Safe Operating Procedure

Transcription

1 Safe Operating Procedure (Revised 2/10) NUgrant IBC PROTOCOL FORM INSTRUCTIONS (For assistance please contact EHS at (402) or visit our web site at Contents Introduction... 1 Requested Information Checklist... 2 NUgrant Login Information... 4 IBC Protocol Approval Process... 5 Logging In to NUgrant... 6 New Protocol Form: Page New Protocol Form: Page New Protocol Form: Pages 2 through New Protocol Form: Page IBC Protocol List and Protocol Details Pages When Revisions are Requested Instructions for Department Head(s)/Chair(s), Deans, or Directors Introduction PLEASE READ ALL INSTRUCTIONS! (Thank you!) In accordance with the UNL Biosafety Guidelines, a protocol must be submitted for review by the Institutional Biological Safety Committee (IBC), for clinical, diagnostic, teaching, and research activities involving: Recombinant nucleic acid (rna) molecules (regardless of origin) and rna-containing organisms or cell cultures. Microorganisms or agents potentially pathogenic to humans, animals, or plants. Human blood or other body fluids, tissues, and cell lines potentially containing bloodborne pathogens, as similarly materials derived from experimentally challenged animals. Select agents and toxins. Animals for which a reasonable potential for transmission of naturally infected zoonotic agents exists, e.g., wild-trapped animals, necropsy, etc. The protocol is submitted for IBC review as an electronic document using the secure NUgrant system administered by the Office of Research. Once approved and assigned an (Created 9/09) Page 1 of 24

2 IBC registration number (NUgrant ID), the protocol is valid indefinitely, contingent on the PI submitting Annual Update Forms and obtaining approval of amendments, as applicable. An Annual Update Form will be requested on the anniversary of the protocol approval date. This form, submitted from within the NUgrant system, is used to inform the BSO and IBC of administrative changes, such as additional grant applications, staffing and location changes, and/or changes in decontamination/ disinfection methods. Modifications in the materials and methods used in your research and other major changes should be submitted by logging into the NUgrant system and submitting a Protocol Amendment Form. Requested Information Checklist Following is a list of the information that will be needed to complete the NUgrant protocol form. Although the system will allow a form to be saved in an unfinished state, it is most efficient to gather the requested information prior to starting the electronic submission process. List of current personnel and collaborators/co-pis (Page 1, Section I) Committee approval numbers (IACUC, IRB, RSC) (Page 1, Section I) NIH Guidelines assessment if applicable (which sections apply) (Page 1, Section I). See EHS SOP, Recombinant DNA IBC and Other Review Requirements. Research Description (in laymen s terms) (Page 1, Section II) Microbes in use (Page 2, Section III) Source, risk group, pathogen type (human, animal, plant), toxin production, use, recipient, antibiotic/drug resistance introduced Organ, Tissue, or Cell culture (OTCC) use (Page 2, Section IV) Source, name, supplier, containment level, passage, use, recipient Research Organism use (Page 2, Section V) Organism name, recipient of rdna, OTCC, microbe (route and dose), or toxin rdna use (Page 3, Section VI) Gene name, source, type, function, use, risk assessment Vector type, source, name, vendor, risk attenuation Viral vectors: system, plasmids used, tropism, transgenes, use Viral vector packaging: system, cell line, location of production/packaging and procedures Toxin use (Page 4, Section VII) Name, source, supplier, pathogen type (human, animal, plant), LD-50 or LDL, Target organs, use, recipient Facility information (Page 4, Section VIII & IX) Building & room numbers Room use (Created 9/09) Page 2 of 24

3 Containment Equipment Sharps Use Specialized Equipment Risk Assessment Safety Information (Page 5, Section X) Proposed containment level Personal Protective Equipment (PPE) Medical surveillance (vaccinations & medical monitoring) Disinfectant use Decontamination and disposal methods Autoclave (location and identification # s) Safe Operating Procedures observed (EHS or lab-specific) Lab security features/practices Sections I, II, and VIII-X are mandatory for all protocols. Sections III-VII are optional, depending on the project attributes. When completing the electronic form, check the not applicable check box if a section does not apply to your work. This will collapse the section so no further questions need be answered for that section. Section XI allows the investigator to attach additional information to aid the IBC in the review process. Examples include: import permits, plasmid maps, lab-specific procedures, etc. The following references are commonly used by the IBC when reviewing a protocol and may be helpful in completing the NUgrant form: Biosafety in Microbiological and Biomedical Laboratories. CDC/NIH. 5 th edition, January UNL Bloodborne Pathogen/Exposure Control Plan University of Nebraska - Lincoln, Environmental Health and Safety. Biosafety Guidelines University of Nebraska - Lincoln, Environmental Health and Safety. Laboratory Standard Department of Labor, Occupational Safety and Health Administration. 29 CFR, Part Federal Register Vol. 55, No. 21. NIH Guidelines for Research Involving Recombinant DNA Molecules. Revised January 2001 and subsequent amendments. National Institutes of Health. Occupational exposure to bloodborne pathogens; final rule Department of Labor, Occupational Safety and Health Administration. 29 CFR, Part Federal Register 56(235). Proposed Guidelines for Research Involving the Planned Introduction into the Environment of Organisms with Deliberately Modified Hereditary Traits USDA. Federal Register Vol. 56, No. 22. A Practical Guide to Containment: Plant Biosafety in Research Greenhouses, D. Adair & R. Irwin, Information Systems for Biotechnology; Blacksburg, VA; (Created 9/09) Page 3 of 24

4 NUgrant Login Information The web address for the NUgrant system is For UNL faculty and staff your login defaults to your My.UNL (Blackboard) login and password. For instructions on how to find your username and password see the FAQs at If you are unable to find your login and password by completing the steps in the FAQ, please send the following information to Name Address Phone Number Physical Address (e.g., street address or Bldg & Room #) University Department affiliation An account will be set up for you within NUgrant and you will be notified of your login and password by . The following pages contain screen shots and additional instructions. (Created 9/09) Page 4 of 24

5 IBC Process IBC Protocol Approval Process Complete/Edit Form in NUgrant Send Form to BSO for Review BSO Signs Off? No BSO Requests Revisions Yes PI Digitally Signs Form and Sends to Dept. H/C for Review Dept. H/C Requests Revisions No Dept. H/C Signs Off? Yes Is Protocol Exempt and BSL-1? Yes Form sent to IBC Chair for approval IBC Chair Requests Revisions No Form sent to IBC Committee for approval IBC Chair Approves? No Yes IBC Committee Requests Revisions No IBC Committee Approves? Yes Approval Letter with Contingencies sent to PI BSO action required IBC action required Yes Contingencies of Approval Met? No PI action required Dept. H/C action req. Final Approval Letter Sent to PI Yes NUgrant routing IBC Chair action req. (Created 9/09) Page 5 of 24

6 Logging In to NUgrant SCREEN SHOT WALK-THROUGH Login here with your My.UNL (Blackboard) ID and password Click this link to start a new protocol or click on IBC Protocol List to search for an existing protocol (Created 9/09) Page 6 of 24

7 Clicking on IBC Protocol List will take you to this screen. Click here Clicking on Start a new IBC protocol or the Add New IBC Protocol button on the screen above will take you to the New Protocol Form page. (Created 9/09) Page 7 of 24

8 New Protocol Form: Page 1 There are several elements here that display on every page of the form. Protocol Workflow This shows the steps of the protocol approval process. Red dots indicate incomplete steps. Protocol Status This shows the current status of the protocol. Form Pages This is a clickable list of the pages of the form, when they are complete a checkmark appears over the page icon. Enter the requested information and check the relevant boxes describing your protocol s attributes. The buttons provide additional information about the items they are next to. Protocol Workflow Protocol Status Enter Protocol Title Here List of Form Pages: Hyperlinks allow moving from page to page freely. If you have existing IBC projects, and are converting them to the NUgrant system, please enter the project numbers here, separated by commas. Important If you are working with multiple model systems or microorganisms but the basic techniques and procedures are the same, you may enter all of the information in one protocol form with a generalized title. The individual projects can be described separately in the Research Description section at the bottom of Page 1. Important Several sections within the form are dynamically linked, meaning they are dependent on information entered in previous sections. It is highly recommended that you complete each section in sequential order to avoid having to go back and edit entries once the missing information is entered. (Created 9/09) Page 8 of 24

9 New Protocol Form: Page 1 continued rdna use requires selection of the applicable sections of the NIH Guidelines. More than one section of the Guidelines may apply. The info icon provides a link to the Guidelines on the NIH website. The Guidelines state that it is the PI s responsibility to determine which sections apply; however, you may contact the UNL Biosafety Officer with any questions at Selecting this triggers a request for citing the applicable section of the NIH Guidelines (Created 9/09) Page 9 of 24

10 New Protocol Form: Page 1 continued Enter Grant/Funding Information Here Enter your Dept. Head/Chair, Dean, or Director Here If you cannot find your Dept. Head/Chair, Dean, Director or equivalent using the search tool, please have them contact the NUgrant support staff at nugrant-ibc@unl.edu to setup an account. For the research description, please provide a general overview of the project(s) and any relevant experimental details that will aid the IBC committee in assessing the risk of the proposed work. You can describe more than one project, but please delineate them with project titles. When you have entered all of the information requested on Page 1, check the box next to Check if Page is Completed, then click Save or Next. This validates the page to confirm that all of the required information has been completed. If required information has been omitted, the missing sections will be listed at the top of the page in red. Repeat the above process when the required information has been entered. Note: You can move between pages without validating the entered information, but you will not be able to submit the protocol for review without the validation check for each page. Moving between pages without validation still saves the entered information. (Created 9/09) Page 10 of 24

11 New Protocol Form: Page 2 There are 3 sections on this page: Microbe information; OTCC information; and Research Organism Information. Complete all applicable sections. If a section does not apply, click the Not Applicable box for that section. Click here to enter microorganism information Additional information not captured by the form questions can be entered in the comments sections. The name of the microorganism will be displayed and the detailed information can be displayed by clicking on the icon next to the microbe name. Enter the microbe information in this pop-up window and click Save or Next. Some questions request more information when answered Yes. All questions must be answered, even if the answer is No, before the information can be saved. To enter another microbe, repeat the process. If the entered information needs to be corrected you can click on the Edit button. (Created 9/09) Page 11 of 24

12 New Protocol Form: Pages 2 through 5 The process of data entry is the same for all sections on the remaining pages. Click on Add a, and then answer all of the questions and click Save. Repeat this as many times as necessary for each section. When you have answered all of the questions, validate the page as described on page 8 above, then move on to the next page or you may exit the system and continue at a later time. New Protocol Form: Page 5 Safety and safety-related information is entered on this page. Enter the proposed containment level for the experiments. If you conduct work at more than one biosafety containment level, enter the highest containment level. Indicate all PPE used in the lab. If you are utilizing facility enhancements beyond those described for the indicated BSL, describe those here. Also indicate other practices that are beyond those required for the BSL indicated. If you are working at multiple BSLs, use this space to detail which experiments are conducted at which BSL. Enter decontamination and disposal methods here. If waste is being autoclaved, enter the location of the autoclave (bldg. and room) and the unique identifier for that autoclave. If not autoclaving waste, check Other and describe the procedure in the box provided. (Created 9/09) Page 12 of 24

13 Check the EHS SOPs that your lab will use and follow. Then go to the EHS website and download a copy for your lab Biosafety Manual if you do not already have a copy. If you opt to use lab-specific procedures in lieu of or in addition to EHS SOPs, please list them and submit a copy in this section. You may attach any materials or documents that you feel would assist the IBC in evaluating and reviewing your protocol. Vector maps are often required by the IBC. (Created 9/09) Page 13 of 24

14 Once all of the pages have been completed and validated, the status at the top of the page will change indicating the preparation task is complete. Click on the Next button in the green bar to move to the next step. Status has changed to indicate the form is complete. Click on this button to move to the next step. (Created 9/09) Page 14 of 24

15 On the page for Step 2, you must click on the Submit button to send your protocol to the Biosafety Officer for initial review. Click on this button to submit your protocol for review by the UNL BSO. Once submitted to the Biosafety officer, you will receive updates as to the status your protocol in the review process. Should anyone request revisions (BSO, Dept. Head/Chair, IBC committee), you will be notified and asked to login and address the issues and/or make necessary changes. The following pages illustrate what you will see when you login to do this. (Created 9/09) Page 15 of 24

16 IBC Protocol List and Protocol Details Pages When you log back in to the system you will click on IBC Protocol List as seen on Page 4 of these instructions. Below is the page that will be displayed. To view your protocol, click on the magnifying glass icon next to your protocol. Click to open protocol details page. This is the IBC Protocol Details page, the homepage for maintenance of your protocol. This gives an overview of the protocol and provides status indicators and a list of the forms you have submitted. Amendment forms and Annual Update forms will be listed here as well. There are tooltips for each icon when you place the mouse cursor over them to tell you what each icon button does. (Created 9/09) Page 16 of 24

17 Click to view your protocol. Click to print a PDF of your protocol. Form Status Click to view uploaded files List. (Created 9/09) Page 17 of 24

18 Clicking on the Assistants tab allows you to designate someone to have access/editing rights to your protocol. Click to view s and Letters sent through NUgrant about this protocol. Clicking on the icon will bring up the or letter so you can view or print it. Revisions requests, letters from the IBC and approval letters will appear here. (Created 9/09) Page 18 of 24

19 When Revisions are Requested After logging in to the NUgrant system, navigate to your IBC protocol Details page as described above. When you click on the icon to view your protocol you will see this page. Clicking on the Preparation icon will take you to a page like the one below. You MUST click on this button to send your revisions back to the BSO for review. You can go through the form and make changes, then write comments back to whomever requested revisions and then submit your revisions. (Created 9/09) Page 19 of 24

20 Once the Biosafety officer has reviewed and signed-off on your protocol you will be notified by and asked to login and digitally sign your protocol. This is the page you will see when you navigate to view your protocol. (See instructions on p. 17 for viewing your protocol) Once you have signed and submitted your protocol it will be sent to your Dept. Head/Chair/Dean or Director (DH/C/DorD) for review and then released for viewing by the IBC committee members once the DH/C/DorD signs-off on the protocol. It will be assigned to an IBC meeting and reviewed at the meeting. If the committee requests revisions, you will be notified by and asked to make the required changes before approval. Once changes have been submitted and approved, you will receive a formal approval letter from the Biosafety Officer on behalf of the IBC. A copy of this letter should be kept in your Biosafety Manual along with the final approved version of your protocol which can be downloaded as a PDF from NUgrant. (Created 9/09) Page 20 of 24

21 Instructions for Department Head(s)/Chair(s), Deans, or Directors When a protocol has been reviewed by the BSO and the PI has electronically signed the protocol. The designated Dept. Head/Chair, Dean or Director will receive an from NUgrant similar to this: Subject: NUgrant Message IBC New Project Form to Review NUgrant Dr. (Dept. Head/Chair name), You have been assigned as Department Chair/Dean/Director on an IBC New Project Form for (PI name). Please note that the project will not be reviewed by the IBC until you have signed off on it. Please click the link below to login and review the project form. Project ID: ### Project Title:????????????????????????????????????????? Principal Investigator: PI name Link: Comment(s): ========================================================= This message has been sent to you through NUgrant. If you have any NUgrant questions you can contact nugrant@unl.edu for help. Clicking on the link in this will take you to the login page for NUgrant. Login here with your My.UNL (Blackboard) ID and password (Created 9/09) Page 21 of 24

22 Click on the title of the protocol to review This will bring you to the IBC protocol Details page. Click to view the protocol. Click to generate a PDF version of the protocol. (Created 9/09) Page 22 of 24

23 When you view the protocol, a new window will pop-up in your browser and you will see the following page. You can review the protocol by clicking on the Form Pages links or if you generated a PDF you can review the protocol in that format. When you have reviewed the protocol, click on the Routing icon at the top of the page to take you to the screen below. Login here with your My.UNL (Blackboard) ID and password You must enter your login information again and check the appropriate box; either I Approve this as written or Request Revisions. Any comments to the PI can be entered into the comments section. When done, click on the Submit button to submit the protocol for IBC review. If you request revisions, the protocol will be routed back to the PI and then the BSO before returning to you for review. See When Revisions are requested section above. By entering your username and password again here you are electronically signing this document and agreeing to the conditions written above the signature section. (Created 9/09) Page 23 of 24

24 After clicking Submit you will see the following screen. You can now logout of NUgrant. Click here to logout (Created 9/09) Page 24 of 24