Transcript Overview of the MUSC IBC Registration Process

Introduction to the MUSC Institutional
Biosafety Committee (IBC)
Registration Process
Daniel Eisenman, PhD
MUSC Biosafety Officer
[email protected]
843-792-4304
NIH Guidelines for Research Involving
Recombinant DNA
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)
Origins of NIH Guidelines for Research Involving
Recombinant DNA
April 18, 1977
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.
Overview of the MUSC IBC Registration Process
Online submission via the ERMA System
http://erma.musc.edu/
Overview of the MUSC IBC
Registration Process
Online submission via the ERMA System
http://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
Instructions
https://erma.musc.edu/ibc_office/GenIntruct.html
Biosafety Officer’s Webpage
www.musc.edu/biosafety
Links to a Frequently Asked Questions page has been
embedded in the IBC Form.
IBC Website
http://research.musc.edu/ori/ibc/home.htm
Additional Assistance
Daniel Eisenman, PhD Biosafety Officer [email protected]
Cynthia Karr, PhD
IBC Administrator [email protected]
Guidance Documents and Assistance
Biosafety Officer’s Webpage
www.musc.edu/biosafety
Links to FAQ Page embedded in the IBC Form
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
Designed to assess potential risks associated with rDNA.
Disclose
Genes to be expressed
Vectors (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
Section 5: Microbes
Designed to assess potential risks associated with 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
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 places
Great
emphasis
On identifying
gene
Hazards.
Determining Risks Associated with Genes
Hazard: Elevated expression of GATA6 may lead to oncogenesis.
Viruses are Diverse!
Several animal virus families possessing varying properties, uses and risks.
Adenovirus
Retrovirus
Lentivirus
AdenoAssociated virus
Example Risk Assessment
Risks Associated with Retroviral Vectors:
Viral Transduction
Viral RNA
Gene of Interest
Target Cell
Virus
Infected target cell
containing the gene of
interest
Cell’s DNA
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
Viral RNA
Gene of Interest
Virus
Target Cell
Host Cell DNA
Proto-Oncogene
Oncogene
Random integration of viral genome may
disrupt endogenous host genes. Of special concern
Is disruption of proto-oncogenes, which can lead
to increased cancer risk.
Likely Consequences of Lab Acquired Infections
with Retro/Lentiviral Vectors
•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.
Risk Assessment 101:
Containment and Safety Practices
Additional Consideration for Containment, personal
protective equipment (PPE) and Safety Practices May be
Required After Assessing:
Experimental Procedures
•Use of Sharps
•Use of Animals
•Potential Creation of Aerosols
•Procedures on Bench Tops vs
Biosafety Cabinets
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 Inspections
Online Guidance: www.musc.edu/biosafety/BSL2
Inspections Ensure
Compliance with the
Containment and
Safety Practices
Detailed in the BMBL,
the CDC’s biosafety
guidelines.
Pre-inspection WalkThroughs 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 Available
Online:
www.musc.edu/biosafety/SafetyProtocol
Expired Biosafety
Cabinet Certifications
Contact the
Biosafety Officer to
arrange certification.
Regulatory Changes
Synthetic Oligonucleotides
Dual Use Research
9 AUGUST 2002 VOL 297 SCIENCE
©2006 EUROPEAN MOLECULAR BIOLOGY ORGANIZATION
EMBO reports VOL 7 | SPECIAL ISSUE | 2006
http://news.sciencemag.org/scienceinsider/2012/03/us-requires-new-dual-use-biologi.html
Questions?
Daniel Eisenman, PhD
MUSC Biosafety Officer
[email protected]
843-792-4304