Findings and Observations
of the NIH OBA
IBC Site Visit Program
Ryan Bayha
Senior Analyst for Science Policy Outreach
NIH Office of Science Policy
NIH Office of Biotechnology Activities
bayhar@od.nih.gov
NEBSA
September 17, 2013
Cambridge, MA
Site 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 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 Institutions
Institution Type
Research Characteristics
 Academic
 Public
 Private
 Commercial
 Research
institute





In vitro
Human gene transfer
Animal
Plant
Biosafety level 1- 4
Selected
Findings to Date
Positive Practices
 IBC staff and member
competencies

Service oriented

Accessible/responsive

Knowledgeable
Positive 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 Practices
 Recognition of IBC service

Acknowledge in a highly
visible way the value that the
institution places on IBC
service
Positive Practices
IBC membership


Broad array of expertise to
compliment research portfolio
Term of membership
Positive 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 Practices
Formal IBC conflict of interest policy

Promotes attention to the topic and
consistent approaches to dealing
with it
Positive 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 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 Practices
 Review of facilities construction and
renovation by IBC
 Routine certification and
maintenance of laboratory
equipment
Positive Practices
 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
Compliance Challenges
 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
Compliance Challenges
 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
Compliance Challenges
• 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_a
nd_Minutes_FAQs.pdf
Compliance Challenges
 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
Compliance Challenges
 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
Compliance Challenges
Periodic review of recombinant DNA research


Have the IBC determine when project
registrations should be renewed
Conduct rigorous laboratory inspections:
Documentation
Frequency
Qualification of inspector
Inspection standards
Compliance Challenges
 Proper disposal of recombinant DNAcontaining 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
Compliance Challenges
Human gene transfer protocols

Review 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
Compliance Challenges
 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
Compliance 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
Incident Reporting Requirements
under the NIH Guidelines
 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
Importance of Incident Reporting
 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
Importance of Incident Reporting

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
Incident Reporting FAQs
National Institutes of Health · Office of Biotechnology Activities
Frequently Asked Questions for Labs Conducting Recombinant or
Synthetic Nucleic Acid Research
Reporting of Incidents Related to Research Subject to the
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids to the
National Institutes of Health (NIH) Office of Biotechnology Activities (OBA)
1. What kinds of incidents involving recombinant DNA must be reported to the
NIH OBA?
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines) states that "...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 reported on a more expedited
basis. Spills or accidents in BL2 laboratories resulting in an overt exposure must be
immediately reported to NIH OBA. Spills or accidents occurring in high containment (BL3
or BL4) laboratories resulting in an overt or potential exposure must be immediately reported
to NIH OBA.
2. How serious must a problem be to warrant reporting to OBA?
Any spill or accident involving recombinant DNA research of the nature described above or
that otherwise leads to personal injury or illness or to a breach of containment must be
reported to OBA. These kinds of events might include skin punctures with needles
containing recombinant DNA, the escape or improper disposition of a transgenic animal, or
http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting.pdf
spills of high-risk recombinant materials occurring outside of a biosafety cabinet. Failure to
adhere to the containment and biosafety practices articulated in the NIH Guidelines must also
be reported to OBA.
NIH OBA Incident Reporting Template
http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting
.pdf
IBCs Registered with NIH OBA
(June 2013)
Research
Institute
= 6%
Gov’t
= 6%
Other
= 1%
Commercial
= 9%
Academic
= 40%
Hospital/Clinic
= 38%
Total = 890
Incident Reports by
Institutional Type (2010 – 2012)
Hospital/Clinic
14%
Research
Institute
8%
Government
5%
Commercial
1%
Academia
72%
Reported Incidents by Type
(2010 – 2012)
Failure to
Obtain IBC
Approval
14%
Animal Bite
7%
Ocular
Exposure
6%
Other
15%
Splash/Spill
17%
Parenteral
Exposure
41%
“Other” includes: equipment failure, loss of containment, potential
exposure, etc.
Institutions Reporting Incidents*
31%
69%
Institutions that have been site-visited
Institutions that have NOT been site-visited
*(Excluding Failure to Obtain IBC Approval)
Incidents reported to OBA by
Biosafety Level (2010 – 2012)
BL1
12%
BL3
17%
BL2
71%
Parenteral Exposures
(2010 – 2012)
Dissection
Tools
10%
Other (e.g.
glassware,
vials,
equipment)
9%
Pipettes
11%
Needles
70%
Approximately 30% of parenteral exposures
occurred while handling a live animal
Animal Bites (2010 - 2012)
Non-human
Primates
10%
Dog
5%
Ferrets
9%
Rodents
76%
We know you know... But…
 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 …
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…

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)
New/Updated
Educational
Materials
IBC Self-Assessment Tool
http://oba.od.nih.gov/rdna_ibc/ibc_training.html
IBC Self-Assessment Tool
Updated/New Educational
Materials
Please request copies!
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