Transcript Tutorial for completing the registration document

Registering Research with the Institutional
Biological Safety Committee (IBC)
A Guide to the Biohazard and Recombinant
DNA Registration Process at Princeton
University
This training is designed to familiarize Principal
Investigators with the revised Biohazard/recombinant
DNA (rDNA)Form, formerly the Memorandum of
Understanding and Agreement (MUA).
The Form has been significantly revised to respond to
feedback received from the NIH Office of Biotechnology
Activities, the government agency that administers the NIH
Guidelines for Research Involving Recombinant DNA Molecules.
What material should be registered?
Use the form to register work with the following materials:
 rDNA that is exempt from the Guidelines
The IBC Chair and the
BSO will review this
research , issue approval
and a containment level.
The IBC does not review
exempt research.
 rDNA that is not exempt from the Guidelines
Non-exempt research
must be reviewed and
approved by the
IBC.
What material should be registered?
The following materials also need to be registered with the IBC:
Can be approved
by the Biological
Safety Officer
biological material from human and non-human primates
Non-recombinant biosafety level 2
organisms and viruses can be approved
by the BSO and the IBC Chair. Either
may request a full Committee review.
All biosafety level 3 research, including
work with select agents and toxins must
be approved by the URB.
microorganisms and viruses pathogenic to humans, plants or
animals, toxins of biological origin
Completing the Registration Form
Check the category (ies) that apply to your research. Only
those questions pertinent to the research categories checked
will appear on the form.
If your research is exempt from the Guidelines, select the
category that best describes your exempt research .
Completing the Registration Form
The IBC Chair and Biosafety Officer will confirm the containment level and issue approval.
The full IBC Committee does not review exempt recombinant or synthetic nucleic acid
molecule research.
More exemptions…
Completing the Registration Form
•Breeding of almost* all transgenic rodents that require BSL-1 housing is exempt under
section III-F-6
*Exceptions
Rodents that contain a transgene encoding >50% of an exogenous eukaryotic virus.
Transgenic rodents in which the transgene is under control of a gammaretroviral promoter.
Any breeding experiments that require BSL-2 conditions.
Completing the Registration Form
Research that falls under Section III-D must be reviewed and approved by the IBC before initiation.
Examples of research in this category:
• using lentiviral or adenoviral vectors
• gene inserts from pathogenic microorganisms
• administering rDNA to animals, except for creating transgenic rodents (see Section III-E-3).
Completing the Registration Form
Section III-E covers experiments in which all components are derived from non-pathogenic
prokaryotes and non-pathogenic lower eukaryotes and may be conducted at Biosafety Level
1 containment. If BSL-2/ABSL-2 containment is required, the research is not covered by
Section III-E.
Examples:
•rDNA molecules of eukaryotic viruses that contain no more than 2/3 of the viral genome:
•in tissue culture only and BSL-1 containment
•must demonstrate the lack of a helper virus for certain families of defective
viruses being used
• Creating transgenic rodents requiring BSL-1 containment
Completing the Registration Form
Experiments that require IBC approval, Recombinant Advisory Committee and NIH
Director approval prior to initiation:
•deliberate transfer of a resistance trait that could compromise the use of a clinically
significant drug to treat infections
•formation of rDNA containing genes for toxin molecules that are lethal to vertebrates:
toxins that have an LD50 of less than 100ng/kg body weight, such as botulinum
toxin, tetanus toxin, diptheria toxin, Shigella dysenteriae neuorotoxin
Completing the Registration Form
If your work with rDNA is not exempt and doesn’t fall into categories III A, B, D or
E, review Section III of the Guidelines, provide a brief description and the appropriate
Guidelines reference.
Completing the Registration Form
For each non-exempt host-vector system used in your research, answer the questions in Section 3.
Completing the Registration Form
Additional questions will appear under each vector you select when completing Section 3.
The information you provide allows the IBC to conduct a thorough risk assessment.
For example, if your research involves use of an adenovirus vector, you’ll be prompted to provide
additional details on the vector.
Completing the Registration Form
For each agent that could potentially cause disease in humans, fill out Section 4, designed to
collect information that will assist the IBC with assigning containment levels for both
recombinant and non-recombinant infectious agents.
If you work with more than one infectious agent,
click on this button to repeat the questions in
section 4.
Completing the Registration Form
Complete Section 5 to register human and non-human primate blood and body fluids, primary cells and
established cell lines, except as noted below, with the IBC.
Established human cell lines that are characterized to be free of contamination from human hepatitis
viruses, human immunodeficiency viruses and other recognized bloodborne pathogens are not covered
by OSHA’s Bloodborne Pathogen Standard and do not have to be registered. Documentation that the
cell lines are free of bloodborne pathogens should be available for review by the Biosafety Officer and
regulatory agencies, such as OSHA.
Completing the Registration Form
Use Section 6 to register research with toxins of biological origin, such as
botulinum toxin, tetrodotoxin or conotoxin.
Completing the Registration Form
Section 7 should be completed if you are working with any organism or
virus, including recombinant materials, that could potentially infect humans.
Risk Assessment
NIH Guidelines require that the Investigator make an initial assessment of risk based on
the Risk Group (RG) of an agent, using information provided in Appendix B of the
Guidelines.
Risk Group 1
Risk Group 2
Risk Group 3
Risk Group 4
Agents that are not
associated with disease in
healthy adult humans
Agents are associated with
human disease which is
rarely serious and for
which preventive or
therapeutic interventions
are often available
Agents that are associated
with serious or lethal
human disease for which
preventive or therapeutic
interventions may be
available
Agents that are likely to
cause serious or lethal
human disease for which
preventive therapeutic
interventions are usually
not available
Examples
All serotypes of adenoassociated virus1, Bacillus
subtilis, Escherichia coli
K-122
1
Listeria, Salmonella
typhimurium,
Staphylococcus aureus,
E. coli 3, human
adenoviruses, Herpes
simplex types 1 and 2
There are no facilities available for
research with Risk Group 3 or 4 agents at
Princeton University.
if transgene does not encode either a potentially tumorigenic gene product or a toxin molecule and virus is produced in absence of a
helper virus
2 if it does not possess a complete lipopolysaccharide and does not carry any active virulence factor or colonization factors and does not
carry any genes encoding these factors.
3 enteropathgenic, enterotoxigenic, enteroinvasive and strains bearing K1 antigen, including E. coli O157:H7
Principal Investigator’s Risk Assessment
After you have determined the Risk Group of the agent:
Evaluate agent factors
virulence, pathogenicity, infectious dose, environmental
stability, route of spread, communicability, quantity,
availability of vaccine or treatment
Evaluate gene product effects
toxicity, physiological activity and allergenicity
Evaluate how the agent will be used:
animal experiments, large production (>10 liters)
Determine the biosafety level required based on the above
information.
Additional Resources:
If you experience technical difficulties when completing
the form, contact:
Research Integrity and Assurance
Email: [email protected]
If you have questions about biosafety issues, contact:
Biosafety Officer
Phone: 609 258-5294
Email: [email protected]