Download IBC Field Release Form - Office for Responsible Research

OFFICE FOR
RESPONSIBLE
RESEARCH
USE ONLY
Review Date:
Committee ID:
Approval Date:
Length of Approval:
Approval Expiration Date:
FULL Committee Review Date:
ISU INSTITUTIONAL BIOSAFETY COMMITTEE
FIELD RELEASE REVIEW FORM
SECTION I: GENERAL INFORMATION
Principal Investigator (PI):
Degrees:
Department:
Center/Institute:
PI Level:
Faculty
Staff
Alternate Contact Person:
Correspondence Address:
Title of Project:
Phone:
Fax:
Correspondence Address:
Postdoctoral
Email Address:
College:
Graduate Student
Email Address:
Phone:
Assurance



I certify that the information provided in this application is complete and accurate and consistent with any
proposal(s) submitted to external funding agencies.
I will follow applicable biosafety level requirements and comply with all shipping requirements and required
waste management practices.
I will ensure that all personnel have appropriate training including but not limited to: biosafety principles and
techniques, accidental spills, shipping regulations, proper handing of biohazardous materials and waste
management, and regulatory permit requirements.
Signatures
Signature of Principal Investigator
Date
Signature of Department Chair
Date
Office for Responsible Research
Revised: 4/11/2017
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For Institutional Biosafety Committee (IBC) Use Only:
Chair’s signature below indicates that the project has been approved by the IBC.
IBC Approval Signature
Date
PLEASE NOTE: Any changes to an approved protocol must be submitted to the appropriate committee(s) before
the changes may be implemented.
Key Personnel
List all members and relevant experience of the project personnel (PI, associates, students, and technicians) who will be
involved. This information is intended to inform the committee of the training and background of the investigators and
key personnel.
NAME
DEGREE
SPECIFIC DUTIES ON
PROJECT
EH&S TRAINING & EXPERIENCE
RELATED TO PROCEDURES
PERFORMED
Add New Row
Funding Information
Yes
No Is this project federally funded?
If Yes, please list source:
Collection or Receipt of Samples
Will you be: (please check all that apply)
Yes
Yes
No Receiving samples from outside of ISU? See examples below.
No Sending samples outside of ISU? See examples below.
Examples include genetically modified organisms, body fluids, tissue samples, blood samples, pathogens.
If you will be receiving samples from or sending samples outside of ISU, please identify the name and location of the
outside organization(s) and the identity of the samples you will be sending or receiving outside of ISU:
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SECTION II: FIELD RELEASE
Note: If planning multiple introductions, please answer the questions for each regulated article.
1) If the appropriate permits have already been obtained, please list the applicable permit numbers and fax copies of all
applications, letters of notification, permits (and phytosanitary certificates for import permits) to 294-4267. The
Department of Environmental Health and Safety (EH&S), 294-5359, can assist you in determining permit
requirements and obtaining any necessary permits.
2) Describe the purpose of the field release.
3) Describe the items that will be field released:
a) List the recipient plant or plants. Provide the common name, scientific name, and cultivar name.
b) List the inserted genetic material. Identify all sources of DNA.
Yes
No Are there Cas9 and gRNA involved?
If yes, please describe the construct:
Yes
No Will the Cas9 and gRNA elements persist in the germline?
If yes, please describe any special containment practices:
Guidance for the Use of Gene Drive Technology in Research
c) List the method or methods of transformation.
d) List the quantity of plants and the size of the plots in square feet or acres.
e) Describe the novel proteins or RNA expressed in the plants.
f) Please indicate where the material to be planted was obtained (e.g., outside company, Plant Transformation
Facility, made in your lab, etc.). If this material was made in your lab, please indicate the IBC approval number
under which the planting material was created.
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g) How does expression of the altered genetic material differ from the unmodified parental organism? For example,
morphological or structural characteristics, physiological activities and processes, number of copies of inserted
genetic material and the physical state of this material inside the recipient organism (integrated or
extrachromosomal), products and secretions, growth characteristics. Indicate possible toxicity or other hazards, if
any.
h) If a pharmaceutical or bioactive industrial compound will be synthesized in a food or feed crop, state the reason
for choosing that crop.
4) What is the duration of the field release or releases?
5) Who will do the planting?
6) Describe the proposed field site assignment. State the location, specifically the state, country, field address, and field
size. For multiple releases, give the number of introductions and the maximum acreage per release.
7) Describe information gained from laboratory and growth room or greenhouse experiments that would be relevant to
assessing potential risks from field tests.
8) Release of the transgenic material may take place through seed, vegetative propagation, or pollen. Briefly describe the
procedures to prevent release or dissemination of the transgenic material into the environment. Identify steps to be
taken to minimize or eliminate risks.
9) Describe the method of final disposition of all plant material resulting from this field release, including material
remaining on the field after harvest. Describe procedures to monitor for and eliminate any volunteer plants.
10a) Will plant material from the field be taken to the lab?
Yes
No
10b) If Yes, please indicate if the material will be immediately devitalized or if any further transgenic work will take
place. If further transgenic work will take place, an IBC research application or amendment may need to be
submitted for review and approval.
10c) If material will be immediately devitalized in the lab, please indicate the method of destruction of the regulated
material.
Office for Responsible Research
Revised: 4/11/2017
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The Office of the Vice President for Research and the Office for Responsible Research recommend that you
develop a communication plan for immediate use in the event of accidental release of the transgenic material. This
plan should be developed with the assistance of the Office of University Relations. Please contact Annette Hacker
(294-3720) or Teddi Barron (294-4778).
Office for Responsible Research
Revised: 4/11/2017
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