Institutional Biosafety Committee Supplemental Form
for the processing of plasmid or plant genomic
dna extraction samples
Rev. June 18, 2008
To ensure compliance with the National Institutes of Health (NIH) Guidelines, we request that clients provide documentation indicating that the project they wish to submit has been approved by Iowa State University's Institutional Biosafety Committee (IBC). As a condition for NIH funding of recombinant DNA research, institutions like Iowa State University are required to ensure that research conducted at or sponsored by this institution, irrespective of the source of funding, comply with NIH Guidelines.
The ISU Institutional Biosafety Committee serves Iowa State University in all matters involving recombinant DNA studies as required by the Federal Register, May 7, 1986 and amendments. The Committee has the responsibility for reviewing the biological and public health safety programs at Iowa State University and verifies compliance with federal, state, and local regulations and recommendations.
Off-campus clients submitting plant or plasmid samples for DNA extraction should complete Iowa State University's Institutional Biosafety Committee Supplemental Form prior to shipping samples. This application is required only once per project or per-modification of a project. Changes in host strain or other modification in the organism being submitted may require resubmission of this application. This information will be kept confidential and is used only to ensure compliance with applicable regulatory agencies.
Please e-mail () or fax your completed IBC supplemental form to (515) 294-1597 (attn: Kevin Cavallin), a minimum of 4-5 days prior to shipping your samples. Incomplete documentation may result in a delay or the return of your samples. Once your IBC supplemental form has been reviewed and approved we will contact you by e-mail to let you know that you can ship your order.
Samples shipped to our facility must be shipped in accordance with U.S. Department of Transportation (DOT) and/or international (IATA, ICAO) regulations. Due to continuing changes in state and federal regulations, clients should always check with their safety office and/or shipping department to ensure regulatory compliance.
Clients working with samples requiring a USDA Animal & Plant Health Inspection Service (APHIS) permit or other transport permits should contact the Iowa State University Department of Environmental Health & Safety at (515) 294-5359 prior to the submission of your IBC supplemental form. EH&S should be able to tell you if any permits are required for your project.
Please note that our facility can only accept non-pathogenic E. coli cultures and plant tissues. We cannot accept any viable pathogenic organisms, diagnostic specimens, blood, or any bodily fluids. Please contact our facility at (515) 294-9585 or dnaextract@ iastate.edu if you have any question regarding samples submission.
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ISU Research Compliance 12/5/06
ISU DNA Facility 6/18/2008
FOR COMPLIANCE COMMITTEE USE ONLY / Review Date: / Committee ID:Approval Date: / Length of Approval:
Approval Expiration Date: / FULL Committee Review Date:
Date OSPA Database: / Date in Compliance Database:
ISU Institutional Biosafety Committee
Modification to DNA Facility Protocol
SECTION I: GENERAL INFORMATION
Client name:Principal Investigator (PI) or Major Professor:
Institution:
Phone:
Yes No Don’t know Are any permits required for the DNA facility to receive the materials to be sent for this project? (Examples of items that might require permits include genes from human, animal, or plant pathogens).
Please fax copies of all required permits with this form to (515) 294-1597 (attn: Kevin Cavallin).
The Iowa State University Department of Environmental Health & Safety, (EH&S, (515) 294-5359) can assist you in determining permit requirements and obtaining any necessary permits.
SIGNATURES
Signature of Facility Manager Date
FOR Institutional Biosafety Committee (IBC) USE ONLY:
Initial action by the IBC :
Project exempt. Date: ______Project referred to the full committee. Date: ______
Project approved. Date: ______Pending further review. Date: ______
Project not approved. Date: ______
Follow-up action by the IBC:
Signature of IBC Chair Date
SECTION II: RECOMBINANT DNA
1) Please indicate the DNA Facility service that you intend to use.
Plant Genomic DNA Extraction & Seed Grinding Service - Extraction of plant genomic DNA from leaf, seed, or other tissue that is either fresh or lyophilized, and is from a plant species that is appropriate for handling at Plant Biosafety Level 1 (BL1-P)
96-well Plasmid Preparation Service - Extraction of plasmid DNA from a non-pathogenic, commercially available strain of E. coli that is classified as a Risk Group 1 agent and is incapable of increased pathogenicity due to transformation.
2) Please describe the source of the inserted DNA or plant tissue including the type of organism, species, strain, cultivar/cell line.
3) Please describe the nature of the inserted DNA sequences, including regulatory or coding region, entire genome, synthetic antisense sequences, etc.
4) Please describe the recipient organism(s) for the DNA. Specify the type of organism, species, strain, cultivar/cell line, origin, etc.
5) List vectors to be used, such as expression vectors, and briefly specify their purpose.
6) Yes No Will there be a deliberate attempt to express a foreign gene?
If “yes,” describe how expression of the inserted DNA sequences will result in differences from the non-modified parental organism (for example, morphological or structural characteristics, physiological activities and processes, growth characteristics). Indicate possible toxicity or other hazards, if any:
PLEASE NOTE: All organisms to be used must be nonpathogenic, Risk Group 1 agents and will be handled at Biosafety Level 1 (BL1). No infectious agents (BL2 or higher), no toxins of biological origin, and no human cell or tissue cultures (primary OR immortalized), or human blood components, body fluids or tissues will be used.
1
ISU Research Compliance 12/5/06
ISU DNA Facility 6/18/2008