Potentially Hazardous Biological Agents Risk Assessment Form

This form is required for all research involving microorganisms, rDNA, fresh/frozen tissue, blood, blood products, and body fluids. SRC/IACUC/IBC approval is required BEFORE experimentation.

SECTION 1: PROJECT ASSESSMENT

1. Identify potentially hazardous biological agents (PHBA) to be used in this experiment. Include the strain, source, quantity, and the biosafety level risk group of each microorganism or tissue.
2. Please indicate the BSL level of the experimentation site:
   • None
   • BSL-1
   • BSL-2

   If BSL-2 laboratory, not at an RRI, include the BSL-2 checklist.

3. Describe the precautions that will be used to minimize risk.
4. Describe the method of disposal of all cultured materials and other potentially hazardous biological agents.

SECTION 2: TRAINING

1. What training will the student receive for this project?
2. Experience/training of Direct Supervisor as it relates to the student’s area of research (if applicable).

SECTION 3: For ALL CELL LINES, MICROORGANISMS AND TISSUES

To be completed by the QUALIFIED SCIENTIST or Direct Supervisor – Check the appropriate box(es) below:

• Experimentation on the microorganisms/cell lines/tissues to be used in this study will NOT be conducted at a Regulated Research Institution, but will be conducted at a (check one)
  • BSL-1
  • BSL-2 (include a copy of the checklist for BSL-2). [This study has been reviewed by the local SRC and the procedures have been approved prior to experimentation.]
• This project involves the culturing of Multi Drug Resistant Organisms (MDROs). It has been conducted in a BSL-2 or higher lab at a Regulated Research Institution and the required IBC pre-approval is attached.
  Date of IBC approval: ___________________________
• Experimentation on the microorganisms/cell lines/tissues to be used in this study will be conducted at a Regulated Research Institution and was approved by the appropriate institutional board prior to experimentation; institutional approval forms are attached.
  Origin of cell lines: __________________________________________
  Date of IRC/IBC/IACUC approval: ___________________________
• Experimentation on the microorganisms/cell lines/tissues to be used will be conducted at a Regulated Research Institution, which does not require IACUC or IBC approval for this type of study.

CERTIFICATION

To be SIGNED by the QUALIFIED SCIENTIST or Direct Supervisor

The QS/DS has seen this project’s research plan and supporting documentation and acknowledges the accuracy of the information provided above. This study has been approved as a (check one)

• BSL-1
• BSL-2

study, and will be conducted in an appropriate laboratory.

QS/DS Printed Name: ___________________________
Signature: ___________________________
Date of review (mm/dd/yy): ___________________________