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

bayhar@od.nih.gov

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!

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Web: http://oba.od.nih.gov/oba/

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Bethesda, MD 20892-7985Phone (301) 496-9838

Fax (301) 496-9839