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 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.

   
  Biosafety Application Forms
  Training and Certification
  Biosafety References

Category   Miami Program Requirements
     
Use of rDNA:
any research using recombinant DNA regardless of assigned biosafety level or risk group.
 
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.

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.
 
It is the responsibility of faculty, staff, and departments to establish a program of adequate standard bench practices. Issues and concerns can be submitted anonymously at:
Research Report


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.
 


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
.


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.
 
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.

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.

 
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.
 

Institutional Biosafety Committee (IBC) 
Miami IBC Chair is Dr. Joseph Carlin (carlinjm@miamioh.edu)
Commitee Members Access





Please contact The Office for the Advancement of Research and Scholarship if you have questions about this web site: 513-529-3600
    or email Neal Sullivan at sullivnh@miamioh.edu or Jennifer Sutton at suttonja@miamioh.edu

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