Institutional Biosafety
Committee
(IBC)
Policy and Procedures

1. INTRODUCTION
   The University of Texas at Arlington (UTA) Institutional Biosafety Committee (IBC) is a University-wide Standing Committee appointed by the President not reporting to the Academic Senate.
   
   The University of Texas at Arlington follows the NIH Guidelines for Research Involving Recombinant DNA Molecules, effective June 24, 1994, published in Federal Register July 5, 1994, (59 FR 34496) and all subsequent amendments issued by the NIH Director with advice of the RAC, and Biosafety in Microbiological and Biomedical Laboratories, CDC/NIH, Fourth Edition, May 1999, HHS Publication No. (CDC) 93-8395.
   
   These policies and procedures comply with applicable federal law, state statutes, and University policy in maintaining the highest standards for the handling and use of recombinant DNA and infectious agents.
   
   The responsibility for compliance with applicable federal law, state statutes, and University policy concerning hazardous materials, hazardous waste management, radiation safety, environmental regulatory affairs, and other general institutional safety requirements rests with the University Environmental Health & Safety Office in the Office of Finance and Administration and is not covered under this policy.
   
   
   
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2. APPLICABILITY
   The responsibilities of the IBC are applicable to all activities which, in whole or in part involve research with recombinant DNA if:
   1. The research is sponsored by UTA, or
      
      
   2. The research is conducted by or under the direction of any employee or agent of UTA in connection with his or her institutional responsibilities, or
      
      
   3. The research is conducted by or under the direction of any employee or agent of UTA using any property or facility of UTA.
   
   
   
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3. INSTITUTIONAL POLICY
   1. It is the policy of UTA that, all research covered by this policy, including those considered exempt under the NIH Guidelines, will be reviewed and approved by the University's Institutional Biosafety Committee.
      
      
   2. The involvement of recombinant DNA or infectious agents in research covered by this policy will not be permitted until the IBC has reviewed and approved the research protocol in accord with and to the extent required by the NIH Guidelines or the CDC's Biosafety in Microbiological and Biomedical Laboratories. The IBC's review of research on a continuing basis will be conducted at appropriate intervals but not less than once per year.
      
      
   3. UTA has established and will maintain one IBC in accordance with the NIH Guidelines. The IBC has the responsibility and authority to review, approve, disapprove, or require changes in appropriate recombinant DNA research activities to ensure compliance with the NIH Guidelines.
      
      
   4. UTA has provided and will continue to provide both meeting space for the IBC and sufficient staff to support the IBC's review and record keeping duties.
      
      
   5. UTA encourages and promotes constructive communication among the research administrators, department heads, research investigators, IBC, and other institutional officials as a means of maintaining a high level of awareness regarding the NIH Guidelines.
      
      
   6. The IBC shall maintain strong liaisons with UTA's Institutional Review Board for the Protection of Human Subjects (IRB) and the Institutional Animal Care & Use Committee (IACUC). The IBC shall operate in close association with Regulatory Services with regard to registration, document preparation, educational efforts, materials, and compliance with biosafety regulations and guidelines.
      
      
   7. UTA will maintain documentation of IBC activities as prescribed by the NIH Guidelines.
      
      
   8. UTA will exercise appropriate administrative overview carried out at least annually to insure that its practices and procedures designed for the research involving recombinant DNA are being effectively applied and are in compliance with the requirements of the NIH Guidelines and this policy.
      
      
   9. UTA will comply with the requirements set forth in the NIH Guidelines regarding cooperative research projects. When research covered by this policy is conducted at or in cooperation with another entity, all provisions of this policy remain in effect for that research. UTA may accept, for the purpose of meeting the IBC review requirements, the review of an IBC established under another policy of compliance with NIH. Such acceptance must be in writing, approved and signed by UTA's Regulatory Services and approved and signed by correlative officials of each of the other cooperating institutions.
      
      
   10. Copies of the general policy will be available to all faculty through Regulatory Services and the Chairperson of the IBC.
       
       
   11. UTA will also provide each individual at the institution conducting or reviewing human subject research a summary of the rules and regulations including any future modifications and an outline of the procedures to be followed in any research involving recombinant DNA as covered by this policy.
       
       
   12. Research covered by this policy will fall into one of the following categories:
       1. rDNA (Recombinant deoxyribonucleic acid): (i.) Molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; (ii.) molecules that replicate as a result of the above (i.);
          
          
       2. RG2 (Risk Group 2): Agents that are associated with diseases that are rarely serious and for which preventive/therapeutic interventions are often available;
          
          
       3. RG3 (Risk Group 3): Agents that are associated with serious/lethal human diseases for which preventive/therapeutic interventions may be available (high individual risk, but low community risk);
          
          
       4. RG4 (Risk Group 4): Agents that are likely to cause serious/lethal human diseases for which preventive/therapeutic interventions are not usually available (high individual risk and high community risk);
          
          
       5. Research considered exempt will be reviewed and approved by the Chair of the IBC. The Chair will then forward the approved exemptions to the UTA Office of Research Compliance. All other categories/risk groups will be approved by the full IBC.
   
   
   
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4. IBC RESPONSIBILITIES
   The specific responsibilities of the IBC include, but are not limited to, the following:
   1. Review and approve all research involving recombinant DNA and infectious agents categorized in Risk Group 2, Risk Group 3, or Risk Group 4, as defined by the NIH Guidelines, Appendix B. These reviews shall include:
      1. Independent assessment of the containment levels required by NIH Guidelines for the proposed research.
         
         
      2. Assessment of the facilities, procedures, practices, and training and expertise of personnel involved in the research.
         
         
      3. Verification and assignment of the classification of the infectious agents and vectors, rDNA pathogens, or toxins research in accordance with the National Institutes of Health (NIH), Centers for Disease Control (CDC), Department of Health and Human Services (DHHS), or other appropriate guidelines or regulations.
         
         
      4. Ensuring that all aspects of Appendix M of the NIH Guidelines (as applicable) have been appropriately addressed by the Principal Investigator.
         
         
      5. Ensuring that no research participant is enrolled (as defined in Section I-E-7 of the NIH Guidelines) in a human gene transfer experiment until the RAC (NIH's Recombinant DNA Advisory Committee) review process has been completed (see NIH Guidelines Appendix M-I-B, RAC Review Requirements), Institutional Biosafety Committee approval (from the clinical trial site) has been obtained, Institutional Review Board (IRB) approval has been obtained, and all applicable regulatory authorizations have been obtained.
         
         
      6. For human gene transfer protocols selected for public RAC review and discussion, consideration of the issues raised and recommendations made as a result of this review and consideration of the Principal Investigator's response to the RAC recommendations.
         
         
      7. Ensuring that final IBC approval is granted only after the RAC review process has been completed (see NIH Guidelines, Appendix M-I-B, RAC Review Requirements).
         
         
      8. Ensuring compliance with surveillance, data reporting, and adverse event reporting requirements set forth in the NIH Guidelines.
      
      
   2. Provide timely reports (within 30 days of the incident) of any significant problems with or violations of the NIH, CDC, or DHHS Guidelines and any significant research-related accidents or illnesses to the Responsible University Official, Environmental Health & Safety Office, DHHS, RAC, FDA, or NIH as applicable.
      
      
   3. Participation in Committee meetings convened to vote on approval or disapproval of research activities, formulate policies and procedures, gather and distribute information relevant to the Committee's functions, and evaluate the structure and function of the Committee.
      
      
   4. Participation in activities to keep faculty, students, and staff of the University informed of the Committee's scope, functions, and concerns.
      
      
   5. Provide an open forum for pro-active discussion of International, National, State, and Institutional biosafety concerns and assist Regulatory Services in the resolution of any contentious or ambiguous biosafety issues or concerns brought before the Committee.
   
   
   
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5. IBC STRUCTURE
   1. Institutional Establishment of the IBC
      1. The IBC is established at The University of Texas at Arlington to review all research involving recombinant DNA. Additionally, the IBC will review all research involving infectious agents categorized in Risk Group 2, Risk Group 3, and Risk Group 4.
         
         
      2. The goals of the IBC are to:
         1. Ensure that reasonable and proper precautions and procedures are used and facilities free of hazards are available for research activities involving biological agents.
            
            
         2. Prevent potential threats to the safety of UTA personnel from biological hazards.
            
            
         3. Assist and advise UTA Principal Investigators and research personnel to become knowledgeable about and comply with appropriate international, federal, state, or local biosafety regulations or guidelines associated with research.
      
      
   2. IBC Membership Requirements
      1. The IBC membership is appointed by the President of the University and shall be composed of no fewer than five members.
         
         
      2. The term of office of the Committee members shall be for two years, effective September 1 to August 31, and members may be reappointed by the President for additional terms. If for any reason a Committee member resigns, the President shall appoint another individual to serve the remainder of the un-expired term.
         
         
      3. To ensure continuity, initial appointments of Committee members will be for staggered terms so that one-half of the appointments expire August 31 of each academic year.
         
         
      4. The IBC is comprised of faculty, administrators, and community members from diverse backgrounds to promote complete and adequate review of research activities covered by this policy, and has the professional competence necessary to review the specific research activities which will be assigned to it.
         
         
      5. The Chairperson shall be appointed by the President of the University according to the following criteria:
         1. Commitment to the goals of ensuring the safety of research involving rDNA and infectious agents, preventing threats to the safety of UTA personnel from biological hazards, and assisting/advising UTA Investigators to become knowledgeable and comply with appropriate regulations and guidelines.
            
            
         2. Willingness to devote energies necessary to maintain and oversee effective continual integrity of the IBC structure and function.
            
            
         3. Possess the expertise necessary to review specific research activities involving rDNA and determine applicable exemptions in accordance with the NIH Guidelines.
            
            
         4. Flexibility to participate in seminars, workshops, etc. at the state and national level serving as a spokesperson from the University as an intermediary transmitting information to the IBC and the University.
         
         
      6. The Vice Chairperson of the Committee shall be appointed by the President or designee annually.
         
         
      7. Members of the IBC shall be appointed by the Chair of the IBC.
         
         
      8. The Vice President for Research shall be the Responsible University Official.
         
         
      9. The IBC is sufficiently qualified through the experience and expertise of its members, and the diversity of the members' backgrounds, including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel.
         
         
      10. The IBC will include at least two members who are not otherwise affiliated with the institution and who are not a part of the immediate family of a person affiliated with the institution; a UTA scientist with expertise in plant, plant pathogen, or plant pest containment principles; a UTA scientist with expertise in animal containment principles; a UTA laboratory technical staff representative; and, the UTA Safety Officer.
   
   
   
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6. IBC CHAIR RESPONSIBILITIES
   The specific responsibilities of the IBC Chair include, but are not limited to, the following:
   1. Call and preside over IBC meetings.
      
      
   2. Act as a liaison between the Committee and University administrators, federal and state officers involved in the practices of institutional biosafety committees, and spokespersons representing committees from other institutions.
      
      
   3. Ensure IBC members are appropriately trained to review rDNA and infectious agent research.
      
      
   4. Maintain a file complete with all documents pertinent to specific research activities credited by the Committee, copies of minutes from Committee meetings, and other information germane to the workings of the Committee.
      
      
   5. Initially review all recombinant DNA research proposals to determine applicable exemptions.
      
      
   6. Review, with full committee membership, research proposals involving non-exempt rDNA research and research involving infectious agents categorized in Risk Groups 2, 3, and 4.
      
      
   7. Initiate continual reviews on active research protocols approved by the IBC.
      
      
   8. Prepare and distribute written notices when research activities have been approved and forward a copy to the IBC Office of Record (Regulatory Services).
      
      
   9. Remain abreast of any literature or information issued by federal, state, or local sources concerned with the nature and procedures of biosafety. The Chairperson must keep Committee members informed of pertinent information.
      
      
   10. Submit written statements of evaluation concerning the Committee structure and function to the University administrative sources annually or as necessary.
   
   
   
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7. PRINCIPAL INVESTIGATOR RESPONSIBILITIES
   The specific responsibilities of Principal Investigators include, but are not limited to, the following:
   1. Identify recombinant DNA materials.
      
      
   2. Identify infectious agents categorized in Risk Groups 2, 3, and 4, as described in the NIH Guidelines, Appendix B.
      
      
   3. Prior to initiating the research, register all protocols involving recombinant DNA materials and infectious agents (Risk Groups 2 and above) with the IBC for review and approval.
      
      
   4. Submit appropriate information in a timely manner for annual reviews of approved biosafety research.
      
      
   5. Obtain formal approval from the IBC before implementing any changes to the approved biosafety research.
   
   
   
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8. REGULATORY SERVICES RESPONSIBILITIES
   The specific responsibilities of Regulatory Services include, but are not limited to, the following:
   1. Receive research protocols involving recombinant DNA and infectious agents and facilitate review by the IBC.
      
      
   2. Maintain a registry of research protocols involving rDNA and infectious agents.
      
      
   3. Maintain confidential and secure database records and archival files of all registration documents, correspondence, membership, meeting minutes, and decisions relating to IBC issues.
   
   
   
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9. IBC EVALUATION PROCEDURES
   The Committee, under the direction of the Chairperson, will evaluate the structure and function of the Committee annually. The Policy and Procedure Manual will serve as a guideline for evaluation. A written evaluation report will be prepared and a copy retained in the IBC files.
   
   
   
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10. PROCEDURES FOR SUBMISSION OF A PROPOSAL
    All faculty, staff, or students using rDNA or infectious agents (Risk Groups 2, 3, and 4) in research must submit a protocol for review and approval by the IBC. All protocols should be filed with Regulatory Services, Box 19188 or 202 E. Border St., Suite 201. The Office of Research Compliance will forward the protocol to the IBC Chair who will determine if the protocol qualifies for exemption. The IBC Chair will either approve the protocol as exempt or refer the protocol for full review at a convened IBC meeting. The UTA Regulatory Services will maintain all files, records and minutes of all IBC activities.
    
    
    
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