Instructions - University of California, Santa Cruz



UC Santa Cruz Biological Use Authorization

The IBC establishes policy and provides oversight for use of biological materials in teaching and research activities at UCSC. The Committee is delegated authority and responsibility from the Vice Chancellor of Research to review and approve use of:

1. Infectious organisms that can cause disease in humans or cause significant environmental or agricultural impact

2. Human or primate tissues, fluids, cells or cell cultures

3. Animal tissues, fluids, cells or cell cultures that may have been exposed to infectious organisms

4. Recombinant DNA in vitro, in vivo, and in clinical trials

5. Transgenic plants or animals

6. Releases of recombinant DNA to the environment

7. Animals known to be infected (experimentally or otherwise) with known human pathogens

8. CDC / USDA Select Agents and Toxins

9. Toxins (biological origin) with LD50 < 100 ug per kilogram body weight

This Biological Use Authorization (BUA) is your application and means to describe your work and answer pertinent questions necessary for the IBC to assess the safety and compliance requirements of your research. Please give thoughtful and complete answers as your ability to receive University support for your grant and research is dependent upon IBC authorization.

General Instructions:

All respondents must complete:

• Application Status

• Principal Investigator and Contact Information

• Section 1. General Project Description

• Section 5. Designated Facilities and Equipment

• Section 6. Designated Persons Conducting Experiments

o Appendix A – Training Checklist

• Principal Investigator Certification

Recombinant DNA:

Individuals conducting rDNA research must complete:

• Section 2. Recombinant DNA and rDNA Experiment Details

• Appendix B. Genetically Modified Animals (if applicable)

Infectious Agents:

Individuals conducting research with Infectious Agents, Animals Known to be Vectors/Reservoirs of Zoonotic Disease or Potentially Infectious Material (Including points 2 and 3 of the above IBC oversight) must complete:

• Section 3. Infectious Agents

Biological Toxins:

Individuals conducting research with Biological Toxins must complete:

• Section 4. Biological Toxins

• Appendix C. CDC/USDA Select Agent Toxins

More specific instructions are included in each section.

APPLICATION STATUS:

New; BUA# (assigned by IBC)

Renewal (every 3 years); BUA# (if known):      

Amendment; BUA#:      

IF AMENDMENT, mark amended Section(s). Check all that apply: Revise applicable section(s) and email revised BUA to biosafety@ucsc.edu.

Contact Information

Section 1 – General Project Description

Section 2 – rDNA

Section 3 – Infectious Agents

Section 4 – Biological Toxins

Section 5 – Designated Facilities and Equipment

Section 6 – Designated Persons Conducting Experiments

Appendix B - Genetically Modified Animals

Other (specify):      

Principal Investigator and Contact Information

Responsible Faculty/PI:

Principal Investigator:      

Division and Department:      

UC Employee ID:      

Address/Mail Code:      

Office Phone:       Lab Extension       Fax:      

E-Mail:       Emergency/Home Phone:      

You must have at least one alternate contact who can respond to an emergency, answer questions for the Committee or an Inspector and/or will always be able to contact you.

Alternate Contacts:

(If you do not have an Administrative Contact, leave blank)

Administrative Contact:      

Division and Department:      

UC Employee ID:      

Address/Mail Code:      

Office Phone:       Lab Extension       Fax:      

E-Mail:       Emergency/Home Phone:      

(Preferably an SRA, Lab Manager or Co-PI – Someone with responsibility for the lab who is informed of the research protocols and emergency response procedures)

Lab Contact      

Job Title:      

Division and Department:      

UC Employee ID:      

Address/Mail Code:      

Office Phone:       Lab Extension       Fax:      

E-Mail:       Emergency/Home Phone:      

Section 1. General Project Description

(to be completed for all applications)

Project/Grant Title(s):

     

General Description

Give a brief (one or two sentence) synopsis without the use of acronyms or abbreviations and which could be understood by the general public (non-scientist):

     

Then, please attach a more specific narrative description of your project or process in the following text cell that includes:

Note: To avoid unnecessary approval delays, please ensure that you provide enough detail that a scientist not working in your specific field can understand your work and assess the hazards and risks. Your narrative should address not only what you’ll do but how you’ll do it. Standard procedures can be referred to by common name (e.g., Southern blot, PCR, transfection by electroporation) but novel procedures and significant modifications to standard procedures should be described. This level of detail is very important to the IBC.

Please be sure that, at a minimum, you address each of the following issues in your detailed description:

• The overall goal and specific objectives of the work:

     

• The experimental procedures and methods involving the biohazardous material:

     

• An assessment of the hazardous potential, including release of materials to the environment and possible vectors:

     

• Containment conditions, controls you will use to ensure the safe conduct of the procedures and the method(s) of terminal inactivation of the biological agents:

     

• Emergency procedures, including management of spills and exposures:

     

• Proper shipping procedures according to DOT regulations and IATA guidelines, import or export of biological materials within, to and from UCSC (See ):

     

Section 2. Recombinant DNA (rDNA)

(to be completed for rDNA applications only)

Please identify any of the following that you intend to use in your research:

|Does the work involve transfer of a drug resistance trait to an organism that does not acquire it| Yes | No |

|normally (Check "no" for standard drug resistance, e.g., ampicillin into E. coli)? | | |

|Does rDNA contain genes coding for molecules toxic to vertebrates (LD50 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download