Biosafety Research Protocol – Notice of Intent
ADDENDUM I: Recombinant or Synthetic DNA and Host-Vector Systems
@ http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
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NOTE: FOR IBC USE ONLY
Date Received:
IBC Protocol #:
Date Reviewed:
1. Principal Investigator:
2. Project Title:
3. PI Email:
4. PI Phone:
Check all
that apply
1.
NIH Guidelines
Reference
Section III-A-1-a
Type of Experiment
Deliberate transfer of a drug resistance trait to microorganisms that
are not known to acquire the trait naturally. (Do not check for standard
drug resistance, e.g., ampicillin into E. coli.)
If applies, explain:
2.
3.
4.
5.
Section III-B-1
Experiments involving the cloning of toxin molecules with LD50 of less
than 100 nanograms per kilogram body weight.
If Yes, explain:
Section III-C-1
Experiments involving the deliberate transfer of rDNA, or DNA or RNA
derived from rDNA, into one or more human research participants.
If Yes, explain:
Section III-D-1
Experiments using Risk Group 2, 3, or 4, or restricted agents as hostvector System.
If Yes, explain:
Section III-D-2
Experiments in which DNA from Risk Group 2, 3, or 4 agents or
restricted organisms is cloned into nonpathogenic prokaryotic or lower
eukaryotic host vector systems.
If Yes, explain:
6.
Section III-D-3
Experiments involving the use of infectious DNA or RNA viruses in
tissue culture systems.
If Yes, explain:
Biosafety Research Protocol Form – Addendum I: Use of Non-Exempt rDNA
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Section III-D-3
7.
Experiments involving the use of defective DNA or RNA viruses in the
presence of a helper virus in tissue culture systems.
If Yes, explain:
Section III-D-4
Section III-E-3
8.
Experiment involving whole animals in which the animal’s genome has
been altered by stable introduction of recombinant DNA, or DNA
derived there from, into the germ-line (transgenic animals).
If Yes, explain:
Section III-D-5
Section III-E-2
9.
10.
11.
12.
Section III-E-1
Experiments involving whole plants.
If Yes, explain:
Experiments involving the formation of rDNA molecules containing no
more than two-thirds of the genome of any eukaryotic virus?
If Yes, explain:
Section III-D-6
Section III-D-7
Experiments involving more than 10 liters of culture.
If Yes, explain:
Exempt Experiments.
If Yes, explain:
1. Provider of inserted DNA (provider/contact, affiliation):
List Genus/Species or common name of the source organism of the insert DNA.
What gene/s will be used?
2. Nature of the inserted DNA sequence: Describe the function/activity of the DNA or its product. (i.e. Biological
marker, sequences, promoter, etc.):
3. Intended use of rDNA: Describe the intended use of the recombinant DNA molecule (i.e. cloning, sequencing,
expression, over expression of protein in yeast for structure/function, CDNA library, screen for clones, etc.):
4. Will you attempt to express a foreign gene?
No
Yes
If so, what protein/s will be produced?
5.
A. Host/s: Indicate the host/s used to propagate
vector plasmid or recombinant virus: (i.e. E. coli,
other bacteria, laboratory animals, humans,
human/animal cells)
5B. Vector/s: Indicate the vector/s used for this
research: (i.e. bacterial plasmid, virus,
Baculovirus, Adenovirus, Lentivirus)
Biosafety Research Protocol Form – Addendum I: Use of Non-Exempt rDNA
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Use of Viral Vectors
1. If viral vectors are used please name the strain and provide detailed information (provider of vector and other
information about the strain including how it is engineered to be replication incompetent).
Testing for Replication Competent Virus (RCV)
2. Describe how you will assure your vector material is free from replication contamination by replication-competent
virus (RCV) (i.e. certification of testing).
3. List previous experience or training for each personnel working with viral vectors:
a.
b.
Biosafety Research Protocol Form – Addendum I: Use of Non-Exempt rDNA
Page 3 of 3