Handbook of Operating Procedures 7-1330

Use of Recombinant/Synthetic DNA and Biohazardous Agents

Effective December 12, 2013
Executive Sponsor: Vice President for Research
Policy Owner: Director, Office of Research Support and Compliance

 

1. Policy Statement

It is the policy of The University of Texas at Austin (University) that any use of recombinant or synthetic nucleic acid molecules 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 an 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 recombinant or synthetic nucleic acid molecules and/or biohazardous agents, materials, and toxins.
 

2. Reason for Policy

To promote the safe use of recombinant or synthetic nucleic acid molecules and other biohazardous agents, materials, and toxins in compliance with relevant laws, regulations, and guidelines including but not limited to those referenced in Section X below.
 

3. Scope & Audience

This policy applies to all University employees, students, and affiliated researchers who utilize recombinant or synthetic nucleic acid molecules 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 involve University faculty, staff, or students when carrying out university responsibilities.
 

4. Definitions (specific to this policy)

Affiliated Researcher:

generally, any non-employee, non-student researcher appointed as an affiliated person in Workday who has authorized access to recombinant or synthetic nucleic acid molecules or a 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 and toxins (as defined by the Federal Select Agent Program), 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 recombinant or synthetic nucleic acid molecules 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.

Investigator:

generally, an investigator is a faculty member, principal investigator, senior 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 the design, conduct, and reporting of the activity.

Recombinant or Synthetic Nucleic Acid Molecules:

the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules defines recombinant or synthetic nucleic acid molecules as: (i) molecules that a) are constructed by joining nucleic acid molecules, and b) can replicate in a living cell (i.e. recombinant nucleic acids); (ii) 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 (iii) molecules that result from the replication of those described in (i) or (ii) 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:

research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
 

5. Website (for policy)

https://secure4.compliancebridge.com/utexas/public/getdoc.ph?file=7-1330
 

6. Contacts

7. Responsibilities & Procedures
   1. Institutional Official (IO)

The vice president for research is assigned the role of institutional official (IO) for the University. In that capacity, he or she is responsible for proper use of recombinant or synthetic nucleic acid molecules 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 Institutional Biosafety Committee (IBC) for establishment and enforcement of relevant University policies and procedures.

Responsibilities of the IO include:

• Ensuring ongoing compliance with federal and state 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 recombinant or synthetic nucleic acid molecules 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 IO 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 recombinant or synthetic nucleic acid molecules 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 recombinant or synthetic nucleic acid molecules, 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.

• Determine that review by an external IBC is appropriate and acceptable for certain types of research, in accordance with NIH Guidelines and any applicable federal regulations.

2. Institutional Biosafety Committee (IBC)

The IBC provides local review and oversight of research, scholarly, and experimental activities utilizing recombinant or synthetic nucleic acid molecules 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 recombinant or synthetic nucleic acid molecules, biohazardous materials for compliance with NIH Guidelines, the Biosafety in Microbiological and Biomedical Laboratories, and Select Agents and Toxins regulations, and local policies and procedures.

• Assess the facilities, procedures, practices, training, and expertise of personnel involved in recombinant or synthetic nucleic acid molecules and/or research with biohazardous agents, materials, or products.

• Assess and set containment levels for recombinant or synthetic nucleic acid molecules and biohazardous research and modify containment levels as necessary.

• Notify the researcher of the IBC's review, approval, or disapproval.

• Adopt emergency plans covering accidental spills, and personnel contamination resulting from recombinant or synthetic nucleic acid molecules 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 recombinant or synthetic nucleic acid molecules and biohazardous material.

• Suspend or terminate protocol approval for possession or use of recombinant or synthetic nucleic acid molecules and biohazardous materials, where the IBC finds non-compliance, 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 (PI) engaged in research, scholarly, and experimental activities utilizing recombinant or synthetic nucleic acid molecules and other biohazardous agents, materials, and toxins.

3. Biosafety Officer (BSO) Responsibilities