Environmental Health & Safety
DPS 207
1420 Austin Bluffs Pkwy.
Colorado Springs, CO 80918
t 719-255-3212
f 719-255-3443
Cynthia.Norton@uccs.edu
Recombinant and Synthetic Nucleic Acid Molecule (rsNA)
Quiz
Directions: Complete this Quiz and e-mail it to cnorton@uccs.edu or mail it to Public Safety
Room 207. In order to receive credit for this training, you must provide the following contact
information.
Name:
e-mail:
Lab PI:
Date:
Status (Undergrad, Grad, PostDoc, Faculty):
Phone #:
Department:
Please refer to the web links in the training module and the support documents for additional
information to assist you in answering these questions.
1. Upon completion of this training, the Principal Investigator should understand:
☐
☐
☐
☐
a)
b)
c)
d)
The general requirements under the NIH Guidelines for Research Involving rsNA Research
His/her responsibilities under the NIH Guidelines
Ethical principles and key safety reporting requirements
All of the above
2. The appendix of the Guidelines that can aid in determination of physical containment for standard
laboratory experiments is:
☐
☐
☐
☐
a)
b)
c)
d)
Appendix B
Appendix G
Appendix K
Appendix Q
3. The original NIH Guidelines were issued in 1976. Multiple revisions have been issued since then,
the last revisions issued in:
☐
☐
☐
☐
a)
b)
c)
d)
with
2000
2004
2011
2013
4. The NIH Guidelines apply only to UCCS research funded by the NIH.
☐
☐
True
False
rsNA 100614
5. The NIH Office of Biotechnology Activities:
☐
☐
a)
b)
☐
☐
☐
c)
d)
e)
Oversees rsNA research, including human gene transfer
Manages the Recombinant DNA Advisory Committee (RAC), a public advisory committee that
advises the Department of Health and Human Services and NIH about rsNA research
Administers the NIH Guidelines for Research Involving rsNA
Partners with Institutional Biosafety Committees in the oversight of rsNA research
All of the above
6. The PI must report any significant problems, violations, illnesses, or accidents to the IBC and:
☐
☐
☐
☐
a)
b)
c)
d)
NIH-OBA and the Biosafety Officer
EH&S
Department Chair
UCCS
7. Who is responsible for investigating lab accidents, conduct inspections, and provide technical advice:
☐
☐
☐
☐
a)
b)
c)
d)
IBC
PI
Biosafety Officer
Lab personnel
8. The IBC must report accidents, illnesses, and NIH violations within how many days of becoming aware of
it?
☐
☐
☐
☐
9.
☐
☐
a)
b)
c)
d)
Immediately
2 weeks
3 weeks
30 days
The PI must notify the IBC of any changes to rsNA experiments previously approved by the IBC.
True
False
10. The NIH Guidelines require that the PI make an initial assessment of risk based on the Risk Group of an
agent.
☐ True
☐ False
rsNA 100614
11. The PI is responsible to instruct and train laboratory personnel in the practices and techniques required to
ensure safety, and the procedures for dealing with accidents.
☐
☐
True
False
12. Transfer of drug resistance traits that would affect control of disease fall under which category of
experiments?
☐
☐
☐
a)
b)
c)
☐
☐
d)
e)
Experiments that require IBC approval, RAC Review, and NIH Director approval before initiation
Experiments that require NIH/OBA and IBC approval before initiation
Experiments that require IBC and Institutional Review Board approvals and RAC review before
research participant enrollment
Experiments that require IBC approval before initiation
Experiments that require IBC approval simultaneous with initiation
13. Experiments involving the cloning of toxin molecules with LD50 < 100 ng/kg fall under which category
of experiments?
☐
☐
☐
a)
b)
c)
☐
☐
d)
e)
Experiments that require IBC approval, RAC Review, and NIH Director approval before initiation
Experiments that require NIH/OBA and IBC approval before initiation
Experiments that require IBC and Institutional Review Board approvals and RAC review before
research participant enrollment
Experiments that require IBC approval before initiation
Experiments that require IBC approval simultaneous with initiation
14. Experiments using Risk Group 2, 3, 4 or restricted agents as host vector systems fall under which
category of experiments?
☐
☐
☐
a)
b)
c)
☐
☐
d)
e)
Experiments that require IBC approval, RAC Review, and NIH Director approval before initiation
Experiments that require NIH/OBA and IBC approval before initiation
Experiments that require IBC and Institutional Review Board approvals and RAC review before
research participant enrollment
Experiments that require IBC approval before initiation
Experiments that require IBC approval simultaneous with initiation
15. Experiments involving the formation of rDNA molecules containing no more than two-thirds of the
genome of any Eukaryotic virus fall under which category of experiments?
☐
☐
☐
a)
b)
c)
☐
☐
d)
e)
Experiments that require IBC approval, RAC Review, and NIH Director approval before initiation
Experiments that require NIH/OBA and IBC approval before initiation
Experiments that require IBC and Institutional Review Board approvals and RAC review before
research participant enrollment
Experiments that require IBC approval before initiation
Experiments that require IBC approval simultaneous with initiation
rsNA 100614
16. 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 fall under which category of experiments?
☐
☐
☐
a)
b)
c)
☐
☐
d)
e)
Experiments that require IBC approval, RAC Review, and NIH Director approval before initiation
Experiments that require NIH/OBA and IBC approval before initiation
Experiments that require IBC and Institutional Review Board approvals and RAC review before
research participant enrollment
Experiments that require IBC approval before initiation
Experiments that require IBC approval simultaneous with initiation
17. If you submit a protocol to the IACUC or IRB and it involves rsNA techniques or other biological materials,
you do not need to submit an IBC application for review and approval.
☐ True
☐ False
18. An approved IBC application is valid for how long?
☐
☐
☐
☐
a)
b)
c)
d)
1 year
3 years
No expiration
No expiration as long as the research doesn’t change
19. Your research involves a strain of E. coli which falls under the “Exempt” classification of the Guidelines,
therefore you do not have to submit an IBC application for review and approval.
☐
☐
True
False
20. Identify which of these items would qualify as a reportable incident under the Guidelines.
☐
☐
☐
☐
☐
a)
b)
c)
d)
e)
A needlestick which involves rsNA molecules
An acquired illness that could be related to one of the agents or materials used in the lab
An accidental aerosolization or inhalation
Lost transgenic animal
All of the above
rsNA 100614