Institutional Biosafety Committee

The University of Southern Mississippi Institutional Biosafety Committee (IBC)
By-Laws

1. Charge to the IBC
   
   The University of Southern Mississippi IBC is charged by the Vice President for Research to review and approve all research and educational activities involving the use of biological agents and to ensure  compliance with applicable regulations. Biological agents are defined as human, animal, and plant pathogens, recombinant DNA, and blood and blood products.
   
   The committee ensures that the University of Southern Mississippi is in compliance with the NIH Guidelines for recombinant DNA research, the CDC/NIH publication Biosafety in the Microbiological and Biomedical Laboratories, the OSHA Bloodborne Pathogens Standards, and HHS and USDA rules for the possession, use, and transfer of select agents and toxins.
2. Committee Membership
   1. The Vice President for Research at the University of Southern Mississippi will appoint the members to the IBC.
   2. The IBC will have a minimum of 5 voting members:
      1. A Chairperson, to be appointed by the Vice President for Research
      2. At least one member to represent research staff
      3. At least one member to represent the community
      4. The Bio-Safety Officer as a non-voting member
   3. The IBC may also include ad hoc non-voting members, such as the animal facility director, as needed.
3. Meetings
   1. The IBC will meet at least twice a year on a regular basis, but members may be called to meet as need arises.
   2. A quorum shall consist of a simple majority. A quorum is required for voting.
   3. Minutes of the meetings shall be prepared and furnished to each member of the IBC for review. An archive of the minutes shall be preserved in the biosafety office.
4. Policies and Procedures
   1. The IBC By-Laws will be reviewed annually by the Chair and Biological Safety Officer.
   2. Ratification of the By-laws and amendments requires a 2/3 majority vote by all voting members at a meeting.
5. Responsibilities 
   1. Institutional Biosafety Committee (IBC)
      1. IBC Policies will be made available via the website.
      2. IBC will promptly review research proposals.
      3. IBC protocol forms, policies, and procedures will be periodically reviewed to:
         1. Ensure that the information meets current regulatory requirements; and
         2. that the IBC has the information needed for a complete review of the research.
      4. IBC will promptly notify the PI of any actions concerning a reviewed research proposal.
   2. Biological Safety Officer (BSO)
      1. The Biological Safety Officer is appointed by the Vice President for Research.
      2. The Biological Safety Officer's duties include, but are not limited to:
         1. Conducting inspections at least annually to ensure laboratory standards are rigorously followed;
         2. Reporting to the Institutional Biosafety Committee and the institution any significant problems, violations of the NIH Guidelines, and any significant research-related accidents or illnesses of which the Biological Safety Officer becomes aware.
         3. Developing emergency plans for handling accidental spills and personnel contamination and investigating laboratory accidents involving recombinant DNA research;
         4. Providing advice on laboratory security; 
         5. Providing technical advice to Principal Investigators and the Institutional Biosafety Committee on research safety procedures.
6. Protocols
   1. Protocol Submission
      1. The principal investigator must electronically submit the application forms to the Chair of the IBC.
      2. All protocol applications must use the current approved submission form.
      3. A protocol may be approved for a maximum of three years.
   2. Protocol Review Process
      1. The assignment of a designated reviewer from the IBC will be made by the IBC Chair.
      2. IBC members who are involved in a protocol being reviewed will recuse themselves from the meeting during the discussion and voting on that protocol.
      3. All protocols are presented by the designated reviewer of the IBC to the full committee for discussion.
      4. Any supporting documentation of the review process shall be submitted to the Biosafety office to be retained as an official record of action and placed in the PI’s file.
      5. The IBC will attempt to complete reviews promptly.
      6. Full approval requires a simple majority vote at a meeting of the Committee at which a quorum is present.
      7. The applicant will be notified by the Chair in writing of the IBC Action, which may include:
      8. Approval, conditional approval, or non-approval.
   3. Applicant’s Rights
      1. The applicant may attend the IBC meeting to answer questions regarding a submitted proposal.
      2. The applicant has the right to appeal any IBC action in writing to the Chair.
      3. The IBC will review any appeals and, if necessary, refer the application to the Vice President for Research.
   4. Amendments and Annual Progress Reports
      1. Written notification must be submitted to the biosafety office using the approved form when there is a significant change in the approved protocol, personnel involved in the protocol, or location of approved activity.
      2. Significant changes to the protocols, as determined by the biosafety officer, must be referred to the IBC for review.
7. Adverse Events
   1. The IBC Chair and BSO will be responsible for investigating any adverse events involving biological agents.
   2. All adverse events must be reported in writing to the BSO and IBC Chair.
   3. The IBC Chair and BSO, in consultation with the IBC, will determine if the adverse event will be reported to regulatory agencies.
   4. Adverse events include but are not limited to the following events that involve the biological agents (defined above): Work-related exposures, injuries, illnesses, laboratory accidents, and/or any non-compliance with institutional, state, and federal regulations.

Name                                          Role                                                       
Shahid Karim, PhD                     Chair
Tom Ricks, DVM                         Outside affiliate (Biomedical Sector)
Kevin Macaluso, PhD                 Outside affiliate (Biosafety Sector)
Vijay Rangachari, PhD               Member (Biophysical Chemist)
Mac Alford, PhD                         Member (Plant Expert)
Fengwei Bai, PhD                      Member (Virologist/Microbiologist)
Martha Sparrow                         Non-voting member
Lisa Wright, PhD, MPH              Non-voting member