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Office of Research Compliance and Assurance

 

     
  biosafety  
  Institutional Biosafety Committee
     
  Roles and Responsibilities  
 
To comply with federal guidelines, University of South Alabama (USACOM) must have in place and implement policies for work with R-DNA.  To oversee this work, USACOM has responsibility to ensure compliance with these guidelines. The members of the IBC must be trained in the requirements of the guidelines, and report to ORDA if any significant problems with the program arise. The IBC is also responsible for determining the necessity for health surveillance for those staff who work with R-DNA.
 
     
  Membership of IBC  
 
The IBC will consist of at least 7 members of the USACOM faculty with expertise in DNA, biosafety or environmental safety, and at least two public members. The members of the committee must be identified by name to NIH ORDA and provide brief, relevant background information on each member. The committee composition should be re-registered with NIH ORDA annually.
 
     
  The function of the IBC is to:  
     
 
  • Review all work for compliance with the criteria listed above.
  • Assess independently the containment levels required.
  • Conduct regular reviews, evaluation and approvals of R-DNA registration documents.
  • Assess facilities, work procedures and practices.
  • Review periodically R-DNA work being conducted to ensure requirements of guidelines being fulfilled.
 
  Registration of Work  
     
 
All work with biohazardous materials must be registered and approved with the Institutional Biosafety Committee (IBC). To initiate the review process, the principal investigator must submit an IBC registration form to the IBC Committee, CSAB 128.  You may obtain the appropriate form by calling (251)460-6625 or by visiting Bioterrorism Preparedness & Response Act of 2002. The Principal Investigator (PI) responsible for initiation and supervision of all potentially biohazardous work at USACOM is responsible for preparing and submitting a biohazardous agent registration (BAR) form or recombinant DNA work application to the IBC, or/and for recombinant work.
 
     
 
The Department Chair supervising the PI carries the final responsibility of ensuring all departmental activities involving work with biohazardous material and the agents they might contain are registered.  All required record keeping, especially for the OSHA Bloodborne Pathogen Standard, must be available for inspection by each department of for inspection by the IBC or other authorities.  The PI must be responsible that these documents are complete and in good order for work assigned by the PI.
 
     
 
The IBC Chairperson is responsible for reviewing and routing of the biohazardous activity registration form or the R-DNA registration document to the Institutional Biosafety Committee (IBC). Initial review of these registration forms will be performed by the IBC chair to ensure completeness of information provided by the PI, correct assignment of the requested biosafety level as specified in "Biosafety in Microbiological and Biomedical Laboratories",  OSHA Bloodborne Pathogen Standard [29 CFR 1910.1030], and/or NIH "Guidelines for R-DNA Activities, 1996" and the evaluation of the need for the preparation of a special, written Biosafety Control Plan by the Principal Investigator.
 
     
  Criteria for Submission of Work with Biohazard Materials.  
     
 
All work with biohazardous materials must be registered with USACOM IBC using the Biohazardous Activity Registration Form (BAR). The BAR form must be fully completed by the Principal Investigator, co-signed by the Department Chair involved and forwarded to the IBC Office, CSAB 128.
 
     
 
All applications will be reviewed for completeness, including the Principal Investigator's signature, Departmental Chair signature, and all required information requested in the BAR registration document. If a more detailed Biohazard Control Plan (BCP) is required, the PI will be contacted. A more detailed BCP is generally required on all large-scale productions (> 10 liters) of R-DNA organisms and for the handling of human pathogens under any special circumstances or in any significant volume.
 
     
 
Upon receipt of any additional clarifying information (BCP, resumes of staff, answers to inquiries etc.), the BAR application will be submitted to the IBC with a recommendation from the Chairperson of the Institutional Biosafety Committee which summarizes any concerns, special requirements and appropriate biosafety level for the conduct of the proposed work.  Routine applications involving BL-1 and BL-2 research may be given preliminary approval by the IBC Chairperson if the work is not unusual and can be readily managed without a special BCP and the work can begin.
 
     
 
The membership of the IBC is composed of members both from within the College of Medicine and from outside the community. The Chairperson of the IBC will initially review and approve the BAR registration form. The Chairperson will notify the PI of the approval in writing. The biohazardous work may begin immediately when all special requirements noted on the BAR approval for safe work are completed.
 
     
 
All registration forms/documents will be presented to the IBC at the next scheduled meeting for reaffirmation. This will permit reflection, group discussion and final recording of the action taken. The IBC, at a future date, may review the status of the approved research and BARS already approved and, after deliberations, may require additional conditions. Based on changing safety considerations, modifications of the BCP may be deemed necessary. In this event, a memorandum will be written stating any necessary changes.
 
     
 
The PI responsible for the proposed research may be requested to attend the scheduled meeting of the IBC to clarify any problems or to brief the committee on the proposed research. The PI may meet with the Committee or the Chairperson of the IBC to ask for special reconsideration or explanation of committee action.
 
     
  Registration of Work with R-DNA Organisms or Activities  
 
The handling of genetically modified organisms, transgenic animal work, or recombinant DNA work in the US is regulated by guidelines produced by NIH in 1996 entitled, "Guidelines for Research Involving Recombinant DNA Molecules".
 
     
  The NIH Guidelines specify practices for constructing and handling:  
     
 
  • Recombinant DNA molecules
  • Organisms and viruses containing recombinant DNA molecules.
 
  Any more recent "guidelines" take immediate precedence over older guidelines. The guidelines define R-DNA molecules as:  
     
 
  • Molecules which are constructed outside living cells by joining natural or synthetic
  • DNA molecules that can replicate in a living cell, or
  • DNA molecules that result from the replication of those described above.
 
     

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Date last changed: April 1, 2014 3:31 PM
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