Indiana University Purdue University at Indianapolis
Research & Sponsored Programs
Human/Primate Cell Culture Registration Form
For New Protocols or Resubmissions Intending to use Human or Primate Cell Cultures in Research	
All research protocols involving human and primate cell cultures at Indiana University-Purdue University Indianapolis must be registered with the Office of Research and Sponsored Programs. Laboratories will be inspected by the Biosafety Manager. The Human/Primate Cell Registration form has become necessary as all human and primate cell lines, primary or established, must be handled at BL2 as per OSHA and CDC regulations/recommendations. All work with human and primate cell lines shall be conducted in a biohazard hood with lab coat and gloves. All lab supplies in contact with such cell lines must be autoclaved or otherwise disinfected prior to disposal.

Laboratory personnel must have access to a biosafety manual. The IUPUI Biosafety Manual can be downloaded from the Environmental Health & Safety web page (http://www.ehs.iupui.edu/ehs/prog_biomanual.asp). Laboratories should pay particular attention to Appendix F of the manual.

When any revision to an approved research protocol is desired, an amendment must be filed with RSP and approved prior to implementation.  The amendment submission form must be completed indicating the changes. Forms can be obtained from the RSP office or website, http://www.iupui.edu/~resgrad/spon/download.htm

Please Note: This form is only for the cultivation, expansion, and other handling of human or primate cell lines. Any use of rDNA methodologies requires completion of the IBC form and any work involving biological toxins or infectious agents requires completion of the BHC form.	
	
Name 
	Campus Address: 
	
Section/Division 
	E-Mail: 	Phone: 	FAX: 	
Primary Lab Contact: 
	Phone: 	
	E-Mail: 	

	

Lab locations where research will be conducted:	
	
Please list all applicable cell cultures:	

Building	
	
Room No.	
	
Biosafety Cabinet	
	
Name of Cell Line/Culture	
Human?	
	
Primate?	

	

	
Yes	

No	

	

	

	

	
Yes	

No	

	

	

	

	
Yes	

No	

	

	

	

	
Yes	

No	

	

	

	

	

	

	

	

	
Lab Personnel/Authorized Users
Please list the names of staff members and their position titles that will take part in the use of human or primate cell cultures. Include the PI, co-investigator, technicians, and students who will be directly involved in carrying out the work described in this protocol. Staff members must sign this protocol**.  

NOTE: Research involving the use of human-derived substances (e.g. blood or blood components, tissues, secretions) or human-derived cell lines, is subject to the OSHA Bloodborne Pathogens (BBP) Standard. Bloodborne Pathogen Training must be renewed each year. Please contact the IUPUI Biosafety Manager at 274-2830 for more information and scheduling.
	
Principal Investigator:  
IUPUI ID# 	Position:   
PI Signature**:	

Name: 
IUPUI ID#  
	Position:   
Staff Signature**:	

Name:  
IUPUI ID#
	Position:   
Staff Signature**:	

Name:  
IUPUI ID#
	Position:   
Staff Signature**:	

Name:  
IUPUI ID#
	Position:   
Staff Signature**:	

Name:  
IUPUI ID#
	Position:   
Staff Signature**:	

Name:  
IUPUI ID#
	Position:   
Staff Signature**:	

Principal Investigator’s Certification:

The Principal Investigator is responsible for providing adequate training and supervision of staff in microbiological techniques and practices required to ensure safety and for procedures in dealing with accidents.  The investigator is responsible for enforcing federal regulations regarding laboratory safety for all persons who work under his/her direction.  The investigator is responsible for correcting work errors and ensuring the integrity of the physical containment.  Any work related injury or exposure must be reported to Occupational Health Services. The investigator is also responsible for ensuring that co-investigators, if any, employ the necessary safeguards to protect laboratory personnel, students, and the community from potential hazards posed by the project.  The investigator must ensure that staff have read this protocol and the biosafety manual.

For further information regarding physical safety issues, laboratory safety, emergency response and training, please contact the Biosafety Manager, James Klenner, at 274-2830.

I certify that I have read the above statements and agree that I and all listed participants will abide by those statements as well as all IUPUI policies and procedures governing the use of human or primate cell cultures as outlined in this application and in the IUPUI Biosafety Manual. In addition, I will:

•	Abide by the General Duty Clause of OSHA and take full responsibility to ensure that listed personnel have received or will receive appropriate training in safe laboratory practices and procedures for this protocol before any work begins on this project and at least annually thereafter. All listed personnel must receive annual Bloodborne Pathogen training. Online refresher training is available at www.ehs.iupui.edu/newBBP/BBP_home.asp
•	Follow the health surveillance practices as approved for this protocol and inform those working on the protocol about appropriate emergency assistance information for their location(s);
•	Inform Employee Health Services of any research-related accident or illness as soon as possible after its occurrence;
•	Adhere to IUPUI biosafety guidelines referred to in this application as well as comply with the requirements of the Biosafety Manual.	

Signatures:	
Principal investigator:		Date:	     	

Please post Attachment A in your laboratory or place in your Biosafety Manual.

Signature of Authorized BHC Representative:

	Date:	
Signature of IUPUI Biosafety Manager:

	Date:	

Attachment A
Biosafety Level 2 Safety Procedures for all Human and/or Primate Cell Cultures/Lines

a)	Handwashing: Hands should be washed immediately or as soon as feasible after removing gloves or other personal protective clothing.

b)	Personal Protective Equipment (PPE): PPE such as gloves, safety glasses and a laboratory coat should be worn whenever biological work is conducted in the laboratory. No sandals are allowed in the laboratory.

c)	Use of Sharps: Minimize the use of and exposure to sharps in the workplace. Never recap, bend or shear needles. As often as possible, replace glassware with less damaging materials such as plastic. Keep sharps containers readily available in all locations where sharps waste may be generated. 

d)	Food and Beverage: Eating, drinking, storing food and drink for human consumption, smoking, applying cosmetics or lip balm and handling contact lenses in the laboratory is prohibited in work areas where there is a reasonable likelihood of occupational exposure. This prohibition should be well posted.

e)	Aerosol Generation: Any procedures that could potentially generate aerosols or other inhalation hazards must be performed in a manner that will minimize airborne pathogen transmission. For BL2 cell lines and cultures, containment should include use of biosafety cabinets and aerosol limiting centrifuges.

f)	Proper Labeling: Place a color-coded label incorporating the universal biohazard label on any potentially contaminated equipment or storage area to warn others of biohazard contamination that may not be easily visible. This includes freezers, refrigerators and incubators.

g)	Autoclave Safety: Always wear heat-resistant gloves, goggles or safety glasses, and a laboratory coat when opening an autoclave. Be sure to allow the superheated steam to exit before attempting to remove the contents. All cell culture waste is considered regulated waste and must be autoclaved prior to disposal.

h)	Spills: Always clean spills from the periphery of the spill towards the center, after placing paper towels over the spill. Make sure that the cleaning materials are disposed of in an appropriate manner.

i)	Mouth Pipetting: Mouth pipetting may lead to accidental ingestion of biological specimens and is strictly prohibited.

j)	Decontamination Procedures: A 0.5-1 percent sodium hypochlorite (a 1 to 10-20 dilution of household bleach) will be used to decontaminate equipment and work surfaces. In locations where bleach would cause corrosion, an iodophor (e.g., Wescodyne) will be used to decontaminate. All cell culture media must be treated with bleach or autoclaved prior to disposal.

k)	Bloodborne Pathogens: All PI’s using human blood or blood products, unfixed tissue, body fluids or organ or cell cultures of human origin will follow the procedures outlined in the IUPUI Bloodborne Pathogen Exposure Control Plan and ensure that all lab personnel receive annual BBP training.

l)	Biosafety Cabinets: ALL manipulations of live cells must be performed in a certified and operational biosafety cabinet.

m)	Biohazard Sign: A biohazard sign stating Human Cell Lines, or Primate Cell Lines should be posted at the lab entrance. This is available at www.iupui.edu/%7Eresgrad/spon/Biosafety-Level-sign.rtf