Biosafety and rDNA Research Program:
Using
NIH and CDC Guidelines, the Institutional Biosafety Committee at Miami
(IBC) reviews, approves, and monitors the use of recombinant DNA,
the storage and use of any materials rated as requiring BSL-2 containment,
and any material listed as a Select Agent. The IBC is tasked with
considering the protection of humans, other animals, plants, and the
environment.
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Miami
Program Requirements |
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Use
of rDNA:
any research using recombinant DNA regardless
of assigned biosafety level or risk group. |
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The IBC reviews protocol applications that provides details
about the locations, procedures, and training. See above for
a link to the application forms and procedures. |
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Biosafety
Level 1 (BSL 1):
work involving well-characterized agents
not known to consistently cause disease in immunocompetent adult
humans, and present minimal potential hazard to laboratory personnel
and the environment. |
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It is the responsibility of faculty, staff, and departments
to establish programs for adequate standard bench practices.
Issues and concerns can be submitted anonymously at: Research
Report |
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Biosafety Level 2 (BSL 2):
builds upon BSL-1. BSL-2 is suitable for
work involving agents that pose moderate hazards to personnel
and the environment. |
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The IBC reviews protocol applications that provides details
about the locations, procedures and training. See above for
a link to the application forms and procedures.
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Biosafety
Level 3 & 4: (BSL-3)
applicable to clinical, diagnostic, teaching,
research, or production facilities where work is performed with
indigenous or exotic agents that may cause serious or potentially
lethal disease through the inhalation route of exposure. (BSL-4)
dangerous and exotic agents that pose a high individual risk
of aerosol-transmitted laboratory infections and life-threatening
disease that is frequently fatal, for which there are no vaccines
or treatments, or a related agent with unknown risk of transmission. |
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Miami does not have facilities for BSL-3,4 research. Researchers
would have to arrange for and use facilities at other institutions
for such work. The protocols would need to obtain IBC approval
at those institutions as well as Miami. |
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Select
and Dual Use Agents:
Select Agent research is a very specific
subset of life sciences research; it involves only those microorganisms
and toxins specifically identified in DHHS and USDA regulations
as having the potential to pose a severe threat to human, animal,
or plant health, or to animal and plant products (for further
information see 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part
121).
Dual
use research is a concept that relates to a broad category
of life sciences research. Certain research projects that
do or do not involve Select Agents may be considered dual
use research depending on the nature of the particular experiments
and the potential for misuse of the results and/or technology.
Within this smaller category there will be some projects that
may be considered dual use research of concern.
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As the field expert, it is the responsibility of the researchers
to identify and report the use and presence of Select or Dual
Use Agents. Resources for investigating materials are provide
on the references page. Periodically, the IBC will conduct an
inventory of covered materials via a survey to life sciences
faculty.
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