Best Practices for IBCs in Challenging Times Betsy Gilman Duane, MS, RBP, CBSP October 21, 2014
Recent Events CDC anthrax incident and influenza shipment FDA discovery of smallpox vials eheinc.com 2
September 2014 During National Biosafety Stewardship Month, institutions should highlight the importance of the requirements and activities that are already part and parcel of a robust biosafety program. It is also an opportunity to further optimize biosafety oversight and strengthen the institutional safety culture. National Institutes of Health eheinc.com 3
So Much To Do So Little Time Are my biosafety procedures robust? eheinc.com 4
So Much To Do So Little Time Are my biosafety procedures robust? What about my IBC? eheinc.com 5
So Much To Do So Little Time Are my biosafety procedures robust? What about my IBC? Has everyone been trained and is it effective? eheinc.com 6
Institutional Biosafety Committee (IBC) Required if institution: receives funding from NIH for research involving recombinant / synthetic nucleic acid molecules resides in city/town with an ordinance eheinc.com 7
NIH Guidelines Safety practices / containment procedures for clinical research involving recombinant / synthetic nucleic acid molecules http://osp.od.nih.gov/office-biotechnologyactivities/biosafety/nih-guidelines eheinc.com 8
Best Practices Enhance experience for IBC members Facilitate compliance and science Provide opportunities for continuous improvement eheinc.com 9
1. Expand Scope of IBC Include additional biohazardous materials Recombinant DNA work involves use of other biohazardous materials Facilitate compliance with additional applicable regulations eheinc.com 10
2. Automate Data Collection & Process Efficiency in review / management of registrations: Automating data collection Recordkeeping Processing tasks Microsoft SharePoint eheinc.com 11
3. Establish Training Programs Roles and responsibilities Overview of NIH Guidelines; other applicable regulations Training topics Document training Professional development eheinc.com 12
4. Designate Appropriate Chairperson Scientific / administrative member Facilitates term limits Safety committees not solely an EH&S function EH&S representative / Biosafety Officer facilitates meetings eheinc.com 13
5. Develop IBC Charter & Procedures Review / update annually Include: Purview of IBC; types of biohazardous materials Membership; term limits Meeting frequency Registration review process Conflict of Interest policy eheinc.com 14
6. Involve Senior Leadership Member of senior leadership team Update on scientific programs, laboratory renovations, etc. Commitment to strong safety culture IBC agendas/minutes eheinc.com 15
7. Implement COI Policy Remind members Conflicts to disclose? Discussion/voting on project registration takes place without PI present eheinc.com 16
8. Invite PI to Present at Meetings Overview of proposed project If project involves new scientific techniques and/or biological materials Improves communication eheinc.com 17
9. Reach Consensus on Votes If no concensus, consider reasons why Defer to future meeting Concerns addressed by entire IBC eheinc.com 18
10. Conduct Lab Tours Lab tour in conjunction with IBC meeting See where work will be conducted; ask questions about biosafety program PI available to present overview; for questions eheinc.com 19
11. Appoint Qualified Biosafety Officer Required for BSL-3 and large scale work Recommended for BSL-1 and BSL-2 Credentials (RBP, CBSP) Assistance from external qualified consultant eheinc.com 20
12. Prepare Transparent Minutes Keep regulators and public in mind Summarize discussions Major points / relevant regulatory citations / how containment levels established Involve legal representatives when redacting sections eheinc.com 21
13. Involve Members in Procedure Review Inactivation protocols Waste management procedures PPE policies eheinc.com 22
14. Obtain Info on Material Disposition PI identifies final disposition of registered materials BSO reviews; shares with IBC Autoclaving/disposal, transfer to collaborator, or storage Internal collaborator: registers materials with IBC External collaborator: provides documentation prior to shipping from respective IBC eheinc.com 23
15. Conduct Regular Audits Part of overall biosafety management system Review: Membership Meetings / minutes Risk assessments / registration reviews Charter/procedures Training / education Independent expert review highlights program gaps; best practices eheinc.com 24
Summary Each IBC is unique! Continuous improvement on ongoing basis! Share best practices! eheinc.com 25
Betsy Gilman Duane bgduane@eheinc.com 800-825-5343 For more information: http://www.eheinc.com/strat_biosafety.htm