introduction to the musc institutional biosafety committee (ibc) registration process daniel...
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Introduction to the MUSC Institutional Biosafety Committee (IBC)
Registration Process
Daniel Eisenman, PhDMUSC Biosafety [email protected]
Requires:
•Institutions receiving NIH funding to have Institutional Biosafety Committees (IBC)
•Registration and IBC review of rDNA Research
•Ensure Risk Assessments are performed
•Implementation of Containment and Safety Practices Outlined in:
Biosafety in Microbiological and Biomedical Laboratories (BMBL)
NIH Guidelines for Research Involving Recombinant DNA
Origins of NIH Guidelines for Research Involving Recombinant DNA
Framework created at the 1976 Asilomar academic conference by researchers in response to public fears over:
•gene therapy
•creation of “super bugs” (e.g. virulent antibiotic resistant microorganisms)
The guidelines were later adopted and implemented by the NIH.
April 18, 1977
Overview of the MUSC IBC Registration Process
Online submission via the ERMA Systemhttp://erma.musc.edu/
Overview of the MUSC IBC Registration Process
Online submission via the ERMA Systemhttp://erma.musc.edu/
Initial Review by IBC Members
Feedback Provided to Investigators
Opportunity to Revise Application Prior to the IBC Meeting
IBC Meets to Review and Discuss Applications
IBC Approval and Laboratory Inspection
Submission Deadlines and Meeting Dates
www.musc.edu/biosafety/IBC
Guidance Documents and Assistance
Instructionshttps://erma.musc.edu/ibc_office/GenIntruct.html
Biosafety Officer’s Webpagewww.musc.edu/biosafety
Links to a Frequently Asked Questions page has been embedded in the IBC Form.
Additional Assistance
Daniel Eisenman, PhD Biosafety Officer [email protected] Karten, PhD IBC Administrator [email protected]
IBC Websitehttp://research.musc.edu/ori/ibc/home.htm
Biosafety Officer’s Webpagewww.musc.edu/biosafety
Links to FAQ Page embedded in the IBC Form
Guidance Documents and Assistance
Design and Structure of the IBC Forms
Modular Forms with 7 Sections
Four Required Sections
Section 1: PI Information and Personnel Listing
Section 2: Locations (laboratories, culture rooms, etc.)
Section 3: Description of Research and Funding Information
Section 7: PI’s Acknowledgement of Responsibilities
Design and Structure of the IBC Forms
Three Sections To Be Used As Needed
Section 4: Recombinant DNA
Section 5: Microbes
Section 6: Biological Toxins
Section 4: rDNA
Disclose Genes to be expressedVectors (plasmids, viruses, etc.)
Investigators should be aware of potential risks associated with:
Aberrant expression of genes in humans
Consequences of Infection with recombinant organisms •e.g. E. coli and viral vectors
Designed to assess potential risks associated with rDNA.
Section 5: Microbes
Includes cloning strains of E. coli and Saccharomyces cerevisiae
www.musc.edu/biosafety/E%20coli
Viral Vectors Must Also Be Disclosed As Microbes.
www.musc.edu/biosafety/IBC
Designed to assess potential risks associated with microbes
Section 6: Biological Toxins
Biological toxins must be registered with the IBC. Toxins of greatest concern are Select Agent Toxins which are regulated by the CDC when possessed in quantities exceeding the permissible amounts listed below.
Risk Assessment 101
The Investigator must be able to identify the risks associated with their experimental design.
The risks associated with genes of interest and vectors must be disclosed.
Section 4e: Registering genes to be expressed
The IBC placesGreat emphasisOn identifying geneHazards.
Determining Risks Associated with Genes
Hazard: Elevated expression of GATA6 may lead to oncogenesis.
RetrovirusLentivirus
AdenovirusAdeno-Associated virus
Viruses are Diverse!
Several animal virus families possessing varying properties, uses and risks.
Virus
Target Cell
Infected target cell containing the gene of interest
Cell’s DNA
Viral RNAGene of Interest
Example Risk Assessment
Risks Associated with Retroviral Vectors: Viral Transduction
Individuals infected with the viral vector may express the insert gene at the site of infection.
Oncogenes, Immune Modulators and Toxins pose the greatest risk.
Example Risk Assessment
Risks Associated with Retroviruses: Insertional Mutagenesis
Virus
Target CellHost Cell DNA
Viral RNAGene of Interest
Proto-Oncogene Oncogene
Random integration of viral genome maydisrupt endogenous host genes. Of special concernIs disruption of proto-oncogenes, which can lead to increased cancer risk.
•Fever / flu-like symptoms
•Possible inflammation of infected tissues
•Random integration of viral genome into host genome can result in insertional mutagenesis and oncogenesis
•Expression of insert genes in infected tissues may pose additional risk depending on the gene’s function.
Likely Consequences of Lab Acquired Infections with Retro/Lentiviral Vectors
Risk Assessment 101: Containment and Safety Practices
Experimental Procedures•Use of Sharps•Use of Animals•Potential Creation of Aerosols•Procedures on Bench Tops vs Biosafety Cabinets
Additional Consideration for Containment, personal protective equipment (PPE) and Safety Practices May be Required After Assessing:
Microbes•Host Range (Infectious to human?)•Virulence•Concentration / Viral Titer•Large Volumes
Approval Pending A Satisfactorily Completed Laboratory Inspection
New applications or amendments covering new Investigators, locations or organisms will require a lab inspection.
Contact the Biosafety Officer to schedule inspections.
Daniel Eisenman, PhD Biosafety Officer [email protected] 843-792-4304
Laboratory InspectionsOnline Guidance: www.musc.edu/biosafety/BSL2
Inspections Ensure Compliance with theContainment and Safety PracticesDetailed in the BMBL, the CDC’s biosafety guidelines.
Pre-inspection Walk-Throughs Can be Scheduled to provide guidance.
Most Deficiencies Are Corrected During or Shortly After Inspection.
Laboratory Inspections:Most Common Deficiencies
Signed Lab Safety Protocol Not Available At Inspection
Template Safety Protocols AvailableOnline:www.musc.edu/biosafety/SafetyProtocol
Expired Biosafety Cabinet Certifications
Contact the Biosafety Officer to arrange certification.
Regulatory Changes
Synthetic Oligonucleotides
9 AUGUST 2002 VOL 297 SCIENCE
Dual Use Research
http://news.sciencemag.org/scienceinsider/2012/03/us-requires-new-dual-use-biologi.html©2006 EUROPEAN MOLECULAR BIOLOGY ORGANIZATION EMBO reports VOL 7 | SPECIAL ISSUE | 2006
