THE OFFICE OF RESEARCH

RESEARCH INVESTIGATOR HANDBOOK

3. OBTAINING REGULATORY COMMITTEE APPROVALS

3.3 Working with biological materials

• What does UCSF consider to be a biologic or biohazard?
• Who do I contact?
• What approvals do I need to work with biohazardous materials?
• What training is required or provided by UCSF?
• Is auditing or monitoring required?
• Top tips to speed up the approval
• Top tips to prevent laboratory problems
• Relevant policies and procedures

What does UCSF consider a biological hazard or biohazard?

At UCSF, biologic hazards or biohazards are any type of organism or material that could present a potential exposure to human pathogens, whether they are an integral part of the research or incidental to it. This includes the use of infectious agents, toxins, human blood, body fluids or unfixed tissue, or any tissue, organ or cell culture of human origin, Old World primates or sheep. Other activities considered to be potential biohazards include all recombinant DNA research, as well as the mailing or transport of human biological specimens outside of clinical settings

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Who do I contact?

The Institutional Biosafety Committee (IBC) within the Office of Research reviews all Biological Use Authorization (BUA) applications at UCSF. Contact your Departmental Safety Advisor (DSA) for guidance on your BUA application. The Technical Committees Coordinator at (415) 476-2198) can provide additional information. If you have specific technological questions about biological hazards, contact the Biosafety Officer at 476-2097.

The level of IBC review depends upon the type of research and level of risk:

•	Biosafety Level 1 (BSL1) applications are reviewed only by the Biosafety Officer (BSO) unless the BSO has specific concerns that warrant full Committee review.
•	Biosafety Level 2 (BSL2) or above applications are reviewed by the IBC once a month (meeting schedule).
•	The IACUC has delegated all biological safety reviews in research involving animals to the Biosafety Committee.

The Biosafety Level (BSL) rankings and requirements for safe containment of various microorganisms are listed in the Biosafety Manual provided by the OEH&S.

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What approvals do I need to work with biohazardous materials?

Authorization: You must have a IBC approved protocol, called a Biological Use Authorization (BUA), prior to initiating the research.

Expiration Date: Studies are valid for three years from the date of the BSO or IBC's approval. You must submit a full Application, including a Universal Principal Investigator Form to renew your study in advance of the expiration date if you wish to continue the research.

Modifications: Any modification you wish to make to your current BUA must be approved by the IBC before it is implemented into your research. (Modification Request Form). Contact your DSA for guidance.

Additional approvals: If biohazardous materials will be used in animals, you must attach the Animal Involvement in LARC to your BUA application as well as have approval from the Institutional Animal Care and Use Committee (IACUC). Additional approvals or use authorizations depend upon your use of biohazardous materials with radioisotopes, controlled substances and/or human subjects, including stem cell research.

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What training is required or provided by UCSF?

OEH&S provides mandatory Safety Training both in person and online at: Research Online; modules cover biosafety issues for both Campus and Medical Center personnel such as Bloodborne Pathogen Training, Biosafety Level 2 Practices, Herpes B virus, Q-Fever Prevention, Animal Biosafety I, II and III, Safe Shipping of Infectious Substances and others. However, these are not meant to replace requirements for supervisors to train employees in the specific hazards of their workplace.

There are additional training requirements for all laboratory personnel who work in research that may expose them to any Risk Group 3 agents, prions, Coxiella burnetti (Q-fever), Herpesvirus simiae (Herpes B virus), Vaccinia, Vaccinia vectors or other orthopox viruses as outlined in the Biosafety Manual, Appendix F.

Is auditing or monitoring required?

Your DSA will audit and monitor your laboratory as part of the standard quarterly safety audit to ensure compliance with safety regulations. The IBC is authorized by the Chancellor to limit or suspend any research that is not in compliance with UCSF biosafety policies and procedures.

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Top tips to speed up the approval

•	When in doubt, ask your DSA for guidance.
•	Allow enough lead-time for the IBC/BSO review of your application including time for you to reply to any questions they may have. You are encouraged to fax a copy of your draft application to the BSO for pre-submittal review or to call and consult with the BSO on biosafety issues.
•	Be sure your application is complete at submission by including:
	•	A brief but clear description of your research goal(s) and how your work will achieve it (them);
	•	A list of all potentially biohazardous organisms to be used in laboratory;
	•	Adequate description of the risks as you understand them;
	•	Adequate description of safety and containment procedures; and
	•	Completed training and experience descriptions of all project personnel.

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Top tips to prent laboratory problems

•	Contact your DSA for questions or problems.
•	Practice standard precautions and always assume material is infectious. Be sure your Biosafety Cabinets are certified annually (date must be current).
•	Manage materials and waste properly. Do not let waste accumulate; call OEH&S at 476-0544 to schedule waste pickup.
•	Focus on minimizing generation of aerosols and splashes.  Handle sharps properly and whenever possible, substitute plastic for glassware and convert to safe sharps and needles.
•	Ensure medical surveillance protocols and trainings are up-to-date.
•	Review SOP prior to working with biohazardous materials and always wear appropriate personal protective equipment. Be familiar with safety equipment such as fume hood, safety shower and eyewash.

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Relevant policies and procedures:

To work with biohazardous materials at UCSF, you will have to abide by all Federal, State, and local regulations in addition to University policies and guidelines. By obtaining your BUA your project will meet these regulations as long as your biological agents, procedures and safety processes have not changed and policies because the Committee review of your research includes an assessment of:

•	Your laboratory facilities, procedures, and practices as required by the UCSF Biosafety Manual,
•	The training and expertise of your personnel (Universal Hazardous Material Use Form),
•	Your appropriate use and containment of the biohazardous materials as required by the NIH Guidelines for Research Involving Recombinant DNA Molecules, and, CDC/NIH Biosafety in Microbiological and Biomedical Laboratories 5th Edition,
•	How well the OEH&S guidelines are followed, as indicated by the DSA inspection of your research facility.