significant changes in the animal's appearance, in physiological parameters such as respiratory or cardiac rate, or fecal or urinary output, or in social responses.
Note: During or after Category C studies, animals must not show self-mutilation, anorexia, dehydration, hyperactivity, increased recumbency or dormancy, increased vocalization, aggressive-defensive behavior or demonstrate social withdrawal and self-isolation. - Experiments which cause moderate to severe distress or discomfort
Possible examples: major surgical procedures conducted under general anesthesia, with subsequent recovery; prolonged (several hours or more) periods of physical restraint; induction of behavioral stresses such as maternal deprivation, aggression, predator-prey interactions; procedures which cause severe, persistent or irreversible disruption of sensorimotor organization; the use of Freund's Complete Adjuvant (see CCAC Guidelines on Acceptable Immunological Procedures ).
Other examples include induction of anatomical and physiological abnormalities that will result in pain or distress; the exposure of an animal to noxious stimuli from which escape is impossible; the production of radiation sickness; exposure to drugs or chemicals at levels that impair physiological systems.
Note: Procedures used in Category D studies should not cause prolonged or severe clinical distress as may be exhibited by a wide range of clinical signs, such as marked abnormalities in behavioral patterns or attitudes, the absence of grooming, dehydration, abnormal vocalization, prolonged anorexia, circulatory collapse, extreme lethargy or disinclination to move, and clinical signs of severe or advanced local or systemic infection, etc.
Procedures which cause severe pain near, at, or above the pain tolerance threshold of unanesthetized conscious animals
This Category of Invasiveness is not necessarily confined to surgical procedures, but may include exposure to noxious stimuli or agents whose effects are unknown; exposure to drugs or chemicals at levels that (may) markedly impair physiological systems and which cause death, severe pain, or extreme distress; completely new biomedical experiments which have a high degree of invasiveness; behavioral studies about which the effects of the degree of distress are not known; use of muscle relaxants or paralytic drugs without anesthetics; burn or trauma infliction on unanesthetized animals; a euthanasia method not approved by the CCAC; any procedures (e.g., the injection of noxious agents or the induction of severe stress or shock) that will result in pain which approaches the pain tolerance threshold and cannot be relieved by analgesia (e.g., when toxicity testing and experimentally-induced infectious disease studies have death as the endpoint).
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