Download synopsis for research involving the use of infectious agents or

(ORSP: Mar 2010)
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University of Texas at El Paso
Synopsis for Research Involving the Use of
Infectious Agents or recombinant DNA (rDNA)
The following should be provided for use by the Institutional rDNA/Biosafety Committee (IBC) in
reviewing any research proposal or activity involving recombinant DNA, infectious agents or
toxins. All protocol information must be typed. The NIH Guidelines can be found at:
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html. The Synopsis is submitted to the Office of
Research and Sponsored Projects (ORSP), IBC Coordinator, where it is administratively checked
and forwarded to the IBC Chairman for classification into exempt and non-exempt protocols.
Exempt Protocols: After review and classification of exempt from NIH Guidelines by the IBC
Chair, the protocol will be returned to the IBC Coordinator. The synopsis will then be forwarded
electronically or by hard copy to the Biological Safety Officer (BSO) or a second IBC committee
member. If both Chair and second committee member reviewer concur that the protocol is
exempt from NIH Guidelines the protocol is administratively approved for a three year term, and
read into the meeting minutes at the next IBC meeting.
Non-exempt Protocols: The IBC Chair and a second IBC committee member will provide the
other committee members with a detailed review at the next full committee meeting of the IBC. All
IBC Members are required to review all protocols brought to the committee. IBC members will
vote to table, approve or approve with modifications, non-exempt protocols. All approved
protocols will be active for three year terms and subject to the NIH Guidelines for Research
Involving Recombinant DNA Molecules (see http://oba.od.nih.gov/rdna/nih_guidelines_oba.html).
Compliance with the NIH Guidelines is a requirement for all research performed at the University
as long as the University receives NIH funding.
Progress reports will be required annually from PIs who wish to keep their IBC protocols
active. ORSP will notify the PIs in writing of the IBC’s decision on their projects. Any adverse
events or injuries that occur while conducting research covered by IBC protocols must be reported
to the UTEP Biosafety Manager (747-7179) and the IBC Coordinator (747-7007) immediately.
(ORSP: Mar 2010)
I.
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General Information:
Principal Investigator:
Dept:
Funding Agency:
Funding Period:
Protocol Title:
Attach a brief summary in non-technical lay terms of the overall aim and scope of the research
protocol. The summary should be no more than 6 sentences long.
Anticipated Start Date:
II. Specific Information:
(Check 'yes' or 'no' to the following questions. The relevant section of the NIH Guidelines
(see http://oba.od.nih.gov/rdna/nih_guidelines_oba.html) is referenced for each question.
1. Does your project include deliberate transfer of a drug resistance
trait to pathogenic microorganisms that are not known to acquire
the trait naturally (Section III-A)?
Yes
No
2. Does your project include cloning toxin molecules with an LD50 of
less than 100 nanograms per kilogram body weight (Section III-B)?
Yes
No
3. Does your project include experiments involving the deliberate
transfer of recombinant DNA, or DNA or RNA derived from
recombinant DNA, into one or more human research participants
(Section III-C)?
Yes
No
4. Does your project include experiments using Risk Group 2, Risk
Group 3, Risk Group 4, or Restricted Agents as host-vector systems
(Section III-D-1) that would require BSL-2 or BSL-3 containment?
Yes
No
5. Does your project include experiments in which DNA from Risk
Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is cloned
into nonpathogenic prokaryotic or lower eukaryotic host-vector
systems (Section III-D-2)?
Yes
No
If Yes, is the cloning into an E. coli K-12 strain or K-12 derivative?
Yes
No
6. Does your project include experiments involving the use of
infectious DNA or RNA viruses or defective DNA or RNA viruses in
the presence of helper virus in tissue culture systems (Section III-D3)?
Yes
No
7. Does your project include experiments involving whole animals in
which the animal’s genome has been altered by introduction of DNA
into the germ line or experiments involving rDNA modified
microorganisms tested on whole animals (Section III-D-4, III-E-3)?
Yes
No
(ORSP: Mar 2010)
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8. Does your project include experiments involving whole plants
(Section III-D-5, III-E-2)?
Yes
No
9. Does your project include experiments involving more than 6 liters of
culture (Section III-D-6)?
Yes
No
10. Does your project include experiments involving the formation of
recombinant DNA molecules containing two-thirds or more of the
genome of any eukaryotic virus (Section III-E-1)?
Yes
No
11. What is the biological safety level (BSL) for this project:
BSL1
BSL2
BSL3
See Biosafety in Microbiological and Biomedical Laboratories (BMBL)
5th Edition at: http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
III. Description of Experiments:
If you answered NO to all questions in Section II your protocol is exempt from the NIH
Guidelines and you can skip Section III. For all “YES” answers in Section II please
ATTACH a description of the specific experiments that will be performed under the protocol
and include:
 Description of organism(s), host(s) and or strain(s) to be used;
 Agent or microorganism characteristics (e.g. virulence, pathogenicity, environmental
stability);
 Source of rDNA, DNA, RNA to be inserted or cloned – include species of organism from
which it is derived;
 Nature of rDNA, DNA, RNA to be inserted or cloned – i.e. structural gene, oncogene;
 Vector(s) information (product literature or vector map describing construction of vector);
 Helper virus or packaging cells if used;
 IACUC or IBC protocol number as reference where applicable;
 Provide literature references if appropriate;
 Include experiments or processes which will generate hazardous aerosols such as
sonicating or cell sorting.
IV. Location of Research:
Please list all locations where work will be conducted. Include building and room numbers:
V. Biological Safety Practices and Procedures:
ATTACH the appropriate containment conditions and biosafety practices that will be
implemented for the proposed project based on risk assessment and biosafety level. Certain
experiments have special considerations that must be taken into account such as the use of
cell sorters for infectious agents or the use of viral vectors. See, CDC/NIH Publication,
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition:
http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm;
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VI. Protocols Involving Lentiviral Vectors must address the following:
Risks of lentivirus vectors: The major risks to be considered for research with HIV-1 based
lentivirus vectors are
• potential for generation of replication-competent lentivirus (RCL), and
• potential for oncogenesis.
These risks can be mitigated by the nature of the vector system (and its safety features) or
exacerbated by the nature of the transgene insert encoded by the vector.
General criteria for risk assessment of lentivirus vectors: Decisions about containment
should take into account a range of parameters/considerations including:
• the nature of the vector system and the potential for regeneration of replication competent
virus from the vector components,
• the nature of the transgene insert (e.g., known oncogenes or genes with high oncogenic
potential may merit special care)
• the vector titer and the total amount of vector,
• the inherent biological containment of the animal host, if relevant.
See also, the NIH guidance document, Biosafety Considerations for Research with Lentiviral
Vectors, http://oba.od.nih.gov/rdna_rac/rac_guidance_lentivirus.html
VII. Personnel:
List all lab personnel (faculty/staff/students) that will conduct research under this protocol and
training dates for each.
Name
Title
UTEP ID
Experience
Safety Class
Basic Laboratory Safety
Date Taken
Bloodborne Pathogens
Basic Laboratory Safety
Bloodborne Pathogens
Basic Laboratory Safety
Bloodborne Pathogens
Basic Laboratory Safety
Bloodborne Pathogens
Basic Laboratory Safety
Bloodborne Pathogens
Basic Laboratory Safety
Bloodborne Pathogens
Basic Laboratory Safety
Bloodborne Pathogens
Basic Laboratory Safety
Bloodborne Pathogens
VIII.
Investigator Agreement:
I attest that the information provided or attached is accurate and complete. I am familiar with
and agree to abide by provisions of the current NIH Guidelines for Research Involving
Recombinant DNA Molecules and accept the responsibilities listed in Section IV-B-7.
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As the Principal Investigator, I accept responsibility for making sure all laboratory personnel
involved in the project have been appropriately trained. All research personnel are familiar with
and understand the potential biohazards and relevant biosafety practices, techniques, and
emergency procedures associated with this research protocol as dictated by the CDC and NIH
document Biosafety in Microbiological and Biomedical Laboratories, 5thd Edition
(http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm).
Signature:
Date:
Department Chair: __________________________________________
Date:
IBC REVIEW RESULTS
Date of Full Committee Meeting:
IBC Committee Determined Containment Level:
Protocol Status:
Tabled Needs Modification (not approved)
Approved Exempt
Approved Non-exempt from NIH Guidelines
Conditionally Approved Non-exempt from NIH Guidelines with Modifications
Remarks:
IBC Chairman:
Date:
2nd Reviewer:
Date: