USF Biosafety Modification Request



Division of Research Integrity and Compliance

Institutional Biosafety Committee

Modification Request

Please complete and submit this form and any supporting documents for all proposed modifications to an existing research study involving rDNA, infectious agents, and biological toxins.

All changes must be approved prior to implementation.

If the proposed modification changes the overall scope or intent of the study, the amendment is considered a major amendment and a new research application must be completed instead of this form. The IBC reserves the right to determine whether proposed changes are substantive and to request further information or a new protocol submission, as appropriate.

Instructions:

1. Please provide complete information for every item. Blank or incomplete items may delay the processing of your application.

2. Completed forms may be submitted by:

• E-mail to biosafety@research.usf.edu and follow with mailed hard copies of signature pages bearing original signatures.

• Mail to Farah Moulvi, Institutional Biosafety Officer, Division of Research Integrity & Compliance, MDC 35.

3. For more information, contact Farah Moulvi at (813) 974-0954 or Debra Howeth at (813) 974-5091.

1. Basic Information:

1.1 Principal Investigator: [Principle Investigator]

Department:       Building:      

Campus Mail:       E-mail:      

Fax:       Office Phone(s):      

Lab Phone:      

1.2 IBC Study(ies) #: _____

1.3 Registration Type (Please check appropriate category):

Exempt Recombinant DNA

Non-Exempt Recombinant DNA

Infectious Agents and Biological Toxins

1.4 Study Title(s):      

1.5 Check all that apply*:

Change in Biological Agent – Sect. 2 Change in Protocol Title Sect. 3.1

Change in Protocol Sponsor – Sect. 3.2 Change in Lab Location – Sect. 4.1

Change in Lab Equipment – Sect. 4.2 Change in Procedure – Sect. 5

Change in Personnel – Sect. 6 Other – Sect. 7:      

*For all boxes checked in question 1.5, please complete the respective sections below.

2. Biological Agent Modification - fill in only where proposed changes apply

2.1

Action Classification Indicate the modification

|Add Delete Modify |rDNA Hosts |      |

|Add Delete Modify |rDNA Vector |      |

|Add Delete Modify |rDNA Genes |      |

|Add Delete Modify |rDNA Gene Sources |      |

|Add Delete Modify |Infectious Agents |      |

|Add Delete Modify |Toxins |      |

|Add Delete Modify |Other(s) |      |

2.2 Provide justification for modification(s) indicated in item 2.1.

NOTE: Modification(s) must be within the scope of the original hypothesis.

     

2.3 Are there any potential risks of adverse effects to humans, animals, and/or plants that might result from exposure to the above indicated organisms/toxins?

No.

Yes. Describe the potential adverse effects to humans, animals, and/or plants for each infectious agent/biological toxin*, including:

a. The symptoms/disease(s) which may result

b. The infectious dose and/or the LD50

c. The target organ(s) for infection/toxicity

d. Exposure management (i.e. how will you handle accidental exposure)

     

Guidance information:

Exposure Management: Appendix B of this form

Medical Treatment: The USF Worker’s Compensation webpage lists facilities that provide treatment:

*Safety information: contact the Institutional Biosafety Officer at (813) 974-0954.

2.4 Indicate the Biosafety Containment Level (BSL) at which the above indicted organism(s)/toxin(s) will be handled (Refer to Appendix G of the NIH Guidelines or Appendix C of this form).

NOTE: An increase in biosafety containment level requires a new registration application.

BSL-1 BSL-2 BSL-3 (Requires new complete application.)

2.5 Indicate disinfectant that will be used if different from the original application.

10% Bleach Solution (1:10 dilution of standard household bleach (5.25% sodium hypochlorite) to water. This needs to be made fresh at least weekly and preferably stored in opaque containers)

Iodophor (Concentration:      )

Phenolic agents (Concentration:      )

Other: [Please specify]

NOTE: The IBC requires a minimum concentration of 10% bleach solution as the primary disinfectant. Unless noted on this application with an explanation and approved by the IBC, all other disinfectants (e.g., 70% alcohol) are secondary disinfectants to be used after the 10% bleach.

2.6 Does this modification request include any animal procedures?

Yes. IACUC #      

No

If yes please provide a revised animal use section (section 6 (Infectious Agent) or section 9 (non-exempt rDNA)).

NOTE: A pre-performance may be required for the animal procedures..

3. Protocol Title / Sponsor Modifications:

3.1 Provide the new title:      

3.2 Provide the new sponsors / sources of funding:      

Location of Facilities and Equipment Modification

4.1 Location of Facility*

Action Justification Building/Room

|Add Delete Modify |      |      |

|Add Delete Modify |      |      |

4.2 Equipment Modification* (e.g., autoclave, biosafety cabinet, etc.)

Action Type of Equipment/Model/Certification Date Building/Room

|Add Delete Modify |      |      |

|Add Delete Modify |      |      |

*Attach a clearly labeled revised diagram of the laboratory that shows the following: 1) where the organism(s) will be manipulated and stored; 2) location of biological safety cabinets and other safety equipment; 3) eye-wash and sink; 4) room entry/exit; and 5) location of the autoclave.

5. Procedures Modification

Change in experimental operations, procedures, or techniques (including animal procedures)

5.1 Describe the proposed changes and provide justification for the changes:

     

6. Personnel Modification

6.1 Check the relevant boxes and provide the requested information.

A. I request that the following individuals(s) be deleted from the study:

[Names of personnel to be deleted]

B. I request that the following individual(s) be added to the study. List the names of additional personnel involved in the table below and have each person initial the following assurance:

I have read and understand the nature of these experiments.

I have the knowledge and training required to safely handle the materials described.

I agree to conduct these experiments in accordance with all USF IBC policies and the USF Biosafety Manual:



I have attended/will attend the annual USF biosafety training indicated.*

|Name |Initial here |Date |Biosafety Training* |Training Date |E-mail |

|      | |      | Yes No |      |      |

|      | |      | Yes No |      |      |

|      | |      | Yes No |      |      |

|      | |      | Yes No |      |      |

|      | |      | Yes No |      |      |

|      | |      | Yes No |      |      |

|      | |      | Yes No |      |      |

|      | |      | Yes No |      |      |

|      | |      | Yes No |      |      |

|      | |      | Yes No |      |      |

*The following types of training classes are required:

Core – Must be completed by those who have not completed it previously.

Continuing Education – Must be completed annually.

Special Topics – Required for persons involved in certain types of work.

For current Biosafety training information, please go to:

7. Other Changes not described above:

Provide a brief description of the changes you are requesting and justification for those changes:

     

8. PI Statement

I acknowledge my responsibility for the conduct of this research in accordance with University Policy, Section IV-B-7 of the NIH Guidelines and/or the recommendations of the CDC/NIH published in Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, and the USF Institutional Biosafety Manual.

| |

| |

|Principal Investigator (signature): Date: |

Appendix A – Biosafety References

• Biosafety in Microbiological and Biomedical Laboratories, 5th Edition

• Material Safety Data Sheets (MSDS) for Infectious Agents

Risk Group Classification for Infectious Agents

• USF Institutional Biosafety Manual

• NIH Guidelines for Research Involving rDNA Molecules

• Biological Spill Response

• CDC Regulated Agents

Appendix B – Response to Laboratory Personnel Bloodborne Pathogen (BBP) Exposure

The following emergency response guidelines shall be followed when a laboratory worker has been exposed to potentially infectious agents, including bloodborne pathogens to ensure prompt and appropriate care. BBP Exposure is defined as

“A percutaneous injury (a needlestick or cut with a sharp object) or contact of mucous membrane or non-intact skin with blood, tissue or other body fluids that are potentially infectious”. Some post-exposure treatments must be started within

1-2 hours of exposure, so time is critical.

If Percutaneous and/or Non-Intact Skin Accidental Exposure Occurs:

Secure sharp device in sharps container

Wash the exposed site thoroughly with soap and water

Remove contaminated clothing

Report exposure to supervisor immediately

If Mucous Membrane Accidental Exposure Occurs:

Flush eyes, nose and/or mouth with copious amounts of water at the nearest faucet or eye wash station.

Remove contaminated clothing

Report exposure to supervisor immediately

If you are exposed to a Bloodborne Pathogen:

Immediately report all possible work-related exposures to potentially infectious agents, including BBP’s to your supervisor. Exposures are to be reported immediately by the supervisor or department designee by telephone to AmeriSys (800)455-2079 (24 hours a day/7 days per week). During working hours (M-F, 8-5PM) the USF Worker’s Compensation Insurance specialist Meica Elridge should also be contacted at (813) 974-5775 or by email at melridge@admin.usf.edu. In the event that follow-up is necessary following initial care from the USF Workers’ Compensation provider, please contact the USF Medical Health Administration (Employee Health) office at (813) 974-3163 or by pager (813) 216-0153.

If you become ill or injured on the job:

An employee who becomes ill or is injured as the result of a job-related incident must report the incident to the supervisor immediately no matter how minor the injury may appear to be. Effective January 1, 2009, all work-related injuries or illnesses are to be reported by the supervisor or department designee by telephone to:

AmeriSys 1-800-455-2079 (toll free). For additional information on how to report a work-related injury or illness go to the USF Worker’s Compensation website at:

USF Employees, Residents, and Student Assistants classified as “Volunteers”: You must report all potential BBP exposures to your supervisor and then call AmeriSys.

USF Students not on official “Volunteer” status and not employed by the University: Your care must be paid for through your student/personal insurance or by some other means

 

If you are the supervisor:

When an employee reports a work-related injury or illness, take prompt action to

1.     Ensure the employee receives necessary medical attention.  In case of emergency, call 911 or immediately send the employee to a hospital emergency room. Call AmeriSys as soon as practicable at (800)455-2079 to report the work-related injury or illness.

2.     With the injured or ill employee, immediately call AmeriSys at (800)455-2079 to report the work-related injury or illness so the employee can receive appropriate care. Except in cases of emergency, the injured or ill employee must be present with the supervisor when the injury or illness is reported.

3.     Complete the Accident Investigation Report for Supervisors and forward to Human Resources within 24 hours.

4.     Take action to correct any safety hazards to prevent the same or similar injury or illness from occurring again.

 

For questions on how to report a work-related injury or illness or other workers’ compensation issues, contact Workers’ Compensation Insurance Specialist Meica Elridge at (813) 974-5775 or melridge@admin.usf.edu.  Reports may be faxed to (813) 974-7535.

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