Findings and Observations of the NIH OBA IBC Site Visit Program Findings and Observations of the NIH...
-
Upload
elfreda-howard -
Category
Documents
-
view
214 -
download
0
Transcript of Findings and Observations of the NIH OBA IBC Site Visit Program Findings and Observations of the NIH...
Findings and Observations Findings and Observations of the NIH OBA of the NIH OBA IBC Site Visit IBC Site Visit
ProgramProgram
Ryan BayhaSenior Analyst for Science Policy Outreach
NIH Office of Science PolicyNIH Office of Biotechnology Activities
NEBSASeptember 17, 2013
Cambridge, MA
Site Visit ProgramSite 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
Site Visit Program MethodologySite 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
Diversity of InstitutionsDiversity of Institutions
Institution Type
Academic Public Private
Commercial Research
institute
Research Characteristics
In vitro Human gene transfer Animal Plant Biosafety level 1- 4
Selected Selected Findings to DateFindings to Date
Positive PracticesPositive Practices
IBC staff and member competencies
Service oriented
Accessible/responsive
Knowledgeable
Positive PracticesPositive 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
Positive PracticesPositive Practices
Recognition of IBC service
Acknowledge in a highly visible way the value that the institution places on IBC service
PositivePositive PracticesPractices
IBC membership
Broad array of expertise to compliment research portfolio
Term of membership
Positive PracticesPositive 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
Positive PracticesPositive Practices
Formal IBC conflict of interest policy
Promotes attention to the topic and consistent approaches to dealing with it
Positive PracticesPositive Practices
Public access to meetings
Transparency encourages public trust and support
Some institutions post IBC meeting minutes and dates on publicly accessible web sites.
Positive PracticesPositive Practices
Senior institutional official on IBC
Enhances the authority and effectiveness of the IBC
Signals to the institutional research community the committee’s importance
Positive PracticesPositive Practices
Review of facilities construction and renovation by IBC
Routine certification and maintenance of laboratory equipment
PositivePositive PracticesPractices
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
ComplianceCompliance ChallengesChallenges
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
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
ComplianceCompliance ChallengesChallenges
• 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_and_Minutes_FAQs.pdf
ComplianceCompliance ChallengesChallenges
ComplianceCompliance ChallengesChallenges
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
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
ComplianceCompliance ChallengesChallenges
ComplianceCompliance ChallengesChallenges
Periodic review of recombinant DNA research
Have the IBC determine when project registrations should be renewed
Conduct rigorous laboratory inspections:DocumentationFrequencyQualification of inspectorInspection standards
ComplianceCompliance ChallengesChallenges
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
Human gene transfer protocolsReview 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
ComplianceCompliance ChallengesChallenges
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
ComplianceCompliance ChallengesChallenges
Compliance ChallengesCompliance 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 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
Incident Reporting: Lessons
Learned
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
IncidentIncident ReportingReporting RequirementsRequirements underunder thethe NIHNIH GuidelinesGuidelines
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
ImportanceImportance ofof IncidentIncident ReportingReporting
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
ImportanceImportance ofof IncidentIncident ReportingReporting
http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting.pdf
IncidentIncident ReportingReporting FAQsFAQs
http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting.pdf
NIHNIH OBAOBA IncidentIncident ReportingReporting TemplateTemplate
IBCs Registered with NIH OBA IBCs Registered with NIH OBA (June 2013)(June 2013)
Academic = 40%
Hospital/Clinic = 38%
Commercial = 9%
Research Institute
= 6%
Gov’t = 6% Other
= 1%
Total = 890
Incident Reports by Incident Reports by Institutional Type (2010 – Institutional Type (2010 –
2012)2012)
Reported Incidents by Type Reported Incidents by Type (2010 – 2012)(2010 – 2012)
“Other” includes: equipment failure, loss of containment, potential exposure, etc.
Institutions Reporting IncidentsInstitutions Reporting Incidents*
*(Excluding Failure to Obtain IBC Approval)
Incidents reported to OBA by Incidents reported to OBA by Biosafety Level (2010 – 2012)Biosafety Level (2010 – 2012)
Approximately 30% of parenteral exposures occurred while handling a live animal
Parenteral Exposures Parenteral Exposures (2010 – 2012) (2010 – 2012)
Animal Bites (2010 - 2012)Animal Bites (2010 - 2012)
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…We know you know... But…
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 …We know you know ... But …
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…We know you know … But…
New/Updated Educational
Materials
IBC Self-Assessment ToolIBC Self-Assessment Tool
http://oba.od.nih.gov/rdna_ibc/ibc_training.html
IBC Self-Assessment ToolIBC Self-Assessment Tool
Updated/New Educational MaterialsUpdated/New Educational Materials
Please request copies!Please request copies!
OBA NEWS ListservOBA NEWS Listserv
Subscribe to OBA_NEWS
Send an email to: [email protected]
In body of message type:
Subscribe OBA_NEWS
Email: [email protected]
Contact UsContact Us
Web: http://oba.od.nih.gov/oba/
NIH Office of Biotechnology Activities6705 Rockledge Drive, Suite 750
Bethesda, MD 20892-7985Phone (301) 496-9838
Fax (301) 496-9839