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Penn Vector Core: IBC Registration Instructions

 

Completing a Upenn IBC registration document for recombinant DNA research involving AAV vectors (example AAV.CMV.EGFP vectors)

AAV Vector Instructions:

1. Go to the EHRS website http://www.ehrs.upenn.edu/sitemap.html and select Biological Safety on the left hand sidebar.

2. Under Biological Safety, select Recombinant DNA http://www.ehrs.upenn.edu/programs/bio/recombinantdna/

3. Instructions and a tutorial for completing Penn’s rDNA registration document are provided.

4. To complete a registration form for a new vector, access the Penn rDNA registration form. Link to: Penn rDNA Registration Form- AAV

5. To register an AAV vector provided by the Penn Vector Core (ie. to register an AAV vector for use but not for production), complete the Project Information and Training sections.

6. The NIH Guidelines Section (Section III) must be completed for each vector type to be registered. Most AAV vectors that will be used in animals will fall under category III-D.4 ie. experiments that require Institutional Biosafety Committee approval before initiation; exceptions include AAV vectors that encode risk group 1, 3, 4 or restriction agent cDNA (see Table 1 below and http://oba.od.nih.gov/rdna/nih_guidelines_oba.html for more information on risk group.)

Section III-D. Experiments that Require Institutional Biosafety Committee Approval Before Initiation

 

1.

Experiments Using Risk Group 2, Risk Group 3, Risk Group 4 or Restricted Agents as Host-Vector Systems.

 

2.

Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems

 

3.

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.

X

4.

Experiments Involving Whole Animals. (Do not check if ONLY generating or crossing transgenic rodents (see III-E-3)
 
5.

Experiments Involving Whole Plants.

 
6.
Experiments Involving More than 10 Liters of Culture.
 
7.
Experiments Involving Influenza Viruses. (Consult with EHRS for guidance. BSL-3 containment may apply)

 

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Appendix B - Table 1. Basis for the Classification of Biohazardous Agents by Risk Group

Risk Group 1 (RG1)

Agents that are not associated with disease in healthy adult humans

Risk Group 2 (RG2)

Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available

Risk Group 3 (RG3)

Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)

Risk Group 4 (RG4)

Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)

7. For vectors obtained from the Vector Core, check USE (blue) box and fill out section 4 only.

         Appendix B - Table 1. Basis for the Classification of Biohazardous Agents by Risk Group

8. Complete the Signature Page and then Section 4: Use of rDNA; Complete Target Recipient.

9. Under Recombinant Material, complete the following as indicated below:

Recombinant Material example

10. Under Transgene, complete section A as indicated below (with examples provided.)

Gene Name

Source of gene

Biological Activity of Sequence

eGFP

Jellyfish.

Aequorea victoria

enhanced green fluorescent protein cDNA; used as a reporter gene; protein exhibits bright green fluorescence when exposed to blue light

CRE

Bacteriophage P1

cre recombinase cDNA; encodes a type I topoisomerase from P1 bacteriophage that catalyzes site-specific recombination of DNA between loxP sites

CFTR

Human

cystic fibrosis transmembrane regulator cDNA; encodes an ABC transporter-class ion channel that transports chloride and thiocyanate ions across epithelial cell membranes. Mutations of the CFTR gene affect functioning of the chloride ion channels in these cell membranes, leading to cystic fibrosis and congenital absence of the vas deferens

 

11. Complete sections B and C with information appropriate for each transgene to be registered.

12. Complete the Biosafety Containment Level for AAV-based vectors as follows:

Biosafety Containment Level

Samples: Provide vector map and sequence information as pasted below for each vector genome registered.

Map of pENN AAV CMV PI-Cre(P1090)

 

Map of pENN AAV CMV PI-eGFP(P1060)

 

Map of pENN AAV CB7 CI-eGFP(1046)

 

Map of pAAV.CB.CFTR_UF
 
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Completing a Upenn IBC registration document for recombinant DNA research involving lentiviral vectors (example HIVSIN.CMV.EGFP vectors.)

Lentiviral Vector Instructions:

1. Go to the EHRS website http://www.ehrs.upenn.edu/sitemap.html and select Biological Safety on the left hand sidebar.

2. Under Biological Safety, select Recombinant DNA http://www.ehrs.upenn.edu/programs/bio/recombinantdna/

3. Instructions and a tutorial for completing Penn’s rDNA registration document are provided.

4. To complete a registration form for a new vector, access the Penn rDNA registration form. Link to: Penn rDNA Registration Form- Lenti

5. To register a lentiviral vector provided by the Penn Vector Core (ie. to register a lentiviral vector for use but not for production), complete the Project Information and Training sections.

6. The NIH Guidelines Section (Section III) must be completed for each vector type to be registered. Most lentiviral vectors will fall under category III.D.I ie. experiments that require Institutional Biosafety Committee approval before initiation; (see Table 1 below and http://oba.od.nih.gov/rdna/nih_guidelines_oba.html for more information on risk group.)

Table of Experiments that Require Institutional Biosafety Committee Approval Before Initiation.

Appendix B - Table 1. Basis for the Classification of Biohazardous Agents by Risk Group

Risk Group 1 (RG1)

Agents that are not associated with disease in healthy adult humans

Risk Group 2 (RG2)

Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available

Risk Group 3 (RG3)

Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)

Risk Group 4 (RG4)

Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)

7. For vectors obtained from the Vector Core, check USE (blue) box and fill out section 4 only.

         Appendix B - Table 1. Basis for the Classification of Biohazardous Agents by Risk Group

8. Complete the Signature Page and then Section 4: Use of rDNA; Complete Target Recipient.

9. Under Recombinant Material, complete the following as indicated below:

Recombinant Material

10. Under Transgene, complete section A as indicated below (with examples provided.)

Gene Name

Source of gene

Biological Activity of Sequence

eGFP

Jellyfish.

Aequorea victoria

enhanced green fluorescent protein cDNA; used as a reporter gene; protein exhibits bright green fluorescence when exposed to blue light

CRE

Bacteriophage P1

cre recombinase cDNA; encodes a type I topoisomerase from P1 bacteriophage that catalyzes site-specific recombination of DNA between loxP sites

CFTR

Human

cystic fibrosis transmembrane regulator cDNA; encodes an ABC transporter-class ion channel that transports chloride and thiocyanate ions across epithelial cell membranes. Mutations of the CFTR gene affect functioning of the chloride ion channels in these cell membranes, leading to cystic fibrosis and congenital absence of the vas deferens

 

Samples: Provide vector map and sequence information as pasted below for each vector genome registered.

Map of pENN.HIV.SIN.cPPT.CMV.EGFP.WP

 

*Map/sequence information for lentiviral vector genomes encoding Cre and CFTR is pending.

 

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