Handbook of Operating Procedures 7-1330

Use of Recombinant/Synthetic DNA and Biohazardous Agents

I. 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 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 recombinant or synthetic nucleic acid molecules and/or biohazardous agents, materials, and toxins.

II. 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.

III. 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 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 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 (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 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 completion of a funded project, directing the research, and reporting directly to the sponsor.

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.

V. Website (for policy) 
http://www.policies.utexas.edu/policies/hop/7-1330
VI. Contacts 
Contact Details Web
Office of Research SupportAddress:

Flawn Academic Center (FAC) Suite 426 Campus Mail Code: A3200

Phone:512-471-8871 Fax:512-471-8873
Website:
IBC ContactsPhone:512-471-8871Fax:512-471-8873Website:Email:ibc@austin.utexas.edu
VII. 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 the safety of research faculty, staff, students, and affiliated researchers utilizing recombinant or synthetic nucleic acid molecules and biohazardous agents, materials, and toxins.
  • 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.

 

  1. 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 Biosaftey in Microbiological and Biomedical Laboratories, 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 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 and implement 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.

 

  1. Principal Investigator (PI) Responsibilities

Responsibilities of the PI 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 recombinant or synthetic nucleic acid molecules or biohazardous agents, materials, or toxins.
  • Complete training, as required by the IBC, environmental health and safety (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 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 EH&S 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).

 

  1. Miscellaneous
  1. Reporting Suspected Non-Compliance

Any person may contact (anonymously, if he or she wishes) the director of the Office of Research Support, director of EH&S, or the IBC chair http://www.utexas.edu/research/rsc/ibc/members.html if there are concerns regarding the use of recombinant or synthetic nucleic acid molecules 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.

 

  1. 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.

 

  1. Filing 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.

 

  1. Media or Public Inquiries

Members of the media or public may contact the University to make inquiries about the conduct of research involving recombinant or synthetic nucleic acid molecules 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 
XI. History 

Last review date: December 12, 2013

Next scheduled review date: December  2015


(This policy replaces HOP 6.35 - Biohazardous Experiments)