The NIH OBA IBC Site Visit Program

1. The NIH OBA IBC Site Visit Program Kathryn Harris, Ph.D., RBP Senior Outreach and Education Specialist NIH Office of Biotechnology Activities

2. Overview • The Importance of Institutional Biosafety Committees • The NIH OBA IBC Site Visit Program

3. N = 789 Research Institute = 10% Gov’t = 4% Other = 1% Academic = 39% Commercial = 11% Hospital/Clinic = 35% IBCs Registered with the NIH OBA

4. Growing Prevalence of IBCs Number of IBCS Year

5. Growing Significance of IBCs • Recombinant DNA research has grown in volume and complexity • NIH budget has more than doubled from 1998 ($13.7 billion) to present ($28.6 billion); comparable growth in recombinant DNA research • Expanding programs of research into • Biodefense strategies • Emerging infectious diseases • New technological capabilities • Genome synthesis (e.g. polio) • Reverse engineering of non-contemporaneous pathogens (e.g., 1918 influenza) • Novel approaches to human gene transfer

6. Public View of Research • Pointed concerns about the potential public health and environmental consequences of research • Apprehension about unprecedented technological capabilities • Reconstruction of pathogenic viruses (e.g., 1918 flu strain) • Synthesis of pathogenic organisms (polio) • Skepticism about the rigor of institutional oversight and investigator safety practices • “NIMBY” – High containment facilities • Boston, MA • Seattle, WA • Hamilton, MT

7. IBCs and Public Support of Research • Public trust is critical to continued scientific support and progress • IBCs are an increasingly critical linchpin to public trust in recombinant DNA research – and by extension, support of the research enterprise broadly • We must ensure that IBCs are equipped to fulfill their responsibilities so that public safety and trust are preserved

8. “Professionalizing” IBCs • IBCs are as IRBs were 25 years ago • Uneven quality • No professional development forum/ certification for staff (other than BSOs) • No accreditation for program performance • Raising the bar: a responsibility of • NIH OBA • Institutions • IBC members and staff

9. OBA Guidance, Training, and Resources • Conferences for IBCs • Policy conference • Professional development conference • Training courses • ASGT, ABSA, ACRP, PRIM&R • Exhibits and presentations at key professional and scientific meetings • AAMC, ABSA, ACLAM, ARENA, ASGT, MSMR, NBAC, PhRMA, PRIM&R, etc.

10. OBA Guidance, Training, and Resources • Electronic communication tools • Listserv: “OBA_NEWS” • Policy notices, meeting announcements, compliance reminders • Email inbox for queries: oba@od.nih.gov • Questions on interpretation of the NIH Guidelines, status of protocols, scientific and medical issues

11. OBA Guidance, Training, and Resources • NIH Guidelines andFederal Register notices • Minutes and video of RAC meetings • Reports of safety symposia • “Latest news” items on meetings, policy guidance, resources, compliance notices, etc. • GeMCRIS • IBC Web page • FAQs • Training materials: Slide Presentations and Video of Professional Development Workshops

12. 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

13. Site Visit Program Methodology • Assessment of the institution's program for recombinant DNA research oversight • Review of the 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

14. Site Visit Program Methodology • Pre Site Visit • Notification letter • Questions regarding recombinant DNA research program • Request for documentation

15. Site Visit Program Methodology • Site Visit • Introductory meeting • Interviews with institutional personnel • Review of additional documentation • Exit debriefing

16. Site Visit Program Methodology • Post site visit • Report from OBA • Positive characteristics and practices • Considerations for possible changes/improvements • Possible deficiencies or practices not in keeping with the NIH Guidelines • Follow-up as required

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

18. Positive Practices • IBC staff and member competencies • Service oriented • Accessible/responsive • Knowledgeable

19. 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

20. Positive Practices • Recognition of IBC service • Acknowledge in a highly visible way the value that the institution places on IBC service.

21. Positive Practices • IBC membership • Adequacy of member competencies • Broad array of expertise to compliment research portfolio • Term of membership

22. 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

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

24. Positive Practices • Public access to meetings • Transparency encourages public trust and support

25. 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

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

27. 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

28. 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.

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

30. Meeting minutes should contain a level of detail sufficient to adequately document fulfillment of IBC responsibilitiesSee OBA guidance on minute taking: http://oba.od.nih.gov/oba/ibc/IBC_Minutes_Guidance_Feb_23_2007.pdf Compliance Challenges

31. Compliance Challenges • 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 DNA • Document attendance

32. 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 IBCSee OBA guidance on meetings http://oba.od.nih.gov/oba/ibc/FAQs/FAQs%20of%20Interest%20to%20IBCs.pdf Compliance Challenges

33. Compliance Challenges • 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: http://oba.od.nih.gov/oba/ibc/FAQs/FAQS%20about%20Incident%20Reporting.pdf

34. Compliance Challenges • 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

35. Compliance Challenges • Health surveillance programs, when required, for personnel involved in recombinant DNA research • Develop plans for high containment or large-scale research • Agent specific

36. 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

37. Compliance Challenges • 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 on OBA Web site: http://oba.od.nih.gov/oba/rac/ic/index.html

38. Compliance Challenges • 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

39. Questions?