Recombinant DNA Training for Research Group Members
How to Use this Training Template
Principal Investigators (PIs) whose research
involves recombinant DNA are required by NIH to
provide their research group members training on
lab-specific hazards and emergency procedures.
The Berkeley Biosafety
Program(bso@berkeley.edu) has prepared this
PowerPoint presentation template to assist PIs in
meeting this requirement. Text in italics
[example] indicates where the template should be
modified to accurately reflect your lab hazards and
procedures.
Working with Recombinant
DNA in the
_[name of PI]_ Laboratory
[Name of PI]
[Name of Department]
[Date Training Is Given]
Basic Requirements
Research involving recombinant DNA is
closely regulated by the National Institutes
of Health (NIH), and requires a Biological
Use Authorization (BUA) approved by the
Berkeley campus Committee on
Laboratory & Environmental Biosafety
(CLEB). CLEB works with the campus
Biosafety Program, which can provide
additional guidance (bso@berkeley.edu)
Basic Requirements (Cont’d)
All work involving recombinant DNA –
regardless of funding source -- must
adhere to the mandatory NIH “Guidelines
for Research Involving recombinant DNA
Molecules” found at
http://oba.od.nih.gov/rdna/nih_guidelines
_oba.html
Purpose of This Training
Section IV-B-7-d-(2) of the NIH Guidelines
The NIH requires that the PI provide labspecific biosafety training on the hazards
of the specific experimental procedures
used in their laboratory to members of
their research group. One way to
document this training is to record it in the
minutes of a group meeting, listing all
participants.
Contents of This Training
•
•
•
•
CLEB Administrative Requirements
What are the NIH Guidelines?
Role of the Investigator/Lab Staff
Description of the Experiment-BUA
– The Agents Used
– The Template
• Risk Assessment/Biosafety Level
– Good Work Practices
– Personal Protective Equipment
– Engineering Controls
• Waste Disposal/Decontamination
• Emergency Procedures
CLEB Administrative Requirements
• CLEB requires the following from every PI
approved to use recombinant DNA:
– Train all research group members on labspecific hazards and procedures
– Report incidents involving recombinant DNA
immediately to EH&S
– Submit a BUA amendment for any change in
personnel or Scope of Work
What are the NIH Guidelines?
Key Sections of the NIH Guidelines
• Appendix B-List of Agents
• Section III-Types of Experiments involving
•
•
•
•
•
•
recombinant DNA
Appendix G-Level of Containment
Appendix K-Large Scale
Appendix M-Gene Transfer/Human Subjects
Appendix P-Transgenic Plants
Appendix Q-Transgenic Animals
Section IV-Responsibilities of PI, IBC
PI RESPONSIBILITIES
Section IV-B-7: ROLE OF THE PI
•
On behalf of the institution, the Principal Investigator
is responsible for full compliance with the NIH
Guidelines for any recombinant DNA research.
The PI must:
Not initiate or modify recombinant DNA research which
requires CLEB approval until that research has been approved
by CLEB and has met all other requirements of the NIH
Guidelines.
• Report any significant problems, violations of the NIH
Guidelines, or any significant research-related accidents and
illnesses to the Biological Safety Officer and CLEB.
OTHER PI RESPONSIBILITIES
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•
Responsibility
Train Lab Staff (Micro technique)
Ship Agents Safely
Follow Emergency Plans
Notify NIH of novel host/vectors
Update Protocol
Notify IBC/CLEB of incident
Make Protocol Available
Offer Medical Surveillance
Supervise Lab Members
Maintain Safety Equipment
NIH Guideline Reference
Section IV-B-7-a, d
Section IV-B-7-a
Section IV-B-7-a
Section IV-B-7-b
Section IV-B-7-c
Section IV-B-7-e
Section IV-B-7-d
Section IV-B-7-d
Section IV-B-7-e
Section IV-B-7-e
Description of the Experiment-BUA
The Scope of Work
• [Cut and paste scope of work narrative from your BUA]
Description of the Experiment-BUA
The Agents Used
[List the agents, recombinant DNA host/vector systems,
human cell lines, packaging cell lines, and clinical
specimens used in the experiment. Include all etiological
agents.]
Description of the Experiment-BUA
The Risks That May Affect Containment Level
• These are some of the common experimental
risks associated with our research: [modify list
as appropriate]
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Route(s) of exposure
volumes of culture
aerosol generating procedures
Procedures involving sharps
high concentrations
the use of vectors and vulnerable animals
inserted genetic sequences that increase virulence
the use of drug/antibiotic resistant strains
Description of the Experiment-BUA
The Risks That May Affect Containment Level
• These are the symptoms of exposure with the
agents we use:
– [List symptoms of exposure]
Our Recombinant DNA Experiment Template
[Cut and paste from BUA form:]
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•
•
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Agent Characteristics:
Routes of Exposure:
Host:
Vector:
Nature of inserted sequences:
Source of inserted sequences:
Types of manipulation:
Attempt to express foreign gene:
Protein produced:
Containment:
Section of Guidelines:
Risk Assessment/Biosafety Level
Good Work Practices
[Modify list as appropriate]
• Wash Hands Frequently
• Use Personal Protective Equipment and
Engineering Controls
• Minimize Use of Sharps
• Do Not Eat, Drink, or Smoke in the lab
• Disinfect Work Areas
Risk Assessment/Biosafety Level
Personal Protective Equipment
[Modify list as appropriate]
• The following personal protective
equipment must be worn when handling
agents in the tissue culture room and the
biosafety cabinet:
– Latex or nitrile gloves
– Lab coat
– Safety glasses
Risk Assessment/Biosafety Level
Engineering Controls [Modify list as appropriate]
• The following engineering controls must be used
whenever handling agents in the tissue culture
room:
–
–
–
–
–
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Biosafety cabinet
Sink for Hand Washing
Mechanical pipettes
Sealed vials
Sharps containers/Broken Glass box
Eyewash/deluge shower (use only in an emergency)
Waste Disposal/Decontamination
[Modify list as appropriate]
• Liquid waste will be treated with 10%
household bleach and allowed to set for
20 minutes and drain-disposed. Solid red
bag wastes will be placed in a red-bag
lined bin and transferred to the
_________ Building, Room______ medical
waste storage area for pick up and
disposal.
• Work areas must be disinfected with dilute
bleach and 70% ethanol.
Emergency Procedures
[modify as appropriate]
• In the event of a laboratory accident:
– Tend to injured person
– Notify the PI or the lab supervisor; inform
the PI IMMEDIATELY if recombinant DNA
was involved so that CLEB and the
Biosafety Officer can be notified within 24
hrs.
– Initiate clean up procedures.
– Notify EHS, if the PI is not available, 6423073 or 642-3333 (After Hours)
– Seek medical attention at Tang or the Alta
Bates ER at 2450 Ashby Avenue after
hours.
Conclusion
This training is designed to inform you of
the NIH requirements regarding use of
recombinant DNA, and our lab’s
implementation of the NIH requirements.
All recombinant DNA experiments require
BUA approval by CLEB and any changes
require an approved amendment to the
BUA. If you have any questions on this
training, let me know, and I will contact
the Biosafety Officer for assistance.