Human research participants laboratory animal subjects biological physical containment safety equipment

University of Missouri-Columbia

IBC #

User Registration No.

INSTITUTIONAL BIOSAFETY COMMITTEE APPLICATION

Grayed Areas for IBC Use Only

Form Reviewed by:

Date:

Form Routed to:

Date:

NOTE: IBC Application instructions available at http://ehs.missouri.edu/bio/forms/bio-Material-instructions.doc

1. Protocol Title:

2. Principal Investigator

E-mail Address

Department

Title

Campus Address

Campus Phone

Co-Investigator

E-mail Address

Department

Title

Campus Address

Campus Phone

3. Application Type ☐ New ☐ Amendment ☐ Renewal

4. Dates of Proposed Research

5. Primary Research Locations and Multiuser Rooms

Building	Room #	Biosafety Level	Shared Room	Inspected
			☐
			☐
			☐
			☐

6. Research Storage and Biosafety Cabinet Locations

Biohazardous Agent	Building	Room #	Storage/Biosafety Cabinet	Shared	Secured	Inspected
				☐	☐
				☐	☐
				☐	☐
				☐	☐

7. Research Animal or Plant Locations

Animal/Plant	Building/Farm	Room #	Biosafety Level	Shared
				☐
				☐
				☐

8. Research Personnel

Name	Employee ID or Student ID	E-mail	Title/Role	Training Class		Date of Last Training
Name	Employee ID or Student ID	E-mail	Title/Role	Intro	BBP	Date of Last Training
				☐	☐
				☐	☐
				☐	☐
				☐	☐
				☐	☐
				☐	☐

9. Research Core Facility (Fee for Service Operations)

Name of Core Facility

Building

Core Director

IBC Protocol #

10. Protocol Risk Assessment

Answer all sub-questions to any question that is answered Yes.

Use of (receiving) biohazardous or recombinant material (animal, plant, human tissue, etc) from a non-MU collaborator? ☐ Yes ☐ No
1. Collaborator information (NOTE: see instructions for additional information needed in #13d)

Use of Recombinant DNA Molecules? ☐ Yes ☐ No
1. Source of cloned DNA

Nature of inserted DNA

Vector(s) Used: Phage (Vectors Used)

Plasmids (conjugative/non conjugative)

Viral Component(s) sequence(s) present?
Host organism(s) for foreign sequences
Will an attempt be made to obtain expression of a foreign gene? ☐ Yes ☐ No
1. What Protein will be produced?
2. Indicate possible toxicity or other hazards, if any:
NIH Experiment Type (Contact EHS for assistance)

Use of Biological Organisms/Agents? ☐ Yes ☐ No
1. Identify Biological Organisms/Agents to be used in conjunction with this protocol and their risk level

Use of a Select Agent/Toxin? ☐ Yes ☐ No
1. Identify all Select Agents/Toxins to be used in conjunction with this protocol:

Use of Radioactive Materials? ☐ Yes ☐ No
1. Type of Isotope(s) to be Used
2. Date of Radiation Safety Committee Approval ☐ Pending Approval

Use of Research Animal Subjects? ☐ Yes ☐ No
1. Genus/Species of Animal
2. Transgenic Animal ☐ Yes ☐ No
  1. Genetic Alteration
3. ACUC Protocol Approval Number ☐ Pending Approval

Use of Animal Blood/Tissue (OPIM—Zoonotic)? ☐ Yes ☐ No
1. Genus/Species of Animal
2. Other Potentially Infectious Material (OPIM) ☐ Yes ☐ No

(a) Identify Zoonotic Disease (OPIM)

Use of Whole Plants? ☐ Yes ☐ No
1. Genus/Species of Plant
2. Transgenic Plant ☐ Yes ☐ No
  1. Genetic Alteration
3. Any rDNA derived from a plant pathogen? ☐ Yes ☐ No

Use of Human Blood, Tissues, Cell Lines or OPIM? ☐ Yes ☐ No
1. Are you using human subjects in this research? ☐ Yes ☐ No
2. Institutional Review Board Protocol Approval Number ☐ Pending Approval

Conducting Gene Therapy or Vaccine Trial? ☐ Yes ☐ No
1. Institutional Review Board Protocol Approval Number ☐ Pending Approval

Will over 10 Liters of Material be possessed at any one time? ☐ Yes ☐ No

11. Proposed Biosafety Level ☐ BL-1 ☐ BL-2 ☐ BL-3

12. Mitigation Assessment

For 12.a. – 12.f. below answer all sub-questions to any question that is answered Yes.

What PPE Devices will be used? ☐ Gloves ☐ Safety Glasses

☐ Lab Coat ☐ Respirator/Mask

☐ Other:

Will access to the laboratory be controlled? ☐ Yes ☐ No
1. How so?
Is a Biological Safety Cabinet available for use? ☐ Yes ☐ No
1. Provide Serial# or EHS MU ID#? Last certification date?
Have Emergency Procedures been developed to respond to an incident? ☐ Yes ☐ No
1. Date of Creation or Last Review
Has an Exposure Control Plan been developed for Laboratory Workers? ☐ Yes ☐ No ☐ N/A
1. Date of Creation or Last Review
Has Emergency Notification and Biohazard signage been posted? ☐ Yes ☐ No ☐ N/A
1. Date of Creation or Last Review
Have all personnel been offered vaccinations/titer check for all material

to be used in your research? ☐ Yes ☐ No ☐ N/A

13. Scope of Work

For 13.a. – 13g. below see instruction document at http://ehs.missouri.edu/bio/forms/bio-Material-instructions.doc

for specific information that must be provided in the fields below.

Purpose of the experiment:

Rationale for the use of the agent:

Description of the experimental procedures

Assessment of risk for your (specific) research protocol

The experimental amplification risk

The use of whole transgenic plants and/or animals

Human research participants used and /or laboratory animal subjects used

STATEMENT OF AGREEMENT

I certify that the information contained in the completed application form, dated _____________, is accurate to the best of my knowledge. I agree to comply with all IBC requirements with regard to the use, handling, storage and disposal of biohazardous agents and recombinant DNA molecules. I also agree to follow the current NIH Guidelines for the Use of Recombinant DNA Molecules, the CDC recommendations from the CDC/NIH handbook, Biosafety in Microbiological and Biomedical Laboratories, 5th Edition and all MU Biosafety Guidelines and Regulations.
I further attest that all research personnel under my supervision on this project, have attended all appropriate biosafety training sessions and that they are familiar with the hazards and symptoms of exposure relevant to the biological Materials used within the laboratory. All laboratory personnel have been briefed on emergency procedures, good laboratory work practices, and the safe operation of laboratory equipment prior to the initiation of experimental work.
I will select and provide personal protective equipment to all laboratory workers as recommended by NIH, CDC, and/or MU that is necessary for experimental procedures. All required biosafety cabinets shall be certified annually and maintained properly. Any vaccinations or medical surveillance requirements recommended by the IBC and MU Occupational Health Safety Program (OHSP) will also be met prior to the initiation of experimental work.
I will complete all required forms and approvals in compliance with the Institutional Review Board (IRB) for any human subject research and Animal Care and Use Committee (ACUC) for any animal subject research prior to initiation of experimental work.
I will notify the MU Biosafety Professional and the respective departmental chair in the event of any of the following:
1. Any accident that results in inoculation, ingestion, and inhalation of biohazardous agents or recombinant DNA or any incident causing serious exposure of personnel or danger of environmental contamination.
2. Any problem pertaining to the operation of biological and physical containment safety equipment such as a biosafety cabinet or a facility failure such as a power outage which may compromise building engineering controls and consequently, the safety of the workers in the lab.
I will notify the MU Biosafety Professional when the experimental work has been completed and/or I am leaving MU, after which a close-out inspection will be conducted at least two weeks before the date of departure/completion.
I will not proceed with the experiment until I have received an official notice of approval from the IBC unless otherwise specified or exempted. I acknowledge IBC approval granted by this application is non-transferable to any other MU researcher.
I acknowledge and understand that failure to comply with any of the above items, as well as the failure to comply with Federal and/or State statutes and their associated regulations will be reported to the IBC. Further, that the IBC has the power and authority thru the Office of Research to take appropriate actions to rectify any non-compliance, including but not limited to letters of reprimand, sanctions against the Principal Investigator, suspension of research activities of Principal Investigator, and revocation of all IBC approved research protocols.

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Human research participants laboratory animal subjects biological physical containment safety equipment

University of Missouri-Columbia

IBC #

User Registration No.

INSTITUTIONAL BIOSAFETY COMMITTEE APPLICATION

Grayed Areas for IBC Use Only

Form Reviewed by:

Date:

Form Routed to:

Date:

NOTE: IBC Application instructions available at http://ehs.missouri.edu/bio/forms/bio-Material-instructions.doc

1. Protocol Title:

2. Principal Investigator

3. Application Type ☐ New ☐ Amendment ☐ Renewal

4. Dates of Proposed Research

5. Primary Research Locations and Multiuser Rooms

Building	Room #	Biosafety Level	Shared Room	Inspected
			☐
			☐
			☐
			☐

6. Research Storage and Biosafety Cabinet Locations

Biohazardous Agent	Building	Room #	Storage/Biosafety Cabinet	Shared	Secured	Inspected
				☐	☐
				☐	☐
				☐	☐
				☐	☐

7. Research Animal or Plant Locations

Animal/Plant	Building/Farm	Room #	Biosafety Level	Shared
				☐
				☐
				☐

8. Research Personnel

Name	Employee ID or Student ID	E-mail	Title/Role	Training Class		Date of Last Training
Name	Employee ID or Student ID	E-mail	Title/Role	Intro	BBP	Date of Last Training
				☐	☐
				☐	☐
				☐	☐
				☐	☐
				☐	☐
				☐	☐

9. Research Core Facility (Fee for Service Operations)

Name of Core Facility

Building

Core Director

IBC Protocol #

10. Protocol Risk Assessment

Answer all sub-questions to any question that is answered Yes.

Use of (receiving) biohazardous or recombinant material (animal, plant, human tissue, etc) from a non-MU collaborator? ☐ Yes ☐ No
1. Collaborator information (NOTE: see instructions for additional information needed in #13d)

Use of Recombinant DNA Molecules? ☐ Yes ☐ No
1. Source of cloned DNA

Nature of inserted DNA

Vector(s) Used: Phage (Vectors Used)

Plasmids (conjugative/non conjugative)

Viral Component(s) sequence(s) present?
Host organism(s) for foreign sequences
Will an attempt be made to obtain expression of a foreign gene? ☐ Yes ☐ No
1. What Protein will be produced?
2. Indicate possible toxicity or other hazards, if any:
NIH Experiment Type (Contact EHS for assistance)

Use of Biological Organisms/Agents? ☐ Yes ☐ No
1. Identify Biological Organisms/Agents to be used in conjunction with this protocol and their risk level

Use of a Select Agent/Toxin? ☐ Yes ☐ No
1. Identify all Select Agents/Toxins to be used in conjunction with this protocol:

Use of Radioactive Materials? ☐ Yes ☐ No
1. Type of Isotope(s) to be Used
2. Date of Radiation Safety Committee Approval ☐ Pending Approval

Use of Research Animal Subjects? ☐ Yes ☐ No
1. Genus/Species of Animal
2. Transgenic Animal ☐ Yes ☐ No
  1. Genetic Alteration
3. ACUC Protocol Approval Number ☐ Pending Approval

Use of Animal Blood/Tissue (OPIM—Zoonotic)? ☐ Yes ☐ No
1. Genus/Species of Animal
2. Other Potentially Infectious Material (OPIM) ☐ Yes ☐ No

(a) Identify Zoonotic Disease (OPIM)

Use of Whole Plants? ☐ Yes ☐ No
1. Genus/Species of Plant
2. Transgenic Plant ☐ Yes ☐ No
  1. Genetic Alteration
3. Any rDNA derived from a plant pathogen? ☐ Yes ☐ No

Use of Human Blood, Tissues, Cell Lines or OPIM? ☐ Yes ☐ No
1. Are you using human subjects in this research? ☐ Yes ☐ No
2. Institutional Review Board Protocol Approval Number ☐ Pending Approval

Conducting Gene Therapy or Vaccine Trial? ☐ Yes ☐ No
1. Institutional Review Board Protocol Approval Number ☐ Pending Approval

Will over 10 Liters of Material be possessed at any one time? ☐ Yes ☐ No

11. Proposed Biosafety Level ☐ BL-1 ☐ BL-2 ☐ BL-3

12. Mitigation Assessment

For 12.a. – 12.f. below answer all sub-questions to any question that is answered Yes.

What PPE Devices will be used? ☐ Gloves ☐ Safety Glasses

☐ Lab Coat ☐ Respirator/Mask

☐ Other:

Will access to the laboratory be controlled? ☐ Yes ☐ No
1. How so?
Is a Biological Safety Cabinet available for use? ☐ Yes ☐ No
1. Provide Serial# or EHS MU ID#? Last certification date?
Have Emergency Procedures been developed to respond to an incident? ☐ Yes ☐ No
1. Date of Creation or Last Review
Has an Exposure Control Plan been developed for Laboratory Workers? ☐ Yes ☐ No ☐ N/A
1. Date of Creation or Last Review
Has Emergency Notification and Biohazard signage been posted? ☐ Yes ☐ No ☐ N/A
1. Date of Creation or Last Review
Have all personnel been offered vaccinations/titer check for all material

to be used in your research? ☐ Yes ☐ No ☐ N/A

13. Scope of Work

For 13.a. – 13g. below see instruction document at http://ehs.missouri.edu/bio/forms/bio-Material-instructions.doc

for specific information that must be provided in the fields below.

Purpose of the experiment:

Rationale for the use of the agent:

Description of the experimental procedures

Assessment of risk for your (specific) research protocol

The experimental amplification risk

The use of whole transgenic plants and/or animals

Human research participants used and /or laboratory animal subjects used

STATEMENT OF AGREEMENT

I certify that the information contained in the completed application form, dated _____________, is accurate to the best of my knowledge. I agree to comply with all IBC requirements with regard to the use, handling, storage and disposal of biohazardous agents and recombinant DNA molecules. I also agree to follow the current NIH Guidelines for the Use of Recombinant DNA Molecules, the CDC recommendations from the CDC/NIH handbook, Biosafety in Microbiological and Biomedical Laboratories, 5th Edition and all MU Biosafety Guidelines and Regulations.
I further attest that all research personnel under my supervision on this project, have attended all appropriate biosafety training sessions and that they are familiar with the hazards and symptoms of exposure relevant to the biological Materials used within the laboratory. All laboratory personnel have been briefed on emergency procedures, good laboratory work practices, and the safe operation of laboratory equipment prior to the initiation of experimental work.
I will select and provide personal protective equipment to all laboratory workers as recommended by NIH, CDC, and/or MU that is necessary for experimental procedures. All required biosafety cabinets shall be certified annually and maintained properly. Any vaccinations or medical surveillance requirements recommended by the IBC and MU Occupational Health Safety Program (OHSP) will also be met prior to the initiation of experimental work.
I will complete all required forms and approvals in compliance with the Institutional Review Board (IRB) for any human subject research and Animal Care and Use Committee (ACUC) for any animal subject research prior to initiation of experimental work.
I will notify the MU Biosafety Professional and the respective departmental chair in the event of any of the following:
1. Any accident that results in inoculation, ingestion, and inhalation of biohazardous agents or recombinant DNA or any incident causing serious exposure of personnel or danger of environmental contamination.
2. Any problem pertaining to the operation of biological and physical containment safety equipment such as a biosafety cabinet or a facility failure such as a power outage which may compromise building engineering controls and consequently, the safety of the workers in the lab.
I will notify the MU Biosafety Professional when the experimental work has been completed and/or I am leaving MU, after which a close-out inspection will be conducted at least two weeks before the date of departure/completion.
I will not proceed with the experiment until I have received an official notice of approval from the IBC unless otherwise specified or exempted. I acknowledge IBC approval granted by this application is non-transferable to any other MU researcher.
I acknowledge and understand that failure to comply with any of the above items, as well as the failure to comply with Federal and/or State statutes and their associated regulations will be reported to the IBC. Further, that the IBC has the power and authority thru the Office of Research to take appropriate actions to rectify any non-compliance, including but not limited to letters of reprimand, sanctions against the Principal Investigator, suspension of research activities of Principal Investigator, and revocation of all IBC approved research protocols.

<< Veterinary Assistants Laboratory Animal Caretakers Clean and disinfect cages work areas sterilize laboratoryAbility provide care study subject patient animal repairs and operate equipment instruments support research laboratory >>