ࡱ> ~3 @bjbj bb,&lDndt<3hR@4tttt8"<$++++M-,.1$4 61@%tt@%@%1*tt2***@%Jtt+*@%+**"+"+tF $ g'"+"+ 30<3"+7*7"+* NC STATE UNIVERSITY BIOSAFETY COMMITTEE INSTRUCTIONS: REPORTING RECOMBINANT DNA EXPERIMENTS This is a selective guide to the recombinant DNA (r-DNA) proposal registration forms. It is not meant to be comprehensive. In the NIH Guidelines for Research Involving Recombinant DNA Molecules experiments are classified according to their potential for biological hazards. Before completing the registration form, check the Guidelines and ascertain the classification of your work.  HYPERLINK "http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm" http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm Your work may include experiments that fall into more than one class of the Guidelines. For instance, E. coli cloning work is mostly Class III-F-5, expression of r-DNA genes in cell culture may be III-D or III-E and animal work will be III-D-4a or b. You are asked to report each Class of experiment separately. Some work of minimal hazards (i.e., Class III-F-5) is exempt from the Guidelines, however it must be reported. 1. Registration Documents. Any r-DNA proposals involving animals must be reviewed and approved by the IACUC and the NCSU BIOCOM before being submitted to the IBC for final review and approval. Submission to the IACUC and NCSU BIOCOM should be made at the same time. r-DNA experiments involving animals cannot be initiated before IBC approval is granted. Any pathogens/human blood/OPIM1 used in r-DNA experiments must also be registered with the NCSU BIOCOM. Exempt work includes: (A) r-DNA containing less than 2 of a eukaryotic viral genome propagated in cell culture. (Class III-F-5 and Appendix C I) (B) Work involving E. coli K12 host-vector systems. (Class III-F-5 and Appendix C II) (C) Work involving Saccharomyces cerevisiae host-vector systems. Class III-F-5 and Appendix C III) Non-Exempt work includes: (A) Experiments including human or animal pathogens as host- vector systems. (Class III-D-1) (B) Experiments involving infectious virus or defective virus plus helper in tissue culture. (Class III-D-3) (C) Experiments involving animals. This includes the use and creation of transgenic animals. (Class III-D-4) (D) Experiments not included in Class III-A, III-B, III-C, III-D and III-F are classed III-E. They include the following: (I) r-DNA molecules containing less than 2/3 genome of an eukaryotic virus propagated in tissue culture, no helper virus being present. (ii) The NCSU BIOCOM place experiments involving the use of defective retrovirus vectors with an enabling packaging cell system in Class III-E. Where there is the potential for infection of human cells, experiments will be performed at BL-2. 2. Amendments to the Recombinant DNA Registration Document. The NC State Biosafety Specialist and Committee (NCSU BIOCOM) should be notified, in writing, when there are any changes made to the r-DNA registration document. In some cases, a new Registration Form will need to be completed. In instances where nonexempt r-DNA changes are proposed, review by the NCSU BIOCOM will be initiated and, if approved, submitted to the NCSU BIOCOM for approval. Where animal protocols are proposed as an amendment, review and approval by both the IACUC and NCSU BIOCOM is required. These amendments include: (A) Changes in the materials being used. These include upgrading host-vector systems (from "Exempt" to "Non-Exempt"), changes in the amount, type and manipulation of virus being used and the use of mammalian cell culture, pathogens or OPIM. (B) Changes in protocol that reclassify "Exempt" experiments as "Non-Exempt" (mentioned above). (C) Initiation of animal protocols associated with materials registered. (D) Personnel additions and/or deletions. (E) Terminations of registered r-DNA programs and/or a change in the principal investigator(s) associated with these programs. 1"Other potentially infectious materials" means: (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV or HBV-containing culture medium or other solutions, and blood, organs or other tissues from experimental animals infected with HIV or HBV. Please call if you have questions, call Safety at x5-6858 Form can be filled out online and saved using MS Word. Send signed hard copy to Biosafety Specialist EHS Box 8007. Only type written applications will be accepted. Hand written forms will be returned. REGISTRATION OF RESEARCH WITH RECOMBINANT DNA MOLECULES BSC#: DATE RECEIVED: ___________________ APPROVAL DATE: _____________________ DO NOT WRITE IN ABOVE SPACE ******************************************************************************************************************* 1. Principal Investigator:  FORMTEXT       FORMTEXT       Telephone:  FORMTEXT       Bldg/Rm:  FORMTEXT       Organization:  FORMTEXT       Program:  FORMTEXT       Project Title:  FORMTEXT       2. Briefly describe the objective of the proposal. (Attach additional sheets as necessary) Include in your description the following items: agent characteristics; types of manipulation planned; sources of the inserted DNA sequences; nature of the DNA sequences (structural gene, ocogene); Host(s) and vector(s) to be used; whether an attempt will be made to obtain expression of a foreign gene and the protein that will be produced; Containment conditions to be implemented.  FORMTEXT       3. Name of organism(s) used as host (cloning vehicle): a) Prokaryotes:  FORMTEXT      (e.g., E. coli K12) b) Eukaryotes:  FORMTEXT      (e.g., mammalian cell lines) c) Higher animals:  FORMTEXT       (e.g., mice) Animal Study Proposal#  FORMTEXT       (Attach copy) 4. a. Describe use of animals: (if applicable)  FORMTEXT       b. Does the possibility of recombination with endogenous virus exist  FORMCHECKBOX YES  FORMCHECKBOX ] NO 5. Nature of gene sequences inserted in the recombinant (give detailed description, attach catalogue description if obtained commercially).  FORMTEXT       6. 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