Section 2: Responsibilities
- 2.0 IO and the University Responsibilities
- REVISED 2.1 IBC Responsibilities
- REVISED 2.2 IBC Subcommittees Responsibilities
- REVISED 2.3 IBC Chair Responsibilities
- REVISED 2.4 BSO Responsibilities
- REVISED 2.5 Principal Investigator Responsibilities
- REVISED 2.6 Rapid Response Team Responsibilities
- 2.7 Office of Biotechnology Activities Responsibilities
- 2.8 Office of Research Support Responsibilities
The NIH Guidelines will never be complete or final since all conceivable experiments involving recombinant or synthetic nucleic acid molecules cannot be foreseen. Therefore, it is the responsibility of the University and those associated with it to adhere to the intent of the NIH Guidelines as well as the specifics. Good judgment is a key along with the assistance of ORS and OBA. The potential consequences of noncompliance with the NIH Guidelines consist of:
- Suspension, limitation or termination of NIH funds for recombinant or synthetic nucleic acid molecules research at the University.
- A requirement for prior NIH approval of any or all recombinant or synthetic nucleic acid molecules projects at the University.
The responsibility for Biosafety Program at the University rests with the Vice President for Research, who is the IO. The IO:
- Appoints IBC members.
- Annually evaluates IBC members with input from the IBC Chair and ORS Director
- Oversees the IBC and research personnel who obtain, possess or use recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins.
- Annually evaluates allocation of resources to the IBC and adjusts as necessary.
The IO has charged the IBC (See Section 1.2) to review, approve and provide oversight and guidance to those research personnel who seek to use recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins in experiments or teaching. Any possession and/or use of recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins at the University must be conducted with appropriate safeguards and in accordance to with University policies and federal guidelines and regulations.
The responsibilities of the IBC include, but are not limited to, the following:
- Review, approve and oversee research utilizing recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins research, conducted at or sponsored by the University, for adherence with the NIH Guidelines and the BMBL. This pertains to the initial and continuing reviews and modifications to the currently approved research.
- Notify the Principal Investigator of the results of the IBC's review, approval, or disapproval.
- Make final determination of physical and biological containment for recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins research and modify containment levels as necessary.
- Review research identified by the principal investigator or identified during the protocol review process as DURC to determine if it meets the criteria defining DURC. When applicable, refer the protocol to the IRE committee for further review.
- Assess the facilities, procedures, practices, training and expertise of personnel involved in research utilizing recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents and toxins.
- Review and report any significant problems, violations of the NIH Guidelines and any significant research-related accidents or illnesses to the IO and to the NIH/OBA per the NIH Guidelines.
- Direct development of appropriate procedures as required by NIH/OBA, CDC, and USDA regulations to oversee the possession and/or use of recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins.
- Suspend or terminate protocol approval for the possession or use of recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins, where the IBC finds noncompliance or that such use or possession poses undue risk to research personnel or a threat to the health and safety of the community.
- Periodically review the IBC policies and procedures and modify them as necessary to ensure appropriate biosafety measures and adherence with federal and state requirements.
- Review research protocols that include the possession and/or use of recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins for compliance with NIH Guidelines, the BMBL, and Select Agents and Toxins regulations. As part of the review process, the IBC will do the following:
- Conduct an independent assessment of the containment levels (BSL-1 to BSL-3), as required by the NIH Guidelines or the BMBL.
- Conduct an assessment of the facilities, procedures, practices, training, and expertise of personnel conducting research involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins.
- Ensure adherence with all surveillance, data reporting, and adverse event reporting requirements set forth in the NIH Guidelines for recombinant or synthetic nucleic acid molecules research and the select agents and toxins regulations.
- Required to submit member rosters (completed by ORS) including members’ biographical sketches to NIH/OBA.
- Obtain specific review, registration and/or approval from NIH/OBA for research that fall under Sections III-A, III-B, III-C and Appendix M.
All submissions that are complete will be reviewed by a designated IBC Subcommittee (subcommittee). Subcommittees will consist of IBC members, the BSO, the IBC Program Coordinator and the Director of ORS. The subcommittee can include faculty members from multiple areas of expertise as necessary to efficiently review the submissions. There are three subcommittees in the following areas of expertise:
- Animals/Fly (vertebrate or invertebrate): transgenic animals and animal hosts (including insects).
- Biochemistry/Plant: basic cloning, sequencing, structure, and function, transgenic plants, and containment.
- Microbiology and Toxins: pathogens and infectious agents, viral vectors, virulence factors.
Additional subcommittees may be formed and or combined as the nature of the submissions dictate.
The subcommittees will meet and review submitted research protocols prior to a convened IBC meeting. They will be responsible for:
- Reviewing research submittal for completeness.
- Determining overall risk assessment.
- Setting appropriate containment levels.
- Determining exempt status, if applicable.
- Requesting clarifications or changes.
- Recommending additional conditions.
- Submission of approval/non-approval recommendation to the IBC.
Institutional Review Entity (IRE) is a committee for the review of research for DURC.
- IRE will be composed of the IBC Chair, BSO, and at least three other members. The IRE will be designated by the IBC Chair as required for expertise to review and develop the risk mitigation plan.
- Determine whether research that uses one or more of the agents or toxins listed in IODURC also produces, aims to produce, or is reasonably anticipated to produce one or more of the effects listed in IODURC and notify the USG funding agency within 30 days of DURC review.
- Identify the anticipated benefits and risks of the research identified as DURC. The anticipated benefits should be considered in conjunction with the previously identified risks in order to develop a draft risk mitigation plan to guide the conduct and communication of the DURC.
- The IBC Chair or person designated to communicate with the funding agency (ICDUR) must send the draft risk mitigation plan to the USG funding agency for approval. The draft risk mitigation plan must be sent to the USG funding agency within 30 days for review. The USG funding agency should provide a response within 30 day of receipt and should finalize the plan within 60 days of receipt of the draft plan.
- Review the DURC project annually or more often if required for changes to the risk mitigation plan, status or changes in status of the DURC, and notify USG funding agency of these changes within 30 days.
The IBC Chair responsibilities include:
- Serve as one of three contacts for all regulatory agencies (in addition to IO who may delegate this function).
- Act as liaison between the research personnel and IBC.
- Assigns subcommittees as needed to review an issue prior to official committee decisions made at the convened meeting.
- Assign members to IRE with expertise necessary to conduct the review for DURC and draft a risk mitigation plan. IRE subcommittee may also include faculty experts, a representative from the HealthPoint Occupational Health Program and University Administration as required to review research for DURC and develop and draft a risk mitigation plan.
- Approve the agenda for the convened meeting of the IBC.
- Calls the meeting and directs the meeting deliberations, requests motions and seconds, and closes the meeting once it has concluded business.
The BSO shall be a member of the IBC. The BSO responsibilities include:
- Performing periodic inspections of laboratories conducting research using recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins to ensure that laboratory standards are rigorously followed.
- Report to the Rapid Response Team (RRT) (Section 2.6), IBC and University any problems, violations, research-related accidents or illnesses.
- Performing and reviewing the required risk assessment to determine appropriate Biosafety level for handling an organism.
- Work with IRE to review research for DURC and develop a risk mitigation plan.
- Developing emergency plans for handling accidental spills and personnel contamination and investigating laboratory accidents involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins.
- Providing advice on laboratory security to the IBC research personnel.
- Providing technical advice to research personnel and the IBC on research safety procedures.
The principal function of the BSO should be to advise the research personnel, the IBC and the laboratory worker concerning the most appropriate safety practices that will assure the safe conduct of research with recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins.
On behalf of the University, the Principal Investigator is responsible to follow the NIH Guidelines, the BMBL and IBC Policies when using recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins. Along with this understanding, the Principal Investigator will also have the following responsibilities:
- Make the initial risk assessment and determination of required levels of physical and biological containment in accordance with the NIH Guidelines and the BMBL. The list is available online at http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf.
- Be adequately trained in good microbiological techniques.
- Provide laboratory research personnel with protocols describing potential biohazards and necessary precautions.
- Instruct, train and supervise research personnel in (1) the practices and techniques required to ensure safety, and (2) the procedures for dealing with spills or potential exposures to the agents described in the research.
- Ensure the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics) and correct procedures or conditions that might result in release of or exposure to recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents or toxins.
- Develop and obtain IBC approval of and adhere to biosafety plans (see EHS website: http://www.utexas.edu/safety/ehs/biosafety/#documents_policies) for handling accidental spills and personnel contamination.
- Inform the research personnel of the Occupational Health & Safety Program and provisions for any precautionary medical practices advised or requested, e.g., vaccinations. (See Section 8)
- Ensure all research personnel, including students, have the required training in the accepted procedures for laboratory practices and safety. (See Section 7)
- Obtain IBC approval prior to initiating or modifying any research involving use of recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents and toxins.
- Maintain IBC approval for use of recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins through timely submission of annual updates.
- Immediately report any significant problems or any research-related accidents and/or illnesses to EHS and any other university committees (Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC)) that have reviewed and approved the research activity.
- Identify any research falling within the scope of DURC to the IBC. The criteria for assessing DURC can be found at: http://www.phe.gov/s3/dualuse/Pages/default.aspx
- Work with IRE to assess the dual use risks and benefits of the DURC and to develop risk mitigation plans.
- Conduct DURC in accordance with the provisions in the risk mitigation plan.
- Be knowledgeable about and comply with all institutional and USG policies and requirements for oversight of DURC.
- Ensure all laboratory personnel conducting life sciences research with one or more of the high consequences pathogens or toxins covered under the IODURC have received education and training on DURC.
- Communicate DURC in a responsible manner and in compliance with the approved risk mitigation plan.
- Comply with permit and shipping requirements for biohazardous materials.
- Although federal regulations allow exemptions for some types of recombinant or synthetic nucleic acid molecules use, the Principal Investigator must submit an application for all projects using recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins so the IBC can verify that they are exempt.
The Rapid Response Team (RRT), is a subcommittee of the IBC to review and notify or report incidents involving recombinant or synthetic nucleic acid molecules and biohazardous materials agents and toxins related to research and teaching activities at The University, to the appropriate university, college and department leadership and the IBC. The RTT is composed of the Biological Safety Office (BSO), IBC Chair, and ORS Director, and may also include a representative from the HealthPoint Occupational Health Program (OHP) (Section 8) if the incident involves an injury or exposure and a medical consultation or treatment. Other members may be designated by the IBC Chair as required. The charge of the RRT is to:
- Immediately notify the following:
- Principal investigator’s Dean or Chair (by the IBC Chair).
- EHS Director and Associate Vice President of University Operations (by the BSO)
- IO (by IBC Chair or ORS Director).
- Review the details of each incident within 24 hours, if it involves recombinant or synthetic nucleic acid molecules and/or biohazardous materials or within four hours if the incident involves select agents or toxins and determine if the incident is reportable to any agency outside of the University.
- Submit detailed report with recommendations to the IBC at the next convened IBC meeting.
OBA serves as the focal point for information on recombinant or synthetic nucleic acid molecules activities and provides advice to all within and outside NIH/OBA. OBA’s responsibilities include, but are not limited to, the following:
- Serving as the focal point for all aspects of gene transfer experiments.
- Reviewing and approving experiments in conjunction with ad hoc experts involving the cloning of genes for toxin molecules that are lethal for vertebrates at an LD50 of less than or equal to 100 ng/kg body weight in organisms other than Escherichia coli K-12.
- Publish proposed changes to rules or guidelines in the Federal Register.
- Reviewing and approving the membership of an Institution’s Biosafety Committee, and where it finds the IBC composition to meet the requirements set forth in the NIH Guidelines, giving approval for the IBC membership.
The ORS Director and the IBC Program Coordinator will provide overall administrative support, and will coordinate IBC reviews and meetings. Their responsibilities include, but are not limited to, the following:
- Provide the necessary liaison between the research personnel, the IBC, federal and regulatory agencies.
- Serve as the office of record for documentation involving IBC.
- Provide all necessary documentation, forms, regulatory guidelines and regulations, to Principal Investigators.
- Maintain IBC registration forms and records.
- Assist the IO in filing annual updates and other reports to the NIH/OBA.
- Communicating with IRB or IACUC when protocols involve human subjects or animals.
- Assist the RRT in initial review of allegations of non-compliance with NIH Guidelines, and preparing reports for the IBC.
- By monitoring Federal and state regulations, draft revised policies and procedures to remain in compliance with those regulations.
- Provide administrative support for the IBC by scheduling meetings, arranging for meeting space and taking meeting minutes.