1. MILWAUKEE SCHOOL OF ENGINEERINGPROTOCOL SUBMISSION FORM TRAININGMARIAN DOWNING, RBP, CBSP, SM(NRCM)

2. Objectives of this course By the end of this course, you will: Understand the fundamentals of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) Understand the importance of properly submitting a protocol form How to successfully complete a protocol form Know what additional documentation you will need to provide Know what happens if your protocol is not approved Know how to submit an amended protocol 3. REVIEW OF THE NIH GUIDELINES 4. The Scope of the NIH GuidelinesSection I NIH Guidelines for Research Involving Recombinant DNAMolecules Specifies practices for construction and handling rDNA molecules Organisms and viruses containing rDNA molecules Definition Constructed outside living cells by joining natural orsynthetic DNA segments to DNA molecules that canreplicate in a living cell Molecules resulting from the replication of those describedabove 5. NIH Guidelines Apply to rDNA research that is Funded by NIH Performed at or sponsored by an institution that receives any NIH funding for rDNA research Are the NIH Guidelines optional? Potential consequences for non-compliance: Suspension, limitation or termination ofNIH funds for rDNA research at theinstitution (and not just for the offendingresearcher!)NIH A requirement for prior NIH approval ofany or all rDNA projects at the institution 6. Non-compliance Consequences UW fined $40K (by NIH) 2010 Major Action Violation UW Madison professor barred from lab for 5 years (by University) Research involved a Select Agent (Brucella) Graduate studentsworking with antibiotic-resistant strains One case of Brucella inlaboratory staff PI claimed inadequate Biosafety training and support 7. Alphabet Soup NIH = National Institutes of Health RAC = Recombinant DNA Advisory Committee OBA = Office of Biotechnology Activities IBC = Institutional Biosafety Committee* >5 members of experts who review rDNA proposals, mayinclude a BSO and must have > 2 community members IRB = Institutional Review Board* Reviews all human subject trials/experiments, required byFDA BSO = Biosafety Officer**affiliated with your institution 8. Guidelines Section IIILevels Of Review Relevant Example of Recombinant DNA Sections of Level of ReviewResearch Involving Animalsthe NIHGuidelinesIBC, RAC review, &Experiments that compromise control ofNIH Director review disease agents in medicine through deliberateIII-A& approvaltransfer of a drug resistance traitIBC approval &NIH/OBA review forExperiments conducted with a recombinant III-Bcontainment DNA modified restricted agent in a whole animaldeterminationsIBC & IRB approval& NIH review beforeNot applicable III-Cresearch participantenrollmentContinued on next slide 9. Guidelines Section IIILevels Of Review RelevantExample of Recombinant DNASections of Level of Review Research Involving Animals the NIHGuidelinesCreating stable germline alterations of anIBC approval before animals genome, or testing viable rDNA III-Dinitiationmodified microorganisms on whole animals,where BL-2 containment or greater is necessaryIBC notice atCreating stable germline alterations of rodentsinitiation. (Notusing recombinant DNA when these III-Ecovered in III-A, -B,experiments require only BL-1 containment-C, -D, -F)Exempt from NIHGuidelines. IBCPurchase or transfer of transgenic rodents III-Fregistration notrequired. 10. Review Of Biological Materials and Infectious Agents (NotRecombinant)Important to keep an accurate inventory of the types of biological materials on site Risk assessment of all materials will beperformed by EHSThis non-recombinant information does not have to be supplied to NIHSelect agents/toxins must follow the Select Agent Law requires review by an institutional body, oftenreferred to as the IBCReview of protocols is by Committee for BSL-2/3/4 agents (usually institutional policy).10 11. PROTOCOL SUBMISSION FORM 12. OVERVIEW OF FORMSection AProject SummarySection BMicroorganismsSection CBiosafety LevelsSection DRisk Assessment JustificationSection EExposure Control Personal Protective Equipment (PPE) Laboratory EquipmentSection FDisinfection and Biological Waste DisposalSection GDocumentation*Section HFaculty Member Assurance*This section will require additional data sheets to be submitted with the protocol form 13. SECTION AProject SummaryProvide basicinformation about theprotocol: is itnew, seekingrenewal, what is theproject title?What is the contactinformation for theresponsible facultymember, and incase of anemergency? 14. SECTION AProject SummaryWhere will themicroorganisms bestored? What BSLis the room? Is there an alternate POC? 15. SECTION AProject Summary Provide everyone that will be working on the research Special provisions project, theirare needed if minors responsibilities andwill be working in the training (with dates of laboratory. completion) 16. SECTION AProject Summary Providingobjectives willprovide the basisfor the riskassessment. 17. SECTION BMicroorganisms List ALL microorganisms, including non- pathogenic ones List ALL Cell lines, including human, insect and animal Select Agents and toxins are not used at MSOE 18. SECTION CBiosafety LevelWhat BSL doesyour biologicalmaterial require?Reference theBMBLMSOE does NOThave facilitiesGiven the nature of that can supportthe biological material BSL-3 or BSL-3and info in BMBL, enhancedwhat BSL are youresearch.suggesting? 19. SECTION DRisk AssessmentReference datasheets from Productmanufacturer or specificationthe supplier. sheets for cell lines. ATCC, for example.Referencethe CDC or Aerosols, mucous membranes, ingestioPBSDS n, cuts/scrapes? If available, the PBSDS will have agent specific routes of 105/mL? transmission.106/mL?0.5 ml? 20. SECTION DRisk AssessmentWhat is available ifthere is an exposure?Antibiotic, antiviral, interferon? Some examples are bleach, dry heat, moist heat. Reference PBSDS for your agent in question. 21. SECTION DRisk Assessment List all items thatcould potentiallypuncture theskin, including glasstubes, coverslips, slides, etc. 22. SECTION DRisk AssessmentMost rDNA work atMSOE will either beunder Section III-Eor Section III-F(exempt) 23. SECTION EExposure Control: PPEWhat specificlaboratoryprocedures need thePPE required forBSL-1 or BSL-2? Are there certain steps in the experiment, that need additional PPE? List and describe here.The BMBL and MSOEpolicies state gloves, labcoat, and safety glassesare standard PPE forBSL1 and BSL2procedures. 24. SECTION EExposure Control: EquipmentHow will you eliminate aerosols? This is the foundation of your risk assessment.What specificequipment will youuse in yourexperiment? Forwhich procedures? 25. SECTION FDisinfection & Biological Waste Disposal Disposables soaked in disinfectant and discarded* Add full strength bleach to a final dilution of ~10% in waste, let sit for > 15 minutes and sewer*List disinfectants to be If mixed waste is present, usually willused . Alcohol will inactivate the biohazard first and treat generally only be used as chemical waste only*for cleaning**See the Biosafety Manual for moredetailed procedures 26. SECTION GDocumentationMSDS areessential for allkits and hazardousmaterials used inyour protocolTo ensure youknowmanufacturers orsuppliersrecommendedhandlinginstructionsPBSDS sheets willIf PBSDS sheets are not contribute to aavailable, CDCse also have mayproper riskrisk assessment information assessment andavailable onlineimplementation ofsafe laboratoryoperations 27. SECTION HFaculty Member Assurance These are your responsibilities as a faculty member.Make sure youhave read andunderstandMSOEs Biosafetypolicies. Are you familiar with the NIH Guidelines and the BMBL, and how they impact your research? 28. SUBMITTING YOUR PROTOCOL 29. Submitting your Protocol Where is the electronic protocol form found? https://inside.msoe.edu/ehs (under Biosafety) How do you submit your protocol? E-mail the completed form to Julie LaRose at: larose@msoe.edu Who reviews your protocol? How is your protocol evaluated/reviewed? What happens once your protocol is reviewed? 30. Thank you for yourattention. Please besure to complete the on line quiz for this module.