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 [email protected]

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

  

Academic



Public



Private Commercial Research institute Research Characteristics

    

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 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

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

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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 I nstitutes of H ealth

··

Office of Biotechnology Activities

Frequently Asked Questions for Labs Conducting Recombinant or Synthetic Nucleic Acid Research

Reporting of I ncidents Related to Research Subject to the NI H Guidelines for Research I nvolving Recombinant or Synthetic Nucleic Acids to the National I nstitutes of Health (NI H) Office of Biotechnology Activities (OBA) 1. What kinds of incidents involving recombinant DNA must be reported to the NI H 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

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. Minor spills of low-risk agents not involving a breach of containment that were properly cleaned and decontaminated generally do not need to be reported. OBA should be consulted if the Institutional Biosafety Committee (IBC), investigator, or other institutional staff are uncertain whether the nature or severity of the incident warrants reporting; OBA can assist in making this determination.

3. Who is responsible for reporting incidents involving recombinant DNA to NI H OBA?

Under the

NIH Guidelines

incident reporting is articulated as a responsibility of the Institution, IBC, Biological Safety Officer, and Principal Investigator. Institutions have the discretion to determine which party should make these reports, and one report for each incident or set of information is generally sufficient. Page

1

of

2 I ncident Reporting FAQs/M arch 2013

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)

Commercial = 9% Research Institute = 6% Gov’t = 6% Other = 1% Hospital/Clinic = 38% Academic = 40% Total = 890

Incident Reports by Institutional Type (2010 – 2012)

Research Institute 8% Hospital/Clinic 14% 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)

BL3 17% BL1 12% BL2 71%

Pipettes 11%

Parenteral Exposures (2010 – 2012)

Dissection Tools 10% Other (e.g. glassware, vials, equipment) 9% Needles 70% Approximately 30% of parenteral exposures occurred while handling a live animal

Animal Bites (2010 - 2012)

Ferrets 9% Non-human Primates 10% Dog 5% 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.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Conduct frequent training on proper sharps use and disposal Pay special attention when using sharps, avoid recapping needles Empty sharps disposal containers regularly. Don’t compact with hands or try to overstuff when full Don’t place sharps disposal containers next to regular trash cans Don’t “retrieve” items from sharps containers Ensure animals are properly restrained or anesthetized before attempting an injection Use plastic rather than glass, or sharps with built in safety features when possible Inspect glassware carefully before use Tidy up breakages and equipment 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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