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KUMC Policy for Activities Involving Recombinant or Synthetic Nucleic Acid Molecules or Other Potentially Hazardous Biological Agents

Policy
Purpose: 

This policy establishes the University of Kansas Medical Center (“KUMC”) Institutional Biosafety Committee and sets forth requirements for the safe and secure use of recombinant or synthetic nucleic acid molecules and other biohazardous agents, materials and toxins in compliance with relevant laws, regulations and guidelines.

Applies to: 

This policy applies to all research or teaching activities conducted at KUMC involving recombinant or synthetic nucleic acid molecules or other potentially hazardous biological agents.

Campus: 
Medical Center, Kansas City
Wichita
Salina
Policy Statement: 

It is the policy of KUMC that any possession or use of recombinant or synthetic nucleic acid molecules and/or biohazardous agents, materials and toxins in research or teaching activities at KUMC facilities, or under the auspices of KUMC, must be conducted in accordance with applicable federal and state laws, regulations and guidelines, and university policies and procedures. 

Because laboratory work can involve exposure not only to recombinant or synthetic nucleic acid molecules or biohazardous agents, materials and toxins, but also to chemical and radiological hazards, IBC policies and procedures relating to recombinant or synthetic nucleic acid molecules must be followed in conjunction with any other pertinent KUMC policies and procedures.

Institutional Biosafety Committee Charge

The KUMC Institutional Biosafety Committee (“IBC”) has been designated to oversee research and teaching activities involving recombinant and synthetic nucleic acid molecules in compliance with safety requirements established by the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (April 2016) (“NIH Guidelines”).  The IBC shall be responsible for carrying out the functions set forth in section IV-B-2-b of the NIH Guidelines, and such other responsibilities as may be delegated by the Vice Chancellor for Administration.  

The Vice Chancellor for Administration shall designate a subcommittee of the IBC to review proposals that would require the use of Etiological Agents at KUMC.  This subcommittee shall operate under a separate charge.  The research reviewed by the subcommittee may involve federally regulated Select Agents that require special review and oversight of security as well as safety measures.  The subcommittee is further designated as the standing institutional review entity required for the identification and review of Dual Use Research of Concern, as specified in the U.S. Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern.   Any investigator planning to work with a Select Agent must contact the KUMC Biosafety Officer for information or to initiate the required review process.

Committee Membership

The IBC shall be comprised of at least five (5) members (two of whom shall not be associated with KUMC) selected so that they collectively have experience and expertise in recombinant DNA technology, the capability to assess the safety of recombinant or synthetic nucleic acid molecule research and the ability to identify potential risks to public health or the environment.  At least one member will have expertise in animal containment principles and one member will be a Biosafety Officer (“BSO”).   At least one member will have expertise in plant, plant pathogen, or plant pest containment principles if KUMC conducts recombinant DNA research that requires IBC approval in accordance with Appendix P of the NIH Guidelines

IBC members will be appointed by the Vice Chancellor for Administration for a term of up to three (3) years.  These appointments may be renewed for a second term of up to three (3) years provided the member has met all expectations for members of the IBC as outlined in the IBC Policy and Procedures document and is willing to serve.  No member of the IBC may be involved (except to provide information requested) in the review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest.

Certain individuals will be appointed “ex-officio” members of the committee and will not have term limits.  These members are also expected to meet all expectations for members of the IBC as outlined applicable IBC procedures.  These members may include, but are not limited to, a member of the Office of Compliance, the Office of General Counsel, Lab Animal Resources, Office of Animal Welfare and the Office of Environment, Health and Safety.  When possible, efforts will be made to rotate members from these areas on and off the IBC. 

As needed, the IBC may engage the services and expertise of ad hoc consultants to the committee.

Training

KUMC’s institutional responsibilities under the NIH Guidelines include the provision of appropriate training for the IBC Chair and members, Biological Safety Officer and other containment experts (when applicable), Principal Investigators, and laboratory staff regarding laboratory safety and implementation of the NIH Guidelines .On behalf of the institution, the IBC Chair is responsible for ensuring that IBC members are appropriately trained. The Principal Investigator is responsible for ensuring that laboratory staff are appropriately trained.

Consequences: 

Non-compliance with this Policy and related procedures may result in one or more of the following actions: 

  • Suspension or termination of use of recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents or toxins.
  • Confiscation or destruction of the recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents or toxins.
  • Other actions necessary to protect the public and/or university, including restricting access to the laboratory in order to suspend activities.
  • 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, or termination.
  • Liability under applicable state and federal law, and disciplinary action under applicable faculty, staff or student policies.
Contact: 

KUMC Biosafety Officer 913-588-1081

Approved by: 
Vice Chancellor for Administration
Approved on: 
Thursday, July 21, 2016
Effective on: 
Thursday, July 21, 2016
Review Cycle: 
Annual (As Needed)
Definitions: 

Etiological Agents:  any kind of microorganism that can cause a human to develop a disease.  The definition includes microorganisms like bacteria and viruses.   Etiologic agents are also referred to as toxins.

Institutional Biosafety Committee:  committee appointed by the Vice Chancellor for Administration in accordance with National Institutes of Health Guidelines and other applicable requirements and policies to review KUMC activities involving recombinant and synthetic nucleic acid molecules or other biological agents.

Recombinant and Synthetic Nucleic Acid Molecules:  (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 abase 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 or as defined by the National Institutes of Health.

Select Agents and Toxins:   materials that have been identified by the U.S. Government as agents that have potential use in biological terrorism or warfare.   Federal regulations (42 CFR Parts 72 & 73, 7 CFR Part 331, 9 CFR Part 121   http://www.selectagents.gov/Regulations.html  ) govern the use, transfer and storage of select agents and toxins at KUMC.   List of select agents and toxins.   http://www.selectagents.gov/SelectAgentsandToxinsList.html

Keywords: 
biological, toxins, select agents
Review, Approval & Change History: 

07/21/2016: New policy approved by the Institutional Biosafety Committee, Vice Chancellor for Research and the Vice Chancellor for Administration

Research and Sponsored Projects Category: 
Research and Sponsored Projects

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