OBA and IBCs · 2019. 7. 25. · NIH OBA Site Visit Program Proactive not‐for‐cause site visits...
Transcript of OBA and IBCs · 2019. 7. 25. · NIH OBA Site Visit Program Proactive not‐for‐cause site visits...
Jacqueline Corrigan‐Curay, J.D., M.D.Acting Director, NIH OBA
OBA and IBCs Partners in the Oversight of Research Subject to the NIH Guidelines
Institutional Biosafety Committees
The cornerstone of oversight for research involving recombinant and synthetic nucleic acid molecules
IBCs and NIH: Partners in Oversight
RACNational Perspective
NIH OBANIH Guidelines
IBCLocal
Oversight
IBCs are the key institutional component of a national system of oversight
IBCs are “sentinels” at the local level, identifying new safety and policy issues for NIH OBA and RAC consideration
IBCs are a critical linchpin to public trust in the safety of research with recombinant and synthetic nucleic acid molecules and other life science research
IBCs and NIH: Partners in Oversight
Impetus for Conference
Offer educational, training, and professional development opportunities for IBC members, staff, and others involved in research oversight
Provide a forum to explore the challenges faced by IBCs in today’s research landscape
Promote discussion and sharing of creative and practical strategies and solutions to implement at institutions to enhance IBC functioning
Impetus for Conference
Promoting excellence among IBCs is a responsibility of
The NIH Office of Biotechnology Activities
Institutions
IBCs Registered with NIH OBA (June 2013)
Academic = 40%
Hospital/Clinic = 38%
Commercial = 9%
Research Institute
= 6%
Gov’t = 6% Other
= 1%
Total = 890
Year
Num
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BA
IBCs Registered with NIH OBA
Rapid expansion of research programs utilizinghighly pathogenic agents brings new challenges, including containment facilities, training, biosecurity and personnel reliability
Biodefense and emerging infectious disease research
The Growing Responsibilities of IBCs
Expansion of human gene transfer research into non‐viral approaches
Zinc finger nucleasessiRNA
The Growing Responsibilities of IBCs
Emerging technologies present new scientific, safety and ethical challenges
Synthetic biology Nanotechnology
The Growing Responsibilities of IBCs
Recently expanded (March 2013) scope of the NIH Guidelines: review of research involving recombinant and synthetic nucleic acid molecules
The Growing Responsibilities of IBCs
IBCs are increasingly assigned ‘other’ review responsibilities Non‐recombinant pathogens Select Agent research Stem cell research Nanotechnology applications Biosecurity (Dual use)
The NIH Guidelines state the institution shall establish an Institutional Biosafety Committee whose responsibilities need not be restricted to recombinant or synthetic nucleic acid molecule research.
The Growing Responsibilities of IBCs
IBC Review Responsibilities
Types of research reviewed by IBCs
2010 Survey of IBCs by Hackney, Myatt, Gilbert, Caruso and Simon* Recombinant DNA only – 16 %
Recombinant DNA and other biohazards – 67%
Recombinant DNA, other biohazards and other laboratory hazards – 17 %
*Applied Biosafety (2012) Volume 17
Life sciences research brings immense benefits to the public:
Biomedical and public health advances
Improvements in agriculture
Safety and quality of food supply
Environmental quality
Strong national security and economy
Public View of Research
However public often has:
Pointed concerns about the potential public health and environmental consequences of research
Apprehension about unprecedented technological capabilities
Skepticism about institutional oversight and investigator safety practices
Public View of Research
Public trust is critical to continued scientific support and progress
IBCs are an increasingly critical linchpin to public trust in recombinant and synthetic nucleic acid molecule research – and by extension, support of the life science research enterprise broadly
We must ensure that IBCs are equipped to fulfill their responsibilities so that public safety and trust are preserved
IBCs and Public Support of Research
How Do We Optimize IBC Function?
Ensure IBCs are:
Well supported Well resourced Well trained Periodically evaluated for effectiveness
Ensure IBCs are: Well supported IBCs often cite a lack of authoritative support
at their institutions – IRBs and IACUCs are often given high priority and attention because of regulations and accreditation requirements for those committees
IBCs and biosafety staff often don’t feel empowered to “persuade” investigators to comply or to pursue possible violations of the NIH Guidelines and to impose sanctions locally
Ensure IBCs:
Have the support of senior administration to be effective
Ensure senior institutional officials are engaged with IBC activities and support the authority of the IBC
Educate the research community about the committee’s importance to the institution but also to the maintaining public trust
Ensure IBCs are:
Well resourced
Examine the staffing and other material 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
Compare IBC resources to those of the IRB and IACUC; are they commensurate with the volume of research?
Ensure IBCs are:
Periodically examined for effectiveness
OBA Site Visit Program
Panel I Self evaluation Peer reviews
Use the updated IBC Self Assessment Tool
NIH OBA Site Visit Program
Proactive not‐for‐cause site visits to: Educate about IBC requirements Provide on‐site advice Identify opportunities for institutional
improvement Inform OBA of institutional challenges Develop a body of information for the
development of “best practices”
NIH OBA Site Visit Program
Year Number of Visits
2006 4
2007 6
2008 8
2009 20
2010 10
2011 15
2012 15
2013 11
Total 89
NIH OBA IBC Site Visits
10
63
3
3
3
3
3
33
3
2
2
2
2
2
22
2
2
2
22
2
2
1
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1 111
1
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5
5
IBC Self‐Assessment Tool
Available online at: http://oba.od.nih.gov/rdna_ibc/ibc_training.html
IBC Self‐Assessment Tool
IBC Self‐Assessment Tool
Use of the tool is voluntary (but a good idea!)
Tool addresses all major elements related to institutional compliance with the NIH Guidelines
Same issues that OBA assesses during its site visits (hence, excellent preparation for a site visit!)
Framework to promote understanding of requirements and develop training
What Are We Learning From the Site Program?
Institutions are trying to “do the right thing”
IBC members and staff are service oriented, accessible and responsive, knowledgeable, and appreciated
What Are We Learning From the Site Program?
Need to ensure institutions have well developed policies and procedures
IBCs need educational and other resources
Need to ensure IBC members and staff are well trained
Train new members as they join the committee
Devote explicit attention to non‐affiliated members
Ongoing training (updates, primers etc)
What Are We Learning From the Site Program?
Training
Tools you can use Utilize materials from OBA’s Web site Develop institutional specific
programs by building on OBA resources (YOU CAN COPY FROM US!)
Network and share tools and strategies with peers!
OBA Resources for IBCs and Investigators
NIH Guidelines and Federal Registernotices FAQs Policy and biosafety guidance documents Brochures Posters Videos Reports of safety symposia
Updated/New Educational Materials
Pick up or request copies at the OBA booth
OBA NEWS Listserv
Subscribe to OBA_NEWS
Send an email to: [email protected]
In body of message type:
Subscribe OBA_NEWS
Email: [email protected]
For Queries Please Contact Us!
Web: http://oba.od.nih.gov/oba/
NIH Office of Biotechnology ActivitiesSuite 750
6705 Rockledge Drive, Bethesda, MD 20892‐7985
Phone (301) 496‐9838Fax (301) 496‐9839
Questions
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