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Th NIH OBATh NIH OBAThe NIH OBA The NIH OBA IBC Sit Vi it PIBC Sit Vi it PIBC Site Visit ProgramIBC Site Visit Program
Site Visit ProgramSite Visit Programgg Proactive not-for-cause site visits:
Local Local Educate about IBC requirements Provide on-site advice
Id tif t iti f i tit ti l i t 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 IBCsCreate a self assessment tool for IBCs
Site Visit Program MethodologySite Visit Program MethodologySite Visit Program MethodologySite Visit Program Methodology
Assessment of the institution's program for p grecombinant DNA research oversight
Review of the institutional documentation related to the Review of the institutional documentation related to the recombinant DNA research program
Interviews with selected institutional personnel involved Interviews with selected institutional personnel involved in the conduct or oversight of research subject to the NIH Guidelines
Site Visit Program MethodologySite Visit Program MethodologySite Visit Program MethodologySite Visit Program Methodology
Pre Site VisitPre Site Visit Notification letter Notification letter
Questions regarding recombinant DNA research program
Request for documentation Request for documentation
Site Visit Program MethodologySite Visit Program MethodologySite Visit Program MethodologySite Visit Program Methodology
Site Visit Introductory meeting
Interviews with institutional personnel
R i f dditi l d t ti Review of additional documentation
Exit debriefingg
Site Visit Program MethodologySite Visit Program Methodologyg gyg gyPost Site Visit
Report from OBA Positive characteristics and practices Positive characteristics and practices
Considerations for possible changes/improvements
Possible deficiencies or practices not in keeping Possible deficiencies or practices not in keeping with the NIH Guidelines
Follow up as required Follow-up as required
Diversity of Institutions VisitedDiversity of Institutions VisitedDiversity of Institutions VisitedDiversity of Institutions Visited
Institutional Type
Academic
Research Characteristics
I it Public Private
In vitro Human gene transfer Animal
Commercial Research institute
H it l/Cli i
Animal Plant Biosafety level 1-4
Hospital/Clinicy
Types of Institutions VisitedTypes of Institutions Visited3
1
1
0
ypyp
3
AcademicGovernmentResearch InstitutionCommercialHospital/ClinicHospital/ClinicOther
40
IBC Site VisitsIBC Site Visits
Self-Assessment ToolSelf Assessment ToolSelf-Assessment Tool
Tool for the Assessment of the IBC and the Institutional Program of
Oversight of Recombinant DNA Research
S lf A t T lSelf-Assessment Tool
• Periodic self-assessment is key to maintaining the quality of theto maintaining the quality of the IBC program
SelfSelf--Assessment ToolAssessment ToolSelfSelf Assessment ToolAssessment Tool
Self-Assessment ToolSelf Assessment Tool
SelfSelf--Assessment ToolAssessment Tool
Available on OBA’s Web site at:http://oba.od.nih.gov/rdna_ibc/ibc.html
SelfSelf Assessment ToolAssessment ToolSelfSelf--Assessment ToolAssessment Tool• Use of the tool is voluntary (but a good idea!)• Use of the tool is voluntary (but a good idea!)• Tool addresses all major requirements of the
NIH Guidelines for Research InvolvingNIH Guidelines for Research Involving Recombinant DNA Molecules
• Same issues that OBA assesses during its site visits (hence, excellent preparation for a site visit)
Questions?Questions?Questions?Questions?
The NIH OBA The NIH OBA IBC Site Visit ProgramIBC Site Visit Programgg
Findings to DateFindings to Dategg
Positive PracticesPositive PracticesPositive PracticesPositive Practices
IBC staff and member competencies
Service oriented Service oriented
Accessible/responsive
Knowledgeable
Positive PracticesPositive PracticesPositive PracticesPositive Practices
IBC charter, procedure manual or SOPs, p
Comprehensive SOPs help ensure that IBCs and others with biosafety responsibilitiesand others with biosafety responsibilities fulfill their duties consistently and correctly
SOPs can also facilitate successful training by articulating clear performance expectationsexpectations
Positive PracticesPositive Practices
Recognition of IBC serviceRecognition of IBC service
Acknowledge in a highly visible way the value that the institution places on IBC service.
Positive PracticesPositive Practices
IBC membershipIBC membership Adequacy of member competenciesq y p Broad array of expertise to compliment
research portfoliop
Term of membership
Positive PracticesPositive Practices
PI attendance at IBC meetingsPI attendance at IBC meetings Enables the IBC to gain a fuller g
understanding of protocol details
Serves to enhance the visibility of the Serves to enhance the visibility of the activities of the IBC among PIs at the institutioninstitution
Positive PracticesPositive Practices
Formal IBC conflict of interestFormal IBC conflict of interest policy
Promotes attention to the topic d i t t h tand consistent approaches to
dealing with it
Positive PracticesPositive Practices
Public access to meetingsTransparency encourages public
trust and supportpp
Positive PracticesPositive Practices
Senior institutional official on IBCEnhances the authority and effectiveness of the IBCeffectiveness of the IBC
Signals to the institutional research community the committee’s importance
Positive PracticesPositive Practices
R i f f iliti t ti dReview of facilities construction and renovation by IBC
Routine certification and maintenance f l b t i tof laboratory equipment
Positive PracticesPositive Practices
Coordination between IBC, IACUC, IRB, , Helps ensure that all recombinant DNA
protocols are reviewed by the IBCp y
Coordination with Grants and Contracts Office Release of funds tied to IBC approval
provides an additional checkpoint for compliance with the NIH Guidelines
Compliance ChallengesCompliance Challengesp gp g
Need for greater institutionalNeed for greater institutional resources Examine the staffing and other resources needed
to fulfill review, oversight and training responsibilities under the NIH Guidelines andresponsibilities under the NIH Guidelines and ensure that these resources are adequate to the tasks at hand.
Compliance ChallengesCompliance Challenges
Appropriateness of non-affiliated
p gp g
Appropriateness of non-affiliated IBC members Actual/perceived conflicts
Affili ti ith th i tit ti i l d Affiliations with the institution include associations with entities with which the institution has business arrangementsinstitution has business arrangements
Compliance ChallengesCompliance Challenges
Meeting minutes should contain a level of
p gp g
Meeting minutes should contain a level of detail sufficient to adequately document fulfillment of IBC responsibilitiesfulfillment of IBC responsibilities
See OBA guidance on minute taking:See OBA guidance on minute taking: http://oba.od.nih.gov/oba/ibc/IBC_Minutes_Guidance_Feb_23_2007.pdf
Compliance ChallengesCompliance Challengesp gp gRobust training for IBC members, research
staff and support staff (e g animal care):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 Develop in-house programs that build on
these resources Devote explicit attention to recombinant DNA Document attendance
Compliance ChallengesCompliance Challengesp gp g
Approval of all projects subject to Sections III-A through III-E of the NIH Guidelines at a
d ti f f th IBCconvened meeting of a quorum of the IBC
See OBA guidance on meetingsSee OBA guidance on meetings http://oba.od.nih.gov/oba/ibc/FAQs/FAQs%20of%20Interest%20to%20IBCs.pdf
Compliance ChallengesCompliance Challengesp gp g
Awareness of incident reporting requirements:p g q
Incorporate incident reporting into training programs Report within 30 days to NIH OBA any significantReport 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-IIS htt // b d ih / b /ib /FAQ /FAQS%20 b t%20I id t%20R ti dfSee: http://oba.od.nih.gov/oba/ibc/FAQs/FAQS%20about%20Incident%20Reporting.pdf
Compliance ChallengesCompliance Challengesp gp g
Periodic review of recombinant DNA research Have the IBC determine when project
registrations should be renewed Conduct rigorous laboratory inspections:DocumentationFrequencyFrequencyQualification of inspectorInspection standards
Compliance ChallengesCompliance Challengesp gp g
Health surveillance programs whenHealth surveillance programs, when required, for personnel involved in recombinant DNA researchrecombinant DNA research
Develop plans for high containmentDevelop plans for high containment or large-scale research
Agent specificAgent specific
Compliance ChallengesCompliance Challengesp gp g Proper disposal of recombinant DNA-
containing waste including transgeniccontaining waste, including transgenic plants and animals
Develop policies and procedures that preclude the entry of transgenic animals and plants into food stream
Ri l t i t ff Rigorously train staff
Compliance ChallengesCompliance Challenges
Human Gene Transfer Protocols
p gp g
Review of informed consent Ensure that human subjects are adequately j q y
informed of the possible risks, discomforts, and side effects that are associated with the use of gene transfer productsgene transfer products.
See Informed Consent Guidance on OBA Web site: http://oba.od.nih.gov/oba/rac/ic/index.html
Compliance ChallengesCompliance ChallengesSurveillance, emergency, and incident
l
p gp g
response plans IBC-approved emergency plans covering
accidental spills and personnel contaminations resulting from recombinant DNA researchspecificallyspecifically
Individual laboratories can tailor these plans to fit their special circumstances p
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