1. Findings and Observations of the NIH OBA IBC Site Visit Program Findings and Observations of the NIH OBA IBC Site Visit Program Ryan Bayha Senior Analyst for Science Policy Outreach NIH Office of Science Policy NIH Office of Biotechnology Activities bayhar@od.nih.gov NEBSA September 17, 2013 Cambridge, MA

2. Site Visit Program  Proactive not-for-cause site visits:  Local  Educate about IBC requirements  Provide on-site advice  Identify opportunities for institutional improvement  Inform OBA of institutional challenges  National  Develop a body of information on best practices and common compliance challenges  Create a self-assessment tool for IBCs

3. Site Visit Program Methodology  Assessment of the institution's program for recombinant DNA research oversight  Review of institutional documentation related to the recombinant DNA research program  Interviews with selected institutional personnel involved in the conduct or oversight of research subject to the NIH Guidelines

4. Diversity of Institutions Diversity of Institutions Institution Type  Academic  Public  Private  Commercial  Research institute Research Characteristics  In vitro  Human gene transfer  Animal  Plant  Biosafety level 1- 4

5. Selected Findings to Date

6. Positive Practices  IBC staff and member competencies  Service oriented  Accessible/responsive  Knowledgeable

7. Positive Practices  IBC charter, procedure manual or SOPs  Comprehensive SOPs help ensure that IBCs and others with biosafety responsibilities fulfill their duties consistently and correctly  SOPs can also facilitate successful training by articulating clear performance expectations

8. Positive Practices  Recognition of IBC service  Acknowledge in a highly visible way the value that the institution places on IBC service

9. Positive Practices  IBC membership  Broad array of expertise to compliment research portfolio  Term of membership

10. Positive Practices  PI attendance at IBC meetings  Enables the IBC to gain a fuller understanding of protocol details  Serves to enhance the visibility of the activities of the IBC among PIs at the institution

11. Positive Practices  Formal IBC conflict of interest policy  Promotes attention to the topic and consistent approaches to dealing with it

12. Positive Practices  Public access to meetings  Transparency encourages public trust and support  Some institutions post IBC meeting minutes and dates on publicly accessible web sites.

13. Positive Practices  Senior institutional official on IBC  Enhances the authority and effectiveness of the IBC  Signals to the institutional research community the committee’s importance

14. Positive Practices  Review of facilities construction and renovation by IBC  Routine certification and maintenance of laboratory equipment

15. Positive Practices  Coordination between IBC, IACUC, IRB  Helps ensure that all recombinant DNA protocols are reviewed by the IBC  Coordination with Grants and Contracts Office  Release of funds tied to IBC approval provides an additional checkpoint for compliance with the NIH Guidelines

16. Compliance Challenges  Need for greater institutional resources  Examine the staffing and other resources needed to fulfill review, oversight and training responsibilities under the NIH Guidelines and ensure that these resources are adequate to the tasks at hand

17.  Appropriateness of non-affiliated IBC members  Actual/perceived conflicts  Affiliations with the institution can include associations with entities with which the institution has business arrangements Compliance Challenges

18. Meeting minutes should contain a level of detail sufficient to adequately document fulfillment of IBC responsibilities See OBA FAQ on minutes content: http://oba.od.nih.gov/oba/ibc/FAQs/IBC_Meetings_a nd_Minutes_FAQs.pdf Compliance Challenges

19.  Robust training for IBC members, research staff, and support staff (e.g., animal care):  Utilize slides on OBA’s Web site  Take advantage of “IBC Basics” and other external training opportunities  Develop in-house programs that build on these resources  Devote explicit attention to recombinant and synthetic nucleic acid molecules  Document attendance

20.  Approval of all projects subject to Sections III-A through III-E of the NIH Guidelines at a convened meeting of a quorum of the IBC See OBA guidance on meetings http://oba.od.nih.gov/oba/ibc/FAQs/IBC_Meetings_ and_Minutes_FAQs.pdf Compliance Challenges

21.  Periodic review of recombinant DNA research  Have the IBC determine when project registrations should be renewed  Conduct rigorous laboratory inspections:  Documentation  Frequency  Qualification of inspector  Inspection standards

22. Compliance Challenges  Proper disposal of recombinant DNA- containing waste, including transgenic plants and animals  Develop policies and procedures that preclude the entry of transgenic animals and plants into food stream  Rigorously train staff

23.  Human gene transfer protocols  Review of informed consent  Ensure that human subjects are adequately informed of the possible risks, discomforts, and side effects that are associated with the use of gene transfer products See Informed Consent Guidance: http://oba.od.nih.gov/oba/rac/ic/index.html Compliance Challenges

24.  Surveillance, emergency, and incident response plans  IBC-approved emergency plans covering accidental spills and personnel contaminations resulting from recombinant DNA research specifically  Individual laboratories can tailor these plans to fit their special circumstances Compliance Challenges

25.  Awareness of incident reporting requirements:  Incorporate incident reporting into training programs  Report within 30 days to NIH OBA any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses  Report immediately to NIH OBA certain incidents described in Appendix G-II See OBA Guidance on Incident reporting: http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting.pdf See OBA Incident Reporting Template: http://oba.od.nih.gov/oba/ibc/FAQs/Incident_Reporting_Template.doc

26. Incident Reporting: Lessons Learned

27.  Under the NIH Guidelines "...any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses" must be reported to NIH OBA within 30 days  Certain types of accidents must be immediately reported to NIH OBA:  Spills or accidents in BL2 laboratories resulting in an overt exposure  Spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure Incident Reporting Requirements under the NIH Guidelines

28.  Keeps institutions aware of and accountable for safety-related problems  Provides OBA an opportunity to educate institutions about optimal responses to safety events  Allows OBA to identify patterns of safety problems at particular institutions, possibly pointing to a need for  Broad-based training  Interventions in particular laboratories Importance of Incident Reporting

29.  Allows OBA to identify patterns of safety problems nationwide which may need broader educational outreach  Issues with particular practices  Safety challenges with particular agents  Points of emphasis in OBA educational programs  Areas where the NIH Guidelines may need clarification or amendment Importance of Incident Reporting Importance of Incident Reporting

30. http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting.pdf Incident Reporting FAQs

31. http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting.pdf NIH OBA Incident Reporting Template

32. IBCs Registered with NIH OBA (June 2013) Academic = 40% Hospital/Clinic = 38% Commercial = 9% Research Institute = 6% Gov’t = 6% Other = 1% Total = 890

33. Incident Reports by Institutional Type (2010 – 2012)

34. Reported Incidents by Type (2010 – 2012) “Other” includes: equipment failure, loss of containment, potential exposure, etc.

35. Institutions Reporting Incidents Institutions Reporting Incidents * *(Excluding Failure to Obtain IBC Approval)

36. Incidents reported to OBA by Biosafety Level (2010 – 2012)

37. Approximately 30% of parenteral exposures occurred while handling a live animal Parenteral Exposures (2010 – 2012)

38. Animal Bites (2010 - 2012)

39.  Ensure proper PPE use at all times, ESPECIALLY EYEWEAR  Legs and feet should be covered  Ensure proper posting of signage for potential hazards, SOPs, and emergency response procedures  Be constantly aware of all types of experiments being conducted, whether they have been approved, and whether they are being conducted at the appropriate containment level We know you know... But…

40. Common Sharps Sense – Top 10 1.Conduct frequent training on proper sharps use and disposal 2.Pay special attention when using sharps, avoid recapping needles 3.Empty sharps disposal containers regularly. Don’t compact with hands or try to overstuff when full 4.Don’t place sharps disposal containers next to regular trash cans 5.Don’t “retrieve” items from sharps containers 6.Ensure animals are properly restrained or anesthetized before attempting an injection 7.Use plastic rather than glass, or sharps with built in safety features when possible 8.Inspect glassware carefully before use 9.Tidy up breakages and equipment 10.Avoid multiple researchers working in proximity with sharps if possible We know you know... But …

41.  Make sure investigators know  Training …training … and more training  Provide specific examples of what can go/has gone wrong  Stress importance of reporting and requirements to do so (and that it’s not punitive) We know you know … But…

42. New/Updated Educational Materials

43. IBC Self-Assessment Tool http://oba.od.nih.gov/rdna_ibc/ibc_training.html

44. IBC Self-Assessment Tool

45. Updated/New Educational Materials Please request copies!

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47. Email: oba@od.nih.gov Contact Us Web: http://oba.od.nih.gov/oba/ NIH Office of Biotechnology Activities 6705 Rockledge Drive, Suite 750 Bethesda, MD 20892-7985 Phone (301) 496-9838 Fax (301) 496-9839