Office for Research Protections Office Use Only: IBC #: _ The 330 Building, Suite 205 University Park, PA 16802 (814) 865-1775 Fax: (814) 863-8699 Institutional Biosafety Committee Application Human Blood and Blood Products, Human Body Fluids, and/or Human Tissue ****** ALL RESPONSES MUST BE TYPED ****** (Valid until 12/31/2016) Complete the items in the form below using as much space as required for each entry Submit this form electronically to The Office for Research Protections at ORP-Biosafety@rtto.psu.edu Transmit it as a Microsoft Word document or as a Rich Text Format (rtf) attachment from the Principal Investigator’s (PI) CAC account (i.e., 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 This application will assist investigators in determining whether the Institutional Biosafety Committee (IBC) needs to review their proposed use of biohazardous materials If the following questions apply to your proposed use of biohazardous substances, in accordance with Penn State Policy SY-24, please complete the following series of questions for IBC review Project Title: 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 experience with biohazards that will be used: Describe training the individual will receive (if applicable): 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 experience with biohazards that will be used: Describe training the individual will receive (if applicable): 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: Page of Telephone: Telephone: Telephone: Describe experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material 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 experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material 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 experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material Telephone: 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 Excluding the individuals listed above, complete the information in the following table for each individual involved with this protocol (cut and paste the table as needed): Name: Mailing Address: PSU Access ID (e.g., abc123): Describe experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material Name: Mailing Address: PSU Access ID (e.g., abc123): Describe experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material Name: Page of PSU Access ID (e.g., abc123): Mailing Address: Describe experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material Name: Mailing Address: PSU Access ID (e.g., abc123): Describe experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material Name: Mailing Address: PSU Access ID (e.g., abc123): Describe experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material Name: Mailing Address: PSU Access ID (e.g., abc123): Describe experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material Name: Mailing Address: PSU Access ID (e.g., abc123): Describe experience with biohazards that will be used: Describe training the individual will receive (if applicable): Will NOT be handling clinical material In lay terminology, describe in detail how all biohazardous material(s) and clinical specimens will be used in the course of your research What is the purpose of this study? Please describe in detail Please provide the location where work with biohazardous material(s) will be conducted Room(s): Building(s): Please provide the name and mailing address of each internal and external funding source Will previously collected human blood, fluids, or tissues be used in this project? Yes No (If YES, an eSubmission must be submitted to the Institutional Review Board – see http://www.research.psu.edu/orp/humans/conducting-study/getting-started.) Will actively collected human blood be used in this project? Yes No (If YES, an eSubmission must be submitted to the Institutional Review Board – see http://www.research.psu.edu/orp/humans/conducting-study/getting-started.) Page of a) How will the blood be drawn? Vacutainer Butterfly Fingerstick Please explain if other: b) Who will draw the blood? Phlebotomist Nurse MD If other, please explain: c) Where will the blood be drawn? University Health Services GCRC Laboratory Off-Campus (see below) Other (see below) If off-campus or other, please explain: Does this project involve any of the following? Biohazard YES NO Comment Saliva Tissue Urine Human Derived Cell Lines Human Stem Cells (Fetal) Human Stem Cells (Embryonic) Human Stem Cells (Other) Other Fluid (Specify) Individuals who handle human blood and blood products, human body fluid and/or human tissue, in addition to principal investigators and advisors listed on protocols that use these materials, are required by the IBC to complete Penn State’s Bloodborne Pathogen (BBP) Training This training is required to ensure that these individuals are aware of the potential hazards involved in handling these materials and use the proper precautions to protect themselves from bloodborne diseases Have all of these individuals completed Penn State’s Bloodborne Pathogen (BBP) Training? Yes No (Note: BBP training must be completed before this application can be approved.) 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 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;” Page of 5 All applicable rules and regulation regarding human subjects, vertebrate animals and radiation protection, etc have been addressed in the preparation of this application and the appropriate reviews have been initiated, and I will attend Bloodborne Pathogen training from Environmental Health and Safety, and will ensure all laboratory personnel also attend this training if I/we have not already done so E-MAIL TO ORP! Page of ... Saliva Tissue Urine Human Derived Cell Lines Human Stem Cells (Fetal) Human Stem Cells (Embryonic) Human Stem Cells (Other) Other Fluid (Specify) Individuals who handle human blood and blood products,. .. products, human body fluid and/ or human tissue, in addition to principal investigators and advisors listed on protocols that use these materials, are required by the IBC to complete Penn State’s Bloodborne... Room(s): Building(s): Please provide the name and mailing address of each internal and external funding source Will previously collected human blood, fluids, or tissues be used in this project? Yes No