IBC MODIFICATION REQUEST FORM

Office for Research Protections The 330 Building, Suite 205 University Park, PA 16802 (814) 865-1775 Fax: (814) 863-8699 IBC MODIFICATION REQUEST FORM ****** ALL RESPONSES MUST BE TYPED ****** Valid until 12/31/2016 Submit this form electronically to The Office for Research Protections at ORP-Biosafety@rtto.psu.edu Transmit it as a Microsoft Word document, Rich Text Format (rtf), or Portable Document Format (PDF) attachment from the Principal Investigator’s (PI) CAC account (e.g., abc123@psu.edu) If you are unable to submit this form electronically, it may be signed by the PI and mailed to the Office for Research Protections, The 330 Building, Suite 205, University Park, PA Handwritten applications are not accepted PLEASE NOTE: The following modifications can be submitted by sending an email to the Office for Research Protections – please email to ORP-Biosafety@rtto.psu.edu Please reference your Institutional Biosafety Committee (IBC) protocol number or title in the email  Title change  Funding source change  Personnel additions – if adding personnel only, please use the one-page addition of personnel form online at https://www.research.psu.edu/orp/biohazardous/documents/add_personnel.doc IF YOUR PROPOSED MODIFICATION DOES NOT FALL INTO ONE OF THE ABOVE CATEGORIES, YOU MUST COMPLETE THE FOLLOWING APPLICATION Project Title: IBC #: Principal Investigator: Email: Note: If the requested modification includes a change in the original purpose of the study or significant changes in scope of work, the IBC may require a new IBC application be submitted Complete the information in the following table if changing the Principal Investigator and/or Advisor: Principal Investigator: Penn State Access UserID (e.g., abc123): Campus Address: Mailing Address (If different than campus): University Status (Faculty, Staff, Post-doc, Grad Student): Dept: College: Campus: Describe type of contact with each biohazard to be used: Describe experience with each biohazard to be used: Describe training the individual will receive (if applicable): Page of Telephone: Advisor, if applicable: Penn State Access UserID (e.g., abc123): Campus Address: Mailing Address (If different than campus): University Status (Faculty, Staff, Post-doc, Grad Student): Dept: College: Campus: Describe type of contact with each biohazard to be used: Describe experience with each biohazard to be used: Describe training the individual will receive (if applicable): Telephone: Complete the information in the following table for each individual, excluding any listed above, being added to this protocol (copy and paste table as needed to add more personnel) Note: If this modification is to add personnel only, please use the one-page addition of personnel form online at https://www.research.psu.edu/orp/biohazardous/documents/add_personnel.doc NOTE:  As principal investigator, it is your responsibility to adequately train all individuals conducting procedures described in this protocol prior to using biohazardous material(s)  As personnel are added, you must submit the IBC’s personnel additional form The personnel additional form must be approved before personnel may begin work with biohazardous materials Co-investigator: Penn State Access UserID (e.g., abc123): Campus Address: Mailing Address (If different than campus): University Status (For example Faculty, Staff, Post-doc, Grad Student): Dept: College: Campus: Describe type of contact with each biohazard to be used: Describe experience with each biohazard to be used: Describe training the individual will receive (if applicable): Telephone: Is there anyone you wish to include on correspondence related to this protocol (e.g., a study coordinator, etc.)? Name: Penn State Access UserID (e.g., abc123) Campus Address: Mailing Address (If different than campus): University Status (Faculty, Staff , Post-doc, Grad Student): Dept: College: Campus: Describe type of contact with each biohazard to be used: Describe experience with each biohazard to be used: Describe training the individual will receive (if applicable): Name of Personnel: Mailing Address: University Status (Faculty, Staff, Post-doc, Grad Student): Dept: College: PSU Access ID (e.g., alb123): Campus: Page of Telephone: Describe type of contact with each biohazard to be used: Describe experience with each biohazard to be used: Describe training the individual will receive (if applicable): Name of Personnel: PSU Access ID (e.g., alb123): Mailing Address: University Status (Faculty, Staff , Post-doc, Grad Student): Dept: College: Campus: Describe type of contact with each biohazard to be used: Describe experience with each biohazard to be used: Describe training the individual will receive (if applicable): Name of Personnel: PSU Access ID (e.g., alb123): Mailing Address: University Status (Faculty, Staff , Post-doc, Grad Student): Dept: College: Campus: Describe type of contact with each biohazard to be used: Describe experience with each biohazard to be used: Describe training the individual will receive (if applicable): Please provide the following information in lay terminology Please describe only changes to the protocol – no need to describe previously approved procedures/materials: a A detailed description of all changes to how biohazardous/regulated materials, as defined in Penn State Policy SY-24, will be used in the course of your activities: b The purpose of the changes/new work: Please provide the name and mailing address of each internal and external funding source being added to this protocol: Do any of the agents being added to this protocol require an APHIS permit? Yes (please provide a copy for the IBC file) No Please list any additional locations (not already approved on this protocol) where the biohazardous material(s) will be used: Laboratory Room(s) including greenhouses and growth chambers: Animal Husbandry Room(s): Building: Building: The activities being added involve the use of (response is required for each item): Page of YES NO Please respond to each item below a Select Agents The Centers for Disease Control and Prevention (CDC) regulates the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety Click on the Select Agents link to determine if the CDC has classified an agent “Select” and Complete Question b Research using Recombinant DNA Technology (Excluding Transgenic Mice) – Complete Question to describe any new/changed work (already-approved work does not need to be described) c Human blood, fluids or tissues – Complete Appendix 1, Attachment for the Use of Human Blood, Blood Products, Human Body Fluids, and/or Human Tissue and submit with this application Note: If your research involves only human blood, fluids or tissues, you should submit the Application for Research - Human Blood and Blood Products, Human Body Fluids, and/or Human Tissue instead of this application d Biohazard (infectious agent, carcinogen, toxin or toxicant) used with live animals - Complete Question Note: An MSDS for each carcinogen, toxin, or toxicant used must be submitted with this application Note: If animals will be infected with any viable organism or if animals, caging, or bedding material will be contaminated with hazardous materials that will pose a risk to personnel caring for or working with the animals - complete Appendix 2, Animal/Biohazard Safety Protocol, in consultation with Dr Jeffery Dodds, D.V.M (814-865-1495 / jwd12@psu.edu) e Infectious Agents that require handling above Biosafety Level - Complete Question Also, complete Appendix 3, Attachment for the Use of Infectious Agents That Require Handling Above Biosafety Level for any agents being added and submit with this application Complete the table Biohazardous Agent (list specific agent, e.g Staph Aureus) Source Type (toxin, toxicant, carcinogen, strain of infectious agent) Working Concentration (chemicals & toxicants) For Work with Recombinant DNA (note: only new/changed work must be described – already-approved work does not need to be described): a Please provide the biological safety level you will use to conduct your research and describe how the rDNA will be contained (i.e if working with plants, describe the security of the greenhouses and/or growth chambers) Biological Safety Level Biological Safety Level Biological Safety Level b Will culture volumes (e.g., microorganisms or genetically modified cells) exceed 10L? No Page of Yes If yes, please describe why is it necessary to culture the recombinant organism in volumes exceeding 10L: c.What is the source of the DNA? Please include genus and species names of the organism(s) from which the DNA is derived If the DNA is from a eukaryotic virus and it is to be introduced into a eukaryotic host, provide the percentage of the viral genome to be cloned d What is the nature of the encoded sequence? Please provide the full names and abbreviations of the gene(s), promoter(s) and/or transposable elements to be studied, and a brief description of the biological function of the gene(s) e.What is the vector(s)? Please provide details of the vector delivery system (i.e., plasmids, cosmids, phages, Ti-plasmid vectors, adenoviral vectors, retroviral vectors)? f Will a foreign protein be expressed? (If yes, provide the name and biological function, if known, for each protein to be produced.) g What is the host(s)? Please provide detailed information about the host(s) (i.e., E coli K-12 system, Saccharomyces, insect cells, plant cells, live animals, whole plants, etc.) ASSURANCES FOR USE OF BIOHAZARDOUS MATERIALS As the principal investigator on this project, I assure… the information provided on this form accurately summarizes the nature and extent of the proposed additional use of biohazardous material(s) If funded by an extramural source, I assure that this application accurately reflects all procedures involving biohazardous material(s) described in the proposal to the funding agency previously noted all individuals performing procedures described in this application are technically competent and have been properly trained I will obtain approval from the IBC before initiating any changes to this application I am familiar with and will comply with Penn State’s Policy SY-24, “Use of Biohazardous Material in Research and Instruction.” all applicable rules and regulation regarding human participants, vertebrate animals and radiation protection, etc have been addressed in the preparation of this application and the appropriate reviews have been initiated I will properly dispose of biological waste material and will contain rDNA molecules as required by the NIH guidelines and Penn State University Policy SY24 “Use of Biohazardous Materials in Research and Instruction” E-MAIL TO ORP! Page of ... biohazardous material(s)  As personnel are added, you must submit the IBC? ??s personnel additional form The personnel additional form must be approved before personnel may begin work with biohazardous... the information in the following table for each individual, excluding any listed above, being added to this protocol (copy and paste table as needed to add more personnel) Note: If this modification. .. BIOHAZARDOUS MATERIALS As the principal investigator on this project, I assure… the information provided on this form accurately summarizes the nature and extent of the proposed additional use of