1. Survey of Institutional Biosafety Committees Raymond W. Hackney, DrPH, CIH, CBSP University of North Carolina at Chapel Hill “The Future Face of Institutional Biosafety Committees…” San Diego, CA February 21, 2003

2. Purpose l Shed light on how IBCs are currently functioning l Assist institutions in administering their IBCs

3. Survey of IBCs l 9/02 An advance notice and questionnaires were mailed to 397 IBC contacts, listed with NIH (publicly available information) l 10/02 Reminder post card to non – responders l 11/02 Reminder email to non-responders

4. Survey Response l 397 IBC contacts l 12 were returned without delivery l 4 formally declined to participate l 2 were completed by one respondent l 1 was removed from survey results (many questions were unanswered) l 168 completed questionnaires l 45 % response rate (adjusted)

5. Institutions in Survey Population (397 IBC contacts)

6. Institutions Participating in Survey (168 Survey Participants)

7. Survey Participants Vs Survey Population Per Cent

8. Person Completing Questionnaire (168 Respondents) per cent of respondents

9. Institutional Office Responsible for IBC Other: IRB office Research & Sponsored Programs Other departments

10. Position Responsible for IBC Faculty 19%

11. Personnel Devoted to IBC

12. Does the IBC Have Formal Policies?

13. Is the IBC Required to Make Formal Reports?

14. How Often Does the IBC Meet?

15. By what mechanisms are committee meetings conducted?

16. Are meetings open to the public?

17. Have members of the public ever attended?

18. If Yes, how often?

19. Public Attendance at IBC Meetings

20. Are IBC minutes available to the public?

21. IBC Responsibilities

22. Ensuring that rDNA Experiments are Reviewed

23. IBC Membership

24. Expertise on IBCs % of total IBC members (1403) l Bacteriology18% l Physician15% l Virology14% l BSO12% l Animals 11% l Plants 7% l Other EHS 7% l Other:15% –Molecular biology –Research staff –Legal counsel –Administrators

25. Community Membership

26. Who Appoints IBC members?

27. IBC Member Term of Service

28. Formal Training for IBC Members

29. Are there Procedures for Expedited Review?

30. Conditions for Expedited Review Per Cent of Responses

31. How Many rDNA Protocols Were Reviewed? Number Reviewed 1998199920002001 < 1052 %48 %45 %39 % 10 - 4933 %34 %33 %37 % 50 – 998 %10 % 15 % 100 – 1994 %6 % 7 % > 2003 %2 % 3 %

32. Are Labs Inspected by BSO?

33. Frequency of Lab Inspections Annually 51% Less often than Annually 23%

34. Coordination with IACUC Per Cent of Responses

35. Coordination with IRB Per Cent of Responses

36. Coordination with IACUC (Corrected for “not applicable”) Per Cent of Responses

37. Coordination with IRB (Corrected for “not applicable”) Per Cent of Responses

38. Observations l Many IBCs are doing an excellent job l IBCs have limited resources l IBCs operate with high degree of informality l IBCs operate with low degree of involvement from institutional leadership

39. Recommendations IBCs can be strengthened by: l Provide more personnel resources to IBC l Require written policies and institutional accountability l Implement institutional controls to ensure compliance with the Guidelines l Ensure strict adherence to Guidelines despite IBC informalities l Provide training programs for IBC administrators and members

40. Acknowledgements l Nancy King, UNC School of Medicine l Allan Shipp, NIH Office of Biotechnology Activities l 168 IBC Professionals who participated in the Survey