Download Recombinant and Synthetic Nucleic Acid Activity Registration

ORGA Use only
Date Received:
IBC#
College of Charleston
Institutional Biosafety Committee
RECOMBINANT DNA ACTIVITY REGISTRATION
Biosafety Levels 1 and 2
Principal Investigator:
Department:
Telephone:
E-mail:
Project Title:
Start Date:
Estimated End Date:
Please select one:
Research
Instruction - Course Number:
Description of Project:
Source(s) of DNA/RNA:
Will there be expression of a toxic or pathogenic gene product?
___ No
___ Yes, describe:
Recombinant DNA Registration
6/09
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Will there be >2/3 of a viral genome in any single clone?
___ No
___ Yes, describe:
Host-Vector-Donor System:
Large Scale(>10 liters):
___ Yes
____No
Is a Recombinant DNA gene product efficiently expressed? ___Yes
___ No
___Unknown
Location(s):
Containment level
___ BL1
___ BL2 - provide applicable section of the NIH Guidelines (see Appendix I of the College of
Charleston Policies and Procedures):
Is this project exempt under the NIH Guidelines?
___ No
___ Yes – please check:
Refer to FAQs About Experiments that are Exempt from the
NIH Guidelines* and specify relevant Section or Appendix number
Recombinant DNA molecules that meet the exemption criteria are those that
Are not in organisms or viruses.
Consist entirely of DNA segments from a single nonchromosomal or viral DNA source,
though one or more of the segments may be a synthetic equivalent.
Consist entirely of DNA from a prokaryotic host including its indigenous plasmids or
viruses when propagated only in that host (or a closely related strain of the same
species), or when transferred to another host by well established physiological means.
Consist entirely of DNA from an eukaryotic host including its chloroplasts, mitochondria, or
plasmids (but excluding viruses) when propagated only in that host (or a closely related
strain of the same species).
Recombinant DNA Registration
6/09
* http://osp.od.nih.gov/sites/default/files/experiments_that_are_
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Exempt_from_the_NIH_Guidelines.pdf
Consist entirely of DNA segments from different species that exchange DNA by known
physiological processes, though one or more of the segments may be a synthetic
equivalent. A list of such exchangers will be prepared and periodically revised by the NIH
Director with advice of the RAC after appropriate notice and opportunity for public
comment.
Do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c),
Major Actions).
List lab personnel to contact in emergency situations requiring immediate remedial action:
Please include full name and contact information for each person; indicate if the person is student, staff, or
faculty.
For research only – list persons in addition to the principal investigator who will be working on this
project. Please include full name and contact information for each person; indicate if the person is student,
staff, or faculty.
Principal Investigator Certification:
I am familiar with and agree to abide by the provisions of the local, state, and federal government regulations
for recombinant DNA use and technology and College of Charleston policies and procedures.
_________________________________________
Signature
Recombinant DNA Registration
6/09
Date: ____________________________
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For IBC Use
Administrative Review
Appr oved
Medical surveillance required:
Yes
No
Needs IBC Review
_________________________________________
IBC Chairperson Signature
______________________________________
Name
Date: ___________________________________
IBC Review
Appr oved
Medical surveillance required:
Yes
No
Denied
_________________________________________
IBC Chairperson Signature
______________________________________
Name
Date: ____________________________________
Recombinant DNA Registration
6/09
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