IBC Application

Institutional Biosafety Application

Instructions: Please complete this application if you plan on using infectious agents, select agents, recombinant DNA, blood, body tissues or fluids as part of your research, teaching or testing activities at Wake Forest University.

Protocol Title:(Required)

Type of Protocol:(Required)

New

Amendment

Resubmission

Protocol number if Amendment or Resubmission:(Required)

Is this application being submitted as part of a(n)?:

IACUC Application

IRB Application

If yes, Protocol # and Date submitted:(Required)

Section I: Principal Investigator Information

Principal Investigator:(Required)

Position/Title:(Required)

Department:(Required)

Phone #:(Required)

Date of IBC Online Training:(Required)

Will this project be funded by a grant, contract, or any pending grants or contracts?(Required)

Yes

N/A

Attach copy:(Required)

Max. file size: 23 MB.

If file is over 23 MB, email to spillmj@wfu.edu

List all personnel involved in the project and their respective roles:(Required)

Name

Roll

Section II: List of Biological Materials

Materials(Required)

Please provide an overall summary of the project, the specific aim(s) of the study and briefly explain in language understandable to the general public:(Required)

Section III: Research Identification

Biosafety level of the proposed work:(Required)

BSL 1

BSL 2

BSL 3

Animal Biosafety Level (if applicable):

ABSL 1

ABSL 2

ABSL 3

Will this project involve human subjects?(Required)

Yes

N/A

Explain how they will be used:(Required)

Attach copy of IRB approval(Required)

Max. file size: 23 MB.

If file is over 23 MB, email to spillmj@wfu.edu

Does the research involve human gene therapy?(Required)

Yes

N/A

Explain:(Required)

Will this project involve the use of animals?(Required)

Yes

N/A

Explain:(Required)

Attach copy of IACUC protocol(Required)

Max. file size: 23 MB.

If file is over 23 MB, email to spillmj@wfu.edu

Are any of your human, animal, or plant pathogens or toxins of biological origins classified as Select Agents?(Required)

Yes

N/A

If yes, STOP and contact the Biosafety Officer at (336) 758-3427. Select Agents require federal registration and authorization prior to use.

Will you be exporting/importing samples (tissues, blood, etc.), plasmids, or research products?(Required)

Yes

N/A

If yes, contact the Biosafety Officer at 336-758-3427 for preparation and shipment.

Section IV: Facilities, Safety Equipment and Materials Storage

Authorized Research locations

Lab Name / PI Name(Required)

Building(Required)

Room #(Required)

Autoclave present?(Required)

Yes

Autoclave Room #(Required)

Handwashing sink?(Required)

Yes

Eye wash station?(Required)

Yes

Biosafety Cabinet present?(Required)

Yes

Biosafety Cabinet Certification Date(Required)

Fume hood present?(Required)

Yes

Fume Hood Certification Date(Required)

Door locked w/ key?(Required)

Yes

Badge/card access?(Required)

Yes

Security Notes

Biological Materials Storage

Building(Required)

Room #(Required)

Equipment and Locations

-80°F Freezer Location(Required)

In this room

None

Other

-20°F Freezer Location(Required)

In this room

None

Other

Refrigerator(Required)

In this room

None

Other

Incubator(Required)

In this room

None

Other

Safety centrifuge/blender/grinder(Required)

In this room

None

Other

Automatic pipettors(Required)

In this room

None

Other

Other Equipment

Personal Protective Equipment (PPE)

Please check all of the PPE and equipment to be used by personnel.

Please check all of the PPE and equipment to be used by personnel:(Required)

Eye/Face protection

Lab Coat

Gloves

Head cover

Shoe covers

Tyveks/Disposable gowns

Check if Respiratory Protection is required:

N95 particulate respirator

PAPR (HEPA) respirator

If Respiratory Protection is required contact EHS for enrollment at 336-758-3427.

Section V: Recombinant DNA

Will your project involve rDNA work?(Required)

Yes

Give a brief summary of your proposed use of rDNA:(Required)

Are you using human DNA?(Required)

Yes

If yes, please complete Section VIII

Is any of the rDNA segment(s) placed inside a viable organism or virus?(Required)

Yes

N/A

Is the entire rDNA segment(s) from a single non-chromosomal or single viral DNA source?(Required)

Yes

N/A

Is the entire rDNA segment(s) from a prokaryotic host (including indigenous plasmids or viruses) and only propagated in that host?(Required)

Yes

N/A

Is the entire rDNA segment(s) from a single eukaryotic host (including chloroplasts, mitochondria, plasmids – but excluding viruses) and only propagated in that host?(Required)

Yes

N/A

Do the rDNA molecules consist entirely of DNA segments from one or more of the following species that exchange DNA by known physiological processes (though one or more of the segments may be a synthetic equivalent):

Does your research involve genomic DNA molecules that have acquired a transposable element which does not contain any recombinant and/or synthetic DNA?(Required)

Yes

N/A

Does use of rDNA molecules fall under one of the following categories in Section III-F-8 of the NIH Guidelines determined by the NIH Director as “those that do not present a significant risk to health or the environment”?(Required)

Yes

N/A

Explain:(Required)

Exemptions from the NIH Guidelines does not indicate that the PI is exempt form IBC Policies, other federal and state standards of biosafety or from completing this application

Select the NIH category for the rDNA experiments:(Required)

Section III-A Transfer of drug resistance genes into microorganisms that are not known to acquire the trait naturally)

Section III-B Cloning of toxin molecules with LD50 <100 Ng/kg body weight

Section III-C Deliberate transfer of rDNA, DNA, or RNA derived from rDNA into one or more human research participants

Section III-D DNA from risk Group 2,3,4 or restricted agents as host-vector systems; use of infectious or defective DNA or RNA viruses; whole animal and plants; large volumes and Influenza viruses.

Section III-E rDNA involving <2/3 of the genome of any Eukaryotic virus in the absence of helper virus or plasmids; whole plants; transgenic rodents

Will you express any drug or immunological resistance genes?(Required)

Yes

Explain:(Required)

Will you express any oncogenic or pathogenic genes?(Required)

Yes

Explain:(Required)

Will you express any toxins?(Required)

Yes

Explain:(Required)

Will you be using hosts, vectors or inserts?(Required)

Yes

Describe what they are, how they will be used, and safety features that prevent the generation of recombinant virus, along with methods of safety testing.(Required)

Which category of microorganism(s) is being used?

Algae, Unicellular

Archaea

Bacteria

Fungi

Parasitic worms

Protozoa

Virus

rDNA Agents, Risk Group, BSL, Provider(Required)

Agent Name

Risk Group

Biosafety Level (BSL)

Provider/Source

Are you using transgenic animals?(Required)

Yes

N/A

Are you using transgenic rodents?(Required)

Yes

N/A

Does this rodent strain contain a transgenic element constitution >50% of an exogenous viral genome?(Required)

Yes

N/A

Explain:(Required)

Does this rodent strain use a non-mouse promoter to express a transgene, such as a functional retroviral (LTR) promoter?(Required)

Yes

N/A

Explain:(Required)

Will you generate or use synthetic nucleic acid molecules (SNM)?(Required)

Yes

N/A

If yes, explain:(Required)

SNM contain more than 100 nucleotides.

SNM possess biological properties that enable integrations into the genome.

SNM have the potential to replicate in a cell.

SNM have the ability to be translated or transcribed.

Section VI: Non-recombinant or Synthetic DNA/RNA

Are you handling and Non-recombinant or Synthetic DNA/RNA(Required)

Yes

N/A

Are you handling DNA or RNA from pathogenic microorganisms?(Required)

Yes

N/A

Explain:(Required)

Are you handling oncogenic DNA sequences?(Required)

Yes

N/A

Explain:(Required)

Are you handing DNA containing drug resistance genes?(Required)

Yes

N/A

Explain:(Required)

Are you working with any prions?(Required)

Yes

N/A

If yes, list the name of prion, pathogenic PrP Isoform, disease and natural host :(Required)

Provider/supplier of the non-recombinant or synthetic DNA/RNA agents, safety precautions and types of sharps.(Required)

Provider/Supplier

Agents

Safety Precautions

Types of Sharps

Section VII: Infectious and Select Agents

Will your project use agents that are infectious or toxic to humans (excluding host for rDNA work)?(Required)

Yes

N/A

Agent 1(Required)

Agent

Strain/Isolates

Biosafety Level

Notes

Use of Agent 1: (check ALL that apply)(Required)

In vitro

In vivo animal

In vivo plant

Other:

Other Use 1:(Required)

Method of Inactivation 1:(Required)

Autoclave

Incinerate

Chemical

Other

Other method of inactivation 1:(Required)

Do you need to list an additional Agent? (2)(Required)

Yes

Agent 2(Required)

Agent

Strain/Isolates

Biosafety Level

Notes

Use of Agent 2: (check ALL that apply)(Required)

In vitro

In vivo animal

In vivo plant

Other:

Other Use 2:(Required)

Method of Inactivation 2:(Required)

Autoclave

Incinerate

Chemical

Other

Other method of inactivation 2:(Required)

Do you need to list an additional Agent? (3)(Required)

Yes

Agent 3(Required)

Agent

Strain/Isolates

Biosafety Level

Notes

Use of Agent 3: (check ALL that apply)(Required)

In vitro

In vivo animal

In vivo plant

Other:

Other Use 3:(Required)

Method of Inactivation 3:(Required)

Autoclave

Incinerate

Chemical

Other

Other method of inactivation 3:(Required)

Attach additional agents using above format.

Max. file size: 23 MB.

If file is over 23 MB, email to spillmj@wfu.edu

Section VIII: Blood, Body Fluids, Cell lines and Tissues

Do you plan to use Non-human primate blood/tissue/fluids/Cell lines/brain tissue(Required)

Yes

N/A

Do you plan to use Human blood/tissue/fluids/Cell lines/brain tissue(Required)

Yes

N/A

If you don’t plan to use any of the above, go to next section IX.

Describe the specific origin (source and provider), uses and infectious potential of tissue/fluids/cell lines/brain tissue(Required)

Describe how you plan to minimize the risk of infection (list procedures for inactivation/decontamination):(Required)

Have all personnel taken the Bloodborne Pathogen Training?(Required)

Yes

N/A

List names and dates in the table below:(Required)

Name

Date

Section IX: Biohazard Control Plan

Please address each item below:

Experimental Procedures(Required)

General types of experimental procedures that will be performed.

Risk Sources & Management(Required)

Potential sources of risk (aerosol generation, needle sticks, etc.) to personnel/environment and how risks will be managed.

Safety Devices(Required)

Describe safety devices that will be used (BSCs, sharps containers, PPE, etc.)

Decontamination Processes(Required)

Decontamination/disinfection processes

Waste Disposal Plan(Required)

Plans for disposing generated biological and chemical waste

Section X: Emergency Phone numbers and Procedures

Principal Investigator Emergency Phone Number(Required)

🏥 EMERGENCY PHONE NUMBERS

Police/Fire/Ambulance: 911
Wake Forest Police (Non-emergency): 336-758-5591
Environmental Health & Safety: 336-758-3427
After Hours EHS: 336-830-9394
Biomedical Waste: 336-758-3427
Spill Response: 336-830-9394
Post this form near lab phone

Section XI: Principal Investigator Agreement

PI Printed Name(Required)

Date(Required)

Environmental Health & Safety

Institutional Biosafety Application

Section I: Principal Investigator Information

Section II: List of Biological Materials

Section III: Research Identification

Section IV: Facilities, Safety Equipment and Materials Storage

Authorized Research locations

Biological Materials Storage

Equipment and Locations

Personal Protective Equipment (PPE)

Section V: Recombinant DNA

Section VI: Non-recombinant or Synthetic DNA/RNA

Section VII: Infectious and Select Agents

Section VIII: Blood, Body Fluids, Cell lines and Tissues

Section IX: Biohazard Control Plan

Section X: Emergency Phone numbers and Procedures

Section XI: Principal Investigator Agreement

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