Writing an IACUC Protocol
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1 Writing an IACUC Protocol 2014
2 Getting Started Download forms from IACUC website: Check date on footer Current forms are dated 2014 Consultation with the LAF is recommended during the planning stage of your study Submit via to Sign your protocol prior to submission Submission date: 1 st working day of the month Meeting date: 3 rd Tuesday of the month
3 PI and Personnel PI full-time employed faculty member with an appointment of Instructor or higher Request by non-faculty members to be a PI will be evaluated by the IACUC on a case-by-case basis Personnel may be granted signing privileges Personnel with signing privileges are able to submit modification requests for the protocol Completion of required training, including refresher training, is verified before approval of protocol
4 Funding Source Departmental funding requires review and signature of the Department Chair prior to submission of protocol. Protocol review will not move forward until Department Chair signature is in place.
5 Animal Numbers Table A New Protocols Table B FSR Protocols (3-year Renewals) Animals may be grouped in broad categories control or wild type genetically modified = transgenics, congenics, ko, etc. Animal numbers in #9 must match the number justified in #17
6 FSR Carry-over Animals Carry-over animals are animals currently on campus that will transfer to the rewritten protocol. Example: You need 100 animals to complete your study and you have 20 animals currently in house to carry over to this is protocol. Total Needed for 3 years Total Carried Over Total Requested = 80 You will be approved for 100 animals to complete the study (number to be justified in question #17) of which you already have 20, so you will have 80 animals available to order.
7 Hazards Discuss any hazards used in the animal. Chemical and/or biological hazards that might be excreted by the animal require proper signage and training must be completed by personnel before activation of protocol. This section is reviewed by the Office of Environmental Health and Safety.
8 Animal Husbandry Identify any nonstandard husbandry Examples include but are not limited to: High/low salt diet, high/low fat diet, etc. Altering drinking water Metabolic caging, restraint chairs Altered light cycle For each nonstandard situation: Describe what is needed Provide reason Identify personnel responsible for overseeing the process
9 Singly Housed Animals Question 12b addresses Singly Housed Animals Describe any instances of single housing Examples: Post operative Pregnant females Metabolic caging Provide justification Provide timeframe for single housing
10 Lay Summary Describe study in non-technical terms What is the objective of the experiments? Why are the experiments proposed? What knowledge do you hope to achieve? What is the potential relevance (e.g. benefits) of experimental findings to human or animal health, advancement of knowledge, and/or the good of society? Describe your study as if speaking to high school students.
11 Justification of Use of Animals Why do you need to use animals versus nonanimal models? Justify the selected species: Presence of a large body of scientific knowledge Existence of a large body of laboratory data Characteristics of the species make it uniquely suited for the study Availability of research tools or reagents unique to the species
12 Brief Outline Describe proposed animal manipulations and experimental time-line. Flow charts, time-lines and tables can be useful tools Describe all groups in the design including control groups, specific animal genotypes/models
13 Justification of Animals Numbers Statistical support of animal numbers is helpful, e.g. Power Analysis Define groups Control and experimental groups Number of animals per group Number of iterations of testing/sampling/injections Animal numbers must equal number requested in #9
14 Endpoints #19A Experimental Endpoints At what point will the animals normally be euthanatized? For studies that include breeding, include time point for euthanasia of breeders. #19B Humane Endpoints Criteria to determine early removal from study: Weight loss range (must describe frequency of weighing) Morbidity assessment Impaired mobility or ability to groom, feed, etc. Excess tumor burden beyond specified size/diameter Pain and/or distress unrelieved by administration of analgesia
15 Euthanasia Procedures Describe method of euthanasia and method used to ensure death Secondary method of euthanasia Tissue harvest Perfusion at terminal event If breeding is included describe method of euthanasia for breeders Consult the AVMA Guidelines for the Euthanasia of Animals: 2013 Edition or LAF Veterinary Staff Decapitation without anesthesia requires scientific justification Euthanasia PowerPoint available for review on the IACUC website
16 Assurances and Narrative A search for alternatives to potentially painful and/or distressful procedures must be conducted using two (2) sources Key words should include any potentially painful procedures Examples: Chronic restraint Surgical procedures (e.g. craniotomy, nephrectomy) For additional information on search strategies please view the OLAW webinar Meeting Requirements for Alternative Searches: Information for IACUC and Investigators
17 3 R s Discussion should include measures taken to incorporate 3 R s into protocol Replacement computer models, cell culture, in vitro Reduction limiting group size to minimum, animal serves as own control Refinement modification of techniques to reduce pain/distress (e.g. pre-operative analgesics)
18 Appendices Include all appropriate appendices A: Environmental Enhancement/Enrichment B: Time-Pregnant/Breeding Programs C: Surgery & Management of Surgical Pain and Distress D: Collection of Biological Samples from the Live Animal E: Antibody Formation/Hybridoma & Ascites F: Administration of Drugs/Test Compounds G: Prolonged Physical Restraint H: Multiple Survival Surgical Procedures I: Food and/or Fluid Regulation J: Animal Pain and/or Distress K: Progress Report L: Behavioral Training and Testing M: Non-Pharmaceutical-Grade Compounds
19 Appendix B: Breeding Breeding program should be described including type of breeding utilized (monogamous pair, trio), plan for weaning, records, and responsible personnel. Describe any anticipated concerns in the offspring, e.g. prone to dermatitis, severe diabetes. Provide estimated total number of pups to be born and include plan for pups not used in experiments
20 Appendix C: Surgery Describe all surgical procedures (survival and acute) Discuss post-operative monitoring and pain management Analgesics should be give pre-operatively Discuss experience/training of the personnel with the specific procedures listed in the protocol. If the procedure is new for the lab, a brief statement of how training will be accomplished should be added.
21 Appendix F: Test Compounds If given to the animal and it is not an anesthetic, analgesic, or euthanasia agent, it needs to be listed in Appendix F This should include vehicle given as a control Include NDC or CAS # and hazard information
22 Appendix K: Progress Report Required for all FSR submissions Provide a brief description of animal use over the previous 3 years List any publications, abstracts, or presentations coming directly from the work in the previous 3 years Describe any unanticipated events occurring during the last year of the study (previous years should have been addressed at each Annual Review)
23 Appendix L: Behavioral Testing If utilizing the Animal Behavioral Core (ABC), review and approval by the Core Director is required prior to submission Fully describe conditions of all behavioral tests
24 Appendix M: Non-Pharmaceutical-Grade Justification Compounds No pharmaceutical grade is available Formulation of pharmaceutical grade does not allow use Discuss steps taken to ensure health and welfare Grade -Purity Sterility -ph
25 Review Process Submissions are received in the IACUC Office on the 1 st working day of the month Each submission is assigned a Primary and Secondary Reviewer Submissions are posted for review on the secure IACUC SharePoint site Committee members review submissions and post comments The Primary Reviewer may communicate the comments to the PI before the monthly meeting
26 Review Process The PI may respond to the pre-meeting comments or wait to see if additional comments are generated at the meeting The IACUC meets the 3 rd Tuesday of each month Post-meeting the Primary Reviewer will contact the PI with all comments The PI should work with the Primary Reviewer to address all comments
27 Review Process The Primary & Secondary Reviewers will recommend approval of the protocol once all comments have been addressed The final signed version of the protocol must be sent via to the IACUC Office, The final version will be routed to the IACUC Chair and Attending Veterinarian for signatures to complete the approval process Official approval will be communicated by the IACUC Office at which time work on the study may begin
28 Tips Download new forms for each submission The IACUC Office requests files follow the naming scheme: PI Last Name First Initial_SubmissionType Examples: DoeJ_New DoeJ_FSR_000 (for FSR submissions, include protocol number) DoeJ_New_AppendixC
29 For assistance, contact the IACUC Office
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