GEORGIA INSTITUTE OF TECHNOLOGY (GIT) INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE APPLICATION Under the Georgia Open Records Act, protocol applications, including information incorporated by reference, may become accessible by the general public. This PROTOCOL APPLICATION must be approved before any animal work begins. Note the institute policy regarding eligibility for the role of Principal Investigator on an animal protocol (See IACUC Policies & Procedures). Occasionally, a large Program or Center grant to a single Principal Investigator will fund multiple faculty members’ activities, and the Program or Center grant PI may not be a member of the research team on animal protocols that the grant funds. For these “umbrella” programs, the IACUC accepts protocols from Principal Investigators who are not PI on the supporting Program/Center grant. Attachments: Statement of Work or Proposal Detailing Vertebrate Animal Research A copy of the funding proposal or final grant pages sent to the funding agency and OSP routing sheet is required. Federal regulations require the IACUC to compare the protocol to the funding proposal Statement of Work or Project Description. Substantive differences must be satisfactorily addressed prior to IACUC approval. Required Training: Everyone named on the protocol—including students, lab techs, Visiting Scholars, and affiliates—is required to complete the online CITI training course, “Working with the IACUC” and the other CITI training modules appropriate for the planned work. For example, if the protocol proposes the use of mice or rats, all named personnel must complete “Working with Mice (or Rats) in Research Settings.” Refresher training is required every 3 years. The online training is linked from the Office of Research Integrity Assurance (ORIA) website at www.researchintegrity.gatech.edu. Enroll in Occupational Health Program: Everyone named on the protocol must enroll in the Georgia Tech Occupational Health Program, managed by Environmental Health & Safety and provided by contract with Concentra Health Services. An opt-out provision is available, but enrollment is still mandatory. See the link to the Occupational Health Program at www.researchintegrity.gatech.edu. Departmental Sign Off: This prepared IACUC application is to be signed by the applicant’s department head or, in lieu of a written signature, department heads may send an email to iacuc@gatech.edu stating that they are aware of the proposed work and concur with its submittal to the IACUC. When the department chair is the Principal Investigator named in the protocol, no other sign-off is required. Preliminary Protocol Submission: Submit the protocol application and attachments to the ORIA via email to iacuc@gatech.edu. Initial Review Process: The protocol application will be given a preliminary review by the ORIA and then will be forwarded to the Georgia Tech Attending Veterinarian/Director of Animal Resources for veterinary consultation. The Principal Investigator may be contacted for clarification or additional information. Following veterinary consultation, the protocol will be returned to the Principal Investigator for modifications, if necessary. Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 1 Final Protocol Submission: If modifications are required, the Principal Investigator should revise the protocol in accordance with the combined veterinary and preliminary consultation and submit the revised protocol to the Office of Research Integrity Assurance via email to iacuc@gatech.edu for distribution to the committee. If none are needed, the protocol will be forwarded by the Veterinarian to the Office of Research Integrity Assurance for distribution to the committee. Committee Review: All protocols are distributed to the committee in the order received. If a committee member calls for Full Committee Review (FCR), the protocol will be placed on the agenda for that month’s meeting, unless it was received without sufficient lead time. The majority of protocols do not require FCR. However, protocols requiring full committee review are due the first of the month for review at that month’s meeting. For assistance, contact the Office of Research Integrity Assurance at 404.385.7316 or 404.385.2083. Please note that Institutional Animal Care and Use Committee approval is required prior to procurement or use of animals. If the project involves the use of any infectious agent or hazardous chemical (including chemical carcinogen), review by the Institutional Biological Materials Safeguards Committee (BSMC) is required. Protocols involving rDNA or synthetic nucleic acids require review by the Institutional Biosafety Committee. See guidance at www.researchintegrity.gatech.edu. In cases where other reviews or approvals are required (i.e., Institutional Biosafety Committee, Material Transfer Agreement, Office of Technology Licensing, Radiation Committee), those should be sought in parallel. If there are any transgenic animals, organisms/agents or proprietary issues necessitating a Material Transfer Agreement (MTA), consult the Office of Technology Licensing for guidance. IACUC Guidelines are located on the Office of Research Integrity Assurance website at http://www.researchintegrity.gatech.edu/forms/IACUC/GIT_IACUC_Policies_and_Procedures.pdf. Applications should be saved as a Word file and submitted to the Office of Research Integrity Assurance by email to iacuc@gatech.edu Please feel free to delete the above tips and guidance before submitting IACUC application. Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 2 Application for the Use of Laboratory Animals in Research, Training, and/or Teaching Institutional Animal Care and Use Committee (IACUC) Office of Research Integrity Assurance (ORIA) Georgia Institute of Technology (GIT) PHS Assurance # A3822-01 Office of Research Integrity Assurance Use Only Protocol Number Submit via email to iacuc@gatech.edu IACUC Policices at: www.iacuc.gatech.edu Protocol Type Check category of this project: New Research Protocol New Teaching/Training Protocol If this is a Renewal (new application after end of 3rd year) please list old protocol number: 1 Principal Investigator Principal Investigator: Emergency number: PI Title: Telephone: Department: Email: Enrolled in the Occupational Health Program: (Yes or No) Completed Required CITI Training: (Yes or No) Briefly describe training plan or qualifications: [Tip: has been working with animals since 20xx…, Surgical skills include…] 2 Title & Funding List all Sponsored funding sources that will be used on this protocol (copy & paste as needed). Note: Department of Defense (DoD) awards (including subs under a DoD Prime) require a separate protocol for each DoD award. Please provide a copy of the final grant pages & copy of the OSP routing sheet for each sponsored award. Discretionary accounts need not be noted in the funding section below as any discretionary account may be used on any IACUC protocol. Protocol Title: Sponsor name: Award Title: PeopleSoft Fund ID, Project number or Doc ID (even if funding is pending): Sponsor name: Award Title: PeopleSoft Fund ID, Project number or Doc ID (even if funding is pending): Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 3 Sponsor name: Award Title: PeopleSoft Fund ID, Project number or Doc ID (even if funding is pending): 3 Other Personnel List all personnel (other than PI) to be directly involved with the animals. Describe each person’s relevant training and experience, and indicate whether s/he will (1) serve as emergency contact for animal care issues and (2) be responsible for weekend/holiday/afterhours observation of animals. Note: No photographs or videos may be taken without prior approval from the PI and/or PRL Manager or Director. Photos may only be used for scientific purposes. Name: Role on Protocol: Email: (Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.) (Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #: ) (Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals (Yes or No) (3) is individual authorized to order animals (Yes or No) Enrolled in the Occupational Health Program (Yes or No) Completed Required CITI Training Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…] Name: Role on Protocol: Email: (Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.) (Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #: ) (Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals (Yes or No) (3) is individual authorized to order animals (Yes or No) Enrolled in the Occupational Health Program (Yes or No) Completed Required CITI Training Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…] Name: Role on Protocol: Email: (Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.) (Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #: ) (Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals (Yes or No) (3) is individual authorized to order animals (Yes or No) Enrolled in the Occupational Health Program (Yes or No) Completed Required CITI Training Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…] Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 2 Name: Role on Protocol: Email: (Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.) (Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #: ) (Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals (Yes or No) (3) is individual authorized to order animals (Yes or No) Enrolled in the Occupational Health Program (Yes or No) Completed Required CITI Training Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…] Name: Role on Protocol: Email: (Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.) (Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #: ) (Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals (Yes or No) (3) is individual authorized to order animals (Yes or No) Enrolled in the Occupational Health Program (Yes or No) Completed Required CITI Training Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…] Name: Role on Protocol: Email: (Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.) (Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #: ) (Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals (Yes or No) (3) is individual authorized to order animals (Yes or No) Enrolled in the Occupational Health Program (Yes or No) Completed Required CITI Training Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…] Name: Role on Protocol: Email: (Post-Doc, Graduate or Undergraduate student, Lab Tech, Staff, Visiting Scholar, Affiliate, etc.) (Yes or No) (1)will serve as emergency contact for animal care issues (Provide emergency phone #: ) (Yes or No) (2) responsible for weekend/holiday/afterhours observation of animals (Yes or No) (3) is individual authorized to order animals (Yes or No) Enrolled in the Occupational Health Program (Yes or No) Completed Required CITI Training Briefly describe training plan or qualifications: [Tip: has been working with animals since 20XX…, Surgical skills include…] 4 Veterinary Consultation Consistent with the Animal Welfare Act (AWA), Principal investigators must involve in their planning consultation with the Attending Veterinarian. You may contact Attending Veterinarian / Director of Animal Resources, Dr. Laura O’Farrell, at 404.385.6233 or via email to: vet@gatech.edu. Date of Consultation: Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 3 5 Study Objectives and Benefits to Society Briefly state the objectives of the study in lay terms and their relevance to advancing scientific knowledge and benefits to society (human/animal health). The answer should be written like a newspaper story about science or medicine using easily understood lay terms. Make minimal use of technical terms, and provide a brief explanation of any technical terms you must use. Routine use of acronyms is not appropriate. A scientific abstract from the funding application using highly technical terms is not acceptable. * Note that scientific merit is not part of the evaluation of this proposal and that representatives of the general community who have no scientific background may be among the readers. 6 Animal Species and Classification by Pain Level USDA Pain Classifications (see IACUC Policy 004 USDA Pain Categories for additional clarification). Class A: There is no direct contact with live animals. This includes observational field studies or use of cadavers not euthanized specifically for this study. Class B: This includes animals used for breeding or being held, but not directly used in research or teaching. Example: breeders and culls from breeding colonies. Breeding colony includes parents and offspring. Class C: Non-Painful/Non-Stressful: Animals upon which teaching, research, experiments, or tests will be conducted involving no pain, distress, or use of pain-relieving drugs. Example: routine procedures causing only slight or momentary discomfort such as venipuncture, injections, and the use of non-inflammatory adjuvants. Class D: Painful/Stressful WITH Analgesia, Anesthesia or Tranquilizers: Animals upon which experiments, teaching, research, surgery, or tests will be conducted that involve accompanying pain or distress to the animals and for which appropriate anesthetic, analgesia, or tranquilizing drugs will be used. Class E: Painful/Stressful WITHOUT Pain or Stress Relieving Measures: Animals upon which teaching, experiments, research, surgery, or tests will be conducted that involve accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. Species A current Scientific Collection Permit from the appropriate Fish & Game Department must accompany the IACUC application for all wild caught animals* USDA Pain Classification (A, B, C, D, or E) Total Number of Animals for 3-Year Project Period (including pups) Lay Summary of why is it necessary to use this species for this purpose? [TIP: Explain in language that can be easily understood by a non-scientist.] If animals are listed in Class E, Painful/Stressful WITHOUT Pain or Stress Relieving Measures, provide references and scientific justification showing that all available or any particularly prescribed anesthetics, analgesics or tranquilizers will interfere with the specific measurements that are proposed in this protocol. 7 Justification of Animal Numbers Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 4 [TIP: If you have previously measured the parameters you propose to measure, then the number of animals per group needs to be justified using statistical power analysis. If you have no previous measurements, so state and indicate that the number of animals per group will be the minimum needed to obtain statistically significant differences between groups. The second part involves listing all your experimental groups with the number in each and the total at the bottom, which should add up to the total number of animals requested. ] [TIP: A power calculator for determining the number of animals per group, if applicable, may be found at http://www.stat.uiowa.edu/~rlenth/Power/index.html. Include a brief description of the statistical analyses, including tests, power and probability levels utilized, if applicable.] [TIP: Note: Scientific need should be used when possible to justify animal numbers rather than limitations of time, personnel, space, money, etc.] Justify the number of animals List and briefly justify the groups, if applicable, or otherwise justify the total animal numbers requested. Animals used for breeding must be included. The total number of animals must equal the number requested in the chart above. Make a list or flowchart or insert a table, if appropriate. The total number of animals must equal the total number of animals requested. 8 Alternatives and Non-Duplication Perform sufficient database searches to verify that unnecessary duplication will be avoided and that there are no alternatives to proposed painful and/or distressful procedures. Alternatives concern both replacement of animals and refinement of procedures so that they cause less pain and/or distress. Describe the searches in the following table: Keywords Used Date limitations placed on the (must include names of Databases Searched Date of the Search search, if any painful or distressful procedures) Provide a written narrative of the sources consulted to determine whether or not alternatives exist to procedures that may cause pain or distress. For example: “Medline was searched on November 1, 2011 for alternatives to tailing a mouse, using keywords: genotyping, tailing, alternative, mouse, animal. No limits were placed on the search.” [TIP: Alternatives are anything that contributes to replacement, reduction, or refinement (the 3 R’s) of animal use with the goal of minimizing pain and distress. The Animal Welfare Information Center, a service of the National Agricultural Library established to provide information about alternatives, can be searched at http://www.nal.usda.gov/awic/. Examples of searches are available via Altweb http://altweb.jhsph.edu/.] Results of the database search: (YES, alternatives were found or NO, alternatives were Not found) If yes, explain why those alternatives cannot be used in lieu of the proposed procedures that may cause more pain or distress. For example: Alternatives to tailing were found, which include use of hair follicle, oral/anal epithelial swabs as sources of DNA. These methods, though possibly less painful/distressful, do not typically yield enough DNA for Southern Blot. 9 Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu Procedures IACUC Protocol Application December 2015 Page 5 Procedure location(s) (Include building and room for each): Completely describe the planned procedures, including breeding and surgery. Describe the aseptic methods to be utilized. Will more than one major survival surgery be performed on any animal? [TIP: Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions or involves extensive tissue dissection or transection (such as laparotomy, thoracotomy, craniotomy, joint replacement, or limb amputation). Insertion of needles or placing subcutaneous implants is not considered major surgery.] (Yes or No) If “Yes,” provide scientific justification for multiple major survival surgeries on the same animal. You must state why the research goal cannot be accomplished by performing the surgeries in separate animals. What is the training or experience of the people who will perform the procedures above? Procedure Summary: List or tabulate all the procedures that will be done to animals in each group in order making the time interval between clear, if applicable, so total life experience is summarized. [Tip: Recovery from prolonged, general anesthesia is normally limited to three times per week, per animal.] Example: Surgical Implantation Study Animals received and acclimatized for a minimum of 5 days Day 0 Surgery Day 12 +/- 5 days Anesthesia for blood collection, recovery Days 20-24 Restraint for once daily gavage Day 30 Anesthesia (3hrs) for imaging, recovery Day 42 Restraint for subcutaneous injection Day 62 +/- 2 days Terminal anesthesia for imaging, blood collection, euthanasia, tissue collection Describe post-procedural observation and care. Include: o Names of personnel responsible for monitoring / observing animals, including afterhours/weekends/holidays o Frequency of observation o Clinical signs you will observe to determine whether treatment is necessary [TIP: Animals must be monitored continuously until fully recovered from anesthesia and ambulatory] 10 Summary: Administration of Materials List materials animals will be exposed to as a part of experiments, teaching or testing including but not limited to drugs, anesthetics, analgesics, fluids, vehicles, diluents, polymers, substances, structures, cells, tissues, organs, plants, microorganisms, prions, genetic material or subparts thereof. Where Dose (mg/kg) / manufactured Possible Species Material Route Frequency or obtained Complications from* Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 6 * List the general type of manufacturing, not the particular company name i.e., drug company, compounding pharmacy, chemical company, manufactured in house, etc. Note: All animal cells, tissues, etc. must be tested for pathogens by the animal facility prior to introduction into the facility. Federal regulations require that pharmaceutical grade materials be used for all animal-related procedures when available, unless justified. Pharmaceutical grade is defined as materials approved by the Food and Drug Administration or for which a chemical purity standard has been established by the United States PharmacopeiaNational Formulary or British Pharmacopeia. Please list and provide justification for each non-pharmaceutical grade material that will be administered to animals. Please see IACUC Policy #002 for further clarification. If non-pharmaceutical grade materials will be used, please address how adverse events related to grade, purity, cleanliness, sterility, pH, pyrogenicity, osmolality, stability, formulation, compatibility, etc. as applicable will be minimized. Who will perform the anesthesia? Describe each person’s training to perform the anesthesia procedures. If the materials will result in a tumor, will the size of the tumor exceed 1.5 in any dimension or 10% of the body weight of the animal? If Yes, provide written scientific justification: 11 Species Summary: Collection of Fluids, Tissue, Substances or Tail Collection Agent Collected Volume Route Frequency Collected 12 Infectious Agents, Biologics, X-rays/Radiation or Chemical Hazards, or rDNA Use Check if any of the following will be used, and specify each by name. Attach copies of approval emails or letters. [TIP: IACUC review will not be delayed by these parallel reviews. However, documentation of the appropriate approval(s) must be received by the ORIA prior to issuance of IACUC approval.] Does Protocol involve any of the following? (answer Yes or No for each) These require approval of the Institutional Biological Materials Safeguards Committee (BSMC): Does protocol involve Infectious Agents or Biologics? (yes or no) If yes, list type: Does protocol involve Biological Hazards? List Type: (yes or no) If yes, list type: Does protocol involve Hazardous Chemicals or Chemical Carcinogens? (yes or no) If yes, list type: Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 7 These require approval of the Radiation Safety Committee (RSC): Does protocol involve Radioactive Materials? (yes or no) If yes, list type: Does protocol involve X-rays/Radiation? (yes or no) If yes, list type: These require approval of the Institutional Biosafety Committee (IBC): Does protocol involve recombinant DNA (rDNA) and Synthetic Nucleic Acid Molecules? (yes or no) For Each YES answer above, do you have IBC, BSMC or RSC approval for the materials indicated above? Not applicable Approval Pending Approval Attached – Approval Number: Describe how personnel safety will be ensured. Specify the containment methods to be followed in protecting other research animals and personnel from any of the agents/hazards listed above. [TIP: If applicable, state how radioactive carcasses, cages and bedding will be handled] 13 Housing and Husbandry Where will animals be housed? GT Physiology Research Laboratory (PRL) location (IBB, TEP, or EBB): If Not in a GT PRL, state campus, building and room number: Provide justification for housing other than the PRL: If animals will be moved between laboratories and housing, provide justification and state that animals will be transported in accordance with GIT Guidance on Transfer and Receipt of Animals. If there will be any exception from Policy 001, please describe and provide justification. 14 Diet Manipulation / Environmental Modifications Unless indicated differently, all animals will be housed, fed and cared for according to legally mandated standards. Unusual diet or housing include: o need for autoclaving cages or deviation from the standard housing (wire-mesh floors must be justified) o special food or water, dietary / water manipulations (withholding of food or water, addition of drugs to food/water) o wearing of additional protective gear by the animal care staff (gloves and lab coat / scrubs are standard) o withholding of PRL standard enrichment devices o use of cages that are larger or smaller than the required minimums o use of running wheels, metabolism cages o individual housing of social species. If social animals are to be housed singly, provide scientific justification for single-housing. This does not apply to animals briefly housed singly post-operatively. o need for special light/dark cycles. Describe any non-standard diet, housing or environmental modifications, and how they will be accomplished. [TIP: Procedures that are specifically pre-operative should be described in Procedures below] 15 Clinically Adverse Rodent Phenotype Will the study involve transgenic/knock-out/knock-in animals? (Yes or No) (If no, skip to next section). If yes, is the strain being made in your lab or commercially available? Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 8 If the phenotype is known, please describe any clinically adverse effects and what percentage of the offspring is affected. (i.e. seizures, skin ulcer, kidney failure, inflammatory bowel disease. If age effected, indicate whether it is present in homozygotes versus heterozygotes and what the morbidity/mortality is, etc.). If you expect any abnormalities to cause pain or distress, how will you minimize or alleviate it? Describe your monitoring and recording procedures for detecting physical or behavioral abnormalities which are indicative of pain or distress. 16 Euthanasia / Disposition of Animals List early endpoints to the study otherwise known as euthanasia criteria. State the clinical signs that will indicate that an animal should be withdrawn from the study and euthanized. Unless otherwise noted it is assumed that meeting ANY ONE CRITERION listed below is an indication for euthanasia. For criteria such as weight loss or loss of appetite, include frequency of observation and measurement. Describe the method of euthanasia. Include agent and dose if applicable. Euthanasia shall be in accord with methods approved by the AVMA guidelines. [Tip: The AVMA Guidelines on Euthanasia can be found at www.avma.org/issues/animal_welfare/euthanasia.pdf . Physical methods of euthanasia (decapitation, thoracotomy, exsanguination, cervical dislocation) may be used when scientifically justified and generally only under general anesthesia. Carbon dioxide must be delivered from a compressed gas cylinder (no dry ice) and must be delivered very slowly to a chamber that has not been pre-filled.] If euthanasia is not the endpoint, specify the planned disposition of the animals. If animals are to be considered for adoption, so indicate here. [TIP: Wild caught animals may not be adopted without express written authorization from the Issuer of the Scientific Collection Permit. This documentation must accompany the IACUC application for review.] Required Protocol Submission Checklist: The following are required for all protocol applications submitted for consideration: Application signed below by PI (or submitted via GIT email by the PI) Application signed below by Chair/Dept. Head/ Lab Director (or authorizing email sent to iacuc@gatech.edu) Copy of final grant pages & OSP routing sheet All personnel completed CITI modules All personnel enrolled in Occupational Health The following are required if applicable: Copy of Scientific Collection Permit from the Fish & Game Department (Required for use of wild caught animals) Approval emails or letters from Institutional Biological Materials Safeguards Committee or Radiation Safety Committee (Required for proposed use of infectious agents, biological hazards, hazardous chemicals, carcinogens, radioactive materials, or X-rays/radiation) Approval letters from Institutional Biosafety Committee (Required if use of rDNA or sNA is proposed) Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 9 Submit this Word doc Application and all attachments via email to: iacuc@gatech.edu Use of GA Tech email accounts (.gatech.edu) is required when submitting protocols. Office of Research Integrity Assurance http://www.researchintegrity.gatech.edu Certifications and Signatures Certification: I will comply with the procedures and methods described in the NIH Guide for the Care and Use of Laboratory Animals (Pub. 85-23), with PHS policy, the Animal Welfare Act, the Georgia Institute of Technology Animal Welfare Assurance A-3822-01, and other applicable Institute policies. Certification: I assure that the activities involving vertebrate animals as described in this application do not unnecessarily duplicate previous experiments. Certification: I assure that the animal use proposed in a grant or contract proposal to support this research corresponds with the information provided herein (if applicable). Certification: As Principal Investigator, I acknowledge responsibility for this project and assure that the personnel who participate in it are qualified and adequately trained to conduct it in a humane manner. In lieu of a written signature, PI may submit protocol application via e-mail to iacuc@gatech.edu from your GT email account. Date: Principal Investigator Signature ________________________(or submit via GIT email for electronic signature) Departmental sign off: I have reviewed this IACUC Application and related research plans and concur with their submission to the Institutional Animal Care and Use Committee for review. Date: Department Chair Signature ________________________(or submit via GIT email for electronic signature) In lieu of Dept. head signatures, the Office of Research Integrity Assurance will accept an email from the Dept. head, sent to IACUC@gatech.edu, in which the department head states something like: “I have reviewed this IACUC Protocol and related research plans and concur with their submission to the Institutional Animal Care and Use Committee for review.” Georgia Institute of Technology Office of Research Integrity Assurance IACUC IACUC@gatech.edu IACUC Protocol Application December 2015 Page 10