IBC Protocol Review Form

IBC Protocol Review Form

PRINCIPAL INVESTIGATOR (PI) / PHONE / FAX / EMAIL
CENTER / INSTITUTE/DEPARTMENT / COLLEGE
CO-INVESTIGATOR / PHONE / EMAIL
CO-INVESTIGATOR / PHONE / EMAIL
PROJECT/GRANT TITLE

______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 that I will not begin this project until receipt of official approval from the 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 University of Georgia 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.

______I am aware that the IBC reserves the right to conduct inspections of the research facilities at any time.

INSTRUCTIONS: Please type your responses in the appropriate sections and submit this form as a word doc to . The comment boxes will expand as needed, but please tab to add a row when applicable since they are in table format. The document will lengthen automatically based on the amount of information included.

Type of Funding Source(s) for this Project:

Department / Institutional / Business / Industry
Foundation / Other
Federal Funds
If project is supported with federal funds, provide name of funding agency and grant/contract number:

Completion of Sections I and II is a requirement for all protocols submitted to the KSU IBC. Failure to complete them will result in the protocol not being processed for IBC review.

Requirement for the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC). If this project is determined to be DURC, the Institutional Contact for Dual Use Research of Concern (ICDUR) will submit to a separate subcommittee for DURC review prior to IBC review.

SECTION I: Agent or Toxin Involved in this Project(Check All that Apply)

Avian influenza virus (Highly Pathogenic) / Marburg virus
Bacillus anthracis / 1918 influenza virus
Botulinum neurotoxin (any quantity) / Rinderpest virus
Burkholderia mallei / Toxin-producing strains of Clostridium botulin
Burkholderiapseudomallei / Variola major virus
Ebola virus / Variola minor virus
Foot-and-Mouth disease / Yersinia pestis
Franciscellatularensis
Noneoftheabovelisted15agentsapplytothisproject –Please skip to Section II

Assessment by the Principal Investigator (PI) for Experimental Effects

PI's are required to assess whether any research directly involving non-attenuated forms of one or more of the 15 listed agents produces, aims to produce or is reasonably anticipated to produce one or more of the experimental effects listed in Section 6.2.2 of the Policy for Institutional DURC Oversight.(Note: the research and this assessment must be submitted to the IBC for review regardless of whether any of the following experimental effects apply. If none apply, choose the last option below.)

Enhances the harmful consequences of the agent or toxin.
If checked, please explain here:
Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification.
If checked, please explain here:
Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates its ability to evade detection methodologies.
If checked, please explain here:
Alters properties of the agent or toxin in a manner that would enhance its stability, transmissibility, or ability to be disseminated.
If checked, please explain here:
Alters the host range or tropism of the agent or toxin.
If checked, please explain here:
Enhances the susceptibility of a host population to the agent or toxin.
If checked, please explain here:
Generates or reconstitutes an eradicated or extinct agent or toxin listed in this form.
If checked, please explain here:
None of the 7 experimental effects listed above apply to this project.
After consideration of the answers provided above, do you consider this work to be “dual use research of concern”?
Yes / No

SECTION II: Infectious Agent or Biological Toxin Use

Will this project involve: human, animal or plant pathogens?Do you plan to attempt to isolate pathogens from blood or body fluids? Are you using human blood or body fluids highly suspected to contain human infectious agents? Do you plan to use biological toxins? If the answer is yes to any of these questions, please complete all of the questions in this section.

Yes / No

1.Please list genus, species and risk group; if describing a material, indicate any known pathogen:

2.Please list the infectious agents or biological toxinsto be used andindicate Yesor Nofor eachcategory. Please use Tab to add rows to the table as necessary.

Material, Infectious Agent or Biological Toxin / Human Hazard / Animal Hazard / Plant Hazard
Yes / No / Yes / No / Yes / No

3.Are any of the agents or toxins listed above Select Agents or Toxins?

Yes / No

NOTE: Select agents are not just the 15 on the dual use of concern list. Please review full list at this website:

4.If this project will involve a human pathogen or human material that originated outside the United States, a CDC Etiologic Agent Import Permit ( may be required.

The Office of Research Compliance can assist you in determining permit requirements and obtaining any necessary permits. If the appropriate permit(s) have already been obtained, please list the applicable permit number(s):

Permit: ______Permit:______Permit:______

5.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.).

6.If you will be using a human infectious agent or biological toxin, is a vaccine available?

Yes / No / N/A

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.

Please list dates and type of vaccination for all potentially exposed personnel (please use Tab to add rows to table as necessary):

Name

/

Vaccination

/

Date Received

/

Declined vaccine

(Y or N)

/

Declination Form on file (Y or N)

7.If this project will involve an animal or plant pathogen that originated outside of Georgia or the United States, a USDA APHIS import/transport permit will be required. See

The Office of Research Compliance can assist you in determining permit requirements and obtaining any necessary permits.

If the appropriate permit(s) have already been obtained, please list the applicable permit number: Permit: Permit: Permit:

SECTIONS A – E. Please answer YES or NO to the questions posed in Sections A through E, and fill out the information in the boxes as appropriate. For any sections in which you have answered ‘yes’, please answer all questions,entering ‘N/A’ or ‘not applicable’ as appropriate rather than leaving boxes blank.

A.Recombinant DNA

Will this project involve the use of recombinant DNA?

Yes / No / If the answer no is checked, please skip to B.Use of Human Samples below A #7.

1.Please specify the relevant guidelines that cover this work(for example, this work is exempt from the NIH Guidelines as per Appendix C-II, or Section III-D-1,Risk Group 2 host -vector system)

Seeformoreinformation.TheOfficeofResearch Compliance canassistyouindeterminingrelevantguidelines.

2.Please describe the source of the DNAincluding 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. Provide vector maps with this submission.

6.Will there be a deliberate attempt to express a foreign gene?

Yes / No

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:

7.Will the work involve the importation, movement, and/or field release of genetically engineered (GE) plants, insects, microorganisms, and anotherorganism that is known to, or could, be a plant pest?

Yes / No

See USDA Permits, Notifications and Petitions for more information. The Office of Research Compliance can assist you in determining permit requirements and obtaining any necessary permits. If the appropriate permit(s) have already been obtained, please list the applicable permit number(s):

Permit: ______Permit:______Permit:______

B.Use of Human Samples (blood, urine, saliva and other primary tissue from humans)

Will this project involve the use of human samples? If “Yes”, please complete the questions below and include your IRB approval documentation with this application.

Yes / No / If the answer no is checked, please skip to C. Plant Use below B #4.

1. List any human samples used:

1. Describe how these samples will be collected and handled:

1. Describe waste deactivation and disposal procedures:

1. Describe laboratory surface decontamination procedures:

C.Plant Use

Will this project involve use of plants? If “Yes”, please complete the questions below.

Yes / No / If the answer no is checked, please skip to D. Projects Involving Animal Studies below C #3.

1. List any plant species used:

1. Are any of these species regulated by the USDA? (e.g. noxious weeds, other regulated plants)?

Yes / No

If “yes”, describe any necessary special procedures for growing, handling, storing and disposal in #3.

1. Describe procedures for growing, handling, storing and disposal.

D.Projects Involving Animal Studies

1.Does this project involve use of animals?

Yes / No / If the answer no is checked, please skip to E. Transgenic Animalsbelow D #4

If "yes", please complete all questions in this section, noting number of animals in each category. You will also need to obtain approval of KSU’s Institutional Animal Care & Use Committee.

At the projects termination the animals will be: / Transferred to another project
Disposal (method)
Euthanized
Other
Final disposal of euthanized animals is incineration or KOH treatment.
How many animals to be used?
Specify what type of animals:

2.Please specify if or how inoculated animal species will shed the infectious agent or toxin.

3.Please check all personal protective equipment required in animal facilities:

Boots / shoe covers / Coveralls / lab coat
Rain suit / Gloves
Face shield / goggles / safety glasses (specify type)______
Mouth / nose / respiratory protection (specify type)______
Other (specify type)______

4.Please describe any special precautions to be used in the animal facility: (e.g., shower in/out).

E.Transgenic Animals

Will this project involve the use of transgenic animals?

Yes / No / If the answer no is checked, please skip to F. Key Personnelbelow E #4.

If yes, please complete these questions. Please attach the full transgenic animal project protocol as an appendix to this application.

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 KSU.

3.Describe the type and frequency of evaluations to be performedon the animals in this project.

4.Describe the marking system to be usedto individually identify all transgenic animals in this project and any resulting offspring.

SECTIONS F – J. Please respond completely to the information asked for in sections F – J

F.Key Personnel

List all project personnel including PI and everyone who does work related to the protocol. List relevant experience. This information is intended to inform the committee of the training and background of the investigators and key personnel. Please use Tab to add rows to the table as necessary.

Name and Degree / Specific Duties on Project / Number of Years Training and Description of Experience

G.Non-Technical Synopsis

Please give a brief description of project easily understood by nonscientists.Use phrasing and words that would be easily understood by someone having no knowledge of your project. Avoid using abbreviations and technical vocabulary or phrases. You can also attach a copy of the grant proposal abstract if desired.

H.Study Location Information

Location: Please use the Biological Materials Inventory Location Datasheet Form to document location information and submit with this application.

I.Containment Levels

If you have indicated "yes" to Sections A, B, C, D or E please complete the following:

1.Please check the federal guidelines applicable to the proposed project. The Office of Research can assist you in determining the proper guidelines.

For recombinant DNA and/or transgenic animals,refer to the NIH Guidelinesfor research involving recombinant DNA molecules:biosafety/nih-guidelines

Please indicate proposed biosafety containment level(s) to be used in this project.

rDNA Biosafety Level 1 (BL1) / rDNA Animal Biosafety Level 1 (BL1-N)
rDNA Biosafety Level 2 (BL2) / rDNA Animal Biosafety Level 2 (BL2-N)
rDNA Biosafety Level 3 (BL3) / rDNA Animal Biosafety Level 3 (BL3-N)
rDNA Large Scale Biosafety Level 1 (BL1-LS) / rDNA Plant Biosafety Level 1 (BL1-P)
rDNA Large Scale Biosafety Level 2 (BL2-LS) / rDNA Plant Biosafety Level 2 (BL2-P
rDNA Large Scale Biosafety Level 3 (BL3-LS) / rDNA Plant Biosafety Level 3 (BL3-P)

For human pathogens or toxins, refer to the CDC publicationBiosafety in Microbiological and Biomedical Laboratories:

Please indicate proposed biosafety containment level(s) to be used in this project.

Biosafety Level 1 (BSL-1) / Animal Biosafety Level 1 (ABSL-1)
Biosafety Level 2 (BSL-2) / Animal Biosafety Level 2 (ABSL-2)
Biosafety Level 3 (BSL-3) / 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 Office of Research for assistance with the development of prudent guidelines specific to the animal-only or plant-only pathogen or toxin used in 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)
Biosafety Level 2 (BSL-2) / Animal Biosafety Level 2 (ABSL-2)
Biosafety Level 3 (BSL-3) / Animal Biosafety Level 3 (ABSL-3)

J.Risk Evaluation and Procedures for Laboratory Safety and Experimentals

1. Equipment used in laboratory activities with biological material:

Centrifuge/micro-centrifuge / Vacuum/aspirating equipment / Vortex
Sonicator / Cell sorters / Cytospin
Aerosolization chamber / Pipettors / Speed vac
Homogenizer / Sharps (e.g. needles, scalpels) / Other______
Shaker / Grinding equipment

1. Aerosol generation?

Yes / No

1. Sharps Use?

Yes / No

1. Large scale (10L or greater)?

Yes / No

1. List primary hazard(s):

1. Assessment of severity:

Negligible / Minor / Serious
Critical / Catastrophic

1. Assessment of probability:

Improbable / Remote / Occasional
Probable / Frequent

1. Overall project risk:

Low (minimal) / Moderate / High

1. Engineering controls required:

Class I BSC / Ventilated animal cage rack system / Glove box
Class II BSC / Sealed centrifuge rotors / Downdraft Table
Class III BSC / Safety centrifuge cups / Filter top animal cage
Chemical fume hood / Other______

Please indicate the location of all engineering controls that you checked:

1. Specific training required by laboratory personnel engaged in this project (other than training required by KSU):

1. Please check all of the personal protective equipment (PPE) required:

Shoe covers / Lab coat
Head Cover / Gloves
Face shield / goggles / safety glasses (specify type)______
Mouth / nose / respiratory protection (specify type)______
Other (specify type)______

12.Please list any special precautions, in addition to the personal protective equipment and the regulatory guideline requirementsthat may be employed in the laboratory for safety and waste handling.

13.Describe the specific disposal and/or decontamination method(s) to be used for all biological waste (including animal carcass disposal) and contaminated equipment. Decontamination methods may include autoclaving, chemical disinfections, etc. If a chemical disinfectant is used, state type, concentration and contact time. Please use Tab to add rows to the table as necessary.

Type of Waste

/

Decontamination / Disposal Method