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Policies and Bylaws

Approved by Committee on May 10, 2004

Western Kentucky University recognizes the need for all faculty, staff, students, and visitors to work and meet in an environment free of undue risks to their health and well being.  The Institutional Biosafety Committee (IBC) will, in part, ensure the University meets this goal.   The IBC will provide oversight for university activities, both instructional and research,  involving recombinant DNA, culturing of microorganisms, agents infectious to plants, humans, and animals,  human gene therapy, cultures of tissues, organs, and cells of human origin, and Select Agents as defined by U.S. federal agencies.  To ensure public trust in these activities, the IBC will include no less than two public citizens serving as members.  This committee shall serve as the IBC as defined by the National Institutes of Health.

Composition and Governance of Committee

Selection of IBC Members

• The IBC shall be appointed by the Vice President of Academic Affairs-Provost of Western Kentucky University.

Composition of the IBC

• The IBC will be collectively capable of assessing the risks to the public or the environment of those activities described above.  The IBC must contain persons with expertise in rDNA technology, biological safety, and physical containment.
• The IBC shall be composed of a Chair/ Biological Safety Officer (BSO) with no less than seven additional (7) members.
  
  The IBC shall include a Chair, who will also serve as the BSO and is a full-time faculty member of WKU.  Duties of the BSO will be as defined by the National Institutes of Health and the IBC.
• The WKU-Environmental Health and Safety Department (EHS) will have committee membership. One person shall be appointed by the Director of the Environmental Health and Safety Department to serve the IBC.
• The IBC must contain no less than one person representing laboratory technical staff.
• The IBC must contain no less than one WKU faculty member, other than the Chair/BSO.
• The IBC must contain no less than two (2) members of the general public unaffiliated with the university.
• The IBC will ensure as least one scientist expert in plant, plant pathogen, or plant pest containment principles is on the committee with full voting privileges when experiments utilizing plants are under review.
• The IBC will ensure at least one scientist expert in animal containment principles is on the committee with full voting privileges when experiments utilizing animals are under review.   Alternatively, the committee reserves the privilege of placing applications under review of the WKU Institutional Animal Care and Use Committee.  In such instances, the recommendation of  the WKU Institutional Animal Care and Use Committee will serve as a single vote.
• The IBC reserves the privilege of appointing ad hoc temporary members to assist in the review of pending applications.  Temporary members will not necessarily be appointed by the VPAA-Provost but as deemed necessary by the committee.  An ad hoc member has one vote on the consideration of specific proposals.  Proposals on which ad hoc members may vote must be specifically identified by the committee prior to the appointment of the ad hoc member.

Term Limits

• Members shall be appointed for three (3) years.
• Members can serve no more than two (consecutive) terms before reappointment.
• The EHS appointee may serve more than two consecutive terms.
• Initially, terms of IBC members shall be staggered in such a fashion that a majority of the committee members will not retire simultaneously.
• The IBC reserves the privilege to recommend to the Vice-President of Academic Affairs-Provost to shorten appointments to less than three (3) years for the purposes of staggering the retirement dates of the IBC members.
• Members of the IBC will appoint the Chair-BSO for three-year appointments.  Any person serving as Chair-BSO may serve more than two consecutive terms.

Conflict of Interest

• No member of the IBC may be involved (except to provide information required by the committee) 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.
• Members of the IBC may not vote on proposals which list the member as the principal investigator (P.I.) or Co-P.I.

Training of IBC Members

• All IBC committee members must undergo no less than one training session per one three year term.  Training sessions will be offered by WKU on an "as needed" basis.  Training sessions could cover, but not necessarily limited to, technical training of laboratory methodologies, informational presentations of the current scientific understanding of relevant fields, and/or instruction on  IBC committee structure and function.

The Office of Sponsored Project  will provide Administrative Support to the IBC

• The WKU Office of Sponsored Programs (OSP) will provide administrative support for the IBC.  Duties of the OSP will include but not limited to: assistance in contacting new members, recording, editing, and distributing the minutes of committee meetings, contacting members or potential members with relevant information concerning the committee, collecting, housing, and distributing committee documents and applications.

Public and University Access to IBC Activities

• The IBC encourages university personnel and public citizens to participate in IBC activities.
• The OSP will make available all meeting minutes, proposals, and actions on proposals to any person making such requests.
• To inform the public, all IBC meeting times, dates, and locations will be posted on the OSP website no less than three (3) days prior to the meeting.

 

Who Must Apply

Researchers or academic programs engaged in activities involving any of the following:

• Recombinant DNA: Recombinant DNA molecules are defined as either:  (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.
• Agents known to infect plants, humans, or animals.
• Explicit exposure of any person to potential infectious agents.
• Human gene therapy
• Select Agents

Researchers

• Researchers conducting scientific inquirers outside of formal teaching duties shall be held responsible for completion of all necessary applications.
• For the purposes presented here, scientific inquiries outside of formal teaching duties are defined as external grant or university supported research initiatives and/or individual student or student groups research initiatives (i.e. "399 courses", cooperative education courses, etc)

 

Procedures for Application and Approval

All application materials will be available on the WKU-OSP website and should be downloaded and completed by the P.I. or administrative head.

Completed applications will be submitted to the OSP office or the IBC, Chair-BSO and reviewed for completeness.  If the applications are incomplete they may be returned to the P.I. without review.  If the application is complete, it will be reviewed by the IBC and the results of the review communicated to the P.I. in a timely manner.

Applications will be scored as follows:

1. • Accept: allows the researcher to begin immediately with experiments
   • Reject: the researcher may not proceed with the experimentation
   • Accept with modification:  the researcher can proceed with experimentation provided he/she accept modifications provided by the committee.

The IBC actively encourages any submitting P.I./ administrative head to seek input from the IBC members or the Chair-BSO to prevent undue delays prior to submission.  In this vain, the IBC seeks to minimize time and effort required by the P.I./ administrative head to successfully acquire permission for the underlying activities.

"Fast Track Approval". For applications encompassing only Risk Group 1 organisms and/or Biological Safety Containment Level 1, the Chair-BSO may grant approval without seeking immediate full committee consideration.  For this approval all applications must still be completed and filed by the applicant.  The full committee, however, reserves the privilege of reviewing and re-considering Fast Track Approved Protocols. It is the intention of the IBC to use Fast Track Approval to speed and simplify grant proposal submission of low risk activities without compromising institutional oversight.

The IBC recognizes that much research and teaching takes place without exterior funding sources.  Therefore, applications must also be filed to seek approval for all relevant activities conducted with out a specific sponsor.  Research, in this category is defined as a "Standing Research Initiative", similarly a teaching activity, in this category, is defined as a "Standing Teaching Initiative".

Filing of Applications and Duration of Approval

• Applications must be filed when grant proposal applications are filed with the WKU-OSP.
• Approved applications of grant proposals will remain approved for the entire duration of the granting period.
• Protocols are approved for the Standing Research Initiatives and Standing Teaching Initiatives for 3 year(s), at which time re-submission is required.
• The P.I./ administrative head must re-submit an application if, for any reason, organisms, methodologies, or protocols are changed or modified on any approved protocol.  The P.I./administrative head is encouraged to seek guidance for an IBC member or the Chair-BSO, in such instances.

Application for Use of Select Agents.

• All applicants will be directed to Environmental Health and Safety for all matter concerning Select Agents.

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