INSTRUCTION MANUAL IACUC ELECTRONIC APPLICATION. UNMC/UNO Institutional Animal Care and Use Committee VOLUME

Transcription

1 UNMC/UNO Institutional Animal Care and Use Committee VOLUME 1 IACUC ELECTRONIC APPLICATION INSTRUCTION MANUAL Nebraska Medical Center Omaha, NE (402) iacucora@unmc.edu

2 TABLE OF CONTENTS 1: Online Quick Start Instructions 4 2: Log-in to the Research Support Systems (RSS) 10 A. Website B. Log In C. Request an Account 3: Initial Screen 12 A. RSS IACUC B. New Protocol C. Protocol View/Edit D. Qualifications E. View IACUC/CM Contacts F. Instruction Manual G. View Qualifications H. View Sample Forms 4: Icons & Buttons 13 5: Personnel Qualifications 15 A. Opening the Personnel Qualifications B. Qualification Requirements C. Completing the Sections D. Updating Personnel Qualifications 6: Starting a New Application 18 A. RSS Electronic Applications B. Research/Teaching/Testing Application 19 Section I Administrative 19 Section II Species 21 Section III Overview 23 Section IV Project Design 27 Section V Field Studies 30 Section VI Non-Surgery Procedures 32 Section VII Surgery 34 Section VIII Potential Pain 38 Section IX Exceptions 41 Section X Euthanasia 44 Section XI Hazardous Material 45 2 P age

3 Section XII Site of Study 47 Section XIII Technical Services 48 Personnel Responsibilities 49 Signature 52 Tools (Upload document/letters) 53 C. Animal Breeding Application 54 Section I Administrative 54 Section II Species 56 Section III Overview 57 Section IV Number Justification 60 Section V Breeding Colony Mgmt. 61 Section VI Additional Procedures 62 Section VII Potential Pain 65 Section VIII Exceptions 65 Section IX Euthanasia 66 Section X Hazardous Material 67 Section XI Site of Study 68 Section XII Technical Services 68 Personnel Responsibilities 69 Signature 69 D. Other Tools 70 a. Add Documents b. Utility c. Deleting Protocol 7: Submitting Modifications to an Approved Application 71 A. Request for Change 8: Submitting a Continuing Review 73 A. Continuing Review (USDA Annual & Three Year) 9: IACUC Submission Process 77 A. Submission B. Review C. Modifications 10: IACUC Correspondence 77 11: Important Tips 77 12: HELP 78 3 P age

4 1. Online Quick Start Instructions RSS Login: Login to the RSS with your Net ID and password. Select IACUC from the menu bar at the top. Qualifications: Select Qualifications from the menu. Note: All personnel must complete the Qualifications form prior to being added to an electronic application. o Section 1. Personal Information - When a person logs in and selects Qualifications it will automatically open up the individuals form with contact and training information that has been pulled from the UNMC database. Complete the Qualifications form: o Section 2. Education - Use the pencil icon to enter education information. o Section 3. Current Skills - Select all applicable Current Skills or None and the relevant species. Note: All experience and species should be included on this form, not just what is relevant to this protocol. Protocol specific responsibilities will be addressed in the application. Text boxes are provided for additional Procedures, Surgeries, and Other. Note: Enter only 1 procedure or surgery per text box and check all applicable species. Each additional skill of a procedure, surgery, or other will be imported into each application that you are added to. Click SAVE after adding a procedure or surgery to generate additional text boxes. If you do not have Current Skills for a particular species select None and check all relevant species that you do not have experience with. o Section 4. Work Related Experience Please describe how you have obtained your related experience. Note: You must answer the question NA or None if you do not have work related experience. Click SAVE when you have completed the form. Select OPEN PDF to view/print/save a pdf of your qualifications. To Exit Qualifications select IACUC from the menu at the top of the page, or select SIGN OUT to exit the RSS. Application: Select IACUC from the menu bar at the top of the page. Select New Protocol from the menu. Note: It is not recommended to submit a multi-species protocol. 4 P age

5 Select either 1. Research/Testing/Teaching or 2. Breeding From the box on the left. Note: The Animal Breeding Application only covers the breeding of animals that will be transferred to an experimental protocol and does not cover the use of animals for experiments. If you require the use of pregnant females, embryonic/fetal tissue, or the use of suckling pups for experimental purposes you should complete an experimental application with a breeding addendum. A separate IACUC Application for Animal Research/Testing/Training must have been previously approved or be submitted to cover the experimental use of bred animals. Use the menu on the left to navigate to the next section, or review already completed sections. Select the New Submission button. You should complete all sections of the application in order because each section may generate additional required questions and/or sections. Note: If you do not complete the sections in order and there are additional required questions unanswered the sections will be marked as incomplete in the menu and will not be able to be submitted. You should select SAVE at the end of each page and allow the page to update which may take 5-10 seconds to ensure there are no more additional questions. 5 P age

6 Note: Some questions that have radial buttons will instantly generate additional required questions. Questions that require a written response have to be Saved in order to generate additional questions. o Questions utilizing text boxes allow copying, pasting, or cutting text, not pictures. Note: The following commands may be used to paste directly into the text box. Copy: Keyboard Cntrl V Paste: Keyboard Cntrl C Cut: Keyboard Cntrl X In Section IV. Project design pictures may be uploaded in png or jpeg format only. You must name the picture and include that name in the text box where you want the picture to appear. Note: The uploaded picture will only be visible in the text in the PDF or View mode. Select the Open PDF button to see how the picture looks in the text. If sizing is an issue you may need to utilize the Add Document option in the menu on the left and indicate in the text that a PDF document has been uploaded containing a picture. In Sections VI-Nonsurgical Procedures and VII-Surgery; if the application contains non-surgical procedures that utilize drugs, and/or surgeries, small text boxes will be generated to list the procedure or surgery. o Click the to generate additional text boxes for additional separate procedures. Note: If multiple procedures and/or surgeries are being performed during the same anesthetic event you may list them together in the text box. This will eliminate answering the drug use and monitoring questions for each procedure or surgery being performed at the same time. Note: Individual procedures and/or surgery being performed during separate anesthetic events need to be listed separately and the drug menu and monitoring questions must be answered for each one. Click the to Save the listed procedure(s) and/or surgeries and it will automatically generate a drop down drug menu with species specific drugs and dosages. 6 P age

7 If answering YES to analgesics being used for Post-Procedure management a drop down menu of species specific analgesics dosages will automatically be generated. Note: If you answer NO You must check the reason why and justify if requested. You must always SAVE and EXIT the application at the end of each work session, but you may return at a later date to finish the application. Warning: You must select the EXIT button before logging out of the RSS or the application will remain locked by you and other personnel will not be able to edit the application. Only the PI or the assigned Contact can sign/submit the protocol after ALL sections of the application indicate they are complete. All of the orange arrows in the section menu and within the sections will be gone when the application is complete and ready to be submitted. o The PI/Contact must complete the Signature section by marking the circle next to the PI name to initiate electronic signing, and then click the SUBMIT button to send the completed application to the IACUC. Note: The PI name will appear exactly how it appears in the UNMC Directory. The PI and Contact, if listed, will receive confirmation from the IACUC that the application has been received and is currently under review. Note: The PI will automatically receive all correspondence. It is not necessary to list the PI as a contact. The PI and all other research personnel listed on the application may login at any time to view the application, or select the OPEN PDF button to view/print/save a pdf version of the application. Accessing Existing Application(s): At any time personnel listed on an application will be able to log into the RSS, select IACUC, select Protocol View/Edit, and then search and open an existing application from the list. The Application may be searched by All, status, Principal Investigator, the individual s role, or by typing in the protocol number. Select the search method or enter the protocol number and a list of applications that you are listed on will be generated. 7 P age

8 To view an application single click on the title of the application in the list. Application Views: o Edit View: An application still in the Edit mode can be viewed and/or modified by anyone listed on the application. In edit mode all instructions, questions, and choice of answers will be visible. o View Only: An Active, Submitted, or currently In Review application will open in View Only mode. In View mode you will see the application with the choice of options listed with a blue dash and the selected answer marked with a green check. o PDF View: Any application can be viewed as a PDF, saved, or printed by selecting the OPEN PDF button. In a PDF of the application you will see the basic questions and only the selected answers. Requests for Change: Once an application has been reviewed and approved by the IACUC changes can be made by logging into the RSS, select IACUC, select Protocol/View/Edit, and select your approved application. Open the approved application by single clicking the title. Select the Request Change button at the top of the application. 8 P age

9 The Request for Change (RFC) form will open and you must complete all of the sections on the form including the Understanding of IACUC Change Criteria. Note: The Request Change form will now be visible in the section menu on the left side of the page. Please be advised that the following situations may prompt the IACUC to request that a new/separate application be submitted: o Changes that do not fit with the overall scope of the science. o Changes that are unrelated to the current aims. o Changes that are so extensive they could be a standalone protocol. o The number of changes submitted has become excessive. Select the section(s) of the application you wish to change from the menu on the top left and make changes. DO NOT; underline, date, highlight, or mark the changed text or areas. Simply delete and/or add the new information where applicable within the application. Note: Once editing is complete within the sections of the protocol your changes will automatically feed in to the RFC form. The PI or Contact must complete the Signature section by marking the circle to initiate electronic signing. Changes will be tracked and may be reviewed by opening the RFC form from the menu on the top left. The RFC may be submitted by selecting Submit on the Change Request form or within the application. Terminating Application: To request to terminate an application that has not been assigned a number (not submitted) select the red x or for protocols already assigned a number (submitted or completed) select the in the protocol list in the far left hand column. By selecting this option a message box will appear asking if you are sure you want to delete this protocol. If you answer OK a message will be sent to the IACUC and the application will be deleted. You will then receive a confirmation from the IACUC. Please delete the following application: Added On: 01/25/2016 Added By: Clemons, Traci ISeq: 163 Requested By: Clemons, T Continuing Review: De novo continuing review of online applications utilizing USDA covered species (NHPs, swine, rabbits, sheep, hamsters) which occurs at a minimum of annually is in process. Please see Section 7: Page 74 Note: De novo continuing review for non-covered species (rats, mice, fish, amphibians), which occurs at a minimum of every 3 years is pending. The IACUC will notify you when and how this will occur with existing paper applications. 9 P age

10 2. Login to the Research Support Systems (RSS) A. WEBSITE: B. LOG IN 1) Enter your UNMC or NHS Olympus NET ID username and password I. If you have a NHS Olympus ID (i.e. Nebraska Medical Center ), click the box II. If you have a login and ID from one of the In Common participating universities choose any of the links below (UNO, UNL, Creighton, or Other University) to open up the InCommon page and choose your university from the drop down list. C. REQUEST AN ACCOUNT. If you do not have an account you will need to click on other users request an account here. 1) A separate window will open up with a form to complete. 10 P age

11 2) Enter in all required information. 3) In the section called ACCOUNT DETAILS for the PRIMARY PURPOSE OF ACCOUNT choose the option UNMC RSS from the drop down menu. 4) Once the form has been submitted and approved, you will receive 2 s from ITS System Access. These s will have your UNMC NetID username and password. For questions regarding this process, please contact the UNMC HELP desk at (402) P age

12 3. INITIAL SCREEN A. RSS Research Support System Online Application 1) Select IACUC from the black menu bar. 2) When the box opens you may select one of the following under IACUC APPLICATION: B. New Protocol - Select New Protocol to submit a new application. C. Protocol View/Edit- Select Protocol View/Edit: 1) To continue working on a protocol that has not been submitted. 2) To make changes or modifications to an approved active protocol. D. Qualifications Each person to be listed on an IACUC protocol must complete Qualifications prior to being added to an IACUC protocol to document education and current skills. Note: The Qualifications form may only be accessed and completed by individuals logged in to RSS. E. View IACUC/CM Contacts Welcome to the IACUC Online contacts to assist you. F. View Instruction Manual G. View Qualifications You can view/print/save other personnel qualifications. H. View Sample Forms You may view online forms containing help text prior to starting an application or form. 12 P age

13 4. ICONS & BUTTONS A. SAVE BUTTON This button is located at the top and bottom of each page and MUST be clicked to update and generate additional required questions and any time you exit an application. B. SIGN OUT BUTTON This button is located in the top right corner of each page and logs you out of the electronic system. C. EXIT BUTTON This button is located at the top and bottom of each page and updates any information you have entered or changed in the application prior to exiting the form. Note: You must exit an application or else it remains locked by you and limits editing by other listed personnel. D. SUBMIT BUTTON This button submits the application to the IACUC only when all sections are complete. Note: Only the PI and the contact have the ability to submit the application to the IACUC. E. OPEN PDF BUTTON This button enables you to view, print or save the.pdf version of the application. F. ORANGE ARROW This icon appears beside each section of the application menu and indicates that the section is not complete. It also indicates that questions within a particular section have not been answered. An application CANNOT be signed until all of the questions have been answered (i.e., there are no more orange arrows.) G. GREEN PLUS This icon adds items (e.g., personnel and documents). H. GREEN PLUS WITH BLUE ARROW This icon adds boxes for additional procedures (nonsurgical and surgical). I. GREEN ARROW This icon indicates additional choices for answering the question. J. RED X This icon deletes information (e.g., personnel, procedures, surgeries), that have been entered. K. BLUE FLOPPY DISC This icon is seen in the procedures section and saves information and generates additional questions that are required to be answered. NOTE: This icon does the same as the SAVE icon in C. above. L. LOCK ICON I 13 P age

14 This icon will appear when opening an application in the VIEW/EDIT mode on the list of protocols if someone else is logged into the application. ONLY one person can edit the application at a time. By placing the cursor over the lock, you will be able to see the name of the person who is logged into the application. NOTE: If you open the application to view it you will see it is in VIEW ONLY MODE and locked for editing by someone else. M. GREEN PENCIL AND PAD ICON This icon indicates a section is able to be updated and/or edited. N. CONTINUING REVIEW ICON This icon will appear in the last column of your protocol list next to the applicable protocol and indicates that the application is ready for an Annual (USDA Only) or 3 year continuing review and when you click on it will open the continuing review form. O. MAGNIFYING GLASS Provides additional information about the section or title it is beside. P. REQUEST TO TERMINATE APPLICATION These icons will be visible in the far left column of the application list when you log in and select View/Edit. For applications that need to be deleted that have never been submitted, or an application that has already been assigned a protocol number. 14 P age

15 5. QUALIFICATIONS STEP #1 (To be completed by each person) A. Select Qualifications from the IACUC application menu. B. Qualification Requirements: The Qualifications Form must be completed by all personnel prior to being listed on an application. Note: The Qualifications form may only be accessed and completed by the person that is logged in to the RSS. 1) Each person must complete the Qualifications form prior to being added to an IACUC protocol to document education and current skills. If you have not completed the Qualifications Form prior to being listed the application will indicate that the Personnel Responsibilities section of the application is not complete and the individual has not entered the required information. Note: The PI/Contact will not be able to submit the application until all added personnel have completed the Qualifications form. 2) When you are added to an IACUC application it will automatically upload your education, training, and Current Skills from your Qualifications form to the Personnel Responsibilities on the application. Note: It is important that you list ALL current skills, (procedures that you are proficient in performing), so that it will import them in to any application that you are added to. This will allow investigators to check applicable Protocol Specific Responsibilities within the application and show that you are trained in those procedures. Procedures not listed on your Current Skills will indicate that training is required in those procedures. 3) The qualifications form may be updated at any time and the information will be automatically uploaded to applications in edit status that you are listed on. Note: Edit status is prior to initial approval or when a Request for Change has been initiated. C. Completing the Sections: 1) When you log in and select Qualifications your personal contact information, and IACUC and CM training that you have completed will appear as listed in the UNMC database. Note: These records also indicate enrollment/completion in the Occupational Health and Safety Program and your Employee Health clearance status. 15 P age

16 2) To complete part 2. Education, click on the Pencil and fill in the information. Click the SAVE button and it will generate additional boxes if needed. When finished entering click on Save and then click the Close button. 3) To complete part 3. Current Career Skills Select all applicable Current Skills or None and the relevant species. Note: All experience and species should be included on this form, not just what is relevant to this protocol. Protocol specific responsibilities will be addressed in the application. Note: If you do not have Current Skills please check None and the species that you will be working with or check all species listed. 16 P age

17 4) Part 3. Additional Surgeries, Procedures, or Others that are not in the standard list: List 1 skill in the appropriate box and mark the relevant species and then click the SAVE button which will save the form and generate more boxes for additional surgeries/procedures/other. NOTE: Only one skill can be entered in one box and then you may check all species you are trained on for that skill. These items must be listed individually because they are imported into Protocol Specific Responsibilities for each application you are added to and the PI can then assign them to you. The Current Skills list within the application will show all of your skills. 5) Part 4. You must answer question 4. Describe how you acquired your Skills in 3. Or answer None or NA if you did not check any Skills in 3. Note: This question must be answered. 6) When the form is complete click the SAVE button at the bottom of the page. 7) To Print/View/Save a pdf click the OPEN PDF button. 8) To return to an application select IACUC from the menu at the top of the page. 9) To sign out of the RSS click the SIGN OUT button. D. Updating Personnel Qualifications: 1) The Qualifications may be updated at any time changes need to be made (i.e. Training has been completed for a procedure). 2) Qualifications should be updated prior to submission of an annual or 3 year continuing review. 17 P age

18 6. STARTING A NEW ELECTRONIC APPLICATION A. RSS IACUC Application: Starting an electronic application form. Select New Protocol from the IACUC application menu. 1) Under New Application-Create New Application 2) select either: 1. IACUC Application for Animal Research/Testing/Training Application or 2. IACUC Application For Animal Breeding I. 1. IACUC Application for Animal Research/Testing/Training: You will select number 1. for all research, testing, or training including breeding for experimental purposes. NOTE: If you require the use of pregnant females, embryonic/fetal tissue, or the use of suckling pups for experimental purposes you will need to complete the Breeding Procedures Addendum. This addendum is created in Section II. 2. when you check the following: II. 2. IACUC Application for Animal Breeding: You will select 2. If you are maintaining a breeding colony to produce weaned animals to be transferred to experimental protocols. 18 P age

19 B. 1. IACUC APPLICATION FOR ANIMAL RESEARCH/TESTING/TRAINING The Section menu on the left will navigate you to each section of the application and will have an orange arrow next to the section until the section is complete. Note: Once the section is complete the orange arrow will be gone from that section. I. ADMINISTRATIVE : 1. Status. Select the New Submission button. Note: Annual, Continuing Reviews, and Requests for changes to currently approved applications will continue to be submitted on the downloadable PDF forms and ed to IACUCORA@unmc.edu until further notice. 2. Title of Protocol. 3. Responsible Personnel. Personnel are added to the application by selecting the under the appropriate category. Research personnel are divided into the following categories: PI, Secondary PI, Research Personnel, and Contact. Contact is one person other than the PI that will receive all official IACUC correspondence. To delete personnel select the beside the person s name. Note: Personnel should only be added to the application after they have completed their online Qualifications form because the application will indicate Personnel Responsibilities as incomplete and the application will not be able to be submitted. Click the green to search the data base for personnel to be listed on the application. 19 P age

20 Type in the name under Search Employees, click Search, when the name appears in the results box place the cursor on the name and click. When the name you chose appears in the selected employees box select the OK button. Note: If you generate a list of names you can use the scroll bar or place your cursor over the list and use the wheel on your mouse to scroll through the names. Note: Principal Investigator (PI): The question must be answered Yes or No if the PI is faculty. If No, Faculty Advisor must be added to the application and an Assurance that the PI has consulted with the Faculty Advisor must be checked. 4. Funding Source. Check all that apply and/or provide the information requested. 5. Unusual Deadlines or considerations. Are there any unusual deadlines or considerations? If Yes, boxes will automatically appear and you must explain. 20 P age

21 6. Type of Project. What is the primary purpose of this protocol? If you select Teaching/Education an assurance will appear that must be checked. II. SPECIES: 1. Species Selection. Select the species to be utilized on this project. Check all that apply. The IACUC recommends submission of a separate protocol for each species to be utilized, when feasible. Select the species to be utilized by clicking the green arrow to display additional breeds/strains, check the box for the species and list the strain when a text box is provided. (i.e. rats, mice, other) Note: A multi-species application is not recommended. If you submit a multi-species application you will need to answer most questions in duplicate and the sections will indicate the species each question is for, i.e. Mice followed by the question(s), Rat followed by the question(s). Note: Do not list the genotype in this section. 21 P age

22 Note: *Click SAVE to generate additional question(s). 2. Source of Animals. Select all that apply. Policy for Rodent Breeding Colonies If you select On campus breeding colony in 2. Source of Animals, it will automatically generate; Status of protocol for on campus breeding colony. Note: If Breeding Colony protocol is already approved list the protocol number in the box provided. If you select Animals will be bred on this protocol and click SAVE it will generate a new section Breeding Procedures Addendum in the application menu. If you open the magnifying glass icon it will explain the Addendum in more detail. 22 P age

23 3. Sex of Animal. The sex of the animal being utilized may be relevant in the review process and must be answered. Note: Justification for the sex of the animal will be required and should be explained in the Section IV. Project Design or in a text box provided below the question. III. OVERVIEW: 1. Project Overview. Provide a non-technical, lay language summary (250 words or less) of the proposed project that can be understood by non-scientists, community members, and IACUC members with varied research backgrounds. Discuss the potential value of the project with respect to human or animal health, the advancement of knowledge or the good of society. Identify the information gaps the project is intended to fill. a. Target Population. Note: Only relevant to a Teaching/Training Application. If this is a Teaching/Training application and you marked that in Section I, it will generate a new question in Section III for you to specify the target population. 23 P age

24 2. Duplication. Does the proposed project duplicate previous projects? In some cases experiments may need to be repeated for a specific reason. If you select YES it will automatically generate a text box to explain. 3. Animal Use Justification. The justification for using live vertebrate animals rather than alternative non-animal models (e.g. mathematical or computer) or in-vitro models (e.g. tissue culture) to achieve the project goal is: (check all that apply) Note: If you select Other you must explain the justification. 4. Species Justification/Animal Use. This species was selected for the project because of the following attributes (check all that apply): Note: If you select Other Attributes you must explain the justification. 24 P age

25 5. Genetically Engineered Animal Use. Will you be using genetically engineered animals? This includes animals with induced mutations, including transgenic, targeted mutations (knockouts or knockins), and retroviral, proviral, or chemically-induced mutations. a. Genotype: If you answer YES to the use of Genetically Modified animals you will need to list each genotype individually and describe the genetic alterations for each one. Note: You may click the should click the to generate additional text boxes for each additional genotype, but you to Save after each entry. Note: Describe the genetic alterations. Describe the alteration for each genotype listed above. If there is a potential for a morphologic or functional impairment it must be addressed in detail in Section VIII- Potential Pain. b. Phenotype Induction. Is induction necessary to activate the genotype? Answering No means that the gene is expressed without induction method. Note: If the gene requires an induction method please check the method below. 25 P age

26 Phenotypic Expression. The phenotypic expression of these genetic alterations will likely result in: Answer whether the gene alteration causes any morphological or functional impairment to the animal. Note: If there are, address in SECTION VIII Potential Pain and will eliminate the option of Category C in 1. Animal pain/distress classification. Special Husbandry Needs. Indicate unique or special animal care needs (e.g. feed, water, temperature, humidity, light, etc.) required for these genetically engineered animals. Answer whether the gene alteration will require special care for the animal. Note: If there are special husbandry needs they must be addressed in SECTION IX- Exceptions 1. Exceptions to Standard Animal Care will already indicate Yes. 6. Immunodeficient Animal Use. Will any of these animals be Immunodeficient? Note: If you answer Yes to the use of Immunodeficient animals you will need to indicate whether any special care is needed and this must be addressed in Section IX-Exceptions 1. Exceptions to Standard Animal Care will already indicate Yes. 26 P age

27 IV. PROJECT DESIGN: 1. Research/Course Design. The design should allow the IACUC reviewer to understand exactly what will be done to all the animals from entry into the study to the endpoint of the study. Provide the following: List the aims, define the groups, identify the strains to be used, and the number of animals per group for each aim. For each group, list the anticipated sequence of all procedures to be performed on live animals by providing a timeline, diagram or flowchart. Note: The IACUC may require additional information and justification for toxicity studies on new/unknown compounds. Define the project endpoint (when the scientific aims and objectives have been reached) for each group of animals (i.e. what determines when the project is complete and the animals are to be euthanized and/or other final disposition). DO NOT include detailed descriptions of procedures, surgeries and in-vitro studies. Note: You may copy and paste into this section by using the tool bar or placing your cursor in the text box and typing Cntrl V on your keyboard which will paste the text directly into the box. You may add images in JPG/PNG format only by utilizing the + link below the text box. 27 P age

28 Uploading Images: To upload a jpg or png image click on the green plus and browse as shown below: Note: Images must be labeled exactly how you label them in your design which will signal the picture to appear within the Research Design text in View or PDF mode only. Example: Label the picture image 1 and where image 1 and the image will replace it in the view or PDF mode. PDF View: Note: The uploaded picture will only be visible in the text in the PDF or View mode. Select the Open PDF button to see how the picture looks in the text. If sizing is an issue please utilize the Add Document option on the menu on the left and indicate in the text box that a PDF document has been uploaded containing a picture. Creating or Copying Tables: If you create a table within the text box or paste a table in the text box check to make sure that the table will not be distorted on the pdf view. Select Open PDF to ensure that the table is not distorted. If the table is distorted right click and select Properties and make sure the width of the table is set at 100%. 28 P age

29 2. Number of Animals. Enter the total number of animals in the box below, select SAVE and it will auto fill the table. Note: A separate box will appear for each as applicable; purchased, transferred, bred, or wild caught to be used for experimental groups regardless of strain or source. 3. Number Justification. Select all methods that apply to justify animal numbers. Selection of method(s) will automatically generate a text box to explain the justification. Note: Do not include the total number of animals in this section, only how you determined that number. 29 P age

30 V. FIELD STUDIES: Policy for Field Studies 1. Field Studies. The question must be answered YES or NO and then select SAVE. Answering No and selecting SAVE will complete the section. Answering YES will automatically generate applicable questions that must be completed for Field Studies. 2. Field Study Location. If yes: Specify the location/s where the field study will take place: 3. Observation/Capture of Animals. How will the aims of the study be accomplished? Select all that apply. Observation or Capture Describe all methods and procedures for observing the animals. Describe all procedures to be used for the capture of the animals: 4. Importation of animals. Will any animals be brought back to UNMC/UNO facilities? If yes: a. Describe the importation plan that has been developed with the UNMC/UNO veterinary staff: 30 P age

31 5. Animal Transportation. Will any animals be transported from one location to another location? If yes: a. Provide justification for animal transportation: b. Specify the point of origin and the final destination: c. Describe the vehicle and how it is equipped to ensure the welfare of animals during transport (e.g., heated, air-conditioned, tie-down straps for caging, etc.): d. Describe the procedures to be used to ensure animal welfare during transport (e.g., caging, food, water, observations, etc.): e. Person responsible for transport: f. Describe the procedures for sanitation of the vehicle interior after transportation: 6. Safety. Does the animal that is to be observed, captured and/or handled pose a risk to human health such as toxin exposure, bites/scratches, and/or potential zoonotic disease carrier, etc.? If Yes: a. List potential risks: b. Describe PPE and safety procedures that will be used to prevent applicable exposures to potential risks: c. Assurance: I assure that UNMC or UNO health and safety committee/office will review potential safety concerns to determine that this protocol does not compromise the health or safety of either animals or persons in the field prior to the start of the study. 7. Permits and Authorizations. Are local, regional, or national permits or other authorizations required for the observation, capture, transportation, data collection or other proposed activity using these animals? An answer of No indicates that permits and/or authorizations are not required; an answer of Yes indicates that permits and/or authorizations are required for the proposed activities. If Yes: a. Agency: b. Assurance: I assure that I will have all applicable local, regional and/or national permits or other authorizations required for the observation, capture, transportation, data collection or other proposed activity using these animals prior to the start of this study and the for appropriate duration. 31 P age

32 VI. NONSURGICAL PROCEDURES: 1. Non-Surgical Procedures. Will non-surgical procedures be performed? Indicate YES even if only collecting tissue post-mortem. Answer No and select SAVE If the only performing Surgical Procedures and move on to Section VII. Surgery. 2. Description of non-surgical procedures. Answering YES will automatically generate a text box to describe ALL non-surgical procedures. Note: Make sure that all non-surgical procedures are included in the description. Those that require the use of drugs will need to be listed again as instructed below. Note: If you are utilizing a UNMC Core protocol for a procedure, (i.e. MRI), please describe the procedure as; MRI will be performed according to protocol number. Warning: Do not answer YES to the use of anesthetics in this application for procedures performed on a Core Protocol. The details of anesthesia will be described in the referenced protocol. 3. Drug Usage. You must answer Yes if you will be using any sedatives, pre-anesthetics, paralytic agents, and/or analgesics. Note: If you are euthanizing the animal prior to tissue collection (Postmortem tissue collection), you will answer NO to the Drug Usage question. You may click the generate additional text boxes for additional separate procedures, and you should click the to to 32 P age

33 Save after each entry, which will generate a drop down menu of drugs to choose from and additional required questions for drug monitoring. Note: If multiple procedures are being performed during the same anesthetic event you may list them together in the text box. This will eliminate answering the drug use questions for each procedure, however, if there are multiple procedures being performed during separate anesthetic events they will need to be listed separately and the drug menu and monitoring questions will be repeated for each procedure. Warning: Do not answer YES to the use of anesthetics in this application for procedures performed on a Core Protocol. The details of anesthesia will be described in the referenced protocol. a. Choose the sedatives, pre-anesthetics, anesthetics, and/or analgesics to be used to perform the procedure. b. Monitoring during anesthesia. Monitoring during anesthesia. Describe methods used to monitor the state of anesthesia and general well-being of the animal during anesthesia of each of the procedures (i.e., reflexes, respiratory rate, body temperature, blood pressure, oxygen saturation, heart rate, EKG, etc.) c. Intra-procedural support: Check and explain if required any support/care that will be provided to animals during anesthesia for each of the procedures (i.e., mechanical ventilation, IV fluids, heat support, etc.). d. Paralyzing Agents. Will neuromuscular blocking agents (paralytics) be used at any time during the procedure? If yes, federal regulations prohibit the use of paralytics for procedures unless the animal is in an appropriate plane of anesthesia. Note: If you are using paralytics you will need to answer Yes and provide justification and describe monitoring parameters. e. Post-anesthetic monitoring. You must ensure all sedated/anesthetized animals are monitored until they are in sternal recumbency and can hold their heads up. 33 P age

34 4. Post-procedure pain management. If Yes you will need to select analgesics and describe the analgesic treatment plan. If No you will need to provide the reason for not using analgesics. Note: If you select Pain, discomfort, or distress is expected but will not be treated. You must provide strong justification understand that this classifies the pain category as E in section VIII. 5. Post-procedural Monitoring. All animals that are anesthetized must be monitored until they are awake and are sitting up. Insert question here: Immediate post-procedural monitoring. I will ensure that all sedated/anesthetized animals from survival procedures will be continuously monitored until they regain sternal recumbency and are capable of holding their heads up. VII. SURGERY: Policy for Surgery 34 P age

35 a. Surgical Procedures. Will Surgery be performed? If you answer No to non-survival or survival surgery select SAVE and move on to section VIII. Answering YES will automatically generate a text box to list the surgery. You may click the to generate a text box for each additional surgery. Click the to Save after each entry to keep the surgeries in sequence and generate additional required questions. Note: If multiple surgeries are being performed during a single anesthetic event they may be listed in the same text box, however if only one surgery is being performed in an anesthetic event then it must be listed individually and you will be required to select anesthetics, sedatives, and analgesics and answer all required questions for each anesthetic event. 2. Surgery. List and describe each surgical procedures to be performed on animals. Note: Enter multiple surgeries into one (1) row if they are ONLY if they are ALL being performed during the same anesthetic event. This will eliminate answering the required questions for each surgery. 35 P age

36 Note: The following questions must be answered for each anesthetic event: 3. Pre-operative animal preparation. Specify pre-operative actions that will be taken to prepare animals for surgery. Do not include anesthesia or analgesia. Select all that apply: Note: Questions must be addressed for each surgery or surgeries performed during a single anesthetic event. If this is a multiple species protocol all surgeries and supporting information must be answered for each species. 4. Anesthesia. Choose the sedatives, pre-anesthetics, anesthetics, and/or analgesics to be used FOR performance of the surgery. Do not address POST-OPERATIVE pain control in this section. Note: If multiple surgeries are being performed during the same anesthetic event you may list them together in the text box. This will eliminate answering the drug use questions for each procedure. 5. Intra-operative animal support. Specify intra-operative care that will be provided to animals during surgery. Select all that apply: 6. Monitoring during anesthesia. Specify intra-operative monitoring of animals during surgery. Select all that apply: 7. Paralyzing Agents. Will neuromuscular blocking agents (paralytics) be used at any time during the surgery? Federal regulations prohibit the use of paralytics for procedures unless the animal is in an appropriate plane of anesthesia. If paralytics are to be used answer Yes and additional questions will be automatically generated for you to provide justification. Note: If you are using paralytics you will need to answer Yes and provide justification and describe monitoring parameters. 8. Survival vs Non-survival surgery. Will the animal awaken from anesthesia after the surgical procedure? If the animal will not awaken from anesthesia after the surgical procedure answer NO. 36 P age

37 If YES post-operative and pain care management questions will be automatically generated. Note: Answering YES or NO will require that all personnel read the Policy for Surgery and assure that they will conduct the project in full accordance with the policy. a. Suture Material. Suture Material. Will skin sutures or staples be removed between 10 and 14 days post-procedure? Ensure that surgical site closure is fully described previously in the surgery description. b. Post-operative animal support during recovery. Specify post-operative care that will be provided to animals during recovery from anesthesia. Select all that apply: c. Post-operative pain management. Will analgesics be used to prevent pain, discomfort, or distress after the surgery? If No you must select a reason why. Note: If you answer: Major surgery is proposed but prophylactic analgesics will not be provided. You must provide strong scientific justification for withholding analgesics and the application will automatically be classified as a Pain category E in Section VIII. 9. Assurance. All surgeries are required to be conducted in full accordance with the Policy for Surgery. The box for the assurance must be checked. 10. Post-operative Monitoring. Surgery is Survival surgeries require that all personnel assure that animals will be monitored until they regain sternal recumbency and are capable of holding their heads up and that all animals will be monitored for 72 hours post-operative. 37 P age

38 VIII. POTENTIAL PAIN: 1. Animal pain/distress classification. Choose the highest pain level classification. A painful procedure or condition is defined as anything that would be reasonably expected to cause more than slight or momentary pain or distress in a human being. Note: Animal Pain Classification will automatically eliminate Category C if the content of the application does not indicate more than momentary pain based on the context of the application or Indicate category E only if you have indicated in Section VI. Or VII. analgesics will not be administered even though painful procedures are proposed. Note: If you answered that the animals had a potential for morphological or functional impairment in Section III. Overview, you must address these impairments in Section VIII. 38 P age

39 Note: If category E has been assigned the following questions must be addressed: You must justify why appropriate anesthetics, analgesics or sedatives WILL NOT BE USED: Assure that pain/distress relief will be withheld for the shortest period of time necessary. 2. Identification/Consideration of Alternatives to Painful/Distressful Procedures. Note: For all Category D and E protocols the following questions must be completed. If the application is a Category C then Question 2. Will not appear. a. Potentially Painful, Distressful Procedures/Conditions. Check and list all specific procedures, surgeries, conditions, and/or phenotypic attributes that may result in animals experiencing more than momentary slight pain, discomfort, or distress. The strategy utilized the following: Date (month/date/year) of search: b. Search Strategy for Alternatives to Potentially Painful Procedures and/or Conditions: Procedures or conditions potentially causing more than momentary pain or distress to an animal, even though the pain will be relieved by administration of proper drugs, requires investigators consider alternative procedures. A literature search for alternatives to the above listed potentially painful/distressful procedure was performed. The strategy utilized the following: Date (month/date/year) of search: Years covered by the search (from-to): Note: Recommended the search cover >10 years. List the search strategy used in the search. Ensure to combine the names of specific procedures, conditions, and/or phenotypic attributes with the body organ or area of focus and the animal species, with the terms such as alternative or refinement. A suggestion for a complete search strategy may include: laparotomy AND ovariectomy AND (refinement OR replacement OR alternative OR pain OR distress) AND (mouse OR mice OR rodent). Databases searched-2 required- Did the literature search reveal less painful/distressful alternatives to the proposed procedures? Yes or No Note: If yes, answer why alternatives cannot be utilized in the application. 39 P age

40 Note: For assistance with alternative searches please review this PAL Bulletin, Guide for an Acceptable Search for Animal Alternatives found in the Protocol Requirements folder or visit the UNMC McGoogan Library website Animal Models in Research: Searching for Alternatives c. Animal Health Consequences: Describe all clinical signs and symptoms that may present in the animals as a result of protocol procedures surgeries, agents, disease processes, genetic alterations, etc. Include onset, duration and severity of signs/symptoms as applicable. Note: Please make sure to include all symptoms that may occur as a result of the procedure or disease state of the animal including onset, duration, and severity. Note: The following questions 4. through 6. must be answered for all Pain Categories and is related to monitoring sick and otherwise healthy animals. 3. Monitoring Parameters: Select parameters from the list below that will be used to detect pain, distress, or discomfort and promote the general well-being of the animals. Monitoring of five or more parameters is recommended. 4. Frequency/Duration of Monitoring: What is the frequency (specified times per day) and duration (number of days) over which monitoring of the animals will be performed by the investigators/technicians? Note: The IACUC expects that all animals will be monitored at appropriate intervals that are dictated by the nature of the protocol, as well as, the degree of potential pain, the likely duration of the pain and possible complications. 5. Management Plan: If signs of pain, distress and/or discomfort are detected, describe the management plan to relieve pain, distress and/or discomfort in the animals. Check all that apply. Note: If some or all groups will not receive analgesics to relieve pain text boxes will be automatically generated when you check the 3 rd box and you must list the groups and justify why pain relief will not be provided. 40 P age

41 6. Premature Euthanasia/Humane Endpoints: Policy for Criteria for Premature Euthanasia-Humane Endpoints Note: If you answer No text boxes will be automatically generated for you to request an exemption, justify, describe supportive care, and state endpoints. IX. EXCEPTIONS TO REGULATIONS/GUIDELINES/POLICIES: Note: All exceptions must be described in detail and scientifically justified. Do not assume that an exception will be approved by the IACUC. 1. Exceptions to Standard Animal Care. If Yes to any of the exceptions listed then it must be described in detail including the affected groups, frequency and duration, and scientifically justified. Note: If the protocol indicated that "Special care required in Section IV. for genetically modified or Immunodeficient animals then the answer is automatically marked Yes. Note: Single Housing exemption is included in this section. 41 P age

42 2. Physical Restraints. This exception is for physical restraint, but does not include hand held or restraints used when the animal is under anesthesia. Policy for Physical Restraint 3. Non-Pharmaceutical Grade Agents. Note: Many test compounds administered to animals for research purposes may not be Pharmaceutical grade and therefore must be listed in this section and explained and scientifically justified. Note: Some anesthetics, (i.e. urethane, chloralose and Tribromoethanol), are not available in Pharmaceutical Grade and please be advised that this is not proper justification for using them. Scientific justification must be provided for the use of these anesthetics. Policy for Non-Pharmaceutical Grade Agents 42 P age

43 4. Multiple Major Survival Surgery. Policy for Multiple Major Survival Surgery 5. Expired Drugs or Devices. Policy for Expired Drugs or Medical Materials 6. (Non-USDA animal) Holding animals outside centralized facility. The holding time for non-usda animals is 24 hours. Policy for Holding Animals outside the Centralized Animal Facility 7. (USDA animal) Holding animals outside centralized animal facility. The maximum holding time for USDA animals to be outside of the facility is 12 hours. Note: If this protocol utilizes only USDA covered species number 6 will not appear, but if the protocol utilizes both USDA and non-usda you will see questions 6 and 7. Note: Policy for Holding Animals outside the Centralized Animal Facility 8. NHP Behavior Management Program. Note: If this protocol utilizes nonhuman primates number 8.will be included and must be answered. Note: Please contact CM for more information about the Behavior Management Program. 43 P age

44 9. Canine Exercise Program. Note: If this protocol utilizes dogs number 9. Will be visible and must be answered. Note: Please contact CM for more information about the Canine Exercise Program. X. DISPOSITION/EUTHANASIA OF ANIMALS: Note: Make sure to include all methods of euthanasia that may be utilized for animals in this protocol. Note: A physical method to ensure death is required following the primary methods of euthanasia. Policy for Euthanasia and Carcass Disposal 1. Final Disposition. All animals require the final disposition to be stated. 2. Methods/s of Euthanasia. Note: Please describe only the primary method of euthanasia in the text box, not the methods to ensure death. 44 P age

45 3. Method to Ensure Death. Performing a physical method of euthanasia following the initial method of euthanasia is required to confirm death prior to disposal. Note: The use of decapitation as a method to ensure death for neonate rodent pups <10 days old is required. XI. HAZARDOUS MATERIAL: This section must be completed for all protocols even if you are not utilizing hazardous material to ensure review of the Policy for Hazard Management which addresses safety for ALL personnel utilizing animals in research. Policy for Hazard Management 1. Animal Biological Materials. 2. Human Cell Lines. 45 P age

46 Note: New requirements involving human fetal cells/tissue will require review by the Scientific Research Oversight Committee (SROC) as well as IRB and/or IBC. 3. Infectious Agents, Viral Vectors, Recombinant or Synthetic Nucleic Acids, Bacteria and Biological Toxins. Note: A drop down menu from the IBC database will allow you to check the agent/vector/toxin. 4. Radioisotopes. Note: A drop down menu from the IBC database will allow you to check the isotope or radiation emitting equipment. 5. Hazardous Chemicals. Note: A drop down menu from the IBC database will allow you to check the chemical or drug. 46 P age

47 6. Chemotherapy Agents. Note: A drop down menu from the IBC database will allow you to check the agent. 7. Assurance. Note: Applicable to all protocols utilizing animals in research. XII. SITE OF STUDY: Note: Even if you have answered in Section XI. Hazardous Materials that you will be conducting the procedure outside of the central facility you will need to list the locations again in this section. Note: For housing inside the central facility please contact CM or UNO for housing arrangement. 47 P age

48 1. Procedure Location. Note: Include all locations outside of the central animal facility where procedures will be taking place. Note: Please be advised that IACUC approval of locations is required and all areas are subject to IACUC inspection. 2. Patient Care Areas. Note: Special approval by CM is required for all procedures utilizing patient care areas. XIII. TECHNICAL SERVICES: 1. Technical Services. Comparative Medicine (CM) offers a fee based service to PIs to perform proposed procedures on a protocol if needed. Please contact CM prior to listing them on your application. If you do not require CM services please check NO. 48 P age

49 PERSONNEL RESPONSIBILITIES: Each person that was added to the application in Section I. will be listed in the Personnel Responsibilities Section. Select an individual to assign Protocol Specific Responsibilities. The Personnel Responsibilities form will open up and display all of the person s information imported from their Qualifications form. Note: It is very important that you have listed all of your skills in the Qualifications section so that they will be imported into the Responsibilities section. When they are assigned for a particular protocol it will show that you are already skilled or trained to perform the procedure. 1. PERSONNEL INFORMATION- Is automatically imported from the IACUC and CM database. 2. EDUCATION To enter education you must click on the pencil icon and it will open up boxes to fill in your education. Select Save and it will generate additional boxes to enter all educational institutions. 49 P age

50 3. CURRENT SKILLS PROTOCOL RESPONSIBILITIES a. The Current Skills column will provide a list of common procedures and indicate if the person has a skill relevant to a specific species. Note: If the person listed additional Procedures/Surgeries/Other on their Qualifications form it will be imported into the list. b. The Protocol Specific Responsibilities column will show the species relevant to the application with a check box to be able to indicate what the person s responsibilities for this application will be. Check all applicable assigned responsibilities for each person. 50 P age

51 c. There is also the option to type in additional Surgeries/Procedures/Other at the bottom of the common list. List all additional Surgeries/Procedures/Other in the appropriate boxes. List all Surgeries/Procedures/Other in one box. See Example below. Note: These would be responsibilities that require training. If personnel are trained and you don t see the responsibility listed, the individual must go to their Qualifications page and add additional procedures/surgeries/other. d. The form will automatically identify if a person requires training by cross referencing the procedure to their Current Skills list. If training is required this will generate Question 5. Training to Be Provided. 4. How you obtained Current Skills or None. This information is automatically generated from the person s Qualifications form. 5. Training to be Provided. You must provide a training plan which includes how you will be trained and who will be responsible for training. Note: The person assigned to train must be listed on the application and have Current Skills marked on the protocol for those procedures in which that person will provide training. Note: If there is no training required (You are skilled in all assigned procedures) you will not see P age

52 SIGNATURE: 1. Certification of Principal Investigator: As soon as the PI is added to the protocol the application will show their name at the bottom of the Signature Section. and indicate unsigned. Note: The PI name will appear exactly how it appears in the UNMC Directory. When the application is complete a box will appear next to the PI name and the PI or the assigned Contact must mark the box next to their name which will electronically sign the application serves as the PI s acknowledgement and certification of the application. Note: Only the PI or assigned Contact is able to mark the Signature box and select the SUBMIT button to send the application to the IACUC. Once the box is checked it will indicate the date it was signed and the application will be ready to Submit. 52 P age

53 OTHER TOOLS FOR THE APPLICATION: Add Document: You may use this to attach additional supportive documentation to your application submission in PDF format. Note: Upon opening the Add Document option you will be asked to choose the appropriate folder for your document. Choose PI Additional Support Documents. Letters: Once an application has been submitted for review and correspondence such as modification letters and/or approval letters will be viewable here. IACUC Utility: This tool may be used to contact personnel listed on the application while working in the RSS. Terminating Application: To request to terminate an application that has not been assigned a number (not submitted) select the red x or for protocols already assigned a number (submitted or completed) select the in the protocol list in the far left hand column. By selecting this option a message box will appear asking if you are sure you want to delete this protocol. If you answer OK a message will be sent to the IACUC and the application will be deleted. You will then receive a confirmation from the IACUC. Please delete the following application: Added On: 01/25/2016 Added By: Clemons, Traci ISeq:163 Requested By: Clemons, T 53 P age

54 C. 2. IACUC APPLICATION FOR ANIMAL BREEDING: Warning: Only 1 species per breeding protocol. Note: The Animal Breeding Application only covers the breeding of animals that will be transferred to an experimental protocol and does not cover the use of animals for experiments. If you require the use of pregnant females, embryonic/fetal tissue, or the use of suckling pups for experimental purposes or you are creating a new transgenic lines of rodents that may be used for experimental purposes if successful, you should complete an experimental application with a breeding addendum. A separate IACUC Application for Animal Research/Testing/Training must have been previously approved or be submitted to cover the experimental use of bred animals. The Section menu on the left will navigate you to each section of the application and will have an orange arrow next to the section until the section is complete. Note: Once the section is complete the orange arrow will be gone from that section. I. ADMINISTRATIVE: 1. Status. Select the New Submission button. 2. Title of Protocol. 3. Responsible Personnel. Personnel are added to the application by selecting the under the appropriate category. Research personnel are divided into the following categories: PI, Secondary PI, Research Personnel, and Contact. Note: The Contact may be one other person, other than the PI. The Contact will receive all official IACUC correspondence. 54 P age

55 Note: Personnel should only be added to the application after they have completed their online Qualifications form because the application will indicate Personnel Responsibilities as incomplete and the application will not be able to be submitted. Click the green to search the data base for personnel to be listed on the application. Type in the name under Search Employees, click Search. When the name appears in the results box place the cursor on the name and click. When the name you chose appears in the selected employees box select the OK button. Note: If you generate a list of names you can use the scroll bar or place your cursor over the list and use the wheel on your mouse to scroll through the names. a. Principal Investigator (PI): The question must be answered Yes or No if the PI is faculty. If No, Faculty Advisor must be added to the application and an Assurance that the PI has consulted with the Faculty Advisor must be checked. 55 P age

56 4. Funding Source. Check all that apply and/or provide the information requested. 5. Unusual Deadlines or considerations. Are there any unusual deadlines or considerations? If YES, boxes will automatically appear and you must explain. II. SPECIES 1. Species Selection. Note: Only one species is allowed per Rodent Breeding Colony Application, but multiple strains are allowed. Select the species to be utilized by clicking the green arrow to display additional breeds/strains, check the box for the species and list the strain(s) in the text box that is provided, (i.e. rats, mice, other). Note: Do not list the genotype in this section. 56 P age

57 2. Source of Animals. Note: If you select On Campus Breeding Colony it will automatically generate a box to type in the protocol #. III. OVERVIEW: 1. Purpose of Study: a. Purpose of Maintaining a Breeding Colony. Select the appropriate answer for the purpose of study. If Other a text box will automatically be generated for you to fill in. Note: Cost alone is not justification. b. Provide a scientific justification for establishing and maintaining a breeding colony. 2. Genetically Engineered Animal Use. Will you be using genetically engineered animals? This includes animals with induced mutations, including transgenic, targeted mutations 57 P age

58 (knockouts or knockins), and retroviral, proviral, or chemically-induced mutations. If you answer YES to the use of Genetically Modified animals you will need to list each genotype individually and describe the genetic alterations for each one. Note: You may click the to generate additional text boxes for each additional genotype, but you should click the after each entry. to Save a. Genotype. Genetically Modified Animals List the each genotype (1 per box) and explain the genetic alteration(s) for each genotype. i. Describe the genetic alterations. Describe the alteration for each genotype listed above. Note: If there is a potential for a morphologic or functional impairment it must be addressed in detail in Section VII- Potential Pain. b. Phenotype Induction. If the gene requires an induction method while on the Breeding Colony protocol please check YES and the method of induction. Describe in section VI. Additional Procedures. Note: Answering No means that the gene is expressed without an induction method. c. Phenotypic Expression. The phenotypic expression of these genetic alterations will likely result in: Answer whether the gene alteration causes any morphological or functional 58 P age

59 impairment to the animal. Note: If yes, address in SECTION VII Potential Pain and will eliminate the option of Category C in 1. Animal pain/distress classification. d. Special Husbandry Needs. Indicate unique or special animal care needs (e.g. feed, water, temperature, humidity, light, etc.) required for these genetically engineered animals. Answer whether the gene alteration will require special care for the animal. Note: If there are special husbandry needs they must be addressed in SECTION VIII. Exceptions 1. Exceptions to Standard Animal Care will already indicate Yes. 3. Immunodeficient Animal Use. Will any of these animals be Immunodeficient? Note: If you answer Yes to the use of Immunodeficient animals you will need to indicate whether any special care is needed and this must be addressed in Section VIII. Exceptions 1. Exceptions to Standard Animal Care will already indicate Yes. 59 P age

60 IV. JUSTIFICATION OF ANIMAL NUMBERS 1. Number of Animals Requested. Fill in all 3 boxes below; founders, # needed to be transferred to experimental protocol, and total number to be produced. Note: The 3 rd box is an estimated # of animals and gives the IACUC an idea of how many animals will need to be produced in order to obtain the required number of animals. 2. Number Justification. Provide an explanation of how you came to the estimated numbers listed above. Note: The IACUC understands that you will not be able to give specific statistical justification. In the box provided below please list the IACUC protocol numbers where weaned animals will be transferred to be utilized for experiments. Note: Procedures utilizing these animals must be on an approved protocol or a protocol that is submitted and pending review. 60 P age

61 V. BREEDING PROCEDURES: 1. Breeding Scheme to be Used. 2. Weaning Schedule. If animals are being weaned older than 21 days please indicate the age and a text box will automatically be generated to provide justification for weaning at a different age. 3. Breeding Stock Selection. Describe how you will choose animals to continue breeding. 61 P age

62 4. Experimental Animal Selection. Describe the criteria of animals selected to be transferred and used in experiments. 5. Breeding Colony Maintenance. How long do you intend to maintain the breeding colony? VI. ADDITIONAL PROCEDURES: 1. Additional Procedures. Please answer yes if there are procedures or surgeries that need to be performed while the animals are on the breeding protocol prior to transferring them to an experimental application. Additional required questions will be automatically generated if you select yes. If no, answer and move on to Section VII. Note: If you answered YES to Section III. Question 2.b. for phenotypic induction on this protocol you should have additional procedures. a. Preparative Regimen. 62 P age

63 b. Description of Procedures. Answering YES will automatically generate a text box to describe ALL procedures. Note: Those that require the use of drugs will need to be listed again as instructed below. c. Drug Usage. You must answer Yes if you will be using any sedatives, pre-anesthetics, paralytic agents, and/or analgesics. Note: If you are euthanizing the animal prior to tissue collection (Postmortem tissue collection), you will answer NO to the Drug Usage question. You may click the to generate additional text boxes for additional separate procedures or surgeries, and you should click the to Save after each entry, which will generate a drop down menu of drugs to choose from and additional required questions for drug monitoring. 1. Monitoring during anesthesia. Describe methods used to monitor the state of anesthesia and general well-being of the animal during anesthesia of each of the 63 P age

64 procedures (i.e., reflexes, respiratory rate, body temperature, blood pressure, oxygen saturation, heart rate, EKG, etc.) 2. Intra-procedural support: Check and explain if required any support/care that will be provided to animals during anesthesia for each of the procedures (i.e., mechanical ventilation, IV fluids, heat support, etc.). 3. Post-anesthetic Monitoring. Ensure that animals will be monitored until they regain sternal recumbency or indicate that they will be euthanized. d. Post-procedure pain management. If Yes you will need to select analgesics and describe the analgesic treatment plan. If No you will need to provide the reason for not using analgesics. Note: If you select Pain, discomfort, or distress is expected but will not be treated. You must provide strong justification understand that this classifies the pain category as E in section VIII. Note: If YES a drop down drug formulary will automatically be generated and you will need to select the analgesics to be used and answer the e. Surgery. If any of the proposed procedures listed above are surgery answer YES and check the assurance that surgery will be conducted in full accordance with the Policy for Surgery. 64 P age

65 VII. POTENTIAL PAIN 1. Animal Pain, Discomfort and/or Distress Note: Breeding alone is generally a category C because it is considered not painful. If you answered YES in Section III.2.c.that there will be a functional deficit you will not see an option for Category C. There is also no option to have a category E for a breeding colony protocol. For more detailed instructions please go to Section VIII. of the Application for Research/Teaching/Testing Page 38 VIII EXCEPTIONS 1. Exceptions: Note: All exceptions must be described in detail and scientifically justified. Do not assume that an exception will be approved by the IACUC. 65 P age

66 For more detailed instructions please go to Section IX. of the Application for Research/Teaching/Testing Page 41 IX. EUTHANASIA 1. Methods of Euthanasia: Disposition/Euthanasia of Animals 2. Method to Ensure Death: What method will be used to determine that euthanized animals are dead? Select all that apply. Note: The IACUC requires decapitation as the method to ensure death of neonate rodents <10 days old. 66 P age

67 Note: The IACUC requires decapitation as the method to ensure death of neonate rodents <10 days old. X. HAZARDOUS MATERIAL: This section must be completed for all protocols even if you are not utilizing hazardous material to ensure review of the Policy for Hazard Management which addresses safety for ALL personnel utilizing animals in research. Policy for Hazard Management 1. Animal Biological Materials. For more detailed instructions please go to Section XI. of the Application for Research/Teaching/Testing Page P age

68 XI. SITE OF STUDY: Note: For housing within the centralized facility please contact Comparative Medicine for housing arrangements. Sites outside of the facility must be approved in advance by the IACUC and are subject to inspection by the IACUC. 1. Procedure Location. XII. RESEARCH TECHNICAL SERVICES: 1. Technical Services. Comparative Medicine (CM) offers a fee based service to PIs to perform proposed procedures on a protocol if needed. Please contact CM prior to listing them on your application. If you do not require CM services please check NO. 68 P age

69 PERSONNEL RESPONSIBILITIES: Each person that was added to the application in Section I. will be listed in the Personnel Responsibilities Section. Select an individual to assign Protocol Specific Responsibilities. The Personnel Responsibilities form will open up and display all of the person s information imported from their Qualifications form. Note: It is very important that you have listed all of your skills in the Qualifications section so that they will be imported into the Responsibilities section. When they are assigned for a particular protocol it will show that you are already skilled or trained to perform the procedure. For more detailed instructions please go to Section Personnel Responsibilities of the Application for Research/Teaching/Testing Page 49 SIGNATURE: 1. Certification of Principal Investigator: As soon as the PI is added to the protocol the application will show their name at the bottom of the Signature Section. and indicate unsigned. Note: The PI name will appear exactly how it appears in the UNMC Directory. -When the application is complete a box will appear next to the PI name and the PI or the assigned Contact must mark the box next to their name which will electronically sign the application serves as the PI s acknowledgement and certification of the application. Note: Only the PI or assigned Contact is able to mark the Signature box and select the SUBMIT button to send the application to the IACUC. -Once the box is checked it will indicate the date it was signed and the application will be ready to Submit. 69 P age

70 D. OTHER TOOLS FOR THE APPLICATION: Add Document: You may use this to attach additional supportive documentation to your application submission in PDF format. Note: Upon opening the Add Document option you will be asked to choose the appropriate folder for your document. Choose PI Additional Support Documents. Letters: Once an application has been submitted for review and correspondence such as modification letters and/or approval letters will be viewable here. IACUC Utility: This tool may be used to contact personnel listed on the application while working in the RSS. Terminating Application: To request to terminate an application that has not been assigned a number (not submitted) select the red x or for protocols already assigned a number (submitted or completed) select the in the protocol list in the far left hand column. By selecting this option a message box will appear asking if you are sure you want to delete this protocol. If you answer OK a message will be sent to the IACUC and the application will be deleted. You will then receive a confirmation from the IACUC. Please delete the following application: Added On: 01/25/2016 Added By: Clemons, Traci ISeq:163 Requested By: Clemons, T 70 P age

71 7. SUBMITTING MODIFICATIONS TO AN APPROVED APPLICATION: A. Select Protocol View/Edit from the IACUC Application menu. B. Choose the protocol from the list of existing applications, search by status, or enter the protocol number into the box and select SEARCH. C. Single click on the title of the application to open it in View mode. D. Select the Request Change button. 1)The Change Request form will be added and accessible in the Section Menu on the left. 71 P age

72 E. Complete all of the sections of the Change Request form including the Understanding of IACUC Change Criteria. Note: Please be advised that the following situations may prompt the IACUC to request that a new/separate application be submitted: a. Changes that do not fit with the overall scope of the science. b. Changes that are unrelated to the current aims. c. Changes that are so extensive they could be a standalone protocol. d. The number of changes submitted has become excessive. F. Select the section(s) of the application you wish to change from the Section Menu on the top left and make applicable changes. Warning: DO NOT; underline, date, highlight, or mark the changed text or areas. Simply delete and/or add the new information where applicable within the application. 1)Once editing is complete within the sections of the protocol your changes will automatically feed in to the Request Change form. To view the changes open the Request Change form. G. The PI must complete the Signature section of the application by marking the circle to initiate electronic signing. Note: The Signature section will indicate that it is not complete until the PI marks the box and selects Save. H. Once the change is signed it is ready to be submitted. Only the PI may submit the change by selecting Submit on the Change Request form or within the application. I. The IACUC will notify the PI and the contact, via , that the change has been reviewed and that the modification or approval letter is available for viewing as a PDF within the application on the RSS. 1) If the application requires modifications the application will be reset to edit so that the PI can make the required changes and resubmit to the IACUC for review. 72 P age

73 8. SUBMITTING A CONTINUING REVIEW: A. Continuing Review: According to Federal Regulations and UNMC/UNO IACUC policy, all projects involving the use of animals must be re-reviewed by the IACUC to ensure the project is being conducted in accordance with current policies and regulations. The IACUC will re-review all protocols of each previously approved, ongoing activity covered by the PHS Policy no less often than every three years, and for protocols utilizing USDA regulated species, no less often than annually. Note: This is a Continuing Review of the currently approved protocol. Warning: Changes are not accepted during the continuing review process. If there is a need for a change please contact the IACUC office to discuss the options or )The PI/Contact will receive a Continuing Review notification instructing them to log in to the RSS to complete the Continuing Review form for the applicable IACUC protocol. 2)Select the applicable IACUC protocol from the application menu. Note the icon the last column. and ContRev Due in 3)When you open the application you will see that the protocol is Active and in View Only mode and that the Continuing Review is available. Warning: If you select Request Change it will display a pop up window warning you that changes are not accepted at the time of Continuing Review and if you need to complete a change prior to CR contact the IACUC office. 4)Select the Continuing Review (CR) link from the menu on the left if you are ready to complete and submit the form. Once the CR is started you will not be able to edit the application. 73 P age

74 Warning: Changes are not accepted during the continuing review process. If there is a need for a change prior to submitting the Continuing Review please contact the IACUC office to discuss the options or Note: A pop up will appear to make sure that you are ready to start the CR. 5) Once the Continuing Review form is opened the process is activated and your protocol will be locked for editing and you will see Protocol Details and the Continuing Review form. The top of the page will indicate the type of Continuing Review (i.e. Annual for USDA species or 3 Year). Note: You may select the Open Protocol PDF button at any time to review your approved IACUC application. I. Protocol Details: When the CR opens you will see the Protocol Details which is currently approved data imported from the Research Administration database and displays information such as; species, amount of animals allowed/remaining, if animals are in house, and approved procedures and drugs. Note: Please review this information about your protocol as it is a summary of approved procedures, drugs, and animal numbers. II. Continuing Review: Select Continuing Review from the menu and select the correct Protocol Status. 74 P age

75 1. Protocol Status: Choose the appropriate status of your protocol. a. Request Protocol Termination. If this project will not be continued and you wish to terminate it please select the first option. Select SAVE and you will be able to check the Signature box and Submit to the IACUC. b. Request Protocol Continuance. If this project will continue select the second option and the continuing review will be generated. Answer all of the questions on the Continuing Review including updating the Search for Alternatives and provide a progress report. 75 P age

76 1. Consideration of Alternatives 2. Identification/Consideration of Alternatives to Painful/Distressful Procedures 3. Duplication 4. Unexpected Outcomes/Adverse Events Not previously reported to the IACUC 5. Study Update. c. Certification of Principal Investigator: Once you have answered all of the questions select SAVE. If the red arrows are gone you will be able to sign the Continuing Review and select Submit. 76 P age

77 9. IACUC SUBMISSION PROCESS: A. A new application or a Change Request may be automatically submitted to the IACUC once the application or change form is complete and signed by the PI. B. Selecting Submit will generate an to the IACUC to alert them that a new submission has arrived. C. The IACUC will process the submission and assign it for review. 1) Personnel listed on an application can log in to the RSS to view the status of the submission or look at the application in the View Only mode. D. The IACUC will notify the PI and the Contact, (if listed), when the submission has been processed and assigned for review. E. The IACUC will notify the PI and the Contact, (if listed), when the review has been completed and that they can log into the RSS to view the modification letter and review sheet or approval letter. F. If modifications are required the PI/designee will view the IACUC modification letter and be able to make the necessary modifications to the application through the RSS. Only the PI may Submit the revised application to the IACUC. 10. IACUC CORRESPONDENCE: All IACUC correspondence is found in the menu in each of your protocols on the RSS. 11. IMPORTANT TIPS: A. Use the section menu on the left to navigate through the application. B. Always select SAVE before proceeding and wait to see if any additional required questions have generated before you continue. C. Never log out or close the browser without selecting EXIT. If you do you will lock the application for editing and other personnel will only be able to view the application. D. You are allowed to skip to other sections but please be aware that it is best to do the sections in order because some questions/answers will feed into other sections later in the protocol which will generate new questions. 77 P age