IBC Bylaws –Revised, January 30, 2019
Article I - Name
The name of this Committee shall be the “Texas Tech University Health Sciences Center El Paso Institutional Biosafety Committee (TTUHSCEP IBC)”.
Article II – Charge
The charge of this Committee shall be to:
- Develop institutional policy for the safe receipt, collection, handling, use, storage, transfer and/or disposal of biologically and chemically hazardous materials, including recombinant DNA;
- Advise the Institution/Investigators on regulations and policies involving biologically and chemically hazardous materials, including recombinant DNA;
- Implement recognized standard procedures for research with biologically and chemically hazardous materials, including recombinant DNA;
- Advise the Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) on safe practices for work involving the use of biologically and chemically hazardous materials, including recombinant DNA;
- Certify to granting agencies, as requested, that facilities, procedures, and practices for handling biologically and chemically hazardous material, including recombinant DNA, have been reviewed and approved by the IBC, and certify that the training and expertise of personnel is sufficient and appropriate;
- Review reports from the laboratory safety division (TTUHSCEP Safety Services) of safety hazards in the laboratories at TTUHSCEP;
- Supervise the institutional educational programs on the use of biologically and chemically hazardous materials, including recombinant DNA
- The IBC may review revisions to the laboratory safety/operations manuals, biosecurity plans, and emergency response plans for laboratories;
- Review any protocols submitted to the IBC;
- Make recommendations to the Vice President for Research (VPR) concerning the biohazards program.
- Enforce punitive measures, including lab closure, when necessary to safeguard employees, the public, and the environment.
- The IBC is also responsible for initially and periodically reviewing registrations
for possession and/or use of biologically and chemically hazardous material, including
recombinant DNA, for compliance with NIH Guidelines, the BMBL manual and select Agent
and Select Agent Toxins regulations, as applicable. As part of the review process,
and in conjunction with the BSO and TTUHSC El Paso Department of Safety Services,
the IBC shall:
- Conduct an independent assessment of the containment levels as required by section II-A-3 of the NIH Guidelines;
- Conduct an assessment of the facilities, procedures, practices, training and expertise of personnel involved in research with biologically and chemically hazardous material, including recombinant DNA, and;
- Ensure compliance with all surveillance, data reporting and adverse event reporting requirements set forth in the NIH Guidelines.
Article III – Members
Section 1. The membership of this Committee shall consist of a minimum of five TTUHSCEP faculty members. Attempts will be made to include representation from each TTUHSCEP School whose faculty conduct basic and/or clinical laboratory research. Efforts will also be made to include faculty with expertise in research with animals, genetic research, and research with microorganisms. A single Committee member may serve multiple roles. Membership will also include appropriate recombinant and synthetic nucleic acid experience, plant and animal experts, a BSO, and at least two members not affiliated with the institution.
Section 2. The VPR or designee shall appoint the members of the Committee for a two year term. Generally, regular terms will begin on September 1, but may be made as needed. Confirmation letters will be sent to each member, along with confidentiality statements, to be signed and returned before appointment is official. As deemed necessary throughout the year, the Committee may vote to nominate new members for appointment by the VPR.
Section 3. Members with more than three (3) unexcused absences per year may be removed from the Committee. A committee member may be removed at any time upon written notice by the VPR or designee.
Section 4. All new members are required to successfully complete two online courses offered through the University of Miami’s Collaborative Institutional Training Initiative (CITI) Program. These include a) IBC Members and Staff, and b) Conflicts of Interest. IBC members are encouraged to participate in ongoing continuing education.
Section 5. No member may participate in the review of any project in which the member has a conflicting interest, either financial or non-financial, except to provide information requested by the Committee.
Article IV – Officers
Section 1. The officers of the Committee shall be a Chairperson and Vice- Chairperson. These officers shall perform the duties prescribed by the bylaws and by the parliamentary authority adopted by the Committee.
Section 2. The VPR shall appoint the Chairperson and Vice-Chairperson of the Committee. Unless notice is given to the Officers by the VPR or to the VPR by the Officers, these appointments shall be automatically renewed on a year-to-year basis.
Article V – Meetings
Section 1. The Committee will meet every month in which there is business to conduct. At a minimum, the Committee shall meet once every fiscal quarter.
Section 2. The regular meetings of the Committee shall be held on the third Tuesday of each month, unless another arrangement is made by the Chairperson.
Section 3. Quorum for this committee to conduct business is defined as a majority of the voting members present, including at least one officer, the BSO, and one member.
Section 4. In special circumstances determined by the Chair, a subcommittee review may be conducted to review a new application, renewal of an established protocol, or an amendment, if a grant transfer or grant award is pending, and approval must be granted prior to the next scheduled IBC meeting. The Chair, Safety Services member, and one additional committee member is required to approve the protocol under review. Business conducted for this review is available in iRIS and reported to the full committee at the next scheduled meeting.
Section 5. Meeting minutes will be retained for three years following the meeting. Any printed or electronic documents related to a protocol will be retained for three years following termination of the protocol.
Article VI– Relationship to other TTUHSC Compliance Committees
The TTUHSCEP IBC functions independently of, but in coordination with other TTUHSCEP Research and Safety compliance Committees, including, but not necessarily limited to the following:
- Radiation Safety Committee (RSC)
- Institutional Review Boards (IRBs)
- Conflict of Interest in Research Committee (COIRC)
- Institutional Animal Care and Use Committee (IACUC)
The IBC may request that review or approval of any of these committees be obtained prior to approval of an IBC protocol.
Article VII – Review and Approval of Bylaws
These bylaws shall be reviewed at least annually by the Chairperson of the Committee, the IBC Coordinator, the BSO, the IBC Director, and the Managing Director of the Office of Research Resources. Proposed changes to the bylaws will be presented to the full Committee for review and comment. The IBC Chairperson has authority to provide final approval of the Bylaws.
Article VIII – Amendment of Bylaws
These bylaws may be modified or amended as needed at the request of the VPR or designee in consultation with the IBC Chairperson.
Article IX – Confidentiality of Records
The TTUHSCEP IBC is a “medical committee” as defined under Texas Health & Safety Code chapter 161, and/or other applicable state and federal statutes. All documents generated by, submitted to, or for the purposes of fulfilling IBC committee duties are considered confidential and privileged as “medical committee documents.” Certain IBC documents are considered privileged and confidential records, not subject to disclosure, except to authorized TTUHSC El Paso representatives and federal regulatory officials. However, in accordance with the NIH Guidelines, TTUHSC El Paso shall, upon request, make available to the public all IBC meeting minutes and any documents submitted to or received from funding agencies, which the federal funding agencies are required to make available to the public. If public comments are made on IBC actions, the IBC Chair shall forward both the public comments and the IBC response to the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985.