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					                                           FOR OFFICE USE ONLY
IBC Protocol #                                        Animal Work
Status                                                Recombinant DNA
Class III
Containment BL                                          Training Complete

                                 INSTITUTIONAL BIOSAFETY COMMITTEE

                                          Registration Document
                                             Last Revised July 2010

    For Research Involving Recombinant DNA, Infectious Agents and/or Tumorigenic Material
Administrative Information:

        A.   Title of Project:

        B.   Funding Sources:

        C.   Principal Investigator:

             Department/Division:                                     Campus Address:

             Campus Phone:                                            Emergency Phone:

             Email Address:                                           Fax Number:

        D.   Co-Principal Investigator:

             Department or Division:

             Campus Phone:                                     Emergency Phone:

        E.   Date Submitted:                                   Estimated Date Research
                                                               to Begin:




                                           FOR COMMITTEE USE ONLY
      Received by IBC:


      Date                                   Chairperson

      Approved by IBC:


      Date                                   Chairperson




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                                                                                    Last revised July 2010
                                            Registration Document

The KSU Institutional Biosafety Committee (IBC) has university oversight responsibility for reviewing and
approving all activities that involve the use of recombinant DNA and / or infectious or tumorigenic materials.
Consequently, it is critical that the IBC receive sufficiently detailed information to fulfill its review and approval
mandate. This IBC Registration Document (RD) is the critical instrument for the IBC to accomplish that review
and approval responsibility. If you are performing rDNA or infectious / tumorigenic material activities that are
not detailed in an approved RD, you may be in violation of federal regulations and / or university policies.

Please type or print legibly. This form must be completed and submitted to the Institutional Biosafety Committee (IBC)
/ University Research Compliance Office for approval prior to the initiation of research involving recombinant DNA
and/or infectious agents, as defined in the NIH and CDC Guidelines. FAILURE TO PROVIDE ALL
INFORMATION REQUESTED MAY LEAD TO A DELAY IN PROCESSING YOUR REQUEST!!!

Registration Documents are approved for a period of 3 years. Continued activity past 3 years will require a new
Registration Document.

Multiple Agent Approval in One Registration Document: The inclusion of multiple agents in a single Registration
Document may hinder the IBC’s ability to adequately review proposed activities. In general, if your request includes
more than one Genus or type of agent, that would affect the risk profile, please consider submitting additional
registration documents to the IBC for those differing agents instead of an all inclusive request. If the IBC concludes that
the activities are indeed too different, and that the information requested is not sufficiently detailed for review purposes,
the committee may request additional RD’s to cover activities deemed too divergent to be described together. This
would result in a delay for approval of those activities.

NOTE: Links in this application are NOT active due to the document’s protection. To use links, you must unprotect
document. All information will be locked when you unprotect, so you will lose what you previously typed.

The NIH and CDC Guidelines and additional reference materials can be found on the URCO webpage. NIH Guidelines
are at: http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
The CDC Guidelines at: http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
Consult the flow chart located on the IBC page within URCO Online if you need assistance.




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                                                                                            Last revised July 2010
TITLE OF PROJECT:



PRINCIPAL INVESTIGATOR:



I.        MODIFICATION
Is this a modification of an approved protocol?
    No          Yes: Please list registration document #_______________________________ and comply with the following:
If you are requesting a modification or a change to an IBC approved protocol, please provide a concise description of all of the changes that
you are proposing in the following block. This will greatly help the committee and facilitate the review.




II.        Non-Technical Synopsis (Please give a brief description (50-75 words) of the activity easily understood by nonscientists. Use
phrasing and words that would be easily understood by someone having no knowledge of your project. Avoid using abbreviations and
technical vocabulary or phrases.




III.      Identification of Agent(s) or Materials – Check all that apply

               Recombinant DNA
               Infectious Agents (bacteria, eukaryotic pathogens, protozoa or viruses pathogenic to plants or animals)
               List genus and species of any infectious agents used:

                Toxins
               Tumorigenic Material (include tumor source, cell types, and whether virally transformed)
               Radioisotopes (must be registered with the Radiation Safety Office)
               Human Blood/Tissue (Bloodborne Pathogens Training Required)
               (http://www.k-state.edu/facilities/depts/resources/bbp/slide1.htm)

          A.         Select Agents: Are you using or planning to use agents listed in the Select Agent Transfer Program.
                     (http://www.selectagent.gov/Select%20Agents%20and%20Toxins%20List.html)?
                          Yes     No

               The National Select Agents Registry Program (NSAR) (http://www.selectagent.gov/), a joint program of
               the Centers for Disease Control and Prevention (CDC) and the USDA Animal and Plant Health Inspection
               Service (APHIS), oversees the activities of possession, use and transfer of biological agents and toxins
               that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant
               products. The NSAR currently requires registration of facilities including government agencies,
               universities, research institutions, and commercial entities that possess, use or transfer biological agents
               and toxins.

               If you plan to use or are using any of the viruses, bacteria, fungi, rickettsial agents, or toxins on the select
               agent list, please contact the K-State Responsible Official for select agent use at the Biosecurity Research
               Institute (785-532-3248), or the URCO (785-532-3224) for information.

          B. Live Animals: Will animals be used in this protocol?
                      Yes     No (if yes, a protocol must be submitted and approved by the IACUC prior to use of
                                  animals and provide the species and building information in the boxes below)
                  Species:
             Building & Room:


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                                                                                                        Last revised July 2010
      C. Human Subjects: Does your proposed activity involve the participation of human research subjects?
               Yes       No (if yes, a protocol must be submitted and approved by the KSU IRB prior to the
                           involvement of human subjects).

      D. Export Controls: Does your proposed activity involve information, technology, materials or intellectual
             property that has been deemed to be sensitive or protected against open publication or disclosure, ie.
             classified, proprietary, business sensitive, sponsor restricted, etc.

                  Yes        No

              If yes, you may be subject to Federal Export Controls Regulations.
              Contact the URCO (532-3224) or the Pre-awards office (532-6804) for information on export
              controls.

      E. Agent Source: Do you currently possess the agent/organism that is intended for use in this protocol?

                  Yes        No

              If no, will acquiring the agent/organism require transportation permits (USDA, CDC, etc..)?
              (Reference “Guidance on Transportation Permit Requirement” http://www.k-
              state.edu/research/comply/ibc/resources/index.htm )
                  Yes         No

              If yes, provide the source of the agent/organism:




IV.   Project Description: Provide a succinct narrative of the experimental protocol proposed involving
         recombinant DNA, infectious agents, and/or tumorigenic material. Provide enough detail for the
         committee to evaluate the containment level required. Attach a copy of the grant proposal abstract or
         project summary if desired. Do not attach an entire grant proposal.



V.    Recombinant DNA:

      A.      My proposed activity involves the use or creation of recombinant DNA

                  Yes        No          If yes, answer section B-I below. If no, you may skip to section VI.

      B.      From what organism is the cloned DNA derived? Please give scientific name and common name of
              the organism.



      If the cloned DNA is from a pathogen, what is the Risk Group?

      C.      What is the source(s) of the inserted DNA sequence (e.g. library, PCR, synthetic oligo, etc)




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                                                                                      Last revised July 2010
        D.       What is the nature of the inserted DNA (toxin gene, anonymous marker, kinase gene, oncogene, etc.)?



        E.       Describe all hosts to be used for the cloned DNA and the vectors to be used for cloning. Give the
                 genotypes of the host bacteria, fungi, insects, etc. and the names of vectors. Please describe the
                 relevant components of all vectors other than standard ones such as pUC18/19 or pBluescript. Please
                 include a description of transgenic animals or plants.



        F.       Will a gene product be expressed from the cloned DNA?

                      Yes         No

        G.       Are you proposing to grow cultures of recombinant DNA of more than 10 liters in a single
                 experiment?
                     Yes        No

        H. Guidelines Section and Biosafety Level: Based on your Risk Assessment for the proposed activities,
        provide the following information using the NIH guidelines for rDNA research at:
        http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm Or the URCO flow chart at located
        on the IBC page within URCO Online


                 1. Applicable Section of NIH Guidelines:

                 2.   Risk Group:

                 3.   Applicable Physical Containment / Biosafety Level:

VI.     Infectious Agents or Tumorigenic Materials:

        A.       My activity involves infectious agents or tumorigenic materials

                      Yes         No        If no, you may skip to Section VII.

        B.       Guidelines Section and Biosafety Level: Based on your Risk Assessment for the infectious agent
                 or tumorigenic material, provide the following information using the BMBL 5th Edition at:
                 http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm, or the Public Health Agency of Canada at:
                 http://www.phac-aspc.gc.ca/msds-ftss/ or the URCO flow chart located within URCO Online.

                 1. Applicable Section of BMBL Guidelines:

                 2.   Applicable Risk Group:

                 3.   Applicable BMBL Physical Containment / Biosafety Level:

ALL INVESTIGATORS MUST ANSWER

One of the important mandates for the IBC is to asses risk associated with a specific project. Please provide responses
for agents that are potential plant, animal or human pathogens. If the questions are not appropriate for your activity,
please respond not applicable or N/A.



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                                                                                         Last revised July 2010
VII.   Agent Characteristics:       Describe the agent characteristics

       A.        Virulence



       B.        Pathogenicity
                 1. Susceptible Hosts:



                 2. Is the agent a human pathogen?        Yes            No

       C.        Environmental stability



       D.        Route(s) of Transmission:



       E.        Agent Countermeasures:

                 1.   Antibiotic susceptibility:



                 2.   Effective decontamination materials:



                 3. Vaccine or treatment availability:



                 4. Other:



VIII. Experimental Location:       Where will the experiments be conducted?
       A.     Building:



       B.        Room / Lab Numbers (Give specific rooms to be used and describe the physical facilities and how
                 these meet the requirements of the NIH or CDC):



       C.        Security:

            1.   Describe room security measures (e.g., doors lock, etc.):




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                                                                                   Last revised July 2010
            2.   Describe agent security measures (e.g., biosafety cabinet secured, etc.):




IX. Agent Manipulations:

       A.        Describe the types of manipulations planned.




       B.        Describe containment conditions you will implement.




       C.        Does your procedure for agent manipulation have potential to creating aerosols?

                     Yes          No

                 If so, specify activity (e.g. , centrifuging, grinding, vortexing, etc.)




       D.        Will you be using a biosafety cabinet or other containment device?

                     Yes          No

                 If so, specify type (e.g. , Class II, Type B2 BSC, etc.)(Information describing BSC can be found at:
                 http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/ch9-eng.php)



                 Provide room location of containment device



                 Provide the date the containment device was last inspected/certified.



       E.        Have you performed a risk assessment for the proposed activity?

                     Yes          No

       F.        Indicate Personal Protective Equipment (PPE) planned for the activity:

                           Lab coats

                           Safety glasses

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                                                                                             Last revised July 2010
              Closed Toe Shoes

              Respirator

              UV Shield

              Gloves

              Disposable gown/coveralls

              Other:


G.   BIOSAFETY MANUAL:
     “Each laboratory should develop or adopt a biosafety or operations manual that identifies the
     hazards that will be encountered, and that specifies practices and procedures designed to minimize
     or eliminate exposures to these hazards. Personnel should be advised of special hazards and
     should be required to read and follow the required practices and procedures. A scientist, trained
     and knowledgeable in appropriate laboratory techniques, safety procedures, and hazards associated
     with handling infectious agents or materials must be responsible for the conduct of work with any
     infectious agents or materials. This individual should consult with biosafety or other health and
     safety professionals with regard to risk assessment.” (BMBL, 5th Edition, Section III, Page 32,
     Laboratory Practice and Techniques).

     Identify all categories that have been completed: (Template can be found at: http://urco.ksu.edu/)

              Key Personnel: (provide roster, current contact information for all key personnel, i.e. phone #, etc)

              Identification of Biological / rDNA agent in use:

              Identification of Containment (Biosafety) Level Assigned:

              Biological Agent Information: (Agent Fact Sheet)

              Targeted Occupational Health Information:

              Agent Specific Risk Assessment:

              Safety and Security/Standard Operating Procedures (SOP’s): (Biosafety manual should
              include copies of applicable SOPs for things like decontamination, waste disposal, security,
              emergency procedures, handling procedures, etc.)
              Emergency Specific Procedures: (Biosafety manual should list procedures to be followed in
              case of an accident such as a spill, injection, ingestion, aerosolization, splash, etc.)

              Emergency Notification: (Primary investigator, Campus Police, Security, emergency
              medical personnel, etc)

              Project Specific Training Records:

              Signature Sheet:




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                                                                                   Last revised July 2010
                If any of the above categories have not been completed, please explain below: (The biosafety
                manual will be reviewed during a scheduled laboratory visit)




X. Training:

        A.      Please provide an overview of your training program / strategy for the proposed activity.

                          URCO online training modules

                          Procedure-specific training - specify below:


                          Other:




                Do you maintain a training log or documentation for training of all pertinent personnel?

                   Yes         No

        B.      Is this activity a part of a clinical trial? (If so, please give product and funding agency.)

                   Yes         No


XI. Other Project Participants

        A.      Other than the PI and Co-PI listed on page 1, will others be involved in the execution of this research,
                including technicians and students?       Yes          No

                If yes, please identify them:

        Name:                                               Position/Assignment:




        C.       Have all collaborators / workers been informed of any potential dangers associated with this activity
                and do you have documentation? (Having a signature sheet in the Biosafety Manual is a suggested
                form of documentation.)

                    Yes            No




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                                                                                            Last revised July 2010
Export Controls Training:
-The Provost has mandated that all KSU faculty/staff with a full-time appointment participate in the Export
Control Program.
-If you are not in our database as having completed the Export Control training, this proposal will not be
approved until your participation is verified.
-To complete the Export Control training, follow the instructions below:
Click on:
         https://online.ksu.edu/Templating/courseHomePage/index.jsp?courseId=101464

        1. After signing into K-State Online, you will be taken to the Export Control Homepage
        2. Read the directions and click on the video link to begin the program
        3. Make sure you enter your name / email when prompted so that participation is verified

        If you click on the link and are not taken to K-State Online, this means that you have already completed
        the Export Control training and have been removed from the roster. If this is the case, no further action
        is required.

-Can’t recall if you have completed this training? Contact the URCO at 785-532-3224 or comply@ksu.edu and
we will be happy to look it up for you.




Post Approval Monitoring: The URCO has a Post-Approval Monitoring (PAM) program to
help assure that activities are performed in accordance with provisions or procedures approved
by the IBC. Accordingly, the URCO staff may arrange a PAM visit as appropriate; to assess
compliance with approved activities.




                                                                                                              10
                                                                                    Last revised July 2010
INVESTIGATOR ASSURANCE FOR RESEARCH INVOLVING RECOMBINANT DNA, INFECTIOUS
AGENTS AND/OR TUMORIGENIC MATERIAL
                 (Print this page separately because it requires a signature by the P.I.)


XII.    Assurance by Principal Investigator

        1.   I agree to conduct this project in accordance with the compliance policies of Kansas State University,
             including all training of project participants.

        2.   I have consulted Section IV-B-7 of the NIH Guidelines which describes the responsibilities of the
             Principal Investigator and hereby agree to comply fully with all provisions of the Guidelines.

        3.   I understand that any proposed changes or modifications to an approved Registration Document (e.g.
             changes in the source of DNA, host-vector system, infectious agent, etc.), or in project participants must
             be submitted to, and approved by the Institutional Biosafety Committee (IBC) prior to execution.

        4.   If funded by an extramural source, I assure that this application accurately reflects all procedures
             involving Recombinant DNA, Infectious Agents and/or Tumorigenic Material described in the grant
             proposal to the funding agency.

        5.   I understand that I have a responsibility to promptly report accidents (loss of containment, illness,
             etc.) associated with my activity to the appropriate entities, i.e., IBC / URCO / EH&S. etc.

        6.   The information within this application is accurate to the best of my knowledge.




        Signature of Principal Investigator                                              Date

The IBC reserves the right to conduct inspections of the research facilities at any time.




                                        Please return the completed form to:
                         University Research Compliance Office (URCO), 203 Fairchild Hall
                                                   (785) 532-3224




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                                                                                        Last revised July 2010

				
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