Administrative Panel Laboratory Animal Care All equipment biohazards agents Biohazard labels further attest

SUBMIT BY MAIL OR E-MAIL

E-MAIL: esegal@stanford.edu

Mail original and 16 copies to:

Environmental Health and Safety Department

c/o Biosafety Manager

480 Oak Road - Mail Code 8007

Stanford, CA 94305-8007

Telephone: (650) 725-1473

FOR OFFICIAL USE ONLY

APPLICATION ID:

DATE OF APPROVAL:

EXPIRES:

STANFORD UNIVERSITY

ADMINISTRATIVE PANEL ON BIOSAFETY

REQUEST FOR INSTITUTIONAL REVIEW/APPROVAL FOR RESEARCH INVOLVING

BIOHAZARDOUS AGENTS, RECOMBINANT DNA, AND USDA-REGULATED MATERIALS

Principal Investigator:

Title:

Department:

Mail Code:

Date:

Phone Number:

E-mail Address:

FAX Number:

Title of Research Project:

Duration of Initial Grant: From: To:

Biohazardous Agent(s) Used:

Biosafety Level (BSL) of Biological Agents:

SPONSORED PROJECT	FELLOWSHIP PROJECT
Source of funds:	Source of funds:
Grant number:	Fellowship title:
SPO Number:
P.I. on grant:	Name of Fellow:

OTHER INSTITUTIONAL REVIEWS/APPROVAL SPECIFIC TO THIS PROJECT

Administrative Panel on Laboratory Animal Care

Use of animals: Yes ☐ No ☐ Approved: Yes ☐ Pending ☐ No ☐

Animal biosafety level: Protocol number:

Administrative Panel on Use of Human Subjects

Use of Human Subjects: Yes ☐ No ☐ Approved: Yes ☐ Pending ☐ No ☐

Date of Approval:

Administrative Panel on Radiological Safety

Use of Radiological material: Yes ☐ No ☐ Approved: Yes ☐ Pending ☐ No ☐

CRA number:

PERSONNEL

The list of personnel should include all those who will physically handle the biohazardous agents or recombinant DNA molecules and are conceivably at risk from research procedures involving the use of these Biological materials. Approval of the proposed experiment is given only for the identified personnel listed below. The Biosafety Officer must be notified if any new personnel are added. List additional personnel on a copy of this sheet as needed.

NAME*	TITLE	DEPARTMENT	E-MAIL	TELEPHONE

* List name as appears in Stanford WhoIs

LOCATIONS OF EXPERIMENTS, STORAGE OF AGENTS, AND AUTOCLAVE

Approval of the proposed experiments is given only for the locations listed below.

	BUILDING	ROOM NUMBER	BS LEVEL	SHARED ROOM
LOCATIONS EXPERIMENTS CONDUCTED				Yes ☐ No ☐
				Yes ☐ No ☐
				Yes ☐ No ☐
LOCATIONS AGENTS STORED				Yes ☐ No ☐
				Yes ☐ No ☐
				Yes ☐ No ☐
NEAREST AUTOCLAVE				Yes ☐ No ☐

* Indicate if room is used by more than one Protocol Director.

PHYSICAL CONTAINMENT EQUIPMENT

BUILDING	ROOM	Biosafety Cabinet MANUFACTURER	MODEL	SERIAL #	DATE OF CERTIFICATION



Do NOT use a non-vented biosafety cabinet if you plan to use volatile radioactive isotopes in work involving viable biohazardous agents at Biosafety Level 2 or above. Consult the Biosafety Manual or contact Environmental Health and Safety at 725-1473 for recommended practices.

DESCRIPTION OF THE EXPERIMENT

Provide a short summary of the project in lay language and a technical description of the project, explaining the goal(s) and methods to be used. List experimental procedures and assays that will be used to enhance biosafety; describe procedures that may create biohazards (i.e., aerosol generation from centrifugation, FACS analysis, exposure to sharps, etc). If animal work is included, state experimental procedures to be used. Provide information concerning potential biohazard shedding during the animal model and any model specific hazards. Continue on a separate sheet if necessary.

1	Does proposed research involve rDNA?		☐ Yes ☐ No
		If no, proceed to question #2.

If vector is plasmid based, describe plasmid and insert, or nature of synthetic nucleic acid, using maps if available. Provide source of plasmid material (e.g., made in lab A, purchased from Company X, gift from Dr. Y)

If vector is viral in origin, complete following:

☐ Adenovirus			☐ Adeno Associated Virus	☐ Alphavirus (e.g., SFV, SIN)
☐ Herpesvirus			☐ Poxvirus (e.g., Vaccinia)	☐ Other:
☐ Retrovirus
	Murine	Strain
	Lenti	Vector Backbone (e.g. HIV, SIV, etc)
☐ Helper Plasmids
Provide strain, vector backbone:
Wild type deletions:
Replication status:
Envelope packaging system(s):
Include source of vector (e.g., made in lab A, purchased from Company X, gift from Dr. Y.
Describe host cells into which rDNA will be introduced. Include source of host cells.
Provide information concerning nature of insert (specific gene(s), class of gene, source of insert, gene function, etc.).

2	Does proposed research involve infectious agents?		☐ Yes ☐ No
		If yes, answer below questions.
		Information on many infectious agents can be found at: http://www.phac-aspc.gc.ca/msds-ftss/index.html
Name of agent(s) and Biosafety level. Include source of agent.
Provide antibiotic/antiviral drug resistance profile for specific strain of agent(s) to be used in project.
Concentration and volumes of agents generated. Will volumes in excess of 10 liters be generated?

3	List target cells/animals to be used. If animals used, describe biosafety precautions to be taken. Include housing conditions and methods of animal transport, if appropriate.

4	Indicate if you will be using Stanford University’s recommended procedures for the following (if not, provide information on substitute procedures to be used):
Biohazardous agents will be stored in secondary containment		☐ Yes ☐ No
All equipment used with biohazards agents will be with Biohazard labels		☐ Yes ☐ No
All biohazards agents will be placed in secondary containment prior to transport within Stanford University. Containers will be labeled with Biohazard stickers.		☐ Yes ☐ No
Decontamination will be performed using 0.5% sodium hypochlorite (1:10 dilution of bleach).		☐ Yes ☐ No
If bleach is not appropriate (e.g., corrosive to equipment) provide name of disinfectant(s), concentration to be used and contact time.

Describe precautions to be taken when handling materials.

PPE: Check all that apply

☐ Mask ☐ Gloves ☐ Lab coat ☐ Shoe covers ☐ Disposable Gown ☐ Safety Sharps

☐ Head cover ☐ Respirator (provide type: ) ☐ Other—describe:

Describe risk of infection, clinical symptoms, and any recommended medical surveillance and preventive laboratory practices to be used.

7	Indicate training status of all listed personnel for:
	a.	*Bloodborne Pathogen (BBP) web based training (required yearly)
		(http://bbp.stanford.edu)
	b.	*Completion of BBP Exposure Control Plan)
		(http://www.stanford.edu/dept/EHS/prod/researchlab/bio/practical.html#bloodborne)
	c.	Shipping of Dangerous Goods web based training (required every two years)
		(http://www.stanford.edu/dept/EHS/prod/researchlab/bio/practical.html#danger_goods)
* required if personnel will have exposure to human blood or other potentially infectious material.

NAME	BLOODBORNE PATHOGENS	EXPOSURE CONTROL PLAN	SHIPPING OF DANGEROUS GOODS
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐

STANFORD UNIVERSITY

ADMINISTRATIVE PANEL ON BIOSAFETY

PROTOCOL DIRECTOR'S STATEMENT OF AGREEMENT

FOR RESEARCH INVOLVING RECOMBINANT DNA, BIOHAZARDOUS AGENTS,

OR USDA-REGULATED AGENTS

Protocol Director:	Telephone Number:
Address:

I attest that the information contained in the attached application is accurate and complete. I agree to comply with the requirements pertaining to shipment and transfer of biohazardous agents, recombinant DNA, and USDA-regulated agents. I am familiar with and agree to abide by the provisions of the current NIH Guidelines and other specific granting agency instructions pertaining to the proposed project.

I further attest that all research personnel are familiar with and understand the potential biohazards, proposed precautions, and appropriate emergency procedures, and that the practices and techniques required to ensure safety will be followed. I agree to accept responsibility for training of all laboratory workers involved in the project. I will ensure that

all listed personnel have received or will receive the required appropriate training in safe laboratory practices and the procedures for this protocol prior to any work beginning on this project.

I will submit a request to the Biosafety office for approval of any significant modifications to this study, facilities or procedures. I will also submit Annual Updates for this study.

Written reports will be submitted to the Panel on Biosafety through the Department of Environmental Health and Safety concerning:

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:
Any problems pertaining to operation and implementation of biological and physical containment safety procedures or equipment or facility failure: and,
Any new information bearing on the Guidelines such as technical information relating to hazards and safety procedures or innovations.

I will not carry out the work described in the attached application until it has been approved by the Administrative Panel on Biosafety or, when necessary, until it has been approved by that Panel and all sponsoring agency requirements have been met.

If submitting electronically, check box and provide date. If submitting hard copy, sign and date where indicated.

☐ By checking this box, I verify that I am the Principal Investigator responsible for the research protocol being submitted to the Administrative Panel on Biosafety for review.

Protocol Director:		Date:
	(Signature—no per signature)

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Administrative Panel Laboratory Animal Care All equipment biohazards agents Biohazard labels further attest

SUBMIT BY MAIL OR E-MAIL

E-MAIL: esegal@stanford.edu

Mail original and 16 copies to:

Environmental Health and Safety Department

c/o Biosafety Manager

480 Oak Road - Mail Code 8007

Stanford, CA 94305-8007

Telephone: (650) 725-1473

FOR OFFICIAL USE ONLY

APPLICATION ID:

DATE OF APPROVAL:

EXPIRES:

STANFORD UNIVERSITY

ADMINISTRATIVE PANEL ON BIOSAFETY

REQUEST FOR INSTITUTIONAL REVIEW/APPROVAL FOR RESEARCH INVOLVING

BIOHAZARDOUS AGENTS, RECOMBINANT DNA, AND USDA-REGULATED MATERIALS

Principal Investigator:

Title:

Department:

Mail Code:

Date:

Phone Number:

E-mail Address:

FAX Number:

Title of Research Project:

Duration of Initial Grant: From: To:

Biohazardous Agent(s) Used:

Biosafety Level (BSL) of Biological Agents:

SPONSORED PROJECT	FELLOWSHIP PROJECT
Source of funds:	Source of funds:
Grant number:	Fellowship title:
SPO Number:
P.I. on grant:	Name of Fellow:

OTHER INSTITUTIONAL REVIEWS/APPROVAL SPECIFIC TO THIS PROJECT

Administrative Panel on Laboratory Animal Care

Use of animals: Yes ☐ No ☐ Approved: Yes ☐ Pending ☐ No ☐

Animal biosafety level: Protocol number:

Administrative Panel on Use of Human Subjects

Use of Human Subjects: Yes ☐ No ☐ Approved: Yes ☐ Pending ☐ No ☐

Date of Approval:

Administrative Panel on Radiological Safety

Use of Radiological material: Yes ☐ No ☐ Approved: Yes ☐ Pending ☐ No ☐

CRA number:

PERSONNEL

NAME*	TITLE	DEPARTMENT	E-MAIL	TELEPHONE

* List name as appears in Stanford WhoIs

LOCATIONS OF EXPERIMENTS, STORAGE OF AGENTS, AND AUTOCLAVE

Approval of the proposed experiments is given only for the locations listed below.

	BUILDING	ROOM NUMBER	BS LEVEL	SHARED ROOM
LOCATIONS EXPERIMENTS CONDUCTED				Yes ☐ No ☐
				Yes ☐ No ☐
				Yes ☐ No ☐
LOCATIONS AGENTS STORED				Yes ☐ No ☐
				Yes ☐ No ☐
				Yes ☐ No ☐
NEAREST AUTOCLAVE				Yes ☐ No ☐

* Indicate if room is used by more than one Protocol Director.

PHYSICAL CONTAINMENT EQUIPMENT

BUILDING	ROOM	Biosafety Cabinet MANUFACTURER	MODEL	SERIAL #	DATE OF CERTIFICATION



Do NOT use a non-vented biosafety cabinet if you plan to use volatile radioactive isotopes in work involving viable biohazardous agents at Biosafety Level 2 or above. Consult the Biosafety Manual or contact Environmental Health and Safety at 725-1473 for recommended practices.

DESCRIPTION OF THE EXPERIMENT

1	Does proposed research involve rDNA?		☐ Yes ☐ No
		If no, proceed to question #2.

If vector is viral in origin, complete following:

☐ Adenovirus			☐ Adeno Associated Virus	☐ Alphavirus (e.g., SFV, SIN)
☐ Herpesvirus			☐ Poxvirus (e.g., Vaccinia)	☐ Other:
☐ Retrovirus
	Murine	Strain
	Lenti	Vector Backbone (e.g. HIV, SIV, etc)
☐ Helper Plasmids
Provide strain, vector backbone:
Wild type deletions:
Replication status:
Envelope packaging system(s):
Include source of vector (e.g., made in lab A, purchased from Company X, gift from Dr. Y.
Describe host cells into which rDNA will be introduced. Include source of host cells.
Provide information concerning nature of insert (specific gene(s), class of gene, source of insert, gene function, etc.).

2	Does proposed research involve infectious agents?		☐ Yes ☐ No
		If yes, answer below questions.
		Information on many infectious agents can be found at: http://www.phac-aspc.gc.ca/msds-ftss/index.html
Name of agent(s) and Biosafety level. Include source of agent.
Provide antibiotic/antiviral drug resistance profile for specific strain of agent(s) to be used in project.
Concentration and volumes of agents generated. Will volumes in excess of 10 liters be generated?

3	List target cells/animals to be used. If animals used, describe biosafety precautions to be taken. Include housing conditions and methods of animal transport, if appropriate.

4	Indicate if you will be using Stanford University’s recommended procedures for the following (if not, provide information on substitute procedures to be used):
Biohazardous agents will be stored in secondary containment		☐ Yes ☐ No
All equipment used with biohazards agents will be with Biohazard labels		☐ Yes ☐ No
All biohazards agents will be placed in secondary containment prior to transport within Stanford University. Containers will be labeled with Biohazard stickers.		☐ Yes ☐ No
Decontamination will be performed using 0.5% sodium hypochlorite (1:10 dilution of bleach).		☐ Yes ☐ No
If bleach is not appropriate (e.g., corrosive to equipment) provide name of disinfectant(s), concentration to be used and contact time.

Describe precautions to be taken when handling materials.

PPE: Check all that apply

☐ Mask ☐ Gloves ☐ Lab coat ☐ Shoe covers ☐ Disposable Gown ☐ Safety Sharps

☐ Head cover ☐ Respirator (provide type: ) ☐ Other—describe:

Describe risk of infection, clinical symptoms, and any recommended medical surveillance and preventive laboratory practices to be used.

7	Indicate training status of all listed personnel for:
	a.	*Bloodborne Pathogen (BBP) web based training (required yearly)
		(http://bbp.stanford.edu)
	b.	*Completion of BBP Exposure Control Plan)
		(http://www.stanford.edu/dept/EHS/prod/researchlab/bio/practical.html#bloodborne)
	c.	Shipping of Dangerous Goods web based training (required every two years)
		(http://www.stanford.edu/dept/EHS/prod/researchlab/bio/practical.html#danger_goods)
* required if personnel will have exposure to human blood or other potentially infectious material.

NAME	BLOODBORNE PATHOGENS	EXPOSURE CONTROL PLAN	SHIPPING OF DANGEROUS GOODS
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐
	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐	Yes ☐ No ☐ N/A ☐

STANFORD UNIVERSITY

ADMINISTRATIVE PANEL ON BIOSAFETY

PROTOCOL DIRECTOR'S STATEMENT OF AGREEMENT

FOR RESEARCH INVOLVING RECOMBINANT DNA, BIOHAZARDOUS AGENTS,

OR USDA-REGULATED AGENTS

Protocol Director:	Telephone Number:
Address:

I will submit a request to the Biosafety office for approval of any significant modifications to this study, facilities or procedures. I will also submit Annual Updates for this study.

Written reports will be submitted to the Panel on Biosafety through the Department of Environmental Health and Safety concerning:

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:
Any problems pertaining to operation and implementation of biological and physical containment safety procedures or equipment or facility failure: and,
Any new information bearing on the Guidelines such as technical information relating to hazards and safety procedures or innovations.

If submitting electronically, check box and provide date. If submitting hard copy, sign and date where indicated.

☐ By checking this box, I verify that I am the Principal Investigator responsible for the research protocol being submitted to the Administrative Panel on Biosafety for review.

Protocol Director:		Date:
	(Signature—no per signature)

<< MAJOR EQUIPMENT List most important equipment items already available standard major equipment conduct biomedicalMark Diamond Research Fund MDRF provides grants graduate GSA staff able offer assistance equipment >>