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
List Previously Approved IBC# _____ No Changes
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 NO
If yes, complete section 2.
Does this study involve the use of Recombinant DNA? ………………………………… YES NO
If yes, complete section 3.
Does this study involve Human subjects/ Human Gene Therapy (HGT)? …………………YES NO
If yes, complete section 4.
Does this study involve an Investigational New Drug (IND)? .…………………………. YES NO
If yes, complete section 5.
Does this study involve the use of animals? …………………………………………….. YES NO
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 NO
Do you intend to use radiological hazards? ……………………………………………… YES NO
Radiation Safety: Approved Pending Authorization #: ______
Do you intend to use Carcinogenic/toxic/acutely hazardous chemicals? ……………….. YES NO
Chemical Safety: Approved Pending
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.
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Principal Investigator (Signature) Date
IBC ADMINISTRATIVE USE ONLY IBC Application #: ______
IBC Chairperson: ______
Date Received: ______Date Approved: ______Date Disapproved: ______
Modifications noted: ______
______
Approval Period: From______to ______Approved BSL: ______
Biosafety Officer: ______Date Reviewed: ______
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Revision 7/30/2007
Registration of Biohazardous Agents and/or Recombinant DNA Research: Personnel at Risk
Name/Title of personnel working with hazardous agents (Include the Principal Investigator): / Experience:List safety training and work experience / Type of training/Date:
(Note: if working at a BSL-2 and/or with rDNA, the Basic Biological Safety course is required. If working with human/primate cells/cell lines, tissues, blood, body fluids, the Basic Bloodborne Pathogen course is also required) / List biologic agents to be used/room # / Medical Surveillance /Date
(If Applicable) / Vaccinations/
vaccination dates
(If Applicable)
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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 Type:
(Bacterium, virus, fungus, parasite, etc.) / Name/Strain and form of Organism: / Risk Group (WHO) and
Biosafety Level (BSL 1-4): / Building/Room(s) agent will be used in during the study: / Building/Room(s) where agent will be stored: / Will culture amount be less than 10 Liters?
1 / YES
NO
2 / YES
NO
3 / YES
NO
4 / 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.
Section 3: Recombinant DNA/RNA
3.1 Does this study involve the use of recombinant DNA/RNA (rDNA)?………… YES NOIf YES,
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)
Complete the In Vivo Biohazard Containment Evaluation form. / III-D-4
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): ______
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 NO N/A
d) Is a Helper virus or packaging system used? YES NO 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 NO
If YES, list sites: ______
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 NO
a) IRB Approval? ………………… YES NO Pending Exempt
Approval # ______
Please include a copy of your IRB approval letter.
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:
______
______
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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
Section 5: Investigational New Drugs (INDs)
5.1 Will the Investigational New Drug involve using Recombinant DNA technology? ….YES NO If YES, then list FDA approval #: ______
5.2 Is the IND prepared on-site? …………………………………………………………….YES NO If YES, then list room #: ______, and COMPLETE THE IN VITRO LABORATORY CONTAINMENT EVALUATIONa) 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 NO
a) Who tests for quality assurance ( list the name, address, and Phone # )?
Name: ______
Address: ______
Phone#______
5.4 How are the products tested for sterility?
______
Section 6: Animal Use
6.1 Does this study involve the use of animals?……………………………………………YES NO
Animal species: Mice Rats Other: ______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.
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 orbetween 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.
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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.