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.
 

  1. 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.
 

  1. 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.
 

  1. 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.
 

  1. Website (for policy)

https://secure2.compliancebridge.com/utexas/public/getdoc.ph?file=7-1330
 

  1. Contacts

CONTACT

DETAILS

WEB

 

 

Office of Research Support and Compliance

Address:

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

Phone: 512-471-8871

Fax: 512-471-8873

 

 

Website:

 http://www.utexas.edu/research/rsc/

 

 

 

IBC Contacts

 

 

Phone: 512-471-8871

Fax: 512-471-8873


Website: http://www.utexas.edu/ibc


Email: ibc@austin.utexas.edu 

 
  1. 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:

 

 

 

The IO shall have the authority to:

 

 

  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:

 

 

  1. Biosafety Officer (BSO) Responsibilities


Responsibilities of the BSO include:

 

 
  1. Principal Investigator (PI) Responsibilities
 

Responsibilities of the PI include:

 

 

  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 and Compliance, 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  utexas.edu/hotline, including a toll-free, anonymous help line at (877) 507-7321 or (800) 216-1288 for Spanish. 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 and Compliance. That office will respond or direct the inquiry to the appropriate office for response.

 

  1. Forms & Tools

 IBC Policies and Procedures Manual

eProtocol IBC (electronic submission system)

 

  1. Frequently Asked Questions

None
 

  1. Related Information

University Recombinant and Synthetic Nucleic Acids and Biosafety website

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Biosafety in Microbiological and Biomedical Laboratories (6th Edition)

APHIS/CDC Select Agent Regulations for the Possession, Use, and Transfer of Select Agents and Toxins (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121)

APHIS/USDA


USDA, FDA, and EPA regulations and guidelines governing the use of recombinant or synthetic nucleic acid molecules and biohazardous agents, materials, and toxins in research and teaching activities.

Dual Use Research and Dual Use Research of Concern

Environmental Protection Agency

 

  1. History

Reviewed with editorial updates: August 10, 2023

Next scheduled review date: February 2021
Previous review date:
     February 27, 2019
     December 12, 2013



(This policy replaces HOP 6.35 - Biohazardous Experiments)