IBC-3
Rev.: 1/2014
FORM IBC-3: For research involving recombinant or synthetic DNA/RNA
Please answer the following questions regarding this research protocol. If ANY question from
1-10 is answered YES, this research requires submission to the IBC for review before initiating
the work.
Yes
No
1. Will the research involve the deliberate transfer of a drug resistance trait to microorganisms that
are not known to acquire the trait naturally, such that acquisition could compromise use of the drug to
control disease agents in humans, veterinary medicine or agriculture?
2. Will the research involve cloning toxin molecules with an LD50 of less than 100 nanograms per
kilogram of body weight?
3. Will the research involve the deliberate transfer of recombinant DNA or RNA or RNA derived from
recombinant DNA; or synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic
acid molecules that meet the following criteria
a. Contain more than 100 nucleotides; or
b. Possess biological properties that enable integration into the genome (e.g., cis elements
involved in integration); or
c. Have the potential to replicate in a cell; or
d. Can be translated or transcribed.
into one or more human subjects? (Human Gene Transfer)
If yes: please contact the Institutional Biosafety Officer (215-503-7422), as this work will require
preliminary review by a combined IRB and IBC Committee
4. Will the research use Risk Group 2, Risk Group 3, Risk Group 4 or Restricted agents as HostVector Systems?
Reference for Risk Groups: NIH Guidelines for Research Involving Recombinant DNA Molecules,
Appendix B
http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.pdf
5. Will the research clone DNA from Risk Group 2, Risk Group 3, Risk Group 4, or restricted agents
into nonpathogenic prokaryotic or lower eukaryotic host-vector systems?
Reference for Risk Groups: NIH Guidelines for Research Involving Recombinant DNA Molecules,
Appendix B
http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.pdf
6. a) Will the research involve the use of infectious DNA or RNA viruses?
If yes, are these viruses replication-competent?
Yes
No
b) Will the research involve the use of defective DNA or RNA viruses in the presence of helper
virus and/or in tissue culture systems that provide genes necessary for replication?
7. Will the research involve whole animals?
If yes, please complete and submit an IBC-5 along with other IBC forms required; your work must be
reviewed and approved by the IACUC . Call 215-503-9135 for further information
8. Will the research involve whole plants?
If yes, please complete and submit an IBC-6 form with other IBC forms reqired
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IBC-3
Rev.: 1/2014
Yes
No
9. Will the research involve using more than 10 liters of culture at one time?
If yes, please estimate the volume:
10. If cloning viral DNA, will the research involve the formation of recombinant DNA molecules
containing more than two-thirds of the genome of any eukaryotic virus?
11. Will the research involve the generation of new transgenic rodents or breeding between 2 distinct
lines? (The purchase or transfer of existing transgenic rodents is exempt from the NIH Guidelines).
The following questions pertain to DNA/RNA constructs to be used in the study
13. Please state the species source of the DNA/RNA being used (e.g. human, mouse, rat, etc):
14. Please state what the inserted DNA/RNA sequences encode (e.g. kinases, oncogenes,
receptors, microRNAs etc):
15. Please describe the biological activity of the gene product or sequence inserted:
16. Does the inserted gene(s) encode a known toxin or potential toxin?
Yes
No
If yes, explain here and complete an IBC-14
17. Will any recombinant molecules contain:
a. an oncogene
Yes
No
b. a human gene
Yes
No
18. Is the DNA/RNA construct designed to or expected to integrate into the host genome?:
Yes
No
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IBC-3
Rev.: 1/2014
The following questions pertain to vectors and host vector systems to be used in the study.
The vector is the plasmid, organelle or virus that carries the recombinant DNA. The host is the
bacterial, plant or animal cell in which the vector is propagated in the laboratory.
19. Please describe the nature and source (commercially purchased or laboratory derived) of
the vectors to be used in this protocol (i.e., plasmid, virus, etc.), AND provide a map of the
vector with your modification(s) and/or insertion site shown.
20. Describe the host range of any vectors being used:
human
prokaryotes
other mammal
other: please describe
plants
21. For work with viruses, do the experiments have the potential to:
a) increase the replication capacity of the virus
b) alter the host range of the virus?
c) alter the cell tropism of the virus?
d) generate replication-competent virus?
Yes
Yes
Yes
Yes
No
No
No
No
N/A
N/A
N/A
N/A
22. Please name all cells involved in the propagation of the vector whether it is viral based or
not. Indicate the species and cell designation and whether normal or tumor cells.
23. Will your research involve:
A deliberate release of any form of recombinant or synthetic DNA into the environment
Yes
No
Use of any recombinant or synthetic DNA/RNA in any mammal, including humans?
Yes
No
If yes to either question, please describe below.
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IBC-3
Rev.: 1/2014
24. What is the target recipient of the Host-Vector System to be used in this study:
Whole animal
Animal tissue culture
Whole plants
Plant tissue culture
Human gene transfer
Human tissue culture
30. Are there any biosafety issues not already addressed previously?
Yes
No
If yes, describe the issues below and state how you would address these potential safety or
biohazard issues. Include information on what procedures to follow in case of an accidental
release of the vector into the environment
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