Fill and Sign the Intake Form2 Veteran Uci

Study No._______________ INSTITUTIONAL BIOSAFETY REPORTING AND APPROVAL FORM Baylor University This form must be submitted for ALL activities (e.g., research, teaching) involving recombinant DNA (rDNA), infectious agents, TAT proteins, toxins, prions, and/or human tissue and fluids use. Submit the original and two copies to: Chris Kearney, Chair, Institutional Biosafety Committee, Baylor University, Campus Box 97388. Call 710-6793 or email Chris_Kearney@baylor.edu for additional forms and information. (Keep a copy for your records.) I. CAMPUS_____________________SCHOOL/DEPARTMENT___________________________________ PRIN. INVEST/INSTR_____________________________________________________________________ ID# (BU ID# or S.S.#) ______________________________________ CO-PRIN.INVEST/INSTR__________________________________________________________________ ID# (BU ID# or S.S.#) ______________________________________ Campus Address:_____________________________________________ Office Phone:___________________ Lab Phone:__________________ Home Phone:____________________ E-mail address:______________________________________________ RANK: Faculty______________ Res. Scientist_______________ Post-Doc____________ Staff____________ Student______________________ ID#______________________ Faculty advisor_______________________ Citizenship: PI_____________________ Co-PI_____________________ Student(s)_____________________ PROJECT TITLE: TITLE OF GRANT UNDER WHICH PROJECT WILL BE CONDUCTED (if different than project title) If this activity involves other campuses, please indicate which ones: FUNDING SOURCE_________________________ APPLICATION DEADLINE____________________ Proposed Start Date:________________ or renewal date PROJECT TYPE: Research ____ Teaching ____ Project# _____ New ____ Renewal Course # _____ New ____ Renewal LOCATION: List the building and room number of each laboratory in which any part of the experiments will be conducted ______________________________________________________________________________ _________________________________________________________________________________________ If grant proposal, list grant numbers and all agencies_______________________________________________ _________________________________________________________________________________________ TERM OF PROJECT: START _____________________________ END ____________________________ If this application requires BL-2 or higher containment circle "yes" or "no": YES NO The facilities used in these activities have been previously inspected by the IBC and meet appropriate biological laboratory safety standards. Indicate (check) agents or materials used and follow instructions: ______Recombinant DNA. Fill out sections even if exempt: Complete sections A,B,C &D asrequired. ______Infectious agents, toxins, TAT proteins, or prions (pathogenic to humans, animals or plants) Fill out section E ______Human tissues or fluids. Fill out section F ______Use and/or possession of select agents according to the Patriot Act. Fill out section G COMPLETION AND SIGNING OF THIS FORM ARE THE RESPONSIBILITY OF THE PRINCIPAL INVESTIGATOR OR FACULTY MEMBER IN CHARGE. In signing this form, I agree to abide by all university and federal guidelines and regulations regarding recombinant DNA, infectious agent, TAT protein and/or human tissues and fluids work. Principal Investigator is responsible for all liabilities related to use of his/her materials. ___________________________________________ Principal Investigator (and Faculty Advisor) Signature __________________________ Date A. Experiments that require RAC or ORDA review; NIH and IBC approval. Circle "Yes" or "No": YES NO YES NO YES NO YES NO 1. Deliberate formation of rDNAs containing genes for biosynthesis of toxic molecules. 2. Deliberate release into the environment of any organism containing rDNA. 3. Deliberate transfer of drug resistance trait to microorganisms such that drug control might be compromised. 4. Deliberate transfer of rDNA into human subjects. B. Experiments that require IBC approval before initiation. Circle "Yes" or "No": YES NO YES NO YES YES YES NO NO NO 1. Use of other than a Class 1 agent as host-vector system (see Appendix B of NIH Guidelines, 2001). 2. Will you use a Class 2,3, or 4 viral vector? If so, will: (YES NO) a. Greater than 2/3's of genome be used? (YES NO) b. helper virus be used? (YES NO) c. your experiment enhance pathogenicity (e.g., insertion of oncogene, extend host range)? 3. Will whole animals or plants be used as hosts? 4. Will experiments involve more than 10 liters of culture? 5. Will a deliberate attempt be made to obtain expression of a Foreign gene? If so, what protein/RNA will be produced? YES YES YES NO NO NO 6. Will TAT proteins be purchased, synthesized or expressed? 7. Will a toxin be used? 8. Will prions be used? ALL "YES" ANSWERS ABOVE MUST BE EXPLAINED IN SECTION BELOW. C. rDNA Constructs: 1. Host organism: 2. List the vector(s) name and type (e.g., -gt11, retroviral pLNL), and append a DNA map of any novel vectors listing components with their sizes): 3. Source organism of DNA to be cloned (e.g., human T-Cell cDNA library, HIV gag gene): 4. If the DNA is microbial, circle the appropriate class as given in Appendix B [Current federal guidelines: http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm ] 1 2 3 4 5 N/A 5. Function of products (protein or RNA) of the cloned DNA: 6. For oncogenic viruses, circle appropriate level (Appendix B [and all federal guidelines and Biosafety Manual]: Low Risk Moderate Risk N/A 7. Circle containment level specified by the current Federal Guidelines (http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm) and the Biosafety Manual: Exempt BL1 BL2 BL3 BL4 *Note: All human tissue/body fluid samples require BL2.* D. Include a succinct description of your project on a separate page and explain WHAT, WHY, and HOW rDNA will be used in the project. This CANNOT be replaced with a grant proposal or reprint. E. Description of proposed research involving infectious agents, toxins, TAT proteins, or prions. a. Submit a succinct statement of your project on a separate page. Explain why and how infectious agent(s), toxins, TAT proteins, or prions will be used in the project. This CANNOT be replaced with a grant proposal or a reprint. b. List the infectious agent(s), toxins, TAT proteins, or prions: c. Circle level of research according to the federal guidelines and Biosafety in Microbiological and Biomedical Laboratories (http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm ).(BL-1, BL-2, BL-3, BL-4) F. Human Tissues and Fluids Usage. Submit to the IBC a statement of that intent and include an outline (abstract) of the proposed activity, and sufficient information that will clarify to the reader that the guidelines involving human tissue and fluids are understood and that the submitting individual is able and intends to adhere to those guidelines. G. Use and/or possession of select agents according to the Patriot Act Amount of Material to be ordered or produced: __________________________________________________ Where will you obtain the material from? ______________________________________________________ Has CDC application been applied for? YES If YES, Date applied_____________________ NO Has CDC certification been received? YES NO Date Received: ________ Has CDC certification been sent to the Biosafety Officer? YES NO FOR BIOSAFETY COMMITTEE USE ONLY: APPROVED __________ DISAPPROVED _____________ EXEMPT/BL1___________ RESTRICTIONS ___________________________________________ For BL-2 Level Research or higher: ________ The facilities used in this activity have been previously inspected and meet appropriate laboratory safety standards. ________ The facilities used in this activity require IBC inspection prior to initiation. Facilities surveyed by:_________________________________________________ ________________________________________________________________________ SIGNATURES: Chair/Biosafety Officer for Biosafety Committee ____________________________________Date____________ This application for use of rDNA, infectious agents, TAT proteins or human tissues or fluids has been reviewed and approved by the Baylor University- Institutional Biosafety Committee. Reporting and Approval Form Revised September 2002