Institutional Biosafety FORM E APPLICATION FOR EXEMPT

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Institutional Biosafety
FORM E
APPLICATION FOR EXEMPT EXPERIMENTS
FOR IBC ADMINISTRATIVE USE ONLY
IBC Number:
Reviewers:
Date Reviewed:
Date Approved:
Date Closed:
Disapproved:
All submissions – must be typed. E-mail a complete form to [email protected] Submit one original application with original
signature and any applicable attachments to:
Alberto J. Martinez, MD, MHA.
Richard Freeman Research Bldg, 2nd Floor Room 218
1516 Jefferson Hwy, New Orleans, LA 70121
SECTION 1 - PROTOCOL INFORMATION
Protocol Title:
IACUC Protocol Title (If applicable):
Funding Source:
SECTION 2 - GENERAL INFORMATION
Principal Investigator’s Name (last, first):
Department:
Office Phone:
Position Title:
Emergency Phone:
E-Mail:
Co-Investigator’s Name (last, first):
Position Title:
Emergency Contact Name:
Phone:
SECTION 3 - APPLICATION STATUS
New:
Renewal (every 3 years), previous IBC No.:
Requested Starting Date:
Projected End Date:
SECTION 4 - ANCILLARY COMMITTEE
Type of Committee
Yes
No
N/A
Protocol No.
Date Submitted
Approval Date
Institutional Review Board (IRB)
Animal Care Committee (IACUC)
Radiation Control Committee (RCC)
Other:
Exception Request Form
Page 1
Institutional Biosafety
FORM E
SECTION 5 - RESEARCH SUMMARY
Please provide a brief summary, including the experimental design and objectives, of the proposed study. For the benefit of the IBC
community representatives, please use non- technical terminology and define all acronyms at first use. Summaries or abstracts from
grant applications or other publications should be avoided. (Do not exceed 2 pages)
Please address all of the items below that are relevant to this study:
1.
Biological source & function of the experimental DNA(s):
2.
Vector types used in study (check all that apply):
General Purpose
Bacterial Expression
Yeast Expression
Mammalian Expression
Other (specify) :
3.
Host(s) used for recombinant DNA propagation and experimentation:
4.
Gene(s) targeted in knockout rodents and the function of its product:
SECTION 6 - EXEMPT EXPERIMENTS
The NIH Guidelines for research involving recombinant DNA molecules and genetically modified rodents includes specific exemptions
under Section III-F and Appendices A and C. In order to qualify, you must indicate which of the following exemptions apply to this
project. (Please check all that apply.) NIH Guidelines - September 2009
1.
Recombinant molecules that are not in organisms or viruses.
2.
Recombinant molecules that consist entirely of DNA segments from a single non-chromosomal or viral DNA source.
3.
Recombinant molecules that consist entirely of DNA from a prokaryotic host when propagated in that host.
4.
Recombinant molecules that consist entirely of DNA from a eukaryotic host when propagated in that host.
5.
Recombinant molecules that consist of DNA from different species that exchange DNA through known physiologic
processes. See Appendices A-I and A-VI for the list of natural exchangers that are exempt
6.
Recombinant DNA molecules containing less than one-half of any eukaryotic viral genome (all viruses from a single
family being considered identical), that are propagated and maintained in cells in tissue culture.
See Appendix C-I-A for exceptions.
7.
Experiments which use Escherichia coli K-12 host-vector systems. See Appendix C-II-A for exceptions.
8.
Experiments involving Saccharomyces cerevisiae and Saccharomyces uvarum host-vector systems.
See Appendix C-III-A for exceptions.
Exception Request Form
Page 2
Institutional Biosafety
FORM E
9.
Cloning experiments involving any asporogenic Bacillus subtilis or asporogenic Bacillus licheniformis strain which
does not revert to a spore-former with a frequency greater than 10-7.
See Appendix C-IV-A for exceptions.
10. The purchase or transfer of transgenic or knockout rodents requiring BL1 containment. Subsequent use of these
animals is also exempt providing the experimental protocol does not involve the use of recombinant DNA. [The
purchase or transfer of transgenic or knockout rodents requiring BL2 or higher containment levels are NOT
EXEMPT.]
11. Breeding transgenic or knockout rodents from one strain (propagation/colony maintenance) requiring BL1
containment. [Breeding transgenic or knockout rodents from two strains (e.g., generating new strain) or rodents
requiring BL2 or higher containment levels are NOT EXEMPT.]
12. An exemption in Appendix C not listed above.
SECTION 7 - PRINCIPAL INVESTIGATOR’S ASSURANCE
1.
I attest that the information contained in the attached application is accurate and complete to the best of my knowledge.
2.
I agree to comply with the requirements pertaining to the possession, use, transfer, and disposal of all regulated
biologically hazardous materials in accordance to Ochsner policies, applicable federal, state, and local laws and regulations
and procedures, including but not limited to OSHA Blood borne Pathogen Standard, the CDC Biosafety in Microbiological
and Biomedical Laboratories and NIH Guidelines.
3.
I will abide by the reporting requirements and submit a report to the IBC for activities that may include, but are not limited
to the following:
a.
b.
c.
All accident that results in exposure to the infectious agents or recombinant DNA or danger of environmental
contamination.
All overt spills and spills outside a physical containment equipment (e.g., outside Biosafety cabinet, outside
centrifuge, etc).
Any problems pertaining to operation, implementation of containment safety procedures or equipment, facility
failure, or breach in security (facility and/or biological agent).
I understand my responsibility with regard to laboratory safety and certify that the protocol as approved by the IBC will be followed
during the period covered by this research project. I certify that no work will be initiated or modified until approval has been issued
by the IBC, other appropriate oversight committees and all sponsoring agency requirements have been met.
__________________________________________________
Date:
Signature of Principal Investigator (must be original)
Exception Request Form
Page 3
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