The University of Texas Health Science Center at San Antonio
Registration Application: Research with Hazardous Biological Agents and/or Recombinant DNA
Application must be typed
Section 1: Please complete this application and return to Environmental Health and Safety, 1.343T.
Principal Investigator (Print):
_____________________ Department / Division:
____________________
Degree:
__ Title/Position:
____________________
Co-Investigators:
__________________________ Faculty Sponsor (If Applicable):
_________________
Office Phone:
___ Lab Phone:
___ Building:
____ Lab Room #:
____
Email:
___________ FAX:
____
Emergency phone number:
________
Contact person (if other than principal investigator):
__________
Title/Position:
_________________Phone#:
_____
Application Status: New
Renewal
Protocol Change
3-year review: Changes
No Changes
List Previously Approved IBC#
_____
Requested Start Date:
_____ Projected End Date:
_____
Title of Project:
________________ Granting Agency:
______ Grant #:
_______
Does this study involve the use of human blood, tissues, or hazardous biological agents? YES
If yes, complete section 2.
Does this study involve the use of Recombinant DNA? ………………………………… YES
If yes, complete section 3.
Does this study involve Human subjects/ Human Gene Therapy (HGT)? …………………YES
If yes, complete section 4.
Does this study involve an Investigational New Drug (IND)? .…………………………. YES
If yes, complete section 5.
Does this study involve the use of animals? …………………………………………….. YES
If yes, complete section 6.
Does this study involve the use of “Dual Use” or potential biological weapons or drug
resistance enhancements. Answer all questions in section 7. (Any “YES” answers,
experiment may be considered “Dual Use”. http://www.biosecurityboard.gov/links.asp YES
Do you intend to use radiological hazards? ……………………………………………… YES
Radiation Safety: Approved
Pending
Authorization #: _______________________
Do you intend to use Carcinogenic/toxic/acutely hazardous chemicals? ……………….. YES
Chemical Safety: Approved
Pending
NO
NO
NO
NO
NO
NO
NO
NO
I certify that the information I have provided is complete and correct, to the best of my knowledge. I am
familiar with and agree to abide by the provisions of the current NIH/CDC Guidelines, UTHSCSA
Handbooks on Biological, Chemical, Physical, and Radiation Safety, and other specific granting agency
instructions pertaining to the proposed project and the administrative procedures and Principal
Investigator’s responsibilities in Appendix A.
________________________________
___
_________
Principal Investigator (Signature)
IBC ADMINISTRATIVE USE ONLY
Date
IBC Application #: ____________________________________
IBC Chairperson: ____________________________________
Date Received: _____________ Date Approved: _______________ Date Disapproved: _______________
Modifications noted: _______________________________________________________________________
________________________________________________________________________________________
Approval Period: From_______________ to ________________
Approved BSL: __________________
Biosafety Officer: _____________________________________
Date Reviewed: __________________
1 of 11
Revision 7/30/2007
Registration of Biohazardous Agents and/or Recombinant DNA Research: Personnel at Risk
Name/Title of personnel Experience:
Type of training/Date:
List
biologic
working with hazardous List safety training and (Note: if working at a BSL-2 and/or with agents
to be
rDNA,
the
Basic
Biological
Safety
agents
(Include
the work experience
used/room #
course is required. If working with
Principal Investigator):
Medical
Surveillance
/Date
(If Applicable)
Vaccinations/
vaccination
dates
(If Applicable)
human/primate cells/cell lines, tissues,
blood, body fluids, the Basic Bloodborne
Pathogen course is also required)
1)
2)
3)
4)
5)
6)
7)
8)
2 of 11
Revision 7/30/2007
Section 2: Hazardous Biological Agents (Use Section 3 for Recombinant DNA)
2.1 Does this study involve the use of Potentially Hazardous Biological Agents?………….YES
NO
If YES, Complete this section and the IN VITRO BIOHAZARD CONTAINMENT EVALUATION
IN RESEARCH LABORATORIES form.
2.2 Is the agent on the CDC Select Agent and Toxins list?………….YES
NO
If YES, Responsible Official approval?………………………YES
NO
PENDING
If YES, List CDC Select Agent Registration #:
_____________________ (Note: See Appendix A to
obtain URL to view list. Requires prior approval of UTHSCSA Responsible Official or Alternate and facility registration for each
agent and lab. For agents not listed, contact the Centers for Disease Control and Prevention, Biosafety Branch, Atlanta Georgia 30333)
2.3 Is the agent on the USDA High consequence Livestock Pathogen and Toxins List?……YES
NO
If YES, List Permit # _
______________ (Note: See Appendix A to obtain URL to view list. Requires prior
approval of UTHSCSA Responsible Official or Alternate and facility registration for each agent and lab)
2.4 Does your project involve handling:
a) Human Blood, tissue, body fluids?……………………………YES
NO
b) Are source patients of high risk with known infection?………YES
NO
UNKNOWN
If YES, then please describe.
____
_____________________________________________________________________________________
c) Human Cell lines?
YES
NO
Primary?
Immortal?
If YES, then list which cell lines.
____________
2.5 If you will you be working with known infectious agents, list the agents.
Organism
Name/Strain
Risk Group Building/Room(s) Building/Room(s)
Type:
and form of (WHO) and agent will be where agent will
(Bacterium,
Organism:
Biosafety
used in during be stored:
virus,
fungus,
Level (BSL the study:
parasite, etc.)
1-4):
1
2
3
4
Will culture
amount be
less than 10
Liters?
YES
NO
YES
NO
YES
NO
YES
NO
2.6 Source of Infectious Agents:
Your lab
Another Lab/hospital
Commercial Company
a) If another lab or commercial company, please list name/address/phone # below:
________
2.7 Shipping/receiving biohazardous agents:
a) Will you receive samples from other institutions in the U.S.?…..YES
NO
N/A
b) Will you receive samples from international sources?…………..YES
NO
N/A
c) Will you ship infectious agents?…………………………………YES
NO
N/A
Shipping/receiving of biohazardous agents may require a permit. http://www.aphis.usda.gov/vs/ncie
Please attach copies of any permits that you may have.
3 of 11
Revision 7/30/2007
Section 3: Recombinant DNA/RNA
3.1 Does this study involve the use of recombinant DNA/RNA (rDNA)?………… YES
If YES,
NO
complete this section and the In Vitro Biohazard Containment Evaluation form.
3.2 DETERMINATION OF USE: The primary reference for completion of this section is the most current
amendment of the NIH Guidelines For Research Involving Recombinant DNA Molecules (NIH
Guidelines) http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
Please Check all that apply in the boxes below:
NIH Guidelines reference:
a.
Use of animal cells/cell lines or tissues (e.g. tissue culture research)
II-A-3, Appendix C-1
b.
Use of human cells/cell lines or tissues (e.g. Human blood, 293 cell lines, CSF)
II-A-3
c.
Transfer of Drug Resistance trait to microorganisms
III-A-1-a
d.
Use or cloning of toxin molecule genes
III-B-1
e.
Use of or the cloning of genes from, or into a Risk Group 2, 3, 4 or restricted agent
III-D-1, 2
f.
Use of virus or viruses
III-D-3, III-E-1
g.
Propagating culture volumes exceeding 10 liters
III-D-6
h.
Creation or Use of c-DNA/genomic libraries
III-E, III-F
i.
Cloning and vector construction in bacteria and yeasts
III-E, III-F
j.
Use of rDNA molecules for detection purposes (e.g. probes)
III-F
k.
Expression of rDNA products in cultured cells
III-E, III-F
l.
Administration of rDNA product into humans (e.g. Gene Transfer Protocol)
III-C-1
m.
Administration of rDNA material into animals (e.g. transformed cells, vectors)
III-D-4
Complete the In Vivo Biohazard Containment Evaluation form.
n.
Experiments involving transgenic rodents
III-E-3
o.
Experiments involving whole Plants
III-D-5
3.3 HOST:
a) Will a microbial cell host or other host expression system be used? ………………..YES
NO
i) If YES, list the species and strain(s) being used:
1) Species: (e.g., E. coli) _
_________
2) Strain: (e.g., K-12) __
__________
3) Source: __
_________
b) Proposed Containment for Microbial Host rDNA/RNA Experiments:
BSL1
BSL2
BSL3
c) Will a mammalian cell or cell line be used for the study or propagation of the rDNA molecules?
YES
NO
i) If YES, list the species and name for each cell or cell line: (note: use of human cell lines are BSL-2)
a) Species (e.g., human)__
___________
b) Name (e.g., HeLa)__
_____________
c) Proposed containment for Eukaryotic Host rDNA Experiments: BSL1
BSL2
BSL3
ii) If NO, list any other cell lines used (e.g. insect cells): __
_____
4 of 11
Revision 7/30/2007
3.4 VECTOR DESCRIPTION:
Describe the vector(s) to be used in the microbial host cell (e.g., pCAL-kc, E. Coli Expression vector from
Stratagene) or the viral vector expression system to be used.__
__________________
If the vector has viral sequences, then:
a) Is the vector replication competent (wild-type)?……YES
NO
N/A
b) Is the vector replication defective?………………….YES
NO
N/A
c) Has the vector (product) been tested for RCV (Replication Competent Virus)? YES
YES
d) Is a Helper virus or packaging system used?
NO
NO
N/A
N/A
3.5 GENE SOURCE:
List the DNA inserts (Gene name, explain acronyms): Gene/biological source (genus, species, strain), Nature
of the insert or protein expressed, any oncogenic potential, the gene function, and any expected toxicity of the
gene products: (Attach a vector map or manufacturer’s product description)
a) Will transcription regulators be used? YES
NO
if yes, please list the transcription regulators used and if virulence will be affected:
3.6 Will the rDNA molecule contain more than 2/3 of the genome of any eukaryotic virus? YES
NO
3.8 Will you ship/receive rDNA from other sites? …………………………………………..YES
If YES, list sites: _
__________________
NO
5 of 11
Revision 7/30/2007
Section 4: Human subjects and/or Human Gene Therapy (HGT)
(Human subjects as defined by the IRB: “An IRB (or a reviewer designated by one of the IRBs to conduct expedited reviews)
must review all proposed research where the investigational procedures involve the use of anything human.”)
4.1 Does the study involve human subjects? ……………………………..YES
a) IRB Approval? ………………… YES
NO
Pending
Approval #
____________________
Please include a copy of your IRB approval letter.
NO
Exempt
b)If yes, does the study involve the transfer of Recombinant DNA (rDNA) or biological agents
containing Recombinant DNA into human subjects? …………YES
NO
If yes, please consult the NIH Recombinant DNA Guidelines Appendix M for a detailed description
of protocol submission guidelines.
4.2 What is the name and description of the HGT product?
_
__________
______________________________________________________________________________________
4.3 Where is the vector product made?
_________
a) Is this location on site? ………………………………………………………………YES
NO
b) If vector is made on-site, what containment level is needed?
BSL 1
BSL 2
BSL 3
(Complete Section 3 & In Vitro Laboratory Containment Evaluation)
4.4 Will these products be produced according to Good Laboratory Practice (GLP)
and Good Manufacturing Practice (GMP) …………………………………………...…YES
NO
4.5 Will this study involve the use of a gene therapy Investigational New Drug (IND)?…..YES
NO
If Yes, give the FDA IND #: _
_________________________,and then complete section 5
4.6 Is vertical transmission of from an individual to the offspring possible?………………YES
NO
4.7 Is transmission of viral infection to other persons or the environment possible? ……...YES
NO
4.8 Indicate the patient care facility and room numbers where the agent will be handled prior to administration:
_
__________________________________________________
_
__________________________________________________
_
__________________________________________________
_
__________________________________________________
4.9 Indicate the patient care facility room numbers where the agent will be administered:
_
___________________________________________________
_
___________________________________________________
PLEASE INCLUDE A COPY OF THE APPROVAL LETTERS FROM THE NIH/RAC
6 of 11
Revision 7/30/2007
Section 5: Investigational New Drugs (INDs)
5.1 Will the Investigational New Drug involve using Recombinant DNA technology? ….YES
If YES, then list FDA approval #:
________
NO
5.2 Is the IND prepared on-site? …………………………………………………………….YES
NO
If YES, then list room #:
___________, and COMPLETE THE IN VITRO LABORATORY
CONTAINMENT EVALUATION
a) What Biosafety level do you plan to work at? …………BSL 1
BSL 2
BSL 3
b) If IND is prepared at another facility, then list:
Name:
______________________________
Address:
____________________________
Phone#_
_________________
5.3 Are products manufactured according to GLP and GLP? ……………………………….YES
a) Who tests for quality assurance ( list the name, address, and Phone # )?
Name:
______________________________
Address:
____________________________
Phone#_
_________________
NO
5.4 How are the products tested for sterility?
__________________________________________________________________________________________
Section 6: Animal Use
6.1 Does this study involve the use of animals?……………………………………………YES
Animal species:
Mice
Rats
Other: __________
NO
6.2 Will transgenic/knockout animals be used in this study?……………………………… YES
NO
Please describe the nature of the genetic modification (gene and function)
If answer is YES to either question, then…
Complete the IN VIVO BIOHAZARD CONTAINMENT EVALUATION form.
7 of 11
Revision 7/30/2007
Section 7: Dual Use
YES
NO
The National Research Council and the National Science Advisory Board for Biosecurity (NSABB) list
seven classes of experiments (Experiments of concern) involving microbial agents that “raise concerns
about their potential for misuse.” If you answer “YES” to any of the following questions, then your
experiment may be considered “Dual Use.”
They include experiments that:
1. Would demonstrate how to render a vaccine ineffective? (applies to human and animal vaccines
example: vaccine resistant smallpox)………………………………………………….YES
NO
2. Would confer resistance to therapeutically useful antibiotics or antiviral agents?
(This would apply to therapeutic agents used to control disease agents in humans and animals
or crops. Example: introducing ciprofloxacin resistance in Bacillus anthracis……YES
NO
3. Would enhance the virulence of a pathogen or render a nonpathogen virulent? (Applies to human,
animal and plant pathogens. Example: introducing cereolysin toxin gene into Bacillus anthracis)
YES
NO
4. Would increase the transmissibility of a pathogen. (includes enhancing transmission within or
between species, altering vector competence to enhance disease transmission.)……. YES
NO
5. Would alter the host range of a pathogen. (includes making nonzoonotics into zoonotic agents,
altering the tropism of viruses)……………………………………………………….YES
NO
6. Would enable the evasion of diagnostic/detection modalities. (includes microencapsulation to avoid
antibody-based detection and/or the alteration of gene sequences to avoid detection by established
molecular methods.)…………………………………………………………………. YES
NO
7. Would enable the weaponization of a biological agent or toxin. (includes environmental stabilization of
pathogens) ……………………………………………………………………………YES
NO
Section 8: PROJECT SUMMARY:
Describe experimental procedures involving recombinant DNA
and other biohazardous materials. Provide information for IBC reviewers to evaluate the containment level and
or clinical safety described in the application. Use non-technical terminology to enable IBC community
representatives to understand the research project. Summary may be directly copied from a document such as a
grant application, but should describe all recombinant materials and procedures used by the investigator.
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
8 of 11
Revision 7/30/2007
The University of Texas Health Science Center at San Antonio
Biological Spill Response and Laboratory Specific Emergency Plan
This template can be used in writing lab specific SOPs (Standard Operating Procedures) to comply with the NIH
Guidelines, Appendix G-I (Emergency Plan). Post this plan in the lab and review it with workers annually.
Complete the highlighted sections with Lab Specific Requirements.
P.I./Lab Supervisor:
Lab Location:
Biological Agent (s)
Emergency Contact Info:
(report all spills to P.I. or Lab Supervisor)
Type of Disinfectant/Notes on Use
Section 1: Spill Response Equipment







Written spill procedure including emergency phone numbers
Disinfectant suitable for biological materials being used
Paper towels, gloves, shoe covers, safety glasses
Forceps to pick up sharps, including broken glass
Sharps container for broken glass, etc.
Autoclavable squeegee & dustpan
Biohazard bags (orange bags or autoclave clear bags for 60
minutes at 1210C)
Lab Specific Requirements:
Section 2: Small and moderate spills of low risk
agents outside the biological safety cabinet:

Notify other workers in the area of the spill and control
traffic through area.

Remove any contaminated clothing and put in autoclavable
bag. Be aware that autoclaving may damage fabric.

Wear shoe covers if spill is on floor, may be splashed beyond
immediate area of spill.

Put on gloves and cover spill area with paper towels.

Pour disinfectant over towels from edges of spill to center, be
careful not to splatter.

Decontaminate all objects in spill area.

Allow 20-30 minutes of contact time.

Use squeegee and dust pan to recover spill materials and put
in biohazard bag.

Pick up any sharps, including broken glass, with forceps and
place in sharps container.

Wipe area with disinfectant and clean towels, mop if spill on
floor.

Remove gloves and foot covers before leaving area of the
spill, put in biohazard bag, and wash hands.
Lab Specific Requirements:
Cleanup Procedures (bench tops, centrifuges, etc.)
Section 3: Large spills (greater than 100 mls) outside
of the biological safety cabinet:


Evacuate room, close doors, prevent others from entering, and wait
30 minutes for aerosols to settle.
Follow procedures for small and moderate spills or contact
Environmental Health and Safety at 567-2955 for assistance.
Lab Specific Requirements:
Section 4: For small to moderate spills
(less than 100 mls) in a biological safety cabinet,
follow Section 2 procedures plus:






Leave the cabinet running.
Wipe down all interior surfaces with appropriate disinfectant.
Determine if spill has gone beyond the work surface such as in the
grilles or side seams. Disassemble and decontaminate if necessary.
If the cabinet has a catch basin below the work surface that may be
involved in the spill, flood the basin with disinfectant. Do not use
alcohol as a large quantity of alcohol presents a flammable hazard.
Clean basin after 20 minutes.
Autoclave or wipe down all items in cabinet with disinfectant.
Let cabinet run for at least 10 minutes after cleanup.
Lab Specific Requirements:
Section 5: For major spills (greater than 100 mls) in a
biological safety cabinet:

Contact Environmental Health and Safety (567-2955) to determine
if professional decontamination is indicated.
For any spills of agents that are transmitted by inhalation, such as Mycobacterium tuberculosis, evacuate the lab immediately, close the
door, place a “Warning: Do Not Enter” sign on the door and do not allow any one to enter the lab. Remove any contaminated clothing,
wash exposed skin with soap and water, call Environmental Health and Safety for assistance at 567-2955.
If Spill Results in a Hazard Exposure ( i.e. face and/or eye splash, cut or puncture with sharps, contact with non-intact skin):

Administer first aid (Wash wound with soap and water or flush eyes with water for 10 minutes) or call 911 or 567-2800 for serious
accidents (use of a university phone will contact UTPD and speed the dispatch process)

Seek medical attention as soon as possible.
During business hours, the UT Health Science Center uses UT Medicine (Diagnostic Pavilion, 592-0150). UT Medicine
is experienced with minor laboratory and clinical hazard exposures (i.e. contaminated needlestick injury).
After business hours, EH&S suggests that you go to the Emergency Room at University Hospital (358-2488). This
location is experienced with laboratory hazard exposures.
Note: Workers’ Compensation Insurance allows you to seek medical attention from alternate healthcare providers.

Report the incident to your supervisor as soon as possible, and with your supervisor, complete the Employer’s First Report of Injury
form available on the UTHSCSA Human Resources website.

Report all biohazard incidents requiring medical treatment to Environmental Health and Safety at 567-2955. Note: It is important to
fill out all of the appropriate paperwork in order to be eligible to collect workers compensation should any illnesses arise from the
hazardous exposure in the future.
Lab Specific Requirements:
9 of 11
Revision 7/30/2007
The University of Texas Health Science Center at San Antonio
Appendix A: Administrative Procedures for Registration of Experimentation Involving
Hazardous Biological Agents and Recombinant DNA
The purpose of this document is to inform the Principle Investigator of the administrative procedures and to
ensure the adequate review of all procedures including health and safety precautions, handling, storage, and
waste disposal of hazardous biological (biohazardous) agents and recombinant DNA. Please refer to the
UTHSCSA Biological Safety Manual for more specific information.
Hazardous Biological Agents that must be Registered and Approved
The purpose of your research will often be associated with the development or use of a potentially hazardous
biological product or agent. Biosafety protocols that must be submitted to the Environmental Health and Safety
department are characterized as those using any of the following:
1. A Biological Product or Agent: Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of
arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or
cure of a disease or condition of human beings. 21 CFR 600.3(h)(1-5)
2. An Infectious Substance (etiological agents) affecting animals or humans as defined in 49 CFR Ch. 1, part
173.134 and 42 CFR part 72.3 (the terms).
3. Select Agents or High Consequence Livestock Pathogens and Toxins: CDC and USDA regulate these
agents and toxins due to their threat to public health and safety. The list of select agents or high
consequence livestock pathogens and toxins is available at http://www.cdc.gov/od/sap and
http://www.aphis.usda.gov/programs/ag_selectagent .
4. Recombinant DNA (rDNA) molecules and rDNA-containing organisms or cell cultures. rDNA molecules
are defined as molecules that are constructed outside living cells by joining natural or synthetic DNA
segments to DNA molecules that can replicate in a living cell or molecules that result from the replication
of those just described. NIH Guidelines for Research Involving Recombinant DNA Molecules: Section I-B.
5. Exotic plants and insect pathogens.
6. Protocols involving Human Subjects and Human Gene Therapy trials (HGT).
7. Animals, including their blood, tissues and cell lines, for which a reasonable potential for transmission of
zoonotic agents exists (e.g. wild-trapped animals, sheep, macaques) and transgenic/knockout animals.
Review Procedures: Environmental Health and Safety Dept. / IBC / Biosafety Officer
The registration form provides the Environmental Health and Safety office and the Institutional Biosafety
Committee (IBC) with a detailed description of the research elements and their management, with an emphasis
on containment practices, and provides a basis for risk assessment.
All proposals that include working with a hazardous biological (biohazardous) agent and/or recombinant DNA
must be submitted to the Environmental Health and Safety office for initial review prior to approval by the IBC
or the Biological Safety (Biosafety) Officer.
The IBC will review and approve/ disapprove all applications for registration of experimentation involving the
use of Hazardous Biological Agents (as described above) prior to the commencement of research for all
experiments except those specifically exempt as listed in Section III-F of the NIH Guidelines for Research
involving recombinant DNA Molecules. The principal investigator should make an initial determination of the
required levels of physical and biological containment in accordance with NIH guidelines. The IBC must
approve the risk assessment and the biosafety containment level. Applications will be reviewed every 3 years.
10 of 11
Revision 7/30/2007
Changes in Methods, Agents, or Administrative information
Minor changes to the biosafety protocol, which involve administrative information that does not alter risk
assessment, may be submitted by providing the first page of the registration form with a highlighted or bold font
for additions, and strike through to show deletions. Minor changes, continuations of existing protocols, or NIH
Guidelines exempt host-vector systems may be approved directly by the Biosafety Officer. Major changes are
those that may alter the risk assessment and may include the addition or deletion of biological materials or
methods. Any change in protocol must be submitted to the Environmental Health and Safety Office (mark the
“Protocol Change” box in Section 1) for review by the Biosafety Officer. Major changes will be referred to the
IBC for full review.
Important Notice to Principal Investigator (PI) Applicants
The principle investigator, the individual who submits the application, has the responsibility to:
1. Be fully aware of the potential hazards associated with the agents used in your work area.
2. Be familiar with and agree to abide by the provisions of the current NIH "Guidelines For Research
Involving Recombinant DNA Molecules" and the current edition of "Biosafety in Microbiological and
Biomedical Laboratories," as published by the CDC and NIH.
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm
3. Agree to comply with all Federal and State requirements pertaining to shipment, storage and disposal of
Recombinant DNA Molecules, Infectious agents, and Biological Specimens.
4. Be aware of the OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030) and Texas Department of
Health regulations (25 TAC Part I TDH, Chap. 96 Bloodborne Pathogen Control) and comply with the
UTHSCSA Bloodborne Pathogen Exposure Control Plan when working with HIV, HBV, and human
blood or other potentially infectious materials as defined in these regulations and plan.
http://www.osha.gov/SLTC/bloodbornepathogens/index.html
http://www.dshs.state.tx.us/idcu/health/bloodborne_pathogens/pathogen_control
5. Accept responsibility for informing and training (or arranging for training by the Environmental Health
and Safety dept. or other qualified personnel) of all laboratory workers about the hazards, risks,
precautions, and appropriate emergency procedures for working with the agent to be used, before
commencing any work. Staff must not be allowed to handle the agent until training is completed and
then Principal Investigator will insure that the proper safety practices and techniques required will be
followed.
6. Prior to commencement of research, the Principle Investigator agrees to an initial and periodic
inspection of the research laboratory to determine whether bio-containment procedures, equipment, and
facilities are adequate. Standard Operating Procedures (SOPs) should be readily available to all
laboratory personnel.
7. Written reports will be submitted to the Institutional Biosafety Committee through the Biosafety Officer
in the Environmental Health and Safety dept. when:
 Any injury involving sharps or other accident that results in inoculation, ingestion, and inhalation
of infectious agents or recombinant DNA or any incident causing serious exposure of personnel
or danger of environmental contamination.
 Any problems pertaining to the operation and implementation of containment safety procedures
or equipment or facility failure.
 Any serious adverse event from a gene transfer clinical trial, regardless of whether or not they
are thought to be related to gene transfer intervention. (The NIH Guidelines apply to all NIHfunded projects involving recombinant DNA techniques as well as to all non-NIH funded
research.)
11 of 11
Revision 7/30/2007