Information for PIs
You, the principal investigator, are ultimately responsible for compliance with all pertinent laws, regulations, and policies having to do with biosafety. This ranges from ensuring that the proper signage is up on lab doors to submitting protocol amendments to the IBC. It is the responsibility of PIs to provide adequate biosafety training for laboratory personnel under their supervision. Furthermore, the PI is responsible for providing laboratory staff with (a) protocols describing potential biohazards and appropriate precautions, (b) training in the area of methods to ensure biosafety and deal with accidents, and (c) information regarding precautionary medical procedures.
Background Information for Principal Investigators
- Read Sections 2, 3, and 4 of the Biosafety on Microbiological and Biomedical Laboratories (BMBL) (Section 5 also, if you are doing animal work). These sections talk about biological risk assessment, principles of Biosafety, and the Biosafety levels. http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
- Read Section IV-B-7 a. through e. of the NIH Guidelines for Research Involving Recombinant DNA Molecules if you are doing rDNA work. This explains your responsibilities as PI. http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Gdlnes_lnk_2002z.pdf
- Read the Mississippi State Department of Health “Adopted Standards for the Regulation of Medical Waste”. This explains how to handle biohazardous waste. http://www.msdh.state.ms.us/msdhsite/index.cfm/30,116,83,pdf/licensureinfecreg%2Epdf
- Read the Mississippi State University policies on biosafety.
- Read OSHA’s regulations on bloodborne pathogens if you will be working with human specimens http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051
&p_text_version=FALSE
The IBC Application
To submit an IBC application for rDNA or infectious disease research, please go to http://www.orc.msstate.edu/quicklinks/forms.php and click on the IBC application form. Follow the instructions and submit both a hard and electronic copy to the BSO.
The IBC meets the first Wednesday of each month. An IBC application must be submitted at least 10 working days prior to that Wednesday to be reviewed at the next meeting.
You will be notified by the BSO as to the disposition of your application.
Each IBC application is assigned a unique registration number. For any inquiries about a project, please include that number on your correspondence.
Any changes to the research project such as protocol, personnel, organism, rDNA or location will require the submission of an Update/Modification form. This will aid in determining if changes are significant enough to result in the submission of a new IBC application. You will also be notified on the yearly anniversary of your project to submit an Update/Modification Form indicating changes, if any to the project.
The IBC application is project dependent! For every new research project involving the use of rDNA or infectious organisms, a new IBC application is required.
If the PI is unsure as to whether his/her research will require IBC oversight, use the Research Biosafety Review Form (found under “Forms”). This is a very short form which gives basic information on the research to be conducted and will allow the BSO to determine if oversight is required. This form can also be used to register research not requiring full review and approval by the IBC.
If a PI is changing labs, leaving the University, or getting out of research please follow the Lab Exit Checklist, also found under the “Forms” page.
Bloodborne Pathogens
Work with human tissues/body fluids will also require an Exposure Control Plan written by the PI and submitted to the IBC. A template for the exposure control plan can be found at http://www.orc.msstate.edu/quicklinks/forms.php Bloodborne pathogen training requires an initial training session and yearly refresher course for the duration of the project. Please contact the BSO to set up an appointment.
BSL-2/ABSL-2 Laboratory Certification
If you will be performing work requiring a BSL-2 laboratory, use the BMBL as your source guide and configure your laboratory such that it can be certified as a BSL-2 facility by the Biosafety Officer. A copy of the BSL-2 Laboratory Certification Form can be found here and will help you determine what is required http://www.orc.msstate.edu/quicklinks/forms.php
BSL-2 lab certification is project-dependent. BSL-2 labs are inspected on an annual basis. Animal BSL-2 facilities have some additional requirements. The inspection form for an ABSL-2 can be found at http://www.orc.msstate.edu/quicklinks/forms.php
Responsibilities of the PI
- Develop specific protocols to ensure the safe use of biohazardous materials by following instructions set forth in the University Biosafety Manual and ensure that all laboratory personnel comply with the specific safety protocols.
- Make the initial determination of the required levels of physical and biological containment as well as the appropriate microbiological practices and laboratory techniques.
- Ensure that the containment equipment and facility requirements for activities performed under his/her direction meet the criteria for the appropriate BSL level.
- Ensure that all maintenance work in, on or around contaminated equipment is conducted only after that piece of equipment is thoroughly decontaminated by the laboratory staff.
- Develop specific protocols that outline proper emergency procedures for response to an accidental exposure of personnel or the environment to the biological agents and ensure that all laboratory staff are familiar with and comply with the emergency procedures.
- Submit an IBC application and obtain approval from the IBC prior to commencement of the work. In, addition, the PI is responsible for submitting any changes to the IBC-approved project using the IBC Update/Amendment Form.
- Obtain approval from the other regulatory committees if required: IACUC – animal care and use; IRB - human subjects research; RSC – radiation safety.
- Comply with all applicable University policies and federal, state, and local laws.
- Ensure that all laboratory staff under his/her supervision are appropriately trained in the safe use of biohazardous materials. Training includes animal care personnel who provide husbandry and care for infected research animals.
- Comply with medical waste laws in the handling and disposal of biohazardous waste.
- Ensure that all laboratory staff, maintenance personnel and visitors are informed of the potential risk and the practices/procedures used to minimize that risk.
- Report any significant problems or violations or any significant research related accident or laboratory acquired infection to the BSO.
- Comply with import/export/shipping requirements of biohazardous materials.
As always, if you require assistance, please call the Biosafety Office at 5-0620.
