ISC Application

Application to the Institutional Safety Committee


* Required Fields

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Section I Administrative Information

Administrative Project Information


Project anticipated start date:*
(click field to select date from calendar)
Project anticipated end date:*
(click field to select date from calendar)
This project contains environmental sustainability component(s)*
Application includes confidential information that should not be disclosed or discussed in a public meeting.*
Project Category: (select all that apply)*
Course is typically taught: (select all that apply)*

Principal Investigator (PI) - (Faculty ONLY, list students as co-investigators)


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PI Name:*

If there is no Chair for this Department/Division - Please use the Name below and select the email at the bottom of the drop-down list:
Laura Hutchison -  lhutchison@fgcu.edu

Dept/Div Chair Name:*

Note: The Application cannot be processed if the email address is incorrect.

Dean Name:*

Note: The Application cannot be processed if the email address is incorrect.

Co-Investigator(s) (Co-PI)

 

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Number of Co-investigators*
Co-PI #1 Name:*
Co-PI #2 Name: *
Co-PI #3 Name: *

Co-Investigator(s) (Co-PI)

 4 or More - Co-Investigators (Co-PIs)

Data File Must Include:  Full Name and Email- For Each Co-PI

Data Upload for 4 or more Co-PIs*
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Research Team Members

The following individual(s) will be involved with the protocol   

FGCU Student(s):*

Student Participants or Involvement

If there is any student involvement upload a data file.
Data File Must Include: Full Name and Email of each Student (email is required for training program registration)


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File of Student Data*
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Minor:*
Non-affiliated Adult Student/ Dual Enrollment Student:*
Volunteer:*
Post Doc:*
Courtesy Faculty:*

Non-affiliated Adult, Volunteer, Post Doc

Upload the name and email address for each so the training materials can be sent.

Upload data File (Name and Email):
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Visiting Faculty or Scholar:*

Collaborating Institutions

Data File for 3 or More - Collaborating Institutions

Data File Must Include: 

Collaborating Institution’s Name - Full (mailing) Address - Protocol Name & Number (if applicable) – Attach a copy of the institutional letter of cooperation and approved protocol, if appropriate.-  For Each Institution

Is this work being undertaken with another entity?*
Select the Number of Collaborating Entities:*
Name & Mailing Address
#1 Protocol approved by Collaborating institution's Research Safety Committee or equivalent? *
#1 Approval Date:*
(click field to select date from calendar)
Name & Mailing Address
#2 Protocol approved by Collaborating institution's Research Safety Committee or equivalent? *
#2 Approval Date: *
(click field to select date from calendar)
3 or More -Upload Data file for all Entities*
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Funding


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Funding
Select the Number of Funding Sources this project is recieving:*
3 or More Sponsors -Upload Data File
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Upload Grant: (if applicable)
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#1 Does this Require Notice of FGCU ISC Approval?
#2
#2 Does this Require Notice of FGCU ISC Approval?

Conflict of Interest

The PI, a co-investigator, research team member, or family member developed the technology, process or product involved in the study.
The PI, a co-investigator, research team member, or family member, holds a financial interest in the technology, process or product involved in this study
The PI, a co-investigator, research team member, or family member is an employee of or holds an executive position in a business engaged in activities related to the study.

Section II Description

Project Description

Please describe the experimental design, e.g., the steps of the experimental design/methodology, the procedures/processes to collect, store, analyze, and dispose of the samples; the analysis that will be performed including the chemicals used; the method(s) used in the analysis, e.g., EPA method, etc.     
 

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Attach copies of any required permits and licenses.
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Section III Risk Assessment

Risk Assessment

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All Text Boxes have a 3,000-character limit.

1. Hazardous waste requiring EH&S disposal will be generated.*
2. Human samples will be used in this project.*
3. Live animals will be used in this project.*
4. Chemicals and/or Reagents will be used in this project, including those administered to animals.*

The Protocol involves the use of the following: (select all that apply)


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4a. This Project will use Chemicals Only.*
4b. Pesticide (substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest) [regulated by the Federal Insecticide, Fungicide, and Rodenticide Act].*
4c. Explosive chemical compound, mixture, or device that is substantially instantaneous with the release of gas and heat [regulated by the Bureau of Alcohol, Tobacco, Firearms, and Explosives].*
4d. Pyrophoric that ignites spontaneously in air at a temperature of 130 0F (54.4 0C) or below [defined by OSHA (29 CFR 1910.1200(c)]. *
4e. Water reactive chemical.*
4f. “Highly toxic” substance.*
“Highly toxic” substance with a high degree of acute toxicity that meets one of the following criteria: -*
4g. Nanoparticle, measuring in the nanoscale (1-100 nanometers) or project that utilizes nanoparticles or nanochemistry.*
4h. Commonly known chemical that has a stimulant, depressant, or hallucinogenic effect on the nervous system.*
4i. Controlled substances are prescription drugs that are further classified as Schedule I-V and can only be obtained by registrants with the DEA.*
4j. Hazardous chemical, Reagent and/or Precursor Chemical (List I and II Chemical) which has the potential to be used in the manufacture of controlled substances.*
4k. Antineoplastic agent or chemotherapeutic agent that controls or kills cancer cells [defined by NIOSH].*
4l. Carcinogen.*
Select carcinogen listed under:*
4m. Please select which one applies:*
Explain
5. Gases, including compressed gases will be used in this project.*
5a. Please select all that apply:*
6. Environmental Samples*
7. Biological Material will be used.*
8. Select Agents will be used in this project.*
9. Recombinant DNA technology will be used in this project.*
10. Laser technology will be used in this project. *
10a. This project will use a Class 3B or 4 Laser.*
11. Working with materials/instruments, etc., (sealed, unsealed, x-ray producing), with a radioactive label.*
11a. Check all that apply: *

Samples

THE FOLLOWING WILL BE INCORPORATED INTO THIS PROTOCOL.

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Origin of the Sample(s):*
Select all that apply
Sample(s) will be shipped out by FGCU at some point during the protocol’s phases. *

Collected Sample(s)

1. Identify the Sample(s) you will be collecting.



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2. Sample Collection



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2f. Upload - Sample Collectors Spreadsheet:
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3. Transferring Samples from the Field to Campus


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3e. Upload - Sample Transporter Spreadsheet:
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Purchased/Donated Sample(s)



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Sample Storage


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Research Protocol

Shipping


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6. I have documentation that all individuals "hands on" with shipping have completed the appropriate CITI and Canvas training (or an equivalent training)on shipping hazardous materials.*
6a. Hazardous Materials Shipping Training Documents.
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4a. Chemicals Only

2a. Individuals performing procedures spreadsheet. (Name, Title/Student Status)
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4. Identify the controls to mitigate the potential hazards:

5. Gas, Fuel and Cryogenic Liquids

Gas, Fuel, and Cryogenic Liquids

* Re

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quired Fields

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5. Gas, Fuel, and Cryogenic Liquids*
Please select the number of substance(s) you plan to use: *

Gas, Fuel, and Cryogenic Liquids

4 or More

The data File Must include all items below for each substance:

  • Gas Name
  • CAS, Vendor Name & Address
  • Gas Class, concentration Quantity (cu. ft.)
  • IDLJ (ppm)
  • PEL (ppm)
  • LD (ppm)
  • Building/Site of storage (including room #)
  • Physical Containment Equipment
  • Dates (start & finish)  
  • What will it be used for
  • Unique Hazards
  • Emergency Response (exposure plan)
  • PPE
  • Additional safety Precautions
Upload Data File for 4 or more Gases
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#1 Physical Containment Equipment:*
#1 Use Date From:*
#1 Use Date To:*
#1 HAZARD CONTROLS - Personal Protection Equipment & Laboratory Safety Controls:*
#2 Physical Containment Equipment: *
#2 Use Date From: *
#2 Use Date To: *
#2 HAZARD CONTROLS - Personal Protection Equipment & Laboratory Safety Controls: *
#3 Physical Containment Equipment: *
#3 Use Date From: *
#3 Use Date To: *
#3 HAZARD CONTROLS - Personal Protection Equipment & Laboratory Safety Controls: *

9. Recombinant DNA/ Genetically Modified Organisms

Recombinant DNA (rDNA)

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Section IV-B-1-h of the NIH Guidelines requires that Principal Investigators and laboratory staff working with rDNA complete training in laboratory safety and implementation of the NIH Guidelines. 

This training requirement can be satisfied by completing the CITI Recombinant DNA (rDNA) Guidelines course.

Note: rDNA that is exempt from the NIH Guidelines needs to be registered with the Institutional Safety Committee.

Please select the appropriate rDNA category below to generate the correct section.

9. Recombinant DNA*
1. My experiment will increase the pathogenicity and/or drug resistance of a pathogen with the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally. This could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture. (NIH Section III-A) *

The experiment requires approval from the FGCU Institutional Safety Committee, RAC Review, and NIH Director Approval BEFORE initiation of the project.

2. My experiment will deliberately form recombinant DNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight (e.g., microbial toxins such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae neurotoxin). (NIH Section III-B)*

The experiment requires approval from the FGCU Institutional Safety Committee and NIH/OBA BEFORE initiation of the project.

3. My experiment involves the the deliberate transfer of rDNA, DNA or RNA derived from recombinant DNA, into human research participants. (NIH Section III-C)*

The experiment requires approval from the FGCU Institutional  Safety Committee, the FGCU IRB, and RAC BEFORE enrollment of participants can begin.

4. My experiment involves the use of Risk Group 2, 3, 4, or Restricted Agents as Host-Vector Systems. (NIH Section III-D-1)*

The experiment requires notice to the FGCU Institutional Safety Committee BEFORE initiation of the project.

5. My experiment involves the transfer of DNA from Risk Group 2, 3, 4 or Restricted Agents (see Section II-A, Risk Assessment) into nonpathogenic prokaryotes or lower eukaryotes host-vector systems. (NIH Section III-D-2).*

The experiment requires notice to the FGCU Institutional Safety Committee BEFORE initiation of the project.

6. My experiment involves the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems. (NIH Section III-D-3)*

The experiment requires notice to the FGCU Institutional Safety Committee BEFORE initiation of the project.

7. My experiment involves the use of whole animals in which the animal's genome has been altered by the stable introduction of rDNA, or DNA derived therefrom, into the germ-line (transgenic animals) and experiments involving viable recombinant DNA-modified microorganisms tested on whole animals. (NIH Section III-D-4)*

The experiment requires notice to the FGCU Institutional Safety Committee BEFORE initiation of the project.

8. My experiment involves the use of whole plants. Based on present understanding, the genetically altered plants will be biohazardous and/ or have the potential for a detrimental impact on the natural ecosystem. (NIH Section III-D-5)*

The experiment requires notice to the FGCU Institutional Safety Committee BEFORE initiation of the project.

9. My experiment involves the use of whole plants. Based on present understanding, the genetically altered plants WILL NOT be biohazardous and/or have the potential for a detrimental impact on the natural ecosystem. (NIH Section III-D-5) *

The experiment requires notice to the FGCU Institutional Safety Committee BEFORE initiation of the project.

10. My experiment involves the use of more than 10 liters of culture. (NIH Section III-D-6)*

The experiment requires notice to the FGCU Institutional Safety Committee BEFORE initiation of the project.

11. My experiment involves the use of influenza viruses generated by recombinant methods (e.g., generation by reverse genetics of chimeric viruses with re-assorted segments, introduction of specific mutations) (NIH Section III-D-7)*

The experiment requires notice to the FGCU Institutional Safety Committee BEFORE initiation of the project.

12. My experiment involves the formation of rDNA Molecules containing no more than two-thirds of the genome of any Eukaryotic Virus (NIH Section III-E)*

The experiment requires notice to the FGCU Institutional Safety Committee simultaneous initiation of the project.

My use of rDNA is exempt because

Note: Registration with the Institutional Safety Committee is needed to track all rDNA use on campus for reporting when required. Please provide the information on the following page to register the use of each source.

13. My experiment involves use of rDNA molecules that are not in organisms or viruses. (NIH Section III-F)*
14. My experiment involves use of rDNA molecules that that consist entirely of DNA segments from a single non-chromosomal or viral DNA source, and one or more of the segments are a synthetic equivalent. (NIH Section III-F)*
15. My experiment involves use of rDNA molecules that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or transferred to another host by well established physiological means. (NIH Section III-F)*
16. My experiment involves use of rDNA molecules that consist entirely of DNA from an eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) propagated only in that host (or a closely related strain of the same species). (NIH Section III-F)*
17. My experiment involves use of rDNA molecules that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. (NIH Section III-F)*
18. My experiment involves use of rDNA molecules that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)- (c), Major Actions), as determined by the NIH Directors. (NIH Section III-F)*

10. Laser

Laser

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10. Laser*
Select the number of Laser(s) you'll be using: *
Specify
Specify
Specify
nm
w
w
J
nm
sec
Hz
J
mm
#1 Beam - Divergence*
#1 Beam - Interlocks are: *
#1 Check all that apply to your laser: *
#1 Check all that apply to your laser:*
Explain

HAZARD CONTROLS for #1

Personal Protection Equipment & Laboratory Safety Controls:

#1 Select All that Apply*
#2 Laboratory Safety Controls: *
Select all the apply
Explain
Specify
Specify
Specify
nm
W
W
J
nm
sec
Hz
J
mm
#2 Beam - Divergence:*
mrad
#2 Beam - Interlocks are: *
#2 Check all that apply to your laser: *
#2 Check all that apply to your laser: *
Explain

HAZARD CONTROLS for #2

Personal Protection Equipment:



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#2 Select All that Apply:*
#2 Laboratory Safety Controls: *
Select all the apply
#2 Location/Building:*
Specify
Specify
Specify
nm
W
W
J
nm
sec
Hz
J
mm
#3 Beam - Divergence: *
mrad
#3 Beam - Interlocks are: *
#3 Check all that apply to your laser: *
#3 Check all that apply to your laser:*
Explain

HAZARD CONTROLS for #3

Personal Protection Equipment:



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#3 Select All that Apply*
#3 Laboratory Safety Controls: *
Select all the apply
#3 Laboratory Safety Controls:*
Select all that apply
Explain
e.g., general lab, etc.

Laser

4 or More

The data File Must include all items below for each laser:

  • Laser Type
  • Hazard Class
  • Manufacture
  • Model
  • Continuous Wave
    • Wavelength(s) (nm)
    • Max. Op. Power (w)
    • Avg. Op. Power (w)
    • Max. Op. Energy (J)
  • Pulse
    • Wavelength(s) (nm)
    • Duration (sec)
    • Repetition Rate (Hz)
    • Avg. Op. Power (J)
  • Beam
    • Shape
    •  Dimensions at Aperture (mm)
    • Divergence
    • Interlocks are (Fail-Safe or Defeatable)
  • Type of Laser
  • Use of each Laser
  • Unique Hazards
  • PPE
  • Laboratory safety controls and Additional Safety Precautions
  • Location Type, Building, and Room Number
Upload Data File for 4 or More Lasers:
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11-A. Radioactive Material: Unsealed Source

Radioactive Materials: Unsealed Source

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11-A. Unsealed Source*
Select the number of Radio Active Material(s) you plan to use:*
The Authorized User is authorized to use radioactive materials by the State of Florida Bureau of Radiation Control. *
The applicant is not an Authorized User.*
The Authorized User for this project is:*
All personnel involved in this project other than the applicant are Supervised Users, Authorized Users or Student Users. *
All laboratory personnel have completed the FGCU Radiation Safety Training Course . *

#1 Isotope

#1 Physical Containment Equipment:*

#2 Isotope

#2 Physical Containment Equipment: *

#3 Isotope

#3 Physical Containment Equipment: *

Radioactive Materials: Unsealed Source

4 or More

The data File Must contain the data below for each Source:

  • Isotope
  • Physical Form
  • Max. Activity in Possession
  • Max. Activity in any Experiment
  • Physical containment Equipment
  • Storage building/Site and Room #
  • Use of Radioactive Material
  • Unique Hazards
  • PPE
  • Laboratory safety Controls
  • Methods to Measure Radiation Levels
  • Protocol Managing Breakage and Clean-up
  • Exposure Plan
Upload file with all Radioactive Materials and the correlating information:
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HAZARD CONTROLS

Personal Protection Equipment:

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Select All that Apply*
Laboratory Safety Controls: *
Select all that apply
Describe

11-B. Radioactive Material: Sealed Source

Radioactive Material: Sealed Source


* Required Fields

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11-B. Radioactive Material: Sealed Source*
Select the number of Radioactive Material(s) you plan to use:*
The applicant is the Authorized User is authorized to use radioactive materials by the State of Florida Bureau of Radiation Control. *
The applicant is not an Authorized User.*
The Authorized User for this project is:*
All personnel involved in this project other than the applicant are Supervised Users, Authorized Users or Student Users. *
All laboratory personnel have completed the FGCU Radiation Safety Training Course.*

#1 Isotope

#1 Physical Containment Equipment:*
List Here

#2 Isotope

#2 Physical Containment Equipment: *

#3 Isotope

#3 Physical Containment Equipment: *

Radioactive Materials: Sealed Source

4 or More

The data File Must contain the data below for each Source:

  • Isotope
  • Physical Form
  • Max. Activity in Possession
  • Max. Activity in any Experiment
  • Physical containment Equipment
  • Storage building/Site and Room #
  • Use of Radioactive Material
  • Unique Hazards
  • PPE
  • Laboratory safety Controls
  • Methods to Measure Radiation Levels
  • Protocol Managing Breakage and Clean-up
  • Exposure Plan
12. Upload file with all Radioactive Materials and the correlating information:
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HAZARD CONTROLS

Personal Protection Equipment:



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Select All that Apply*