IBC Policies and Procedures
- Section 1: Introduction
- 1.0 Purpose
It is the responsibility of The University of Texas at Austin (University) Institutional Biosafety Committee (IBC) to review, approve and oversee the use of recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins in all teaching, research, or testing activities conducted by University facilities or research personnel. The Institutional Biosafety Committee Policies and Procedures Manual (IBC Policies) and the UT Austin Revised Handbook of Operating Procedures (HOP) provides a review of the relevant regulatory and local requirements. Since laboratory work can involve exposure not only to recombinant or synthetic nucleic acid molecules and biohazardous agents, materials and toxins, but also to chemical and radiological hazards, the IBC Policies should be used in conjunction with any other pertinent University policies and procedures.
- 1.1 Mission Statement
Ensure the University safeguards human health and the environment by maintaining an adherence with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (PDF) and the Biosafety in Microbiological and Biomedical Laboratories (BMBL), and the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (IODURC). Through a balance of outreach and support for research personnel, the IBC will:
- Assure activities meet the ethical and legal requirements for the responsible use of recombinant or synthetic nucleic acid molecules, biohazardous agents, materials and toxins.
- Establish policies and make recommendations to the University regarding such activities.
- Minimize risks to the research personnel, community and the environment by educating the University community regarding the regulatory requirements for the use of recombinant or synthetic nucleic acid molecules, biohazardous agents, materials and toxins.
The Institutional Officer (IO) has charged the IBC with review, approval and oversight of research involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins in research and teaching activities. Responsibilities of the IBC include assessment of facilities, procedures, practices and training of research personnel to assure compliance with NIH/OBA and other pertinent guidelines and regulations. To successfully carry out these responsibilities, the IBC is appointed to achieve sufficient knowledge and expertise in biomedical research and biosafety. The IBC has the authority to approve, require modifications to secure approval, disapprove, suspend or terminate research activities as required to assure adherence to the appropriate regulations and guidelines.
The IBC has been charged in the planning and implementation of the campus Biosafety program with a purpose to ensure the health and safety of all personnel working with recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins. The IBC makes certain that research conducted at the University is in compliance with the NIH Guidelines, BMBL, and the HHS and USDA regulations, and the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, drafts campus policies and procedures, and reviews individual research proposals using recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins. Since the University receives NIH funding for research involving recombinant or synthetic nucleic acid molecules, all activities involving recombinant or synthetic nucleic acid molecules must follow the NIH Guidelines. Failure to adhere to these guidelines can result in suspension or termination of NIH funding, or to a requirement for prior NIH approval of any or all recombinant or synthetic nucleic acid molecules projects at the institution. The IBC is therefore responsible for establishing and implementing policies that provide for the safe conduct of research involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins to ensure adherence with NIH Guidelines. IBC responsibilities with regards to activities involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins are specified in the NIH Guidelines. Also, as delineated in the IO’s charge to the IBC, the committee is given authority to oversee all research involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins including suspension or termination of research that does not comply with IBC Policies.
- 1.3 Committee Composition
The President of the University delegates the IO authority to appoint the chair, IBC members and alternates as needed. Members consist of faculty, research personnel, and the community. The Chair shall be a scientific researcher with experience in recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins. The term of membership is one year and is renewable upon mutual agreement. Members will be evaluated annually by the IO and Director of RSC. They will be evaluated on satisfactory attendance, their preparation for each meeting by reviewing the submitted research, and if they have effectively contributed.
Members will collectively have appropriate expertise and experience in the use of recombinant or synthetic nucleic acid molecules and biohazardous materials, agents or toxins. They must have expertise in assessment of risk to environment and public health along with knowledge of institutional commitments and policies, applicable law, professional standards, community and environment. The IBC will have no fewer than five members who will be composed of the following:
- At least one member with expertise in recombinant or synthetic nucleic acid molecules technology.
- At least one member with expertise in biological safety and physical containment.
- At least one member with expertise in select agents and toxins (use, storage, transfer, and disposal).
- At least one member with expertise in plant, plant pathogen, or plant pest containment principles.
- At least one member with expertise in animal containment principles.
- An individual representing laboratory technical staff.
- The Biological Safety Officer.
- At least two members from the surrounding community, and not affiliated with the University, to represent the interests of the community in regards to health and protection of the environment. These will be chosen from:
- Representatives of community interests with respect to health and protection of the environment, e.g., officials of state or local public health or environment authorities, local government bodies, persons with medical, occupational, or environmental expertise.
- They can also be the individuals who represent community attitudes.
Consultants may be invited to meeting for their expert advice when necessary but will not be allowed to vote on any protocol.
- 1.4 Scope
The IBC policies apply to all research personnel engaged in activities and/or research involving recombinant or synthetic nucleic acid molecules, biohazardous agents, materials and toxins that are:
- Sponsored by the University.
- Conducted by University research personnel.
- Conducted using the University’s property, and facilities.
- Received, stored, used, transferred or disposed of at any of the University facilities.
- Research at other institutions conducted on behalf of the University.
- 1.5 Federal Registrations
The purpose of registration and annual membership updates are:
- Provide assurance of local review of biosafety risks to the Office of Biotechnology Activities (OBA).
- Indicates University point of contact.
- Provides census of the field: where recombinant or synthetic nucleic acid molecules research is being conducted.
The IBC is registered with OBA for purposes of recombinant or synthetic nucleic acid molecules research. For more information visit https://osp.od.nih.gov/biosafety-biosecurity-and-emerging-biotechnology/. An annual report is filed with OBA, which includes an updated list of IBC members indicating the role of each member and biosketches for each member. The OBA is notified of any changes in IBC membership when they occur. Such notice shall include a revised list of members, contact information and a biosketch for each new member. The Office of Research Support and Compliance (RSC) notifies OBA of changes in IBC membership and submits an annual report on behalf of the University.
Should a Principal Investigator request use, possession, or transfer of a biological material listed as a Select Agent and/or Select Agent Toxin, and not listed as an exempt strain or quantity, the University will initiate a Laboratory Registration for Select Agents and Toxins with the National Select Agent Registry. Laboratory registrations for Select Agents and Toxins will be maintained by the Responsible Official (RO) in the Office of Environmental Health and Safety (EHS). For additional information visit https://www.selectagents.gov
- 1.6 Regulations and Guidelines
The IBC Policies are based upon the following regulations and guidelines:
- NIH Guidelines This document specifies practices and provides guidelines for constructing and handling recombinant or synthetic nucleic acid molecules and organisms containing recombinant or synthetic nucleic acid molecules. Institutions conducting or sponsoring recombinant or synthetic nucleic acid molecules research covered by NIH Guidelines are responsible, through established policies and its IBC, for ensuring that such research is conducted in compliance with the NIH Guidelines and are available online https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf (PDF)
- BMBL is published by Centers for Disease Control and Prevention (CDC) and the NIH – This document contains guidelines for microbiological practices, safety equipment, and facilities that constitute the four established biosafety levels. The BMBL is considered the standard for biosafety. The BMBL is available online https://www.cdc.gov/labs/BMBL.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fbiosafety%2Fpublications%2Fbmbl5%2Findex.htm
- Select Agents and Select Agent Toxins – The Department of Health and Human Services (HHS), Center for Disease Control and Prevention (CDC) regulations, 42 CFR Part 73, and the United States Department of Agriculture (USDA) regulations, 9 CFR Part 121, establish requirements regarding the possession, use, receipt, and transfer of listed select agents and select agent toxins. The regulations set forth the requirements for registration of listed select agents and select agent toxins, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications. For more information visit https://www.selectagents.gov
- United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (IODURC) - IODURC is a US Government (USG) policy established with the purpose of instituting regular review of USG funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC) in order to: (a) mitigate risks where appropriate; and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. IODURC addresses the institutional oversight of DURC, which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable. For more information visit http://www.phe.gov/s3/dualuse/Pages/default.aspx
- Guidelines for Working Safely with Human Cell Lines
- Guidelines for Research Involving Human Specimen Collection
- For Research Involving Animals and Plants -The Animal and Plant Health Inspection Service (APHIS) regulates genetically engineered (GE) organisms and certain GE organisms that may pose a risk to plant or animal health. APHIS uses the term biotechnology to mean the use of recombinant or synthetic nucleic acid molecules technology, or genetic engineering to modify living organisms. Permits are required for the importation, transit, domestic movement and environmental release of organisms that impact plants. For more information visit:
- 1.7 Definitions
Biohazardous Materials, Agents and Toxins: Infectious biological or synthetic agents, biologically derived materials and toxins that present a risk or potential risk to the health of humans, animals, or plants either directly through exposure or infection or indirectly through damage to the environment. Categories of potentially infectious biological materials include the following:
- Human, animal, and plant pathogens (bacteria, parasites, fungi, viruses, prions).
- All human and nonhuman primate blood, blood products, tissues, and certain body fluids (use of human blood and body fluid for clinical diagnostic and treatment purposes is excluded).
- Cultured cells and potentially infectious agents these cells may contain.
- Infected animals and animal tissues.
Recombinant or Synthetic Nucleic Acid Molecules: In the context of the NIH Guidelines recombinant and synthetic nucleic acid molecules are defined as (1) recombinant nucleic acid molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell, i.e., recombinant nucleic acids; (2) nucleic acid molecules that are chemically, or by other means, synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or (3) molecules that result from the replication of those described in (1) or (2) above. Synthetic nucleic acid molecule segments that are likely to yield a potentially harmful polynucleotide or polypeptide (e.g., a toxin or a pharmacologically active agent) are considered as equivalent to their natural DNA counterpart.
Dual Use Research of Concern (DURC): DURC is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. "Life sciences" pertains to living organisms (e.g., microbes, human beings, animals, and plants) and their products, including all disciplines and methodologies of biology such as aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, synthetic biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches for understanding life at the level of ecosystems, organisms, organs, tissues, cells, and molecules.
- Section 2: 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 RSC 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.
- 2.0 IO and the University Responsibilities
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 RSC 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.
- 2.1 IBC Responsibilities
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 RSC) 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.
- 2.2 IBC Subcommittees Responsibilities
All submissions that are complete will be reviewed by designated reviewers. Designated reviewers will consist of one or more IBC members in addition to the BSO or EHS alternate, and can include faculty members from multiple areas of expertise as necessary to efficiently review the submissions. Protocols are generally grouped into three subject areas and are assigned to reviewers with the appropriate 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.
The designated reviewer(s) will review 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.
- Review of eProtocols amendments with non-significant changes and continuing reviews with no changes or non-significant changes for administrative approval (see Sections 3.3, 3.5, and 4.1.2).
- 2.3 IBC Chair Responsibilities
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.
- 2.4 BSO Responsibilities
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.
- 2.5 Principal Investigator Responsibilities
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 (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) 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.
- 2.6 Rapid Response Team Responsibilities
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 RSC 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 RSC 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.
- Immediately notify the following:
- 2.7 Office of Biotechnology Activities Responsibilities
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.
- 2.8 Office of Research Support and Compliance Responsibilities
The RSC 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.
- Section 3: Protocol/Modification Submission and Review
- 3.0 Submissions
The IBC is responsible for overseeing and evaluating all aspects of research involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins, and is charged with reviewing proposals that involve recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins to ensure that the criteria established in the IBC Policy and the federal regulations and guidelines are implemented. In its review of the proposals, the primary goal of the IBC is to facilitate research personnel compliance with applicable laws, regulations, guidelines and policies consistent with the performance of appropriate and productive scientific endeavors.
IBC protocol submissions, whether they are new IBC protocol submissions, modifications or renewals, must be submitted to RSC by the Principal Investigator for review and IBC approval. No research involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins can be initiated until the Principal Investigator has received the approval of the IBC.
Although federal regulations allow exemptions for some types of recombinant or synthetic nucleic acid molecules used, the Principal Investigator must submit an application for all projects using recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins so that the IBC is aware of the activities and can verify that they are exempt. For more information on exemptions visit: https://osp.od.nih.gov/biotechnology/faqs-about-experiments-that-are-exempt-from-the-nih-guidelines/?pdf=10454 (PDF)
No one shall obtain or use recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents and toxins until the protocol has been approved by the IBC. Modifications to approved protocols shall not be implemented until approved by the IBC.
3.0.1 Who can be a Principal Investigator?
Principal Investigators (PI) can submit applications to the IBC to work with recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents, and toxins. In general, a PI is a tenured, tenure track, or research faculty with assigned research space. Should a PI not have assigned space to conduct the research, the PI must submit the below statement from the person who is responsible for the research space. Exceptions to this policy will be considered by the IBC on a case-by-case basis.
I, [insert name of person with assigned research space] am aware of the attached research of [insert name of PI without assigned space] that will be conducted in space assigned to me. I acknowledge my responsibility for ensuring that this research will be conducted in a safe manner and in accordance with institutional and federal regulations.
- 3.1 Experiments Requiring IBC Review
Experiments that required IBC review include, but are not limited to:
- Studies using recombinant or synthetic nucleic acid molecules that are exempt from the NIH Guidelines.
- The deliberate transfer of a drug resistance trait to micro-organisms that are not known to acquire the trait naturally.
- The deliberate transfer of recombinant or synthetic nucleic acid molecules or DNA or RNA derived from recombinant or synthetic nucleic acid molecules into human research participants (human gene transfer).
- The deliberate formation of recombinant or synthetic nucleic acid molecules containing genes or sequences for the biosynthesis of toxin molecules.
- The use of RG-2 or RG-3 agents as host-vector systems.
- The use of human etiologic and animal viral etiologic agents.
- The cloning of DNA from RG-2 or greater agents into non-pathogenic prokaryotes or lower eukaryotic host-vector systems.
- The use of infectious or defective RG-2 or greater agents.
- Whole animals in which the animal’s genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules or DNA derived into the germ-line (transgenic animal).
- Viable micro-organisms or cell lines with modified recombinant or synthetic nucleic acid molecules - tested on whole animals.
- Genetically engineered plants by recombinant or synthetic nucleic acid molecules methods.
- More than 10 liters culture of organisms or cells containing recombinant or synthetic nucleic acid molecules in a single vessel.
- The formation of recombinant or synthetic nucleic acid molecules containing one-half or more of the genome of a eukaryotic virus or from the same virus family.
- Experiments using BSL-2 or BSL-3 containment.
- Non-recombinant research using biohazardous materials, agents or toxins.
- All research using biological toxins or bioactive derivatives or subunits of toxins.
- Research collecting or analyzing human or non-human primate cell lines, tissues, fluids or other potentially infectious material.
- 3.2 New Submissions
Protocol application forms for research, teaching, and testing activities involving recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents, or toxins must be accurately completed and submitted for review and IBC approval.
Requirements for Review and Approval:
- To facilitate the review of protocols, Principal Investigators submitting IBC protocols will have their labs inspected and they must develop a Lab Biosafety Manual. The BSO, as agent for the IBC, will assist the Principal Investigator in completing this step of the application. For information on this process and Biosafety Manual Templates go to EHS website.
- Principal Investigators will need to enter basic information (such as Protocol Title, Personnel Information) before the application form is generated and a protocol number assigned. Once a protocol number has been assigned, that can be used to reference the study with Office of Research Support and Compliance (RSC) or Office of Sponsored Projects (OSP) for grant applications.
- Upon submission, the protocol will be reviewed for completeness by the IBC Program Coordinator and it may be necessary for the Principal Investigator to submit additional information, to ensure a complete submission, if requested.
- Additional IBC protocols may be required based on the nature of the activities described in the protocol.
- The protocol will be assigned to designated reviewers (see Section 2.2) for review prior to a convened IBC meeting. It may be necessary for the Principal Investigator to submit additional information and/or clarifications if requested by the designated reviewers.
- Approval/Non-approval will be determined by the IBC, and the Principal Investigator will be notified of the decision.
- For submission deadlines and meeting dates visit:
- The protocol application form is available at:
- 3.3 Continuing Review / Renewal
The Principal Investigator is required to resubmit their legacy rDNA or Biosafety protocols for renewal or a continuing review application for eProtocols annually. The Principal Investigator will be notified of pending expiration of approval at regular intervals prior to expiration of approval period. All annual renewals of legacy rDNA and Biosafety protocols and continuing review of eProtocol with significant changes are reviewed in the same manner as new protocol submissions (see Section 4.1.1). Continuing reviews of eProtocols without changes or with non-significant changes may be reviewed by designated reviewers and approved administratively (see Section 4.1.2). Research cannot be continued if protocol renewal or continuing review is not approved prior to the expiration date of the previous approval period.
- 3.4 Failure to Submit Renewal/Respond to IBC Requirements
If the Principal Investigator fails to renew rDNA or Biosafety protocols or submit a continuing review application by the anniversary date, a letter will be sent to the Principal Investigator, and copied to the Chair/Dean of the department. All activities pertaining to the project described in the expired protocol must cease. If the Principal Investigator does not provide a renewal or continuing review application within five business days, this issue is added to the agenda and the IBC determines whether or not to close the IBC protocol.
- 3.5 Modification Process
Changes or modifications to approved protocols (i.e. change in or additional of research personnel, room changes, new procedures or agents) must be reviewed and approved by the IBC prior to initiation.
Major changes are those that change the scope of the review or that are inconsistent with the focus of the approved protocol. For major changes the PI should submit a new protocol.
Significant changes are changes to approved protocols that are extensive and include but are not limited to the following:
- Change in Principal Investigator
- Change of an infectious agent or toxin
- Change of protocol components that are not exempt from the NIH Guidelines
- Changes that affect the risk assessment of the protocol
Significant changes will be reviewed by designated review and require approval at a convened IBC meeting. Proposed significant changes require designated review and IBC approval prior to initiation.
Minor-risk changes are changes to approved protocols including recombinant that that are minor, do not affect the risk assessment or applicable NIH Guidelines such as:
- Addition of human biological materials (fluids, cells, or tissue) from sources not known to be infectious
- Transgenic, knockout, and knock in animal strains
- BSL-1 viral vectors from approved sources
- Genes and host changes that do not significantly change the focus of the project
Minor-risk changes can be reviewed through designated review by designated qualified member(s) and may be approved outside a convened IBC meeting. Proposed minor-risk changes require designated review and IBC approval prior to initiation.
Non-significant changes are changes to approved protocols including recombinant that are nonsignificant, do not affect the risk assessment or applicable NIH Guidelines such as changes to:
- Research personnel other than Principal Investigator
- Protocol title
- IACUC and IRB protocol numbers or OSP grant number
- Lab Biosafety Manual
- Research locations
- Additional cell lines
- Changes in BSL-1 agents, vectors (except viral), hosts and genes
Non-significant changes may be approved by administrative approval by a member or RSC staff outside a convened IBC meeting. Proposed non-significant changes require administrative review and approval prior to initiation.
- 3.6 Protocol Termination
The Principal Investigator will notify the IBC Program Coordinator when a protocol involving recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents and toxins is completed or no longer active. The IBC shall contact the Principal Investigator if there are any questions or concerns regarding closure of a protocol.
As stated in Section 3.4 failure to renew a previously approved IBC protocol may result in closure of the protocol. In addition, non-compliance with institutional and federal regulations, policies and guidelines or requirements of the IBC that are either serious or ongoing will be evaluated and the IBC may determine that the incidents require protocol closure.
- 3.7 Relationships to IACUC and IRB
IBC protocols submission involving the use of live animals will require IACUC review and approval prior to initiation.
IBC protocol submissions involving the administration of recombinant or synthetic nucleic acid molecules or biohazardous materials, agents or toxins to humans, or involves the collection of tissues or fluids from humans, requires IRB review and approval prior to initiation.
Current IACUC and IRB protocol numbers must be included on the IBC submission.
- Section 4: Meeting Process
- 4.0 Requirements for Quorum
The conduct of official IBC business occurs at convened meetings that must include a quorum of members in order for the meeting to be held. The IBC defines a “quorum” as more than half the regular voting members. A protocol is approved only if a quorum is present, and if more that 50% of the quorum votes in favor or protocol approval. For reasons other than conflict of interest, abstentions from voting do not alter the quorum or change the number of votes required. Members are expected to attend the convened meetings unless they have notified the IBC Program Coordinator in advance, that they are unable to do so. Members who fail to attend meetings on a regular basis may be removed from the committee.
- 4.1 Protocol Review
For the protocol to be reviewed by the IBC prior to the convened meeting and to allow ample time for Principal Investigator to respond to comments or any explicit conditions, a submission deadline is listed on the RSC IBC website. The protocols must be submitted by the submission deadline or the protocol will be held until the next convened meeting.
4.1.1 Full Review
New protocols, (except non-recombinant protocols only involving human biological materials (Section 4.1.2)), legacy rDNA and Biosafety protocols and approved eProtocols submitted with significant changes (Section 3.5), require a full review and will be assigned to designated reviewers. Review comments if any will be sent to the Principal Investigator. The Principal Investigator must respond to any queries or questions.
4.1.2 Designated Review
New non-recombinant protocols submitted for the collection, processing, storage, and testing of human biological materials (fluids, cells, or tissue) not known to be infected with a pathogen and approved eProtocol amendments and continuing reviews submitted with minor-risk changes (Section 3.5) may be reviewed by designated review and approved. The IBC Chair (and in his/her absence, the Vice-Chair) may designate one or more qualified members to review new non-recombinant protocols or proposed minor-risk amendments. These designated member(s) have authority to approve, require modifications (to secure approval), or request full committee review. Designated review approval may occur outside a convened IBC meeting. The IBC will be notified of all designated review approvals.
4.1.3 Administrative Review
eProtocols amendments submitted with non-significant changes (Section 3.5) and continuing reviews submitted with no changes or non-significant changes may be reviewed administratively and approved. Administrative approval may occur outside a convened IBC meeting. The IBC will be notified of all administrative approvals.
- 4.2 Procedures
IBC meetings are routinely held once per month on the second Tuesday of the month. Rescheduling may occur due to inability to achieve a quorum of members and non-scheduled meetings may be called by the IBC Chair to discuss matters that arise and require immediate resolution. The IBC Program Coordinator is responsible for assuring that a meeting room is located and scheduled and that all other arrangements for the meeting are made.
At the scheduled time and upon reaching a quorum, the IBC Chair will call the meeting to order and follow an agenda prepared prior to the meeting. The typical order of the agenda is as follows:
Call to order.
Chair’s reminder to members of conflict of interest requirements.
Approval of the previous month’s meeting minutes.
IBC related announcements.
Educational items for discussion.
Next meeting announcement.
When reviewing protocols for initial review or periodic review of ongoing research activities, there are several activities that the IBC must carry out on behalf of the University:
- Conduct assessment of the containment levels required by the NIH Guidelines.
- Assessing the facilities, procedures, practices, and training and expertise of personnel involved in research with recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents or toxins.
- Ensure compliance with the NIH Guidelines and the BMBL.
In reviewing proposed recombinant or synthetic nucleic acid molecules research, the NIH Guidelines, in Sections II and III, cite a number of matters that the IBC should consider that include:
- Agent characteristics (e.g. virulence, pathogenicity, environmental stability).
- Types of manipulations planned.
- Source(s) of nucleic acid molecules sequences (e.g., species).
- Nature or function of the gene encoded by recombinant or synthetic nucleic acid molecule sequences (e.g., structural gene, oncogene).
- Host(s) and vector(s) to be used.
- Whether an attempt will be made to obtain expression of a foreign gene, and if so, the protein that will be produced.
- Change in biosafety risk for organism formed through combination of sequences from multiple sources or synergistic effect of combining transgenes resulting in new phenotype.
- Containment conditions to be implemented.
- Applicable section(s) of the NIH Guidelines (e.g., Section II-D-1, Section III-E-1, etc.).
- 4.3 Possible Review Outcomes
All non-exempt protocols are presented and discussed individually and the IBC votes on the disposition of the protocol. Possible outcomes include:
- Approval – When the IBC has determined that all review criteria, based on the IBC Policies and federal-mandated regulations have been adequately addressed by the Principal Investigator, the IBC may approve the research, thus providing the Principal Investigator permission to perform the research.
- Approval with conditions – This status is used for protocols for which all required information has not been received, required training has not been completed and/or there are remaining issues or questions regarding the safety of the protocol.
- Tabled – If the protocol requires clarification in order for the IBC to make judgment, certain committee members with certain expertise is not present, the IBC wishes to seek external consultation, or any of a number of other reasons prevents the IBC from conducting its review, then the IBC may wish to defer or table review.
- Withhold Approval- When the IBC determines that a protocol has not adequately addressed all of the requirements of the IBC Policies and regulations as applicable, the IBC may withhold approval. The IBC Subcommittees may not withhold approval; this action may only be taken if the review is conducted using the IBC method of review.
- 4.4 Conflict of Interest
Both the NIH Guidelines and the IBC Polices state that no IBC member* may participate in the IBC review or approval who have a conflict of interest in the project (e.g.; are acting as the Principal Investigator, have financial interest in the project). All Principal Investigators and/or IBC members are required to disclose any conflicts of interest according to the HOP. Guidelines are listed on the Vice President for Research website.
Should an IBC member declare involvement in any way in a research protocol under review by the IBC, or state a conflict of interest with a research protocol, then the member(s):
- Are excluded from discussion and voting except to provide information requested by the IBC.
- May be asked to leave the meeting room for discussion and voting.
- Are not counted towards quorum.
* For purposes of these policies, the University considers “Member” to include the research personnel’s spouse, children, parents, brothers, sisters, grandparents, grandchildren, daughters-in-law and sons-in-law (HOP Objectivity in Research: Conflict of Interest and Commitment).
- 4.5 Minutes
Review of protocols by the IBC invokes a deliberative process, and section IV-B-2-b of the NIH Guidelines require that the IBC meeting minutes should offer sufficient detail about the discussion of the matters that were discussed in order to document the IBC rationale for particular decisions. The IBC has some latitude in the degree of detail in these minutes.
Recorded minutes of IBC meetings are intended to reflect the substantive discussion of protocols. Minutes are intended to contain sufficient information that a reasonable person could understand the nature of the discussion. In general, the minutes should offer sufficient detail to serve as a record of major points of discussion and the Committee’s rationale for particular decisions, documenting that the IBC has fulfilled its review and oversight responsibilities as outlined under Section IV-B-2-b of the NIH Guidelines.
Meeting minutes are not intended to provide a verbatim transcript of discussion nor to reiterate shared knowledge of the Committee such as recent discussions about a protocol in previous minutes. Historical evidence of compliance or non-compliance would be recorded in the minutes if it were germane to the discussion. Minutes may include reference to historical discussion by the IBC from members who have served on the Committee and observed the procedures being proposed, served as reviewers for protocols involving similar procedures (where their questions were answered), or participated in past IBC discussions about the procedures.
Guidance and clarification concerning the preparation of, and the public access to, minutes of the IBC meetings has been issued by NIH/OBA. (PDF)
Minutes of each IBC meeting are recorded in writing and contain:
- Date and place of meeting,
- Individuals in attendance,
- Whether and why the meeting was open or closed,
- All major motions, major points of order, and whether motions were approved,
- Protocols reviewed (identified by protocol number and protocol title), and
- The time of meeting adjournment.
In addition, in order to document the adequate fulfillment of the Committee’s review and oversight responsibilities described in Section IV-B-2-b of the NIH Guidelines, the meeting minutes should also document the IBC’s consideration of several matters described in Section II and Section III of the NIH Guidelines (see Section 4.2). The inclusion of this material in the meeting minutes will document the biosafety aspects of each protocol.
- 4.6 Principal Investigator Notification
Upon completion of the review process (Section 3), the Principal Investigator will receive written notification of the review decisions (approved/not approved) and whether any special conditions for approval of work is required. Included in the notification will be the IBC decision on the biocontainment/biosafety level to be used for the proposed research, any special safety considerations, applicable sections of the NIH Guidelines, along with the approval period (begin/end dates).
- 4.7 Reports to the IO
Copies of minutes and reports of laboratory incidents, accidents, spills, potential or actual exposure to infectious or biohazardous materials, and incidents of non-compliance, protocol suspensions or terminations will be forwarded to the IO. For many of the above, the IO may be required to file a report with the Office of Biotechnology Activities or other agencies (See Section 5).
- 4.8 Meeting Frequency
Convened meetings of the IBC occur monthly unless cancelled by the IBC Chair. Meeting schedules are typically set six months in advance and posted on the RSC website. The Chair may call an emergency meeting of the IBC as necessary to address such issues as noncompliance or serious and/or unexpected events involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins.
- 4.9 Attendance of Non-Members
IBC meetings are considered open and, as such, members of the UT community and the public at large may request to attend an IBC meeting. Those who wish to attend an IBC meeting must notify the IBC Program Coordinator in advance at (512) 471-8871 or IBC@austin.utexas.edu regarding the desire to attend. While no one will be denied access to a meeting, the IBC Program Coordinator must be made aware of additional attendees in order to schedule a room of appropriate size. Last minute requests may not be honored if the meeting room cannot accommodate additional attendees.
- Section 5: Reporting Requirements
- 5.0 Reportable Incidents and Violations
Incidents/problems involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins must be immediately reported to the Biological Safety Officer (BSO). Examples of reportable significant incident include but are not limited to any overt exposure, such as a needle stick, splash, and contamination due to equipment failure, and any potential exposure in a BSL-3 facility. A significant event may also occur from a containment breach, which may be subsequently determined to pose either an overt or potential exposure to individuals. It should be noted that waste from recombinant or synthetic nucleic acid molecules research is also considered biohazardous and incidents involving improper disposal of recombinant or synthetic nucleic acid molecules must also be reported. Questions regarding reportable incidents should be directed to the BSO.
Failure by research personnel to follow federal and institutional regulations, guidelines, policies and/or procedures may also require reporting to the appropriate institutional, local, state and/or federal agencies. Violations may include but is not limited to conduct of new or ongoing research without appropriate federal or institutional registration, review, approval or oversight.
- 5.1 Principal Investigator Reporting
The Principal Investigator and their personnel must report any significant incident, violation of the NIH Guidelines, or any significant, research-related accidents and illnesses immediately by contacting the BSO. Examples of incidents and violations include:
- Overt exposures are defined as exposures that result in direct personnel exposure to biohazardous materials such as injection, spills, splashes or aerosol inhalation.
- Potential exposures are defined as exposures that have a high risk of exposing personnel to biohazardous materials such as spills, containment failure while working with the agent or equipment failure that may produce aerosols.
- Any exposure (overt or potential) in a BSL-3 lab.
- Overt exposure in BSL-1 or BSL-2 labs
- Any illness that may be caused by the agents used in the laboratory incidents involving the improper disposal of recombinant or synthetic nucleic acid molecules.
In addition, Principal Investigators must report other information to the IBC as soon as they become aware of the information (must also be reported to OBA):
- Information to support a new host-vector system.
- Petitions for proposed exemptions to the NIH Guidelines.
- Petitions for approval to conduct experiments specified in Sections III-A-1 and III-B.
- Petition for determination of containment for experiments not covered by the NIH Guidelines.
- 5.2 BSO Reporting
The BSO is required, by the NIH Guidelines, to report to the IBC:
- All violations of the NIH Guidelines and significant incidents.
- Any significant research-related accidents or illnesses.
- 5.3 IBC Reporting
The IBC, through the IO, will file an annual report with OBA that includes:
- A roster of all IBC members clearly indicating the Chair, contact person, BSO, plant expert, and animal expert.
- Biographical sketches of all IBC members.
The IBC is required, by the NIH Guidelines, to report to the appropriate University official and to the NIH/OBA within 30 days any significant incidents, violations of the NIH Guidelines, or any significant research-related accidents and illnesses copies of these reports should be sent to the Director, University Compliance Services. The IBC will be responsible to determine what actions, if any, are necessary. For example the IBC may choose to change the frequency of lab inspections, or change the Biosafety Level of the protocol, based on results of the incident. The IBC is required to complete a final copy of the Biological Incident Reporting Form which it will be signed and dated by the IO, IBC Chair and the BSO.
Other IBC reporting requirements (to OBA and other agencies) include but are not limited to:
- Research involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins without prior IBC approval.
- Lax security, unsafe procedures used in a laboratory setting, improper disposal of recombinant waste.
- Significant changes to proposed research risk without prior notification and approval by IBC.
Certain types of incidents must be reported to OBA on an expedited basis. Spills or accidents in BL2 laboratories (involving recombinant or synthetic nucleic acid molecules) resulting in an overt exposure must be immediately reported to OBA. In addition, spills or accidents involving recombinant or synthetic nucleic acid molecules occurring in high containment (BL3 or higher) laboratories resulting in an overt or potential exposure must be immediately reported to OBA. The IBC will report to the appropriate institutional official, who, in turn will report to OBA, any of the above-described incidents.
Institutional violations that will be reported to the appropriate College or department head may include but are not limited to:
- Lapses in protocol approval.
- Failure to comply with institutional and federal regulations, guidelines, and policies.
As per Section IV-B-2-a-(7) of the NIH Guidelines, if public comments are made on IBC actions, the IBC, through the IO, will forward both the public comments and the IBC’s response to the Office of Biotechnology Activities.
- 5.4 IO Reporting
Upon receiving a report from the IBC, the IO will report:
- In writing any problems with or violations (non-compliance) of the NIH Guidelines any significant incident, accidents, or illnesses related to recombinant or synthetic nucleic acid molecules to the NIH/OBA within 30 days or immediately for overt exposure to a BSL-2 agent or potential/overt exposure to a BSL-3 agent.
- For incidents involving Select Agents and/or Select Toxins the RO must notify the CDC/USDA.
- Any significant research-related illness or accident that may be hazardous to the public health and cooperate with state and local public health departments.
- 5.5 Response to External Requests for Information
In accordance with the NIH Guidelines, upon request, the institution will make available to the public all IBC meeting minutes and any documents submitted to or received from funding agencies which the latter are required to make available to the public. Redaction of proprietary and private information is allowed but “must be done so judiciously and consistently for all requested documents.&rdquo In addition, the IBC will adhere to requirements for providing copies of minutes and files as specified in the Texas Public Information Act.
- Section 6: Non-Compliance
- 6.0 Allegations
Any allegations of non-compliance or unsafe working conditions shall be made to the IBC Chair, to any member of the IBC, the Office of Research Support and Compliance (RSC) or to the IO. In all instances, allegations shall be immediately forwarded to the IBC Chair. The IBC Chair is responsible for investigation and resolution of all allegations of non-compliance. The allegations and resulting investigations will remain confidential to the extent possible.
- 6.1 Investigation and Review Process
The IBC Chair will appoint a subcommittee to investigate the allegation. The subcommittee will inform all persons involved in the investigation of the purpose and the manner in which it will be conducted. The subcommittee, in its investigation, will examine all documents and procedures relating to the allegation and will interview individuals who are named in the allegation and others who may have knowledge of the circumstances surrounding the allegation and determine if there is a basis in fact to support the allegation. The subcommittee will report its findings to the full IBC for the final determinations (see Section 6.2).
- 6.2 IBC Determination
At a convened meeting, the IBC will discuss the subcommittee report and determine if there is a consensus that the allegation of non-compliance is substantiated and, if so, the seriousness of the incident. All persons involved in the allegation of non-compliance will be given the opportunity to appear to respond to the allegation and/or findings. After all persons who have appeared to respond have left, the report and recommendations will be further discussed and voted upon. The IBC will inform all parties involved, including the submitter of the allegations, if known, of the committee’s findings.
- 6.3 Possible Outcomes
The IBC has the authority to address non-compliance with the NIH Guidelines, the BMBL, University policies and procedures and other legal requirements. Findings of non-compliance may result in one or more of the following actions:
- Suspension of use of recombinant or synthetic nucleic acid molecules and/or biohazardous materials agents or toxins.
- Termination of approval for use of recombinant or synthetic nucleic acid molecules and/or biohazardous materials agents or toxins.
- Confiscation of the recombinant or synthetic nucleic acid molecules and/or biohazardous materials agents or toxins.
- Destruction of the recombinant or synthetic nucleic acid molecules and/or biohazardous materials agents or toxins.
- Any other action necessary to protect the public and/or University, including restricting access to the laboratory in order to suspend activities.
- Section 7: Training
Training is required for all research personnel working with recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins. Completion of the courses is a requirement for the approval of new and continuing Biosafety and Recombinant protocols. All existing training materials and course content required by the IBC will be reviewed every two years by a subcommittee of IBC members, and any new training material or course content will be reviewed by a subcommittee of IBC members prior to release.
- 7.0 IBC Member Training
All IBC members will complete OH207 and CW512 and receive initial training regarding the IBC Policies.
The training program for all members consists of information provided at each IBC meeting. The objectives of providing ongoing training for IBC members is to increase their knowledge, understanding and awareness of current laws and regulations, new directives, best practice guidelines and institutional policies. It also provides a regular forum for the IBC to discuss concerns or questions brought forth by the faculty and research personnel. Information provided for these sessions will include questions and concerns brought to the attention of the IBC, official directives, relevant publications, conference announcements, seminar proceedings, and compliance issues. It will be the responsibility of the IBC Program Coordinator to document all training.
- 7.1 BSO Training
The BSO is a Certified Biosafety Professional (CBSP), a certification requiring continuing education in biosafety. The BSO, designated by the University as professional personnel, has the job requirement to maintain CBSP certification so training must be upheld by EHS.
- 7.2 Principal Investigator and Research Personnel Training
General biosafety training (OH207) is mandatory for all Principal Investigators and research personnel. The NIH Guidelines (CW512) training is mandatory only for Principal Investigators and research personnel performing recombinant or synthetic nucleic acid molecules research that is non-exempt. DURC training is mandatory for Principal Investigators and lab personnel associated with any project identified as DURC. Principal Investigators and research personnel who collect or work with human and non-human primate’s fluids, tissues or cells (including cell lines) are required to take Bloodborne Pathogen training (OH 218), renewed annually. It is the Principal Investigator’s responsibility to complete and ensure all research personnel has received the required training prior to protocol review by IBC. Documentation of successful completion of training is required in order to receive IBC approval. Information and links to IBC required training courses can found on the RSC website.
- Section Section 8: Occupational Health Services Program - Laboratory Animals and Biomedical Services (OHPLABS)
- 8.0 Overview
The University provides occupational health and safety services to ensure appropriate occupational health and safety surveillance (and if necessary care) for lab personnel involved in research approved by the IBC. HealthPoint OHPLABS is limited to research personnel (faculty, research personnel, students and visitors) who may be exposed to biohazardous materials. This program is provided free of charge to research personnel and all information collected will maintained in a confidential manner, as required by law.
- 8.1 Enrollment Requirement
All personnel who may be potentially exposed to biohazardous materials are strongly encouraged to enroll and those working with human pathogens may be required to enroll in the program. See the HealthPoint OHPLABS website for more information.
- 8.2 Services Provided
HealthPoint OHPLABS services include:
- Medical Evaluation
- Serum Banking
- Respirator Fit Testing
- Case Management
- Consultation for medical issues
- Section 9: Record Retention Policy at The University of Texas at Austin
- Record Retention Policy at The University of Texas at Austin
No official state records may be destroyed without permission from the Texas State Library as outlined in Texas Government Code, Section 441.187 and 13 Texas Administrative Code, Title 13, Part 1, Chapter 6, Subchapter A, Rule 6.7. The Texas State Library certifies Agency retention schedules as a means of granting permission to destroy official state records.
The University of Texas at Austin Records Retention Schedule (UTRRS) is certified by the Texas State Library and Archives Commission. It has been adopted as an administrative rule of the University. All official state records (paper, microform, electronic, or any other media) listed on the UTRRS must be retained for the minimum period designated. Once official University records have met their retention periods, they must be disposed of in accordance with the policies and procedures of Office of Accounting’s Division of Records Management Services.