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I’m From the IBC and I’m Here to Help You!

I’m From the IBC and I’m Here to Help You! Debra L. Hunt, DrPH , CBSP Director, Biological Safety. IBC must follow NIH rDNA Guidelines. http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm. Duke University IBC Membership 2009/10. Co-chairs:

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I’m From the IBC and I’m Here to Help You!

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  1. I’m From the IBC and I’m Here to Help You! Debra L. Hunt, DrPH, CBSP Director, Biological Safety

  2. IBC must follow NIH rDNA Guidelines http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm

  3. Duke University IBC Membership2009/10 • Co-chairs: • Richard Frothingham, MD – Dept of Med., ID, DHVI • Wayne Thomann, DrPH - OESO • Members: • David Pickup, PhD - Virologist • Timothy Clay, PhD – Virologist, Clinical Trials • Elizabeth Ramsburg, PhD - Virologist • Wiley Schell, MS – Mycologist, Other Research • Tai-Ping Sun, PhD – Plant Expert • Scott Alderman, MS – DHVI Safety • Randall Reynolds, DVM, MS – Animal Care • Peg Hogan – Animal Care • Carol Epling, MD - EOHW • Debra L. Hunt, DrPH - BSO • Community Members: • Tom Kost, PhD, GSK R&D • Brian Letourneau, MSPH, Durham Co. Public Health Dept, Retired • Pat Condreay, PhD, GSK • Arlene Sena, Durham Co. Public Health Dept.

  4. IBC Responsibilities Duke University • Per IBC Policy: • Review and oversight of rDNA research • Review and oversight of human gene transfer research • Oversight of research involving Select Agents • Oversight of research involving Risk Group 3 or 4 organisms • Advice on “high risk” procedures involving infectious agents (i.e., Q fever in sheep)

  5. IBCs and Exempt Research • Do IBCs determine what research is exempt? Does the PI? • New for 2010: On-line Survey to determine exempt status • http://www.safety.duke.edu/BioSafety/ibc.htm • To Start June 1, 2010, as a required module under the Safety Training site

  6. http://www.safety.duke.edu/BioSafety/ibc.htm

  7. On-line Survey Tool to Determine Exemption

  8. On-line Survey Tool to Determine Exemption • Assists PIs: • Provides an easy tool to determine if their work is exempt from the NIH rDNA Guidelines, or needs to be registered with the IBC • Provides documented “training” on rDNA, as required by the NIH rDNA Guidelines • Assists Duke: • Assures compliance with the NIH rDNA Guidelines • Assists the Duke IBC: • Captures all PIs who need to register with the IBC

  9. http://www.safety.duke.edu/BioSafety/ibc.htm

  10. Required Documents to Register with the IBC

  11. New rDNA Registration form, 2010

  12. http://www.safety.duke.edu/BioSafety/ibc.htm

  13. IBC IRB IACUC IBCs and Other Research Oversight Committees

  14. IBCs and Other Research Oversight Committees • How should IBCs work with other institutional oversight committees? • Not prescribed in the NIH Guidelines • Institutions should determine best way for these committees to interact and share information

  15. IBCs and IACUCsAnimal Research • Joint purview, and ideally collaborative review, over certain types of research • Transgenic or cloned animals (any creation or cross-breeding of transgenics) • Use of recombinant DNA molecules in animals • Use of rDNA in cells to be put in animals

  16. Animal Research with rDNA: Points to Consider for IBC • Containment procedures (SOP’s) • Physical and biological • Plans for recapture of escapees • Consequences should containment fail • Procedures for transfer of animals • Disposal and destruction methods • Breeding SOP’s • Occupational biosafety concerns • Personal protective equipment • Decontamination

  17. IBCs and IRBsHuman Gene Transfer Research

  18. http://www.safety.duke.edu/BioSafety/ibc.htm

  19. Duke IBC Process • Monthly meetings (registration docs must be submitted 2 weeks before meeting) • Forms and information on website • BSO reviews submissions, prepares agenda, sends out packets • BSO maintains access database of rDNA proposals

  20. http://www.safety.duke.edu/BioSafety/ibc.htm

  21. Scheduled IBC Meetings

  22. Duke IBC Process • Annual Periodic Review form sent to PIs re IBC information (e-mail) • Coordination with IACUC (IBC members sit on this committee) • Coordination with IRB (notifications of IBC approvals and recommendations regarding human gene transfer protocols sent to e-IRB)

  23. Access to Minutes (Duke) • IBC Committee Minutes are posted as .pdf files on the IBC Website • Names of researchers are removed • Public minutes do not include discussions of Select Agents

  24. http://www.safety.duke.edu/BioSafety/ibc.htm

  25. http://www.safety.duke.edu/BioSafety/ibc.htm

  26. Duke IBC Protocols By the Numbers • Total in Database (since ‘86): 973 • # Active Protocols: 525 • # Active, “Exempt”: 128 (24%) • # Active, Animals: 189 (36%) • # Active, BSL2: 280 (53%) • # Active, BSL3: 10 (2%)

  27. New NIH OBA Website (November, 2008) http://oba.od.nih.gov/oba/index.html

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