Approval Date: / Length of Approval:
Approval Expiration Date: / FULL Committee Review Date:
Date OSPA Database: / Date in Assurances Database:
Project Closure Date:
Key Personnel Training: Complete / Date of Completion: Incomplete
ISU INSTITUTIONAL BIOSAFETY COMMITTEE
PROJECT REVIEW FORM
SECTION I: GENERAL INFORMATION
Principal Investigator (PI): / Phone: / Fax:Degrees: / Correspondence Address:
Department: / Email Address:
Center/Institute: / College:
PI Level: Faculty Staff Postdoctoral Graduate Student
Alternate Contact Person: / Email Address:
Correspondence Address: / Phone:
Title of Project:
Start Date for involvement of Biohazards: [mm/dd/yy]
Key Personnel
List all members and relevant experience of the project personnel. This information is intended to inform the committee of the training and background of the investigators and key personnel.
NAME / DEGREE(S) / SPECIFIC DUTIES ON PROJECT / TRAINING & EXPERIENCE RELATED TO PROCEDURES PERFORMED, DATE OF TRAININGAdd New Row
Funding Information
Provide the funding source for the project below. Do not skip this question. If not applicable, please explain under “Other.”
If internally funded, please provide account number:If externally funded, please provide funding source and account number:
If funding is pending, please provide OSPA Record ID on GoldSheet:
Title on GoldSheet if different from above:
Other:
Scientific Review
YesNoHas or will this project receive peer review?
If the answer is “yes,” please indicate who did or will conduct the review:
If a review was conducted, please indicate the outcome of the review:
Collection or Receipt of Samples
Will you be: (Please check all that apply.)
YesNoReceiving samples from outside of ISU? See examples below.
YesNoSending 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 of the outside organization(s) and the identity of the samples you will be sending or receiving outside of ISU:
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 agree to provide proper surveillance of this project to ensure that the rights and welfare of the human subjects or welfare of animal subjects are protected. I will report any problems to the appropriate compliance review committee(s).
- I agree that I will not begin this project until receipt of official approval from all appropriate committee(s).
- I agree that modifications to the originally approved project will not take place without prior review and approval by the appropriate committee(s), and that all activities will be performed in accordance with all applicable federal, state, local, and IowaStateUniversity policies.
- I will follow applicable biosafety level requirements, 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 handling of biohazardous materials and waste management, animal welfare regulations, and human subject regulations training.
Conflict of Interest
YesNoWill you or any member of your research team have an actual or potential conflict of interest?
YesNoIf yes, have the appropriate disclosure forms been completed?
SIGNATURES
Signature of Principal InvestigatorDate
Signature of Department Chair 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 ChairDate
PLEASE NOTE: Any changes to an approved protocol must be submitted to the appropriate committee(s) before the changes may be implemented.
SECTION II: APPLICATION FOR INSTITUTIONAL BIOSAFETY COMMITTEE APPROVAL
Study Objectives
Provide an overall summary of the project and briefly explain in language understandable to the general public the specific aim(s) of the study.
Benefit
Explain in language understandable to the general public how the information gained in this study will benefit human or animal health, the advancement of knowledge, and/or serve the good of society.
Briefly explain the experimental design. Please describe the project with respect to use of recombinant DNA, pathogens, or biological toxins.
YesNoWill this project involve any of the following: (i) recombinant DNA (including transgenic animals); (ii) human, plant or animal pathogens; (iii) biological toxins; or (iv) administration of experimental biological products? If the answer “yes” is checked, please proceed to PART A: TRANSGENIC ANIMALS. If “no” is checked, please proceed to Section III.
Part A: Transgenic Animals
YesNoWill this project involve the use of transgenic animals? If “no” is checked, please proceed to Part B: Experimental Biological Products.
YesNoWill this project involve breeding transgenic animals at ISU? If the answer “yes” is checked, you must also submit a Breeding Colony Form.
1)Describe how these animals are genetically altered.
2)Please indicate how these animals will be procured. This information is intended to inform the committee if animals will be purchased from a vendor, transferred from another institution, or produced here at ISU.
3)NIH Guidelines require that transgenic animals must be individually marked (e.g., ear notch, toe clip, etc.) within 72 hours after birth, if size permits. If size does not permit, their container should be marked. Describe the marking system that will be used to individually identify all transgenic animals in this project and any resulting offspring.
4)Describe the type and frequency of evaluations to be performed on the animals in this project.
Part B: Experimental Biological Products
YesNoWill this project involve use of unlicensed experimental biological products in animals?If the answer “no” is checked, please skip to PART C: RECOMBINANT DNA.
5)Please describe how you will comply with requirements of the FDA and USDA under 9 CFR 103.2 (Disposition of animals administered experimental biological products or live organisms) and 9 CFR 309.17 (Livestock used for research).
Part C: Recombinant DNA
Yes NoWill this project involve recombinant DNA? If the answer “no” is checked, please skip to PART D: INFECTIOUS AGENT OR BIOLOGICAL TOXIN USE.
6)Please describe the source of the DNA including the type of organism, species, strain, cultivar/cell line.
7)Please describe the nature of the inserted DNA sequences, including regulatory or coding region, entire genome, synthetic antisense sequences, etc.
8)Please describe the recipient organism(s) for the DNA. Specify the type of organism, species, strain, cultivar/cell line, origin, etc.
9)List vectors to be used, such as expression vectors, and briefly specify their purpose.
10) Yes NoWill 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 (e.g., morphological or structural characteristics, physiological activities and processes, growth characteristics). Indicate possible toxicity or other hazards, if any:
Part D: Infectious Agent or Biological Toxin Use
Yes NoWill this project involve human, animal or plant pathogens, or biological toxins? If the answer is “yes,” please complete all of the questions in this section.
11)Please list the infectious agents or biological toxins to be used and check appropriate categories:
INFECTIOUS AGENT OR BIOLOGICAL TOXIN / HUMAN HAZARD(Answer Yes or No) / ANIMAL HAZARD
(Answer Yes or No) / PLANT HAZARD
(Answer Yes or No) / IF PLANT PATHOGEN, IS IT INDIGENOUS TO IOWA?
(Answer Yes or No)
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12)If this project will involve infectious agents or biological toxins that affect humans, please describe symptoms, severity of disease, vulnerable populations, and mode of transmission (fecal-oral, direct contact, aerosol, etc.).
13)YesNoIf you will be using a human infectious agent or biological toxin, is a vaccine available?
If a vaccine is available, all potentially exposed personnel must be informed of the potential hazards and benefits and offered the option of receiving the vaccine. Vaccinations may be obtained at Occupational Medicine office (294-2056).
If a vaccine is available, list dates and type of vaccination for all potentially exposed personnel:
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For any potentially exposed personnel not receiving available vaccination(s), please attach a completed and signed Decline of Immunization Form.
14) Yes No Will this project involve the use of Select Biological Agents (
14a) Yes NoIf select agents will be used, have all requirements of the University Biological Research Security Plan been met?
All possession and use of Select Biological Agents requires special registration that must be done through the University Biosafety Officer(294-5359).
Part E: Biosafety Containment Level
If you have indicated “yes” to Part A, B, C, or D, please complete the following.
15) Please check the federal guidelines applicable to the proposed project. The IBC Administrator (294-5412) can assist you in determining the proper guidelines. All guidelines are also available on the Internet.
For recombinant DNA and/or transgenic animals, refer to the NIH Guidelines for Research Involving Recombinant DNA Molecules. Please list the specific guidelines under section III to be followed for this project in the box below:
Please indicate proposed biosafety containment level(s) to be used in this project. Refer to the NIH Guidelines for Research Involving Recombinant DNA Molecules.
rDNA Biosafety Level 1 (BL1)
rDNA Biosafety Level 2 (BL2)
rDNA Biosafety Level 3 (BL3)
rDNA Animal Biosafety Level 1 (BL1-N)
rDNA Animal Biosafety Level 2 (BL2-N)
rDNA Animal Biosafety Level 3 (BL3-N)
rDNA Large Scale Biosafety Level 1 (BL1-LS)
rDNA Large Scale Biosafety Level 2 (BL2-LS)
rDNA Large Scale Biosafety Level 3 (BL3-LS)
rDNA Plant Biosafety Level 1 (BL1-P)
rDNA Plant Biosafety Level 2 (BL2-P)
rDNA Plant Biosafety Level 3 (BL3-P)
For human pathogens or toxins, refer to the CDC publication Biosafety in Microbiological and Biomedical Laboratories ( Please list the specific safety and/or containment practices to be followed for this project:
Please indicate proposed biosafety containment level(s) to be used in this project. Refer to Biosafety in Microbiological and Biomedical Laboratories.
Biosafety Level 1 (BSL-1)
Biosafety Level 2 (BSL-2)
Biosafety Level 3 (BSL-3)
Animal Biosafety Level 1 (ABSL-1)
Animal Biosafety Level 2 (ABSL-2)
Animal Biosafety Level 3 (ABSL-3)
For animal-only or plant-only pathogens or toxins, there are currently no applicable regulatory guidelines. Please contact the University Biosafety Officer (294-5359) for assistance with the development of prudent guidelines specific to the animal-only or plant-only pathogen or toxin used in this project. Please list the specific safety and/or containment practices to be followed for this project:
Please indicate proposed biosafety containment level(s) to be used in this project. Refer to Biosafety in Microbiological and Biomedical Laboratories.
Biosafety Level 1 (BSL-1)
Animal Biosafety Level 1 (ABSL-1)
Animal Biosafety Level 1 with special practices to prevent spread to other (susceptible) animals in the facilities (ABSL-1+)
16)Describe the specific decontamination method(s) to be used for all biohazardous waste (except animal carcass disposal) and contaminated equipment. Decontamination methods may include autoclaving, chemical disinfections, etc. If a chemical disinfectant is used, state type and concentration. Please refer to the EH&S Sharps and Biohazardous Waste Policy ( and the Sharps and Biohazardous Waste Disposal Flow Chart ( for assistance
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Part F: Procedures for Laboratory Safety and Experimental Procedures
17)Please check all of the personal protective equipment required for work in the laboratory.
face shield/goggles/safety glasses (specify the type protection and when it will be used):
shoe covers
lab coat
gloves
head cover
mouth/nose covering (specify the type and when it will be used):
other (specify):
18)Please list any special precautions, in addition to the personal protective equipment and the regulatory guideline requirements,that may be employed in the laboratory for safety and waste handling. If this question is not applicable, please indicate N/A.
Part G: Study Location Information
19)Please list the location(s) where the project will be carried out. Include all laboratory and animal facilities as well as field locations and greenhouses.
BUILDING, FIELD LOCATION OR GREENHOUSE / ROOM NUMBER IF APPLICABLEAdd New Row
20)List locations of biological safety equipment (e.g., biosafety cabinet, autoclave). Include most recent certification date for biosafety cabinets. Please enter “failed” if the cabinet did not pass certification testing.
ROOM NUMBER
/ CERTIFICATION DATE(Required only for biosafety cabinets.)
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Part H: Projects Involving Animal Studies
21)Yes No Does this project involve animals? If the answer is “yes,” please complete all of the questions in this section.
At the project’s termination the animals will be:
Note: If multiple categories are checked, designate the number of animals for each category.
Slaughtered
Sold
Returned to colony, herd, or owner
Transferred to another project (if yes, give log # and investigator:
Other (specify):
Euthanized
Specify how the carcass will be disposed of following euthanasia.
Can be rendered
Must be incinerated (Per ISU EH&S Sharps and Biohazardous Waste Policy, all sheep and goats and any animals infected with human pathogens must be incinerated.)
Other (specify):
Please describe how the carcass will be disposed (e.g., PI will euthanize, place carcass in the freezer and LAR will take carcass to the incinerator, etc.)
22)YesNoWill this project involve the use of infectious agents or biological toxins in animals? If the answer is “yes,” please complete all of the questions in this section. Please specify all animal species that are affected by this infectious agent or biological toxin and describe the expected clinical signs, severity of the disease, and mode of transmission (fecal-oral, direct contact, aerosol, etc.).
23)Please check all personal protective equipment required in animal facilities:
face shield/goggles/safety glasses specify the type protection and when it will be used):
boots/shoe covers
coveralls/lab coat
rain suit
gloves
head cover
mouth/nose covering (specify type): specify the type and when it will be used):
other (specify):
24)Please describe any special precautions to be used in the animal facility: (e.g., shower in/out). If this question is not applicable, please indicate N/A.
SECTION III: ENVIRONMENTAL HEALTH AND SAFETY
YesNoWill this project involve any of the following: human cell or tissue cultures (primary OR immortalized), or human blood components, body fluids or tissues? If the answer is “yes,” please proceed to Part A: Human Cell or Tissue Cultures.
Part A: Human Cell or Tissue Cultures
YesNoWill this project involve human cell or tissue cultures (primary OR immortalized cell lines/strains)?
1)Please list the specific cell lines/strains to be used, their source and description of use.
CELL LINE / SOURCE / DESCRIPTION OF USEAdd New Row
YesNoHave the human cell or tissue cultures been documented to be free of bloodborne pathogens? If “yes,” please fax or attach copies of the documentation. If “no,” please complete this section.
2)Please refer to the ISU “Bloodborne Pathogens Manual,” which contains the requirements of the OSHA Bloodborne Pathogens Standard. Please list the specific precautions to be used for this project below (e.g., retractable needles will be used for blood draws):
Anyone working with human cell lines/strains who has not been documented to be free of bloodborne pathogens is required to have Bloodborne Pathogen Training annually. Current Bloodborne Pathogen Training dates must be listed in Section I for all Key Personnel. Please contact Environmental Health and Safety (294-5359) if you need to sign up for training and/or to get a copy of the “Bloodborne Pathogens Manual.”
Part B: Human Blood Components, Body Fluids or Tissues
YesNoWill this project involve human blood components, body fluids or tissues? If “yes,” please answer all of the questions in the “Human Blood Components, Body Fluids or Tissues” section.
3)Please list the specific human substances used, their source, amount, and description of use.
SUBSTANCE / SOURCE / AMOUNT / DESCRIPTION OF USEE.g., Blood / Normal healthy volunteers / 2 ml / Approximate quantity, assays to be done.
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4)Please refer to the ISU “Bloodborne Pathogens Manual,” which contains the requirements of the OSHA Bloodborne Pathogens Standard. Please list the specific precautions to be followed for this project.
Anyone working with human blood components, body fluids or tissues is required to have Bloodborne Pathogen Training annually. Current Bloodborne Pathogen Training dates must be listed in Section I for all Key Personnel. Please contact Environmental Health and Safety (294-5359) if you need to sign up for training and/or to get a copy of the “Bloodborne Pathogens Manual.”
Part C: Permits
5)YesNoAre any permits required for this project?
If the appropriate permits have already been obtained, please list the applicable permit numbers:
Permit: Permit: Permit:
The Department of Environmental Health and Safety (EH&S) can assist you in determining permit requirements and obtaining any necessary permits. Permit requirement information is available on the EH&S website. Please submit permits to the EH&S Permit Specialist, 294-5359.
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Office for Responsible Research
Revised 2/7/11