Institutional Biosafety Committee

• Texas State University

The University must ensure that all recombinant or synthetic nucleic acid research conducted at or sponsored by Texas State University is conducted in compliance with the NIH Guidelines regardless of funding source. The University places institutional authority with the Texas State University  IBC committee to review research involving rDNA and to ensure that all research is conducted in full conformity with the provisions of the NIH Guidelines.

• Institutional Office (IO)

The IO is responsible for appointing members to the IBC and ensuring that the IBC conducts business as required in compliance with NIH Guidelines.

• Institutional Biosafety Committee (IBC)

The IBC is responsible for reviewing rDNA research activities and for approving those which are in conformity with the intent and specifics of the NIH Guidelines. Furthermore, the IBC is authorized by the IO to enforce the NIH Guidelines and to ensure that investigators adhere to approved protocol conditions. This may include site visits by an IBC designee and ORIC member. The IBC also reviews research protocols involving Risk Group 2 or higher microorganisms that do not involve rDNA or synthetic DNA. As per the NIH Guidelines, the IBC, through the IO is responsible for reporting significant incidents, violations, and research-related accidents and illnesses involving recombinant or synthetic nucleic acids to the NIH Office of Science Policy (OSP).

• Biosafety Officer (BSO)

The Biosafety Officer's duties include but are not limited to periodic inspections as determined to be necessary to ensure laboratory standards; Reporting to the Institutional Biosafety Committee and the institution any significant problems, violations of the NIH Guidelines, and any significant research-related accidents or illnesses of which the Biological Safety Officer becomes aware unless the Biological Safety Officer determines that a report has already been filed by the Principal Investigator; Developing emergency plans for handling accidental spills and personnel contamination and investigating laboratory accidents involving recombinant or synthetic nucleic acid molecule research; Providing advice on laboratory security; Providing technical advice to Principal Investigators and the Institutional Biosafety Committee on research safety procedures.

• Principal Investigator/Project Director (PI/PD)

The Principal Investigator or Project Director (PI/PD), deemed as a current Texas State University faculty, is responsible for full compliance with the NIH Guidelines in the conduct of rDNA research. The PI shall submit a research protocol proposal to the IBC for review. The PI shall ensure that rDNA research activities subject to the NIH Guidelines are initiated or modified only after that research or proposed modification thereof has been reviewed and approved by the IBC. Furthermore, the PI must report to the Office of Research Integrity and Compliance (ORSP) and Texas State Biosafety Officer (BSO) any incidents involving contamination of personnel, research-related illnesses, accidental spills, loss of containment, and violations of the NIH Guidelines.

Research covered by this policy will fall into one of the following categories.

1. rDNA (Recombinant or synthetic nucleic acids):

• Molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell;
• Molecules that replicate as a result of the above.

2. RG2 (Risk Group 2): Agents that are associated with diseases that are rarely serious and for which preventive/therapeutic interventions are often available.

3. RG3 (Risk Group 3): Agents that are associated with serious/lethal human diseases for which preventive/therapeutic interventions may be available (high individual risk, but low community risk).

4. RG4 (Risk Group 4): Agents that are likely to cause serious/lethal human diseases for which preventive/therapeutic interventions are not usually available (high individual risk and high community risk).

5. Research protocols that involve potentially biohazardous materials and agents.

6. Research protocols using tissue isolated from vertebrates.

• The  IBC shall be comprised of a minimum of five members so that collectively they have the experience and expertise in rDNA technology, the capability to assess the safety of rDNA research, and identify any potential risk to public health or the environment.
• Each member of the IBC is appointed by the IO for a term of three (3) years. Members may be reappointed by the IO for additional terms. The IBC shall include: at least two members who are not affiliated with Texas State University and who are not part of the immediate family of a person affiliated with Texas State University; the University Veterinarian; a person with expertise in plant pathogens or plant pest containment principles if research with plant rDNA molecules is being reviewed; and, the University BSO.
• To ensure continuity, the appointment of committee members shall be for staggered terms so that no more than one-half of the appointments expire each academic year.

Consultants may be used when additional expertise is required for certain protocols.

• The IBC will meet to review rDNA and biosafety protocols at least twice a year, and more frequently if deemed necessary. The rDNA and biosafety protocols must be prepared by the PI/PD on the standardized IBC Protocol application that is available on the Texas State University IBC website. All protocol information must be typed, and only one research project per submittal form will be accepted. Protocols are approved for a three-year term.
• Initial Submissions Continuing reviews, and Procedural Modi cations will be reviewed by a minimum the IBC Chair and if needed at the next scheduled convened meeting.
• Closing reports will be administratively reviewed by the IBC Chair and/or BSO.
• Personnel Modifications(s), will be administratively reviewed and approved upon training verification by the ORIC. If modifications are not administrative in nature such as changes to procedures, they will be assigned to the IBC chair, BSO, or IBC member, depending on the nature of the amendment.
• Submitted protocols received and deemed exempt from NIH Guidelines per Section III F will be administratively reviewed and acknowledged by the IBC Chair and BSO, or their Designees, unless the research involves agents that fall into RG2 (Risk Group 2) and higher. The convened IBC committee will review these submissions. In the event the IBC reviews the submission and requests modifications from the PI, the revised exempt protocol will be reviewed by an assigned reviewer(s) and approved if all requested modifications have been satisfactorily addressed. The assigned reviewer(s) has/have the right to bring back the revised protocol for Full Committee review at the following convened meeting.
• Submissions (to include New Protocols, Procedural Amendments) should be received at least 2 weeks prior to the scheduled convened meeting. Continuing reports (mid reviews) approximately 18 months from the initial approval should be received at least 30 days prior to the expiration date.
• Personnel Modifications and Closing Reports can be submitted at any time during the three-year approval period.
• If a Closing Report is not submitted within 30 days before the approved project’s expiration date, the project will be considered expired, and the PI will be notified by the ORSP IBC administrator alerting them that no further research cannot be conducted until a new application is approved.
• All submissions must be submitted to ORIC by email at ricibc@txstate.edu to be considered for review.
• The BSO will inform the IBC at each meeting, as applicable, on laboratory safety inspections, laboratory construction/modifications, and spills/incidents.
• ORIC will provide an annual report to NIH which will include the IBC members and biographical sketches for each member. The points of contact regarding questions and information about the IBC, other than Texas Public Information Act (TPIA) requests, are the IBC Chair and/ORIC IBC Coordinator. In the case of a TPIA request, the IBC Chair through the ORIC will notify OSP of any public comments made on IBC activities. All information requested via TPIA request will be provided by ORIC and in compliance with the Texas State Attorney General's Office. 
• The IBC requires that all individuals covered under a new research protocol complete Biosafety training courses through CITI or CANVAS, Protocol specific training including General Laboratory Safety; as well as Biosafety/Bloodborne Pathogens are completed through CANVAS, and the BSO will need to be contacted for access.

• After the Principal Investigator (PI) submits a protocol, the protocol form will be administratively checked by the Research Integrity and Compliance office IBC administrator for completeness. Once an administrative review has been completed one or more of the following may occur:

1. Assigned to the IBC Chair and the BSO for review. If needed an additional IBC member with expertise may be assigned.
2. Protocol will be reviewed at a scheduled meeting of the IBC (occurs monthly), if a quorum is present. The IBC schedule and deadlines are posted on the IBC website for an administrative screening.

• A quorum for IBC meetings is deemed as a majority of the voting members including at least one non-affiliated member of the committee. The IBC can, by majority vote, approve a protocol as is; approve a protocol conditionally; or table a protocol for modifications and further review.
  
  If a PI fails to address any concern by the IBC or fails to provide additional information requested by the IBC after 30 days from the request, then the IBC can take administrative action. (i.e., abandon application)
  
  The IBC promotes compliance with the University policy regarding Conflicts of Interest. IBC member(s) that serve as a Principal Investigator of a protocol that is being reviewed or has a personal or financial interest, must recuse themselves from the vote. This action will be recorded in the meeting minutes. Any protocols involving animals or human subjects will be shared between the IACUC and the IRB, and concurrent approvals will be required. All approved protocols will be active for three-year terms and subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The Principal Investigator will be notified of the IBC's decision via email with a formal letter for all protocols.  

• The PI must immediately report any incidents involving contamination of personnel, research-related illnesses, accidental spills, loss of containment, and violations of the NIH Guidelines to the IBC Chair (phone number or email) and BSO (phone number or email) immediately and must reference the incident in the next continuing report. The IBC Chair and Research Integrity and Compliance office in consultation with the BSO is responsible for reporting significant incidents, violations, and research-related accidents and illnesses involving recombinant DNA to the OSP within thirty (30) days or immediately, depending on the nature of the incident.

PI's are expected to comply with the IBC standards outlined in this Charter. Noncompliance incudes, but is not limited to:

1. Failure to register biohazardous agents, including non-exempt recombinant DNA molecules;
2. Failure to provide the required mid-report and/or other required documentation within 60 days of the specified due date;
3. Poor biological safety/biological containment practices as documented through routine lab inspections; or
4. Failure to correct a documented (confirmed) biological safety complaint or concern.

Noncompliance will be reported to the IBC, which may result in the suspension or termination of all approved IBC protocols.