SAN DIEGO STATE UNIVERSITY
BIOLOGICAL USE AUTHORIZATION APPLICATION
HUMAN SOURCE MATERIAL
INSTRUCTIONS
This is a Human Source Material Biological Use Authorization Application. Research involving only human source materials*
(blood, tissue, cells, body fluids, etc.) should complete this application. If you research involves human source materials and
other biological materials or recombinant nucleic acid techniques, complete the General BUA Application.
Submit an electronic copy to ibc@mail.sdsu.edu. If more space is needed please attach a separate sheet. If you need
assistance in completing the form contact the Biosafety Officer (BSO) at (619) 594-6965.
Protocol approval is valid for three years but must be updated annually using the SDSU BUA Annual Continuation Form. For
changes to the project, submit the BUA Amendment Application. To update personnel, contact the Biosafety Officer directly
with name, red ID and email address. At the end of three years, the BUA can be cancelled or continued by submitting a new
Human Source Material Biological Use Authorization Application. To view submission deadlines and meeting dates for the
Institutional Biosafety Committee (IBC) refer to the IBC Meeting Dates and Submission Deadlines.
Working with human source materials excluding saliva and vomitus from healthy populations is covered under the CalOSHA
Bloodborne Pathogen (BBP) Standard. The SDSU BBP Exposure Control Program (ECP) details how SDSU implements
and ensures compliance with the CalOSHA standard, thereby eliminating or minimizing occupational exposure to
bloodborne pathogens. Individual labs working with human source materials covered by the SDSU BBP ECP are required to
have a lab specific BBP ECP tailored to the individual requirements of the laboratory. This BUA application serves as a lab
specific BBP ECP. All personnel working on this BUA are covered under the BBP ECP and must review this document.
Review of the following guidelines, where applicable, is required and may assist you in submission of the application.
(http://bfa.sdsu.edu/ehs/biosafety.htm) Check box if not applicable.
☐ Guidelines for Working with Human Source Materials [DOC]
☐ Guidelines for Drawing Human Blood [DOC]
☐ Emergency Response Procedures and Contacts — Needle-stick or Exposure to Blood, Body Fluids, and Infectious
Agents [DOC]
☐ Biohazardous and Sharps Waste Disposal Policies and Procedures [DOC]
*Human Source Material: human blood, blood-derived products, body fluids, cells (primary or established), tissue, or organ cultures.
I.
CORE REGISTRATION INFORMATION
Name of Principal Investigator (PI)/Faculty:
Job Title:
Department:
Office Location:
Lab Location:
Office Phone:
Lab Phone:
Email Address:
Mail Code:
Co-Investigator or Faculty*:
Job Title:
Office Location:
Office Phone:
Email Address:
Department:
Lab Location:
Lab Phone:
Mail Code:
Cell Phone:
Fax:
Home Phone:
Fax:
*If more than one Co-Investigator, list in Section VI. Laboratory Personnel
Lab Supervisor/Manager:
Job Title:
Office Location:
Office Phone:
Email Address:
Department:
Lab Location:
Lab Phone:
Mail Code:
BUA Type (select one)
New
Renewal
Amendment
Fill out New BUA
Fill out
Home Phone:
Fax:
If Renewal
Applicable BUA/NIH Number & Approval Date
Original
Approval
NIH Recombinant
Risk
1/8
IBC Approved 10/14/2015
Application
Amendment Form
BUA#
Date
DNA Designation
Group
Type of Activity (Check One*):
*Submit a separate BUA application for research activities or teaching activities.
☐Research
General Project Title*:
*Covering all individual studies and projects within this BUA
Grant Title(s):
Granting
Agency(s):
Sponsor Award Proposal
Routing #:
# or Fund #:
Project Period:
Non-Funded Project Titles:
☐Teaching
Course Name/Number:
Course Period:
II.
Semester:
RESEARCH PROTOCOL
Describe the research objectives and experimental design involving the human source material
such as major goals, protocols, experiment technique and procedures, and safety equipment (ex.
biosafety cabinet). List all projects, whether or not the project is currently funded, with a project title and
a short description of each project. Provide a grant number for each funded project/study title. Provide
sufficient information for the IBC to evaluate work with research materials for the purpose of making a
biohazard risk assessment. (Do not attach Grant Application)
III.
HUMAN SOURCE MATERIALS
Check all that apply and complete the table.
Material
Type
Origin of Material
e.g. HEK Cell
Check all that Apply
(e.g. ☒Clinical Specimens: Scripps Hospital)
☐Commercial Vendor/Collaborator:
☐Blood, serum, plasma
2/8
Known
Pathogens
IBC Approved 10/14/2015
☐Clinical Specimens:
☐Other
☐Commercial Vendor/Collaborator:
☐Clinical Specimens:
☐Other
☐Commercial Vendor/Collaborator:
☐Clinical Specimens:
☐Other
☐Commercial Vendor/Collaborator:
☐Clinical Specimens:
☐Other
☐Commercial Vendor/Collaborator:
☐Clinical Specimens:
☐Other
☐Commercial Vendor/Collaborator:
☐Clinical Specimens:
☐Other
☐Commercial Vendor/Collaborator:
☐Clinical Specimens:
☐Other
☐Blood-derived product
☐Body fluids
☐Cells - primary
☐Cell lines
☐Tissue
☐Organ
IV.
A.
BIOSAFETY SUMMARY
Procedures and Work Practices performed which may result in the generation of aerosols,
splashed and or sprays of human source materials material and safety precautions that should
be followed by personnel performing these procedures are as follows:
i. Procedures
Procedures/Equipment
☐ Sample Collection
☐ Tissue Culture/ Cell Culture
☐ Centrifugation
☐ Ultracentrifugation
☐ Sonication
☐ Vortexing
☐ Homogenization/Blender
☐ Opening vacuum vials
☐ Pipetting/Aliquoting
☐ Needles/Blades/ Capillary Tubes
☐ Venipuncture
☐ Finger Prick
☐ Needleless Systems*: Type
☐ Engineered Sharps Injury Protection~: Type
☐ Bench Work
☐ Other:
*Needleless systems shall be used for:
 Withdrawal of body fluids after initial venous or arterial access is established
 Administration of medications or fluids
 Any other procedure involving the potential for an exposure incident for which a needless system is available as an
alternative to the use of needle devices
~
Engineered sharps injury protection (needle devices) shall be used for:
 Withdrawal of body fluids
 Accessing a vein or artery
 Any other procedure involving the potential for an exposure incident for which a needle device with engineered sharps
injury protection is available.
If sharps other than needle devices are used, non-needle sharps shall include engineered sharps injury protection.
Engineering control is not required if:

It is not available in the marketplace.

Engineering control is not more effective in preventing exposure incidents than the alternative used by the
employer.

Reasonably specific and reliable information is not available on the safety performance of the engineering
control for the employer’s procedures.
Indicate reasons for NOT using engineered sharps or engineering controls for needles or non-needle sharps.
☐N/A
ii. Work Practices – Describe specific safe work practice procedures that will be taken to prevent exposure to human
source materials.
Work with human source materials should be handled using universal precautions. Universal
3/8
IBC Approved 10/14/2015
precautions is an approach to infection control to treat all human blood and certain human body
fluids as if they were known to be infectious for HIV, HBV and other bloodborne pathogens.
Procedure/Equipment
Work Practices
e.g. Biosafety cabinet
e.g. All cell lines will be handled in a biosafety cabinet
B.
Storage and access control of human source materials include the following:
Storage/Access
1. Human source materials are contained inside well-labeled containers i.e. cups, tubes, vials.
2. Biohazard labels are clearly affixed on any human source materials storage equipment clearly identifying the hazards
inside.
3. Storage refrigerators/freezers/cryotanks/incubators are in rooms whose access is limited or restricted to authorized
personnel.
4. Human source materials are stored in locked facility or secure storage equipment.
5. Only persons who have been advised of the human source materials and meet any specific entry requirements (e.g.
immunization) are authorized to enter the laboratory or have access to agents.
6. Others (please specify):
C.
Waste Disinfection/Decontamination and Disposal
i.
Liq
uid Wastes
☐N/A
a. Disposal of liquid human source materials:
i. Human source materials in a leakproof, puncture resistant container such as an eppindorf tube,
dispose directly as biohazardous waste. Make sure absorbent material is present in biohazardous
waste red bag and bags are doubled to prevent accidental leakage.
ii. Human source materials in glass containers, dispose as sharps waste. Make sure absorbent
material is present in Sharps container.
iii. Liquid human source materials (e.g. tissue culture media) can be disposed down the sewer after
decontaminated with an appropriate chemical germicide (e.g.1:10 bleach solution for 15 minutes).
iv. Other: Describe all proposed disposal methods for liquid waste.
b. Disposal of fixed human source material
i. If fixative inactivates all potential pathogens, dispose as hazardous waste. Place Hazardous
Waste Label on container and contact EH&S for disposal (619) 594-6778.
ii. If fixatives DO NOT inactivate all potential pathogens, dispose as biohazardous waste in sealed
container in a doubled red biohazardous bag with absorbent materials to prevent accidental
leakage.
iii. When replenishing or changing fixative, decant fixative from tissue or specimen into hazardous
waste container.
ii.
Sol
id Wastes
☐N/A
a. Plastic ware, glassware, sample containers, tissues: Biohazardous waste container
b. Reusable items contaminated with blood or OPIM shall be decontaminated prior to washing.
c.
Disposal of Sharps: Sharps Container
d. Other: Describe all proposed disposal methods for liquid waste.
4/8
IBC Approved 10/14/2015
Note: All sharps containers and biohazardous waste bags and secondary containers are purchased
and supplied by the laboratory.
D.
Disinfection/Decontamination.
Work surfaces, equipment, reusable materials, etc. must be decontaminated after use,
contamination, and on a regular frequency to reduce the level of contamination thus eliminating
infection transmission. Indicate in the table all decontamination methods used in the lab:
Refer to Guidelines for Selection of Disinfectants and Decontamination
Disinfection/Decontamination Method
Method
☐Autoclave
☐Chemical (list)
Contact Time (minutes)
Temperature Range
Contact Time (minutes)
☐Other: (list)
Note: UV light is not recommended as appropriate means of disinfection/decontamination.
E.
Spill/Release Response
Describe laboratory specific protocol for spills or releases in your laboratory, shared
spaces or public areas.
Spill Kit Location:
Refer to the following guidance documents: BBP Precautions and Spill Kit Requirements
[DOC], Needlestick Injury or Exposure to Human Source Materials [DOC], Guidance for
Use of Needles at SDSU [DOC]
F.
Personal Protective Equipment (PPE) which will be utilized to minimize exposure of personnel
to agents while in the laboratory:
Mandatory:
Appropriate Attire - close-toed shoes, long pants or skirt (no shorts, short skirts, sandals, etc.)
Lab Coat or Gown
Safety Glasses or Goggles
Gloves (nitrile or latex)
☐ Other: List additional PPE used in the Lab.
Personal protective equipment is provided by the laboratory to all research personnel working in
the facility.
V.
A.
RESEARCH FACILITIES
Lab Location
The IBC requests prior notification, via submission of a BUA Amendment Application, regarding any
change in location of labs.
Human Source
Materials
Storage Location
Proposed
BSL
Shared
Room?
☐ Yes ☐ No
☐ Yes ☐ No
Handling Location
Proposed
BSL
Shared
Room?
☐ Yes ☐ No
☐ Yes ☐ No
Note: Proposed Biosafety Level (BSL) can be obtained from the BMBL 5th Edition and should reflect the risk group of the agent/materials,
practices and facilities. The BSL is dictated by the highest BSL containment required by any agent utilized in that room.
5/8
IBC Approved 10/14/2015
B.
Biosafety Cabinet
Provide the following information for each Biosafety Cabinet:
Make
Model
Serial
Location
UV Light?
Number
☐ Yes ☐ No
☐ Yes ☐ No
☐N/A
Certification
Expiration Date
C.
Biohazard Signs and Labels
Are biohazard signs and labels posted? ☐ Yes ☐ Need signs and labels (Contact BSO at (619)
594-6965 to obtain the signs and labels)
Signs should be posted at the lab entrance and procedure rooms within the lab. Labels (stickers)
should be placed on refrigerators, freezers, biosafety cabinets, and incubators.
VI.
A.
LABORATORY PERSONNEL
Personnel
List all personnel involved with work covered under this biological use authorization, including lab
manager/supervisor, investigators, and students. If additional space is needed, attach a separate
sheet. The personnel indicated on the list who have not completed the IBC Biosafety Training or
Bloodborne Pathogen Training will be enrolled in the training and notified via email. Contact BSO for
questions (619) 594-6965.
Last Name/First
Job Title Red ID # Email Address
Biosafety Training
Bloodborne
Name
Completion Date
Pathogen Training
Date
B.
Health Status, Health Surveillance, and/or Immunization Program
SDSU offers lab personnel working with human source materials the Hepatitis B vaccination free
of charge. Acceptance of the vaccination is not contingent upon hiring. All personnel listed in
Section VI.A Personnel will be automatically enrolled in the SDSU BBP Program unless otherwise
indicated by the PI.
If there are additional vaccinations or medical screenings needed to safely conduct your research,
describe below:
VII.
A.
REGULATORY REQUIREMENTS
Required Institutional Safety Approval
Additional protocol submission may be required if this research involves human source materials that
carry identifiers and can be traced back to an individual, please contact SDSU Institutional Review
Board. Contact the IRB prior to collection or receipt of samples.
Does this research involve human
subjects or tissue?
B.
☐ Yes ☐ No
Protocol #
(IRB Approval)
Expiration
Date
DOT/IATA Infectious Substance & Specimen Shipping Regulations, Material Transfer
Agreements, and CDC/APHIS/DOC Import/Export Permit
Note: SDSU Shipment of Biological Materials and SDSU Guide to Shipping with Dry Ice are included in the Biosafety Training 2008 revision version and all
subsequent versions. The documents are also available for reference on the EHS Website. (http://bfa.sdsu.edu/ehs/ )
Materials
Transport Training
Import/Export Permit
Biosafety Training
N/A
☐ Transported within campus labs
6/8
IBC Approved 10/14/2015
☐ Domestically (Locally, or Intrastate or interstate)
☐ Internationally
SDSU Shipment of Biological Materials
☐ Transported in Dry
☐ Transported in Ethanol
☐ Transported in Formalin (Formaldehyde)
VIII.
SDSU Shipment of Biological Materials
☐ N/A ☐ CDC Import Permit #:
☐ N/A ☐ CDC Import Permit #:
☐ N/A ☐ Dept. of Commerce Permit #:
SDSU Guide to Shipping with Dry Ice
N/A
SDSU Shipment of Ethanol Solutions
N/A
SDSU Guidelines Shipment of
Formaldehyde by Air
N/A
ACKNOWLEDGEMENT OF RESPONSIBILITIES
Principal Investigator:
BUA #:
Project Title:
Date:
By signing and initialing each statement below, I certify that I have read the following statements and
agree that I and all listed participants will abide by those statements as well as all SDSU policies and
procedures governing the use of human source materials as outlined in this application and in the
SDSU Biosafety Manual. I:
Recognize that I have a responsibility for ensuring the information provided in this application
is complete, accurate and thorough by participating in the development of the BUA
application and conducting a review of the protocols.
Recognize that I have responsibilities for ensuring that anyone who enters my laboratory
practices appropriate biosafety precautions.
Recognize that I have responsibilities for ensuring that all listed participants conducting this
work have received or will receive appropriate training in safe laboratory practices and
procedures for this protocol before any work begins on this project. Also, I have a
responsibility for ensuring that anyone working in or having access to spaces where this
project is conducted must be instructed on the hazards associated with this project. The IBC
or EH&S may review my records documenting the training or instruction and may enter my
laboratory at any time to review my operations.
Recognize that I have a responsibility to be informed (and ensure that all staff members are
similarly informed) that certain medical conditions might increase an individual’s risk of
potential health problems when working with human source materials containing. These
conditions can include: pregnancy, immunosuppression, and chronic skin conditions. If any of
these conditions applies, I will send the personnel to consult with a personal physician/health
care professional about the work. These conditions may restrict someone from working with
the human source materials. If an employee is restricted from working with the human source
materials in my laboratory, I am responsible for ensuring the restriction.
Recognize that I will abide by the storage and access requirements indicated in this
application.
Recognize that I have a responsibility for complying with the requirements pertaining to the
shipment and transfer of human source materials.
Shipping Human Source Materials: Initialize by statement.
By initialing, I certify that I will properly classify, identify, pack, mark, label and document
shipments for transport. Any special arrangements such as notifying the consignee
(receiver) of import permits for international shipments shall fall under my responsibility. I
shall ensure that the consignee has obtained all necessary import permits to facilitate the
safe and legal acceptance of the shipment. I am also responsible for notifying the courier
for whom the packaged should be directly delivered. I am responsible for ensuring the
7/8
IBC Approved 10/14/2015
package is delivered directly to the person and address indicated on the outer packaging.
Obtaining export permits is my responsibility. I certify that I or other authorized personnel
in the laboratory have been trained to properly package and ship the materials.
Receiving Human Source Materials: Initialize by statement.
By initialing, I certify that I will inspect the package and documents and close the
shipping loop by informing the shipper that the consignment has arrived. I am also
responsible for reporting any leakage and, if required, obtaining any import permits. I shall
ensure special arrangements are in place for the courier to directly deliver the package to
the person named on the outer packaging.
Recognize that I have a responsibility for reporting to the Biosafety Officer immediately any
spill of human source materials, any containment equipment or facility failure, any permitted
decontamination of equipment, and/or any breakdown in procedures, which may result in
potential exposure of laboratory personnel and/or the public to the human source material.
Recognize that I have a responsibility for reporting to the Biosafety Officer immediately
should an employee become ill and/or exhibit symptoms and signs consistent with an
infectious by an organism associated with my research.
Recognize that I have a responsibility for following all the applicable guidelines as approved
for this protocol.
Recognize that I have a responsibility for submitting in writing a request for approval from the
IBC of any significant modifications to the study.
Recognize that I will not carry out the work described in this application including all revisions
until it has been approved by the IBC.
Signatures
Signature of Principal Investigator who will be working on this project
Date
Signature of Co-Principal Investigator who will be working in this project
Date
Signature of Faculty Member to whom the laboratory space is assigned
Date
8/8
IBC Approved 10/14/2015