Handbook of Operating Procedures 7-1330
Use of Recombinant DNA and Biohazardous Agents, Materials, and Toxins
I. Policy Statement
It is the policy of The University of Texas at Austin (“University”) that any use of recombinant DNA (rDNA) and/or biohazardous agents, materials, and toxins in research or teaching activities at University facilities or under the auspices of the University must be conducted in accordance with applicable federal and state laws, regulations and guidelines, the University’s governing policies and procedures, and The University of Texas System Board of Regents’ Rules and Regulations.
All such use of these materials must be approved in advance by the Institutional Biosafety Committee (IBC).
Failure to comply with this policy may result in disciplinary action up to and including loss of approval to conduct research or teaching activities involving use or generation of rDNA and/or biohazardous agents, materials, and toxins.
II. Reason for Policy
To promote the safe use of rDNA and other biohazardous agents, materials and toxins in compliance with relevant laws, regulations and guidelines including but not limited to:
- NIH Guidelines for Research Involving Recombinant DNA Molecules
- Biosafety in Microbiological and Biomedical Laboratories (5th Ed.)
- The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107–188
- USDA and EPA regulations and guidelines governing the use of rDNA and biohazardous agents, materials, and toxins in research and teaching activities
III. Scope & Audience
This policy applies to all University employees, students and affiliated researchers who utilize rDNA and/or biohazardous agents, materials or toxins in research and scholarly activities. It applies to those activities occurring in University facilities and at other locations when those projects involve University funding, sponsorship, faculty scholarship or involve University faculty, staff or student effort as part of that activity.
IV. Definitions (specific to this policy)
- Affiliated Researcher:
Generally, any non-employee non-student researcher appointed as an Affiliated Person in the institutional Human Resources Management System (HRMS) who has authorized access to a rDNA or biohazardous research project under the supervision of a Principal Investigator (e.g., visiting scientist, non-employee postdoc).
- Biohazardous Agents, Materials, and Toxins:
Infectious biological agents, biological agents and biologically derived materials 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. This definition includes Select Agents (as defined by the National Select Agents Registry) and toxins, whether synthetically or biologically produced, deemed to pose a threat to public, animal or plant health.
- Institutional Biosafety Committee (IBC):
A committee appointed by the University’s Institutional Official charged with providing local review and oversight of all aspects of research and other scholarly activities or experimentation utilizing rDNA and/or other biohazardous agents, materials, and toxins.
- Institutional Official (IO):
A University official having responsibility and authority for oversight of the IBC and application of policy compliance.
Generally, an Investigator is a faculty member, Principal Investigator, Sr. Research Scientist/Engineer, Research Scientist/Engineer, Research Associate, or other researcher responsible for the design, conduct, or reporting of research or other educational activity proposed for funding.
- Principal Investigator (PI):
A principal investigator (PI) is the lead scientist for a particular well-defined science or other academic project who takes direct responsibility for completion of a funded project, directing the research and reporting directly to the sponsor.
- Recombinant DNA (rDNA):
The NIH Guidelines for Research Involving Recombinant DNA Molecules defines recombinant DNA molecules as either (i) molecules constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules resulting from the replication of those described in (i) above. Synthetic DNA segments which 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.
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
V. Website (for policy)
|Office of Research Support||Address:|
Flawn Academic Center (FAC) Suite 426 Campus Mail Code: A3200Phone:512-471-8871 Fax:512-471-8873
VII. Responsibilities & Procedures
- Institutional Official (IO)
The Vice President for Research is assigned the role of Institutional Official (IO) for the University. In that capacity, he/she is responsible for proper use of rDNA and biohazardous agents, materials, and toxins at the University with specific responsibilities and authorities delineated below. The IO is responsible for the delegation of authority to the IBC for establishment and enforcement of relevant University policies and procedures.
Responsibilities of the Institutional Official include:
- Ensuring the safety of research faculty, staff, students and affiliated researchers utilizing rDNA and biohazardous agents, materials, and toxins.
- Ensuring ongoing compliance with state and federal law.
- Ensuring the authority of the IBC.
- Ensuring the IBC has sufficient resources for conducting the activities under its jurisdiction.
- Ensuring the number and experience of the IBC members is adequate to address the volume and types of rDNA and biohazardous agents, materials, and toxins to be reviewed, so reviews are accomplished in a thorough and timely manner.
- Conducting periodic reviews of the IBC and its activities.
The Institutional Official shall have the authority to:
- Establish, appoint members to, or modify the structure of the IBC.
- Require the IBC to establish and implement policies and procedures governing use of rDNA and biohazardous agents, materials, and toxins as covered by this policy.
- Grant authority to the IBC to review and oversee research or educational activities which include the possession and/or use of rDNA, biohazardous agents, materials, or toxins.
- Provide resources, including budgetary authority, for the IBC and its activities.
- Suspend or terminate research previously approved by the IBC.
- Provide the IBC access to legal counsel for the University.
- Place administrative sanctions on Investigators for non-compliance with applicable federal or state laws and regulations and applicable University policies, procedures and guidelines.
- Institutional Biosafety Committee (IBC)
The IBC provides local review and oversight of research, scholarly and experimental activities utilizing rDNA and other biohazardous agents, materials, and toxins.
Responsibilities of the IBC include:
- Establish, periodically review and modify policies and procedures of the IBC as needed to ensure appropriate biosafety measures and compliance with federal and state requirements.
- Review and oversee research or education activities (initial and continuing review and modifications to proposals and activities) that include the possession and/or use of rDNA, biohazardous materials for compliance with NIH Guidelines, the BMBL, and Select Agents and Toxins regulations, and local policies and procedures (See IBC Policies and Procedures at http://www.utexas.edu/research/rsc/ibc/policies_index.html).
- Assess the facilities, procedures, practices, training, and expertise of personnel involved in rDNA and/or research with biohazardous agents, materials, or products.
- Assess and set containment levels for rDNA and biohazardous research and modify containment levels as necessary.
- Notify the researcher of the IBC’s review, approval, or disapproval.
- Adopt and implement emergency plans covering accidental spills and personnel contamination resulting from rDNA or biohazardous research.
- Review and report significant problems with or violations of federal, state or local policies, procedures, regulations, or guidelines to applicable oversight agencies.
- Assist in the development of appropriate procedures as required by NIH, CDC, USDA, and EPA in accordance with regulations and local policy to oversee the possession and/or use of rDNA and biohazardous material.
- Suspend or terminate protocol approval for possession or use of rDNA and biohazardous materials, where the IBC finds noncompliance or that such use or possession poses a threat to the health and safety of the community.
- Establish policies regarding eligibility requirements for faculty allowed to be Principal Investigators engaged in research, scholarly and experimental activities utilizing rDNA and other biohazardous agents, materials, and toxins.
- Principal Investigator Responsibilities
Responsibilities of the Principal Investigator include:
- Complete appropriate forms in accordance with requirements of the funding agency..
- Assure the project is performed in accordance with the IBC-approved protocol.
- Ensure IBC approvals are obtained, and subsequent significant changes to the project are approved, prior to initiation of research utilizing rDNA or biohazardous agents, materials, or toxins.
- Complete training, as required by the IBC, EH&S, and/or any oversight agency, and assure that all research staff in or associated with the laboratory have appropriate training and maintain documentation of training.
- Ensure all research staff in or associated with the laboratory are familiar with symptoms of exposure to biohazardous agents or materials used in the laboratory.
- Ensure protocol-specific training of research staff in or associated with the laboratory and assure that appropriate Personal Protective Equipment is available.
- Ensure that researchers and research staff working on the project are aware of and comply with this policy.
- Develop and obtain IBC approval of emergency plans for handling accidental spills and personnel contamination, and adhere to such plans.
- Correct conditions that may result in exposure to or release of biohazardous agents or materials.
- Immediately investigate and report significant problems or research-related accidents and illnesses to the Environmental Health and Safety Department and any other university committee that has reviewed and approved the research activity (e.g., IRB, IBC, IACUC) (See IBC Policies and Procedures Manual at http://www.utexas.edu/research/rsc/ibc/policies_index.html).
- Reporting Suspected Non-Compliance
Any person may contact (anonymously, if he or she wishes) the Director of the Office of Research Support, Director of Environmental Health and Safety, or the IBC Chair http://www.utexas.edu/research/rsc/ibc/members.html if there are concerns regarding the use of rDNA and biohazardous agents, materials, or toxins by faculty, staff, students or affiliated researchers at the University. (Refer to Sec. VI – Contacts).
University Compliance Services may also be contacted. See details regarding reporting options at http://www.utexas.edu/compliance/hotline/, including a toll-free, anonymous help line at (877) 507-7321. Anyone reporting concerns may not be retaliated against for a good-faith report of suspected wrongdoing.
All such concerns will be referred to the IBC for review and inquiry. If warranted, an investigation will be conducted to determine if corrective action is appropriate.
- Retaliation Prohibited
A student, faculty, staff member, or affiliated researcher who retaliates against an individual who has brought a complaint pursuant to this policy and/or participated in an investigation of such a complaint, is subject to disciplinary action, up to and including termination or dismissal from the University.
- Filing of False Complaints
Any person who knowingly and intentionally files a false complaint under this policy is subject to disciplinary action, up to and including termination or dismissal from the University.
- Media or Public Inquiries
Members of the media or public may contact the University to make inquiries about the conduct of research involving rDNA and biohazardous agents, materials, and toxins. All such inquiries are to be directed initially to the Office of Research Support. That office will respond or direct the inquiry to the appropriate office for response.
VIII. Form & Tools
IBC Policies and Procedures Manual:http://www.utexas.edu/research/rsc/ibc/policies_index.html
Original Issue Date: March 23, 2012
(This policy replaces HOP 6.35 - Biohazardous Experiments)
Next scheduled review date: March, 2015